Generic name: linaclotide 145ug
Dosage form: capsule, gelatin coated
Medically reviewed by Drugs.com. Last updated on Oct 10, 2018.
2.1 Recommended Dosage
Irritable Bowel Syndrome with Constipation (IBS-C)
The recommended dosage of LINZESS is 290 mcg orally once daily.
Chronic Idiopathic Constipation (CIC)
The recommended dosage of LINZESS is 145 mcg orally once daily. A dosage of 72 mcg once daily may be used based on individual presentation or tolerability.
2.2 Preparation and Administration Instructions
- Take LINZESS on an empty stomach, at least 30 minutes prior to the first meal of the day
- If a dose is missed, skip the missed dose and take the next dose at the regular time. Do not take 2 doses at the same time.
- Do not crush or chew LINZESS capsule or capsule contents.
- Swallow LINZESS capsule whole.
- For adult patients with swallowing difficulties, LINZESS capsules can be opened and administered orally in either applesauce or with water or administered with water via a nasogastric or gastrostomy tube. Sprinkling of LINZESS beads on other soft foods or in other liquids has not been tested.
Oral Administration in Applesauce:
- Place one teaspoonful of room-temperature applesauce into a clean container.
- Open the capsule.
- Sprinkle the entire contents (beads) on applesauce.
- Consume the entire contents immediately. Do not chew the beads. Do not store the bead-applesauce mixture for later use.
Oral Administration in Water:
- Pour approximately 30 mL of room-temperature bottled water into a clean cup.
- Open the capsule
- Sprinkle the entire contents (beads) into the water
- Gently swirl beads and water for at least 20 seconds.
- Swallow the entire mixture of beads and water immediately.
- Add another 30 mL of water to any beads remaining in cup, swirl for 20 seconds, and swallow immediately.
- Do not store the bead-water mixture for later use.
Note: The drug is coated on the surface of the beads and will dissolve off the beads into the water. The beads will remain visible and will not dissolve. Therefore, it is not necessary to consume all the beads to deliver the complete dose.
Administration with Water via a Nasogastric or Gastrostomy Tube:
- Open the capsule and empty the beads into a clean container with 30 mL of room-temperature bottled water.
- Mix by gently swirling beads for at least 20 seconds
- Draw-up the beads and water mixture into an appropriately sized catheter-tipped syringe and apply rapid and steady pressure (10 mL/10 seconds) to dispense the syringe contents into the tube.
- Add another 30 mL of water to any beads remaining in the container and repeat the process
- After administering the bead-water mixture, flush nasogastric/ gastrostomy tube with a minimum of 10 mL of water.
Note: It is not necessary to flush all the beads through to deliver the complete dose.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Generic Name: Linaclotide (lin AK loe tide)
Brand Name: Linzess
Medically reviewed by Drugs.com. Last updated on Mar 14, 2020.
Warning
- Do not give to a child younger than 18 years of age. This medicine may cause harm if given to a child. Talk with the doctor.
Uses of Linzess:
- It is used to treat irritable bowel syndrome.
- It is used to treat constipation.
What do I need to tell my doctor BEFORE I take Linzess?
- If you have an allergy to linaclotide or any other part of this medicine (Linzess).
- If you are allergic to this medicine (Linzess); any part of this medicine (Linzess); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you have a bowel block.
This is not a list of all drugs or health problems that interact with this medicine (Linzess).
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (Linzess) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Linzess?
- Tell all of your health care providers that you take this medicine (Linzess). This includes your doctors, nurses, pharmacists, and dentists.
- If you get diarrhea, you will need to make sure to avoid getting dehydrated. Drink plenty of fluids and watch for weight loss. Talk with your doctor.
- Keep this medicine (Linzess) away from children. Children who take this medicine (Linzess) by accident may have very bad side effects, like very bad diarrhea and dehydration. If a child takes this medicine (Linzess) by accident, get medical help right away.
- Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
How is this medicine (Linzess) best taken?
Use this medicine (Linzess) as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Take on an empty stomach.
- Take 30 minutes before the first meal of the day.
- Swallow capsule whole. Do not chew, break, or crush.
- If you have trouble swallowing, you may mix this medicine (Linzess) with applesauce or water. Follow how to mix as you have been told or read the package insert. If you are not sure how to mix this medicine (Linzess), call your doctor or pharmacist.
- If mixed, swallow the mixed drug right away. Do not store for use at a later time.
- Do not chew the mixture.
- Those who have feeding tubes may use this medicine (Linzess). Use as you have been told. Flush the feeding tube after this medicine (Linzess) is given.
What do I do if I miss a dose?
- Skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
See also:
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Black, tarry, or bloody stools.
- Swelling of belly.
- Bloating.
- Sometimes, very bad diarrhea has led to the need to go to the hospital. Call your doctor right away if you have very bad diarrhea or diarrhea that will not go away. Call your doctor right away if you have signs of dehydration like very bad dizziness or passing out, not able to pass urine or change in how much urine is passed, or feeling very tired.
What are some other side effects of Linzess?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at
See also:
If OVERDOSE is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Linzess?
- Store at room temperature.
- Store in the original container. Do not take out the antimoisture cube or packet.
- Keep lid tightly closed.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
Consumer information use
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else’s drugs.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (Linzess) is refilled. If you have any questions about this medicine (Linzess), please talk with the doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
I take it in the morning but can’t really go anywhere before 9am when I take it at 6-7a, I just wondered what happens if you take it at night, does it keep you up all night?
Love the drug, you all are right it is so much better than constipation but sometimes it overworks but if I skip it, I am right back in the same boat. thanks!
Responses (8)
I actually take Linzess between 2:00 am & 3:00 am daily. I get up at 5:00 am and by 5:30 am I am usually in the bathroom. While I am glad to be able to have a bm, it usually is violent diarrhea and I cannot always be guaranteed that by 7:30 am when I am due at work that it will have run its course.
The diarrhea was something I was willing to endure after months of pain and an inability to have any bm whatsoever, which also meant no appetite.
Unfortunately, Linzess has stopped working for me & I now have samples of Amitiza to try for a month.
Thanks for your response, I guess we all have the same dilemma. I agree the problems that come with constipation out weigh the diarrhea but you are right it is hard to be anywhere early. I am sorry it isn’t working for you anymore. I used amitiza years ago but had to pair it with Miralax and it too was violent diarrhea. I used miralax for a while by itself and that is the most natural but it got to where it gave me reflux when I would lay down and eventually just didn’t work for me.Good luck and thanks for sharing.
I have been using Costco Kirkland brand of psyllium husk capsules and love them. No pain, no fear of diarrhea. 3 caplets in the a.m. and 3 at bedtime. Your BM is healthy and normal when you get up in the morning. I use it 2x a day and it’s wonderful!
I was having violent diarrhea also. The dr. Put me on a stranger dose. That took care of the awful symptoms. I know it sounds crazy but ask your dr about it.
I just got out on linzess and been really dizzy lately, was wondering does anybody else have that problem.
I take linzess right before I go to sleep any time from 10 pm and up.. I tried it right before I eat and it would cramp me and not work very well gurgling of water in my stomach. Now that I have switched to before bed time with a glass of water as soon as I wake up I have a bowel movement . I feel more regulated this way. I have also lost weight since I have taken it at night time.
Do you take it on some what of an empty stomach? I would much rather take this at night but I thought that you had to take it on an empty stomach.
I am new to taking a prescription for comstipafion. My doctor prescribed one 145 mg Linzess capsule daily. She told me to take it with my first meal of the day. (I see that this is not usually the prescribing directions). It has worked all right but I do not take it everyday. I am going to start taking it at night on the weekends to see if it works better taking it this way. I really appreciate are your replies. This is a sensitive subject for me, but I appreciate the site and being able “talk” to people who take Linzess and HOW they take it.
I just began linzess and was on the lowest dose- 75mg. No BM for 3 days, upped it to the 145mg (as per drs instructions) and finally had BM within 3 hrs of taking it at 9pm. However after the BM, I have violent diarrhea and then repeated small bouts all night and this morning. Have any of you had this happen? Now my tummy is gurgling and I’m not comfortable. Ugh.
I take it first thing in the morning & it usually makes me go after an hour. And yes it’s violent diarrhea followed my small bouts for hours. I can’t take it every day because of this. I originally started on 290mg but I now take 145 mg.
Can some one please explain to me how to take this at night. like do you not eat for a few hours before taking it? Thanks in advance!!
Hi Krysrey101! I think a person has to “experiment” with the time he/she takes Linzesz. I tried taking it in the morning with my first meal as my doctor directed. This didn’t work. Since many laxatives are taken at night, I decided to take Linzess at night. (I know it is not a laxative). This is how it worked for me. I do. It take this medicine unless I am really constipated terribly. It works all right. I take 145 mg. and have considered taking two of them. (I have take an opioid for years and have chronic constipation). I would say to take your prescribed dose at a different time if it is not working for you at the time you are taking it. That is what worked for me.
Warning: LOL if u take sleep meds and you take it at night prepare yourself and buy yourself some adult diapers
I have been on Linzess 290mg for over a month. Its starts 2 hours once you take it. I tried in the morning at 8am then I started taking it at 8pm 2 hours later I’m in the bathroom it can last up to 3 to 4 hrs. Believe me its midnight I’m still running to the bathroom I might take it as needed from now on. Cause I can not handle it. I hope that will help you out. There is never a good time to take it.
I just started taking this again, my second try at it. First, I took the 290, that caused me to go from one extreme to the other! But, now I’m going to try the middle dose. Thanks for the comments. I think I will start taking when I wake up in the middle of the night to go to the bathroom. Hopefully, it’ll be more effective, somewhat of an empty stomach and maybe it’ll work before I leave for work.
Gain a greater understanding of your condition and LINZESS.
Gain a greater understanding of your condition and LINZESS.
How LINZESS can help
How is LINZESS different from a laxative?
LINZESS was the first approved treatment in a class of drugs that works differently from other available medications. LINZESS acts locally in the intestine and is thought to work in two ways: by helping to calm pain-sensing nerves* and by accelerating bowel movements. LINZESS helps you proactively manage your IBS‑C or CIC symptoms.
*This was seen in animal studies, and the relevance to humans is not known.
Why do I need to take LINZESS daily?
What is the best time of day to take LINZESS?
How do I know if LINZESS is working for me?
Learn about IBS-C and CIC
What is the difference between IBS-C and CIC?
Talking with your doctor
How do I start a conversation with my doctor about my symptoms?
In addition to talking to my doctor, where else can I find information about IBS‑C and CIC?
Side effects
Is it common to experience diarrhea when starting LINZESS?
What should I do if I experience any severe side effects?
Storage tips
Where to keep LINZESS?
LINZESS may provide the relief you need
See how it works.
Could it be more?
Answer 5 quick questions to learn more about the symptoms of IBS-C.
- Do not give LINZESS to children who are less than 6 years of age. It may harm them. LINZESS can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt).
- You should not give LINZESS to children 6 years to less than 18 years of age. It may harm them.
- Do not take LINZESS if a doctor has told you that you have a bowel blockage (intestinal obstruction).
- Pregnant or plan to become pregnant. It is not known if LINZESS will harm your unborn baby.
- Breastfeeding or plan to breastfeed. It is not known if LINZESS passes into your breast milk.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
LINZESS can cause serious side effects, including diarrhea, the most common side effect, which can sometimes be severe. Diarrhea often begins within the first 2 weeks of LINZESS treatment. Stop taking LINZESS and call your doctor right away if you get severe diarrhea during treatment with LINZESS.
Other common side effects of LINZESS include gas, stomach-area (abdominal) pain, swelling, or a feeling of fullness or pressure in your abdomen (distension). Call your doctor or go to the nearest hospital emergency room right away if you develop unusual or severe stomach-area (abdominal) pain, especially if you also have bright red, bloody stools or black stools that look like tar.
These are not all the possible side effects of LINZESS. For more information, ask your doctor or pharmacist.
LINZESS ® (linaclotide) is a prescription medication used in adults to treat irritable bowel syndrome with constipation (IBS‑C) and chronic idiopathic constipation (CIC). “Idiopathic” means the cause of the constipation is unknown. It is not known if LINZESS is safe and effective in children less than 18 years of age.
Allergan ® and its design are trademarks of Allergan, Inc.
Ironwood ® and its three-leaf design are registered trademarks of Ironwood Pharmaceuticals, Inc.
LINZESS ® and its design are registered trademarks of Ironwood Pharmaceuticals, Inc.
From the Gut SM is a service mark of Allergan Sales, LLC.
© 2020 Allergan and Ironwood Pharmaceuticals, Inc. All rights reserved.
The product information provided in this site is intended only for residents of the United States. The products discussed on this site may have different product labeling outside of the United States. The health information described in this site is provided for educational purposes only and is not intended to substitute for discussions with a healthcare provider.
This website uses cookies and other technologies to personalize content and to show you more personalized ads (for example, Google Ads and Facebook) on this and other websites, as well as provide you with social media Read More features on this website (such as, Facebook, Twitter, LinkedIn). By clicking “Accept” you understand that you are directing Allergan to disclose your personal information, including internet tracking data (like cookies and the IP address you used to access this website), to these third parties for the purposes stated above. You can still use this website if you do not click “Accept,” but your experience may be different. For more information, including a list of the categories of third parties to whom we disclose your personal information, please refer to our Allergan California Privacy Policy opens in a new window or for additional options please check your browser’s settings. Read Less
- Do not give LINZESS to children who are less than 6 years of age. It may harm them. LINZESS can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt).
- You should not give LINZESS to children 6 years to less than 18 years of age. It may harm them.
- Do not take LINZESS if a doctor has told you that you have a bowel blockage (intestinal obstruction).
- Pregnant or plan to become pregnant. It is not known if LINZESS will harm your unborn baby.
- Breastfeeding or plan to breastfeed. It is not known if LINZESS passes into your breast milk.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
LINZESS can cause serious side effects, including diarrhea, the most common side effect, which can sometimes be severe. Diarrhea often begins within the first 2 weeks of LINZESS treatment. Stop taking LINZESS and call your doctor right away if you get severe diarrhea during treatment with LINZESS.
Other common side effects of LINZESS include gas, stomach-area (abdominal) pain, swelling, or a feeling of fullness or pressure in your abdomen (distension). Call your doctor or go to the nearest hospital emergency room right away if you develop unusual or severe stomach-area (abdominal) pain, especially if you also have bright red, bloody stools or black stools that look like tar.
These are not all the possible side effects of LINZESS. For more information, ask your doctor or pharmacist.
LINZESS ® (linaclotide) is a prescription medication used in adults to treat irritable bowel syndrome with constipation (IBS‑C) and chronic idiopathic constipation (CIC). “Idiopathic” means the cause of the constipation is unknown. It is not known if LINZESS is safe and effective in children less than 18 years of age.
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Links to other websites are provided as a service to you. Allergan and Ironwood Pharmaceuticals accept no responsibility for the content of other websites.
Generic Name: linaclotide (LIN a KLOE tide)
Brand Names: Linzess
Medically reviewed by Sanjai Sinha, MD. Last updated on Feb 7, 2019.
What is Linzess?
Linzess (linaclotide) works by increasing the secretion of chloride and water in the intestines, which can soften stools and stimulate bowel movements.
Linzess is a prescription medicine used to treat chronic constipation, or chronic irritable bowel syndrome (IBS) in adults who have had constipation as the main symptom. The safety and effectiveness of Linzess has not been established in patients under 18 years of age.
Important information
You should not use Linzess if you have a blockage in your intestines.
Linzess should not be given to a child younger than 6 years old. Linaclotide can cause severe dehydration in a child.
Take Linzess in the morning on an empty stomach, at least 30 minutes before your first meal. Do not crush, chew, break, or open a capsule. Swallow it whole.
Stop using Linzess and call your doctor at once if you have severe or ongoing diarrhea, severe stomach pain, or black, bloody, or tarry stools.
Before taking this medicine
You should not use Linzess if you are allergic to linaclotide, or if you have:
a blockage in your intestines.
Linzess should not be given to a child younger than 6 years old. Linaclotide can cause severe dehydration in a child. Do not give this medicine to any child or teenager without the advice of a doctor.
It is not known whether Linzess will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.
It is not known whether linaclotide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
How should I take Linzess?
Take Linzess exactly as prescribed by your doctor. Follow the directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Take Linzess in the morning on an empty stomach, at least 30 minutes before your first meal.
Do not crush, chew, or break a Linzess capsule. Swallow the capsule whole.
If you cannot swallow the capsule whole, you may open the capsule and sprinkle the medicine into a spoonful of applesauce or bottled water. Swallow the mixture right away without chewing. Do not save it for later use.
Even if you have taken this medicine with applesauce, wait at least 30 minutes before eating a full meal.
If needed, medicine from the Linzess capsule may be given through a nasogastric (NG) or gastronomy tube.
Read all patient information, medication guides, and instruction sheets provided to you. Carefully follow instructions for mixing medicine from the capsule with applesauce or water, or giving the medicine through a feeding tube. Ask your doctor or pharmacist if you have any questions.
It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed. Call your doctor if your symptoms do not improve, or if they get worse while using Linzess.
Store at room temperature away from moisture and heat.
Keep this medicine out of the reach of children. Linzess can cause severe diarrhea and dehydration in a child who accidentally swallows this medicine. Seek emergency medical attention if this happens.
Keep the capsules in their original container, along with the packet of moisture-absorbing preservative that comes with this medicine. Keep the bottle tightly closed when not in use.
Linzess dosing information
Usual Adult Dose for Irritable Bowel Syndrome:
290 mcg orally once a day
Comments:
-Take on an empty stomach, at least 30 minutes prior to the first meal of the day
-Swallow capsules whole; do not break apart or chew
Use: Irritable bowel syndrome with constipation
Usual Adult Dose for Constipation:
145 mcg orally once a day
Comments:
-Take on an empty stomach, at least 30 minutes prior to the first meal of the day
-Swallow capsules whole; do not break apart or chew
Use: Chronic idiopathic constipation
See also:
What happens if I miss a dose?
Skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Linzess?
Follow your doctor’s instructions about any restrictions on food, beverages, or activity.
Linzess side effects
Get emergency medical help if you have any signs of an allergic reaction to Linzess: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Linzess and call your doctor at once if you have:
severe or ongoing diarrhea;
diarrhea with dizziness or a light-headed feeling (like you might pass out);
signs of an electrolyte imbalance – increased thirst or urination, leg cramps, mood changes, confusion, feeling unsteady, irregular heartbeats, fluttering in your chest, muscle weakness or limp feeling;
severe stomach pain; or
black, bloody, or tarry stools.
Common Linzess side effects may include:
bloating or full feeling in your stomach.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also:
What other drugs will affect Linzess?
Other drugs may interact with linaclotide, including prescription, over-the-counter, vitamin, and herbal products. Tell your doctor about all medications you use, and those you start or stop using during your treatment.
See also:
Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Copyright 1996-2020 Cerner Multum, Inc. Version: 4.02.
LINZESS is not a laxative. LINZESS was the first approved treatment in a class of drugs that is thought to work in two ways: by helping to calm pain-sensing nerves † and by accelerating bowel movements. LINZESS helps you proactively manage your symptoms of Irritable Bowel Syndrome with Constipation (IBS‑C) or Chronic Idiopathic Constipation (CIC).
LINZESS is not a laxative. LINZESS was the first approved treatment in a class of drugs that is thought to work in two ways: by helping to calm pain-sensing nerves † and by accelerating bowel movements. LINZESS helps you proactively manage your symptoms of Irritable Bowel Syndrome with Constipation (IBS‑C) or Chronic Idiopathic Constipation (CIC).
† This was seen in animal studies, and the relevance to humans is not known.
What is the best time of day to take LINZESS?
Take LINZESS on an empty stomach, at least 30 minutes before your first meal of the day. Remember to take LINZESS daily, as prescribed by your doctor, to proactively manage your symptoms.
Patient stories
See what people are saying about their experiences with LINZESS.
Save on LINZESS
See how you can save on the #1 prescribed IBS-C/CIC branded treatment.
- Do not give LINZESS to children who are less than 6 years of age. It may harm them. LINZESS can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt).
- You should not give LINZESS to children 6 years to less than 18 years of age. It may harm them.
- Do not take LINZESS if a doctor has told you that you have a bowel blockage (intestinal obstruction).
- Pregnant or plan to become pregnant. It is not known if LINZESS will harm your unborn baby.
- Breastfeeding or plan to breastfeed. It is not known if LINZESS passes into your breast milk.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
LINZESS can cause serious side effects, including diarrhea, the most common side effect, which can sometimes be severe. Diarrhea often begins within the first 2 weeks of LINZESS treatment. Stop taking LINZESS and call your doctor right away if you get severe diarrhea during treatment with LINZESS.
Other common side effects of LINZESS include gas, stomach-area (abdominal) pain, swelling, or a feeling of fullness or pressure in your abdomen (distension). Call your doctor or go to the nearest hospital emergency room right away if you develop unusual or severe stomach-area (abdominal) pain, especially if you also have bright red, bloody stools or black stools that look like tar.
These are not all the possible side effects of LINZESS. For more information, ask your doctor or pharmacist.
LINZESS ® (linaclotide) is a prescription medication used in adults to treat irritable bowel syndrome with constipation (IBS‑C) and chronic idiopathic constipation (CIC). “Idiopathic” means the cause of the constipation is unknown. It is not known if LINZESS is safe and effective in children less than 18 years of age.
Allergan ® and its design are trademarks of Allergan, Inc.
Ironwood ® and its three-leaf design are registered trademarks of Ironwood Pharmaceuticals, Inc.
LINZESS ® and its design are registered trademarks of Ironwood Pharmaceuticals, Inc.
From the Gut SM is a service mark of Allergan Sales, LLC.
© 2020 Allergan and Ironwood Pharmaceuticals, Inc. All rights reserved.
The product information provided in this site is intended only for residents of the United States. The products discussed on this site may have different product labeling outside of the United States. The health information described in this site is provided for educational purposes only and is not intended to substitute for discussions with a healthcare provider.
This website uses cookies and other technologies to personalize content and to show you more personalized ads (for example, Google Ads and Facebook) on this and other websites, as well as provide you with social media Read More features on this website (such as, Facebook, Twitter, LinkedIn). By clicking “Accept” you understand that you are directing Allergan to disclose your personal information, including internet tracking data (like cookies and the IP address you used to access this website), to these third parties for the purposes stated above. You can still use this website if you do not click “Accept,” but your experience may be different. For more information, including a list of the categories of third parties to whom we disclose your personal information, please refer to our Allergan California Privacy Policy opens in a new window or for additional options please check your browser’s settings. Read Less
- Do not give LINZESS to children who are less than 6 years of age. It may harm them. LINZESS can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt).
- You should not give LINZESS to children 6 years to less than 18 years of age. It may harm them.
- Do not take LINZESS if a doctor has told you that you have a bowel blockage (intestinal obstruction).
- Pregnant or plan to become pregnant. It is not known if LINZESS will harm your unborn baby.
- Breastfeeding or plan to breastfeed. It is not known if LINZESS passes into your breast milk.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
LINZESS can cause serious side effects, including diarrhea, the most common side effect, which can sometimes be severe. Diarrhea often begins within the first 2 weeks of LINZESS treatment. Stop taking LINZESS and call your doctor right away if you get severe diarrhea during treatment with LINZESS.
Other common side effects of LINZESS include gas, stomach-area (abdominal) pain, swelling, or a feeling of fullness or pressure in your abdomen (distension). Call your doctor or go to the nearest hospital emergency room right away if you develop unusual or severe stomach-area (abdominal) pain, especially if you also have bright red, bloody stools or black stools that look like tar.
These are not all the possible side effects of LINZESS. For more information, ask your doctor or pharmacist.
LINZESS ® (linaclotide) is a prescription medication used in adults to treat irritable bowel syndrome with constipation (IBS‑C) and chronic idiopathic constipation (CIC). “Idiopathic” means the cause of the constipation is unknown. It is not known if LINZESS is safe and effective in children less than 18 years of age.
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Linaclotide works by increasing the secretion of chloride and water in the intestines, which can soften stools and stimulate bowel movements.
Linaclotide is used to treat chronic constipation, or chronic irritable bowel syndrome (IBS) in people who have had constipation as the main symptom.
Linaclotide may also be used for purposes not listed in this medication guide.
What is Linzess used for?
- Constipation
- Irritable Bowel Syndrome
warnings
What is the most important information I should know about Linzess ?
You should not use linaclotide if you are allergic to it, or if you have:
- a blockage in your intestines.
Linaclotide can cause severe dehydration in a child. Linaclotide should not be given to a child younger than 6 years old. Do not give this medicine to any child or teenager without the advice of a doctor.
It is not known whether linaclotide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.
It is not known whether linaclotide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
User Reviews & Rating
Overall rating for Linzess
Side Effects
What are the side effects of Linzess ?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using linaclotide and call your doctor at once if you have:
- severe or ongoing diarrhea;
- diarrhea with dizziness or a light-headed feeling (like you might pass out);
- signs of an electrolyte imbalance–increased thirst or urination, leg cramps, mood changes, confusion, feeling unsteady, irregular heartbeats, fluttering in your chest, muscle weakness or limp feeling;
- severe stomach pain; or
- black, bloody, or tarry stools.
Common side effects may include:
- diarrhea;
- stomach pain;
- gas; or
- bloating or full feeling in your stomach.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
GENERIC NAME(S): Linaclotide
OTHER NAME(S): Linzess Capsule
This medication is not recommended for use in people younger than 18 years. It may cause harm, especially in children younger than 6 years. Talk to your doctor for details.
See also Warning section.
Linaclotide is used to treat certain types of bowel problems (irritable bowel syndrome with constipation, chronic idiopathic constipation). It works by increasing fluid in your intestines and helping speed up movement of food through the gut. Linaclotide may improve stool texture and lessen symptoms such as bloating, abdominal pain/discomfort, straining, and feelings of incomplete bowel movements.
This medication must not be used in children younger than 6 years because of the risk of serious side effects.
How to use Linzess
Read the Medication Guide provided by your pharmacist before you start taking linaclotide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth on an empty stomach as directed by your doctor, usually once daily at least 30 minutes before your first meal of the day. Swallow the capsules whole. Do not break or chew the capsules.
If you have trouble swallowing the capsule, it may be opened and the contents mixed in a teaspoonful of applesauce. Swallow the mixture right away, without chewing it. Do not save the mixture for future use.
You may also empty the capsule’s content into an ounce (30 milliliters) of water. Swirl the mixture for 20 seconds and drink right away, without chewing it. Add another ounce (30 milliliters) of water to the cup, swirl for 20 seconds and drink right away to get your whole dose. The water mixture may also be given through a tube into the stomach (nasogastric or gastric tube). If you are giving this medication through a tube, ask your health care professional for detailed instructions on how to give it.
The dosage is based on your medical condition and response to treatment.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
Tell your doctor if your condition does not improve or if it worsens.
Related Links
Side Effects
Diarrhea, bloating, gas, or stomach/abdominal pain/discomfort may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Stop taking this medication and tell your doctor right away if you have any serious side effects, including: severe diarrhea.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
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Precautions
Before taking linaclotide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal blockage.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Known generically as linaclotide, this is effective for IBS-C and CIC
Emmy Ludwig, MD, is board-certified in gastroenterology and hepatology. She practices at the Memorial Sloan-Kettering Cancer Center in New York.
Constipation can be easy to joke about, but of course not being able to comfortably pass a bowel movement is no laughing matter. And while there are lots of potential causes of constipation (eating too little fiber, taking certain medications, lack of fluids), in most cases the condition is temporary and is easy to deal with by changing the diet, getting more exercise, or taking over-the-counter laxatives or stool softeners.
But for some folks, constipation can be a bigger problem—one that requires more aggressive treatment. That’s where the prescription medication Linzess (linaclotide) comes in. (In Europe, linaclotide is sold under the brand name Costella.) It’s used to treat people with a subtype of irritable bowel syndrome (IBS) who have constipation along with stomach pain, cramps, and bloating. It’s often referred to as constipation-predominant irritable bowel syndrome (IBS-C).
Linzess also is used to treat chronic idiopathic constipation (CIC), which the National Institutes of Health defines as “difficult or infrequent passage of stools that lasts for three months or longer and is not caused by a disease or medication.” If you’re dealing with either IBS-C or CIC and your doctor prescribes Linzess for you, here’s what you need to know about how the drug helps relieve constipation and more.
How Linzess Works
Linzess is characterized as a “peptide agonist of guanylate cyclase-C receptors.” This means the medication stimulates specific receptor cells within the digestive tract to increase the flow of fluid into the intestines.
This action is thought to speed up the rate at which the colon contracts and to reduce the amount of pain a person feels within the abdomen and digestive tract, what’s known as “visceral hypersensitivity.” Because Linzess is believed to work “locally,” within the small and large intestine, there’s a little risk that it will cause unwanted side effects, such as mild to moderate diarrhea.
The Effectiveness
Research shows Linzess works really well. For example, in clinical studies, compared to people taking a placebo, those taking Linzess were more likely to experience:
- An increase in the number of bowel movements
- Improved stool consistency
- Less straining
- Less abdominal pain and discomfort
- Decrease in bloating
What’s more, the drug works quickly once a person starts taking and is effective for as long as she’s on it.
How to Take Linzess
Linzess comes as a capsule. It’s easy to take: Swallow the capsule whole (don’t crush it up, for example, because this will affect the rate at which your body absorbs it) and, unless your doctor tells you otherwise, take it at the same time every day, on an empty stomach, no less than a half-hour before your first meal of the day. So for instance, if you normally have breakfast around 8 a.m., take your Linzess capsule before 7:30.
One more precaution: Even though Linzess is a safe and effective medication for most people, it may not be a good idea for women who are pregnant or nursing a baby to take it. Make sure your doctor knows if you’re expecting or breastfeeding if he says he wants to prescribe Linzess for you. Otherwise, know that once you start taking the drug, you may start feeling better within a week or so.
Effective treatment with LINZESS starts with adherence
Irritable Bowel Syndrome with Constipation (IBS-C) and Chronic Idiopathic Constipation (CIC) are chronic conditions that require ongoing treatment. Taken once daily, LINZESS can help patients experience relief in as little as one week. However, if patients do not continue to take their medicine as prescribed, symptoms could return just as fast. 1,4
Follow the tips below to help manage your patients’ expectations about treatment with LINZESS and help them continue to take the medicine as prescribed.
Once a day, every day
Remind patients to take one capsule of LINZESS every day. 1
Same treatment, same time
Because patients are instructed to take one capsule a day on an empty stomach, suggest that they take it 30 minutes before breakfast every day 1
Stay on top of refills
Encourage your patients to fill their LINZESS prescription right away. You may also want to suggest that they sign up for refill reminders through their pharmacy.
Set the clock
Suggest that patients set a daily alarm on their phone reminding them when to take their pill.
Store and more
Tell patients to keep LINZESS in a convenient place. However, it is important to store LINZESS, with the dessicant, in its original bottle. The bottle should be kept tightly closed in a dry location. Additionally, patients must keep LINZESS out of the reach of children. 1
Setting expectations
Let patients know that diarrhea often begins within the first 2 weeks of LINZESS treatment. Diarrhea is the most common side effect of LINZESS and can sometimes be severe. Advise patients to stop taking LINZESS and call you right away if they get severe diarrhea during treatment with LINZESS. 1
Skip what was missed
Remind patients that if they miss a dose, they should skip the missed dose and take the next dose at their regular time. Patients should not take 2 doses at the same time 1
Gut check
Encourage patients to keep track of how they are feeling and talk to you about how LINZESS is working for them. The more they tell you, the better you will understand how to manage their IBS-C or CIC symptoms.
blood pressure is up and down even when I take my medicine. Also I take Xanax daily.Please tell me . Hi I have been on linzess for two weeks the last few days I have been very sick I have had. View answer
Can Linzess be taken at night?
I am 91 years old with ibs – constipation . I take 290 linzess each morning and then wait 30 . take the linzess at bedtime? . View answer
Can Linzess cause hair loss?
Can taking lizness cause hair loss? . View answer
Suggest treatment for constipation due to Linzess
I am taking 290 mcg of Linzess a day for constipation caused by psychiatric drugs. The problem . Is this possible? When will the diarrhea go away? I know the Linzess causes diarrhea as a side. View answer
What are the side effects of taking double dosage of Linzess?
I took twice the recommended dosage of linzess by mistake (580 mcg instead of 290). What are the possible side effects of this? . View answer
Public Forum Discussions
Is it fine to take Linzess in the evening?
I just started taking Linzess over the week end. I didn t take this a.m. because of work . home from work before eating anything. Is it OK to take it at this time of day? . View answer
Is Linzess safe for urinary problem?
with no result. The urinary problems are back. Should I continue to take Linzess even though it is not working . My doc prescribed Linzess to elevate a problem being unable to urinate which he. View answer
What are the side effects of Linzess when taken after food?
I took linzess for the first time this evening but did not realize it should be taken on an empty stomach. I ate my dinner about 2 hours ago. Does this mean Linzess will not work? What sid effects will. View answer
How long should Linzess be taken for treatment of constipation?
a colonopsy. It finally broke loose. Dr sent me prescription for linzess and says take at least 30 min before . constapation all my live even when younger and very active playing ball Etc. Thank. View answer
Is Linzess safe to take at night?
I have been plaqued with IBS-C my entire life. The past three months I have been using Linzess 145 . question is can I take this med at night? Reason being, sometimes it works just before I have to leave . View answer
Mobile Questions and Answers
Can I use linzess and miralax or other over the counter constipation med together
hello, as such both can be used in constipation , linzess is a a dug used in pathological constipation like irritable bowl syndrome, ulcerative colitis. where as miralax is a osmotic laxative it holds water in.
dx with IBS-C. Hysterectomy year ago. Now I can not have BM without dulcolax. I take linzess qd. Severe cramps, pressure, in abd.
Better to get done ultrasound examination of abdomen to rule out internal cause of constipation like adhesion, obstruction etc. Take plenty of fluids and high fiber diet. Please hit thanks.
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How often do l take Linzess for constipation? Do l stop taking it ater a bowel movement
Doctor’s Assistant: Have you seen a doctor about this yet? What medications are you taking?
Yes, but he did not explain usage. I have Parkinson’s
Doctor’s Assistant: Anything else in your medical history you think the doctor should know?
L am taking sentiment
Hello I’m Dr Chip
The dosage for Linzess for constipation is 290 mcgm taken 30 minutes before your first meal of the day every day. It’s meant to be taken every day whether or not you have a bowel movement daily
Please let me know if you need any more information
Yes–it’s fine to take it every third day if that relieves your constipation
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Linzess (linaclotide), a medication for irritable bowel syndrome (IBS) with constipation or chronic idiopathic constipation is now available in American pharmacies, Ironwood Pharmaceuticals Inc. and Forest Laboratories Inc announced.
The FDA (Food and Drug Administration) recently approved the once-daily oral capsule, Linzess, for adults of either sex who suffer from IBS-C (IBS with constipation) or CIC (chronic idiopathic constipation).
Linaclotide is the only FDA-approved GC-C (guanylate cyclase-C) agonist that acts locally in the gut. Ironwood Pharmaceuticals says this is the first new prescription option for adults with these disorders in over six years.
Linzess (linaclotide) is the “first and only guanylate cyclase‐C (GC‐C) agonist approved by the FDA for the treatment of both irritable bowel syndrome with constipation (IBS‐C) and chronic idiopathic constipation (CIC) in adults”, according to Ironwood Pharmaceuticals.
Linzess is taken orally, in capsule form, once a day. It helps relieve the pain and constipation linked to IBS-C and constipation and hard stools experienced by patients with CIC.
The recommended doses are:
- 290 mcg for IBS‐C patients
- 145 mcg for CIC patients
You should take Linzess at least thirty minutes before breakfast (or your first meal of the day).
Scientists believe Linzess works in two ways “Linzess binds to the GC‐C receptor locally, within the intestinal epithelium. Activation of GC‐C results in increased intestinal fluid secretion and transit and a reduction in visceral pain, which is thought to be mediated by decreased activity of pain‐sensing nerves. The clinical relevance of the effect on pain fibers in nonclinical studies has not been established.”
In randomized, placebo-controlled Phase III human studies involving over 2,800 adults, Linzess was shown to alleviate abdominal pain in patients with IBS-C, as well as increasing bowel movement frequency among those with CIC and IBS-C.
Abdominal pain relief was reported during the first week of treatment and was maintained during the whole of the 12-week treatment period. Maximum effect on constipation was seen during week two, and on abdominal pain at weeks 6 to 9.
A subset of patients who had been on Linzess were switched over to placebo during the trial. They reported that their symptoms went back to pretreatment levels within seven days. Some placebo patients were switched over to Linzess and reported improvements soon after taking the medication.
Linzess should not be taken by patients up to the age of six years. The medication should be avoided in patients aged from 6 to 17 years. Animal studies showed that a clinically relevant adult dose of linaclotide caused deaths in juvenile mice. No trials have been carried out on children. The most commonly reported side effect associated with Linzess treatment was diarrhea.
Linzess is being co-promoted by Ironwood and Forest in the USA. Linaclotide, which was also approved in the European Union, will be marketed under the brand name Constella through a licence agreement between Ironwood and Almirall S.A. The development and commercialization in Japan and other Asian markets will be done via agreements between Ironwood and Astellas Pharma Inc. and AstraZeneca.
Up to 13 million people are thought to have irritable bowel syndrome with constipation (IBS‐C) in the USA. It is a chronic functional gastrointestinal disorder. IBS‐C symptoms can be severe enough to seriously undermine a patient’s ability to properly carry out daily living duties.
Patients typically suffer recurring abdominal discomfort or pain, constipation, hard or lumpy stools in over 25% of their bowel movements, and soft/watery stools in less than 25%.
Ironwood says there are very few approved therapies for IBS‐C available today.
CIC (chronic idiopathic constipation) is thought to affect up to 35 million Americans today. It is a functional gastrointestinal disorder in which the sufferer has fewer than three bowel movements each week for at least three months.
CIC patients may also have a sensation of incomplete evacuation after going to the toilet, as well as hard stools.
I take Linzess 145 everyday. Had bowel movements everyday also. Good bowel movements too. I have IBS and linzess has been good for me to use! But today l have not passed anything with this. Is this the normal thing from time to time?? Any help will be appreciated too! I have had every test. scope 2 1/2 ago. Ct Scan recently. Nothing there! I have drank tons of water too. Thanks for any help!
I am kind of surprised that you are on the 145mg. I was under the impression that they used the 290 mg for IBS patients. Maybe you just need more. Although I am on the 290 and I can go four or five days and not go. So it is not really helping me that much.
Thank you Mapleleaf17. I was but my doctor put me on meta mucel but it was giving me so much gas problems.. She said just go back on the linzess. She was under the impression l was on the 290 also. But l did tell her l started back on the 145 because l had samples this time. But the new linzess 290 finally came in because l ran out of the 290. I will pick this up tomorrow. The 145 was doing great until today and seem to be milder on the stomach for me. Thank you so much for asking and letting me know what you experience from time to time. I do try to eat better and seems like when l do a little more eating things like this happen. Then l go hysterical and l don’t know why because it has been something else with these bowel movements with IBS. l was so over joyed with the 145 working so good! Thanks Again Mapleleaf very much!
I am based in the UK and have never heard of Linzess 145 before.
Do you mind me asking how you found out about this product (i.e: via GP, gastro specialist,etc.)??
Also do you use it just to help regulate your bowel movements of for pain relief purposes?
I have been diagnosed with IBS, though mine is sometimes “mixed”, I could say it has more of an inclination towards IBS-C type. However, in my case, the worst symptom is the mostly daily lower abdominal pain, which is incapacitating.
Thankful for your feedback/advice
Side Effects News & Reports
April 28, 2016
Possible Linzess Recall By FDA Suggested By Phase Five Research Analyst Report, Which Has Become A Bit Of A Mystery
Here Are Some Of The “Findings” From An April 26, 2016 Document Which Seems To Have Disappeared Only Two Days Later
In a citizen’s petition to the FDA, Synergy Pharmaceuticals urged the FDA to require a revision of the approved package insert of Ironwood Pharmaceutical’s irritable bowel syndrome medication Linzess (linaclotide).
Synergy claimed the Linzess package insert fails to provide adequate information for its use because the incidences of adverse effects in its clinical trials are unclear or misrepresented.
(3/2/18)
(6/9/16)
This morning (4/28/16) my interest was easily piqued by this Google Alert:
Uncovered: Safety Issues Linked With Ironwood’s Drug, Linzess
Seeking Alpha
Ironwood’s constipation drug, Linzess, is a primary suspect in at least 7 deaths, 85 hospitalizations, 16 disabilities, all in just 3 years since its launch in .
When I clicked through to that article on the Seeking Alpha website, however, I found this notification (accessed 4/28/16, 10:10 am New York time):
- This article has been removed at the request of the author.
Intrigued, I put that article title into a search engine and quickly found online this 65-page PDF document: “Uncovered: fatal safety issues linked with Ironwood’s drug, Linzess” (accessed 4/28/16, 10:15 am New York time). A little while later I decided it might be prudent to “Save” this PDF file given what I had read on the Seeking Alpha site earlier.
And I am sure glad I did so — because when I started to write this article at about 4:00 pm and tried to access the online PDF version of this April 26, 2016 Phase Five Research analyst report about Linzess, I saw that it was no longer available at the URL where I found it this morning (but perhaps it will be available when you read this article).
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With that background and/or caveat, I want to share with you some of what I found in this analyst report — as it appeared online this morning — which information suggests that there might be an FDA recall of Linzess for safety reasons.
Executive summary
- [Ironwood (IRWD)’s] constipation drug, Linzess, is causing severe and fatal adverse events – Our research has uncovered Linzess (linaclotide) to be the primary suspect in at least 7 deaths, 85 hospitalizations, 16 disabilities and 10 cases of adverse events which required intervention, all in just 3 years since its launch in 2013. Backed by FDA case files, we believe that the findings outlined in this report will lead to the removal of Linzess from the market. We have been in discussion with the FDA’s Division of Gastroenterology and Inborn Errors Products representatives and shared our findings with them .
- Linzess is the most dangerous drug among Irritable Bowel Syndrome (IBS) and Chronic Idiopathic Constipation (CIC) Drugs – According to the evidence we have gathered, Linzess is by far the most harmful drug among any other IBS and CIC drug across any parameter, including all serious outcomes. In fact, our research indicates that Linzess carries a substantially greater risk even when compared to Lotronex, an IBS drug that was taken off the market in 2000 due to severe safety concerns after causing deaths, dozens of hospitalizations, bowel surgeries and disabilities.
- Contrary to IRWD’s claims, Linzess’s side effects are not limited to the gastrointestinal (GI) tract – We present evidence that Linzess is causing previously unknown, unreported and unlabeled severe systemic adverse events, including documented cases of rapid weight gain, renal failure, seizures and strokes . Since IRWD states that Linzess is confined to the GI tract in its mechanism of action, such systemic adverse events were unexpected, and likely remained undetected in the post-market setting. [Note: bolded text and color per the original document; footnotes omitted]
Be assured I will be watching for more developments concerning this April 26, 2016 Phase Five Research analyst report about Linzess.
If you happen to know or learn anything about the circumstances of this rather mysterious analyst report, please share it with us by posting a Comment below. (Or, if you prefer, you can use the Email Me link in the right sidebar of this Drug Injury Watch blog.)
Linzess (linaclotide) was approved by the FDA in 2012 for irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation.
What, if anything, do you think will the FDA do next as regards Linzess?
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Tags: adverse events, analyst report, drug injury, drug recall, FDA, Linzess, Phase Five Research, renal failure, safey issues, seizures, side effects, strokes
What is linaclotide (Linzess)? What is linaclotide used for?
Linaclotide is an oral medication for the treatment of constipation. It is the first in a new class of drugs called guanylate cyclase-C agonists. It is used for relieving symptoms of irritable bowel syndrome (IBS) with constipation and for treating chronic constipation of unknown cause (idiopathic constipation).
Linaclotide works locally in the intestine (it is not absorbed into the body) to increase bowel movements and reduce pain. Linaclotide’s effects are due to an increase in the production of a chemical called cyclic guanosine monophosphate which increases fluid secretion into the intestine and reduces the sensitivity of pain-sensing nerves. The FDA approved linaclotide in August 2012.
What brand names are available for linaclotide (Linzess)?
Is linaclotide (Linzess) available as a generic drug?
Do I need a prescription for linaclotide (Linzess)?
What are the side effects of linaclotide (Linzess)?
The most common side effects of linaclotide are:
Linaclotide should be stopped if patients develop severe diarrhea. Other important side effects include:
Rarely, patients may experience passage of blood from the rectum.
What is the dosage for linaclotide (Linzess)?
The dose for treating IBS with constipation is 290 mcg once daily, and the dose for treating chronic idiopathic constipation is 145 mcg once daily. Linaclotide should be taken on an empty stomach at least 30 minutes before the first meal of the day.
Which drugs or supplements interact with linaclotide (Linzess)?
Drug interaction studies have not been conducted.
QUESTION
Is linaclotide (Linzess) safe to take if I’m pregnant or breastfeeding?
Linaclotide has not been adequately evaluated in pregnant women.
It is not known whether linaclotide is excreted in human milk. It is unlikely that linaclotide is excreted in breast milk because it is poorly absorbed and therefore undetectable in blood at recommended doses.
What else should I know about linaclotide (Linzess)?
What preparations of linaclotide (Linzess) are available?
Capsules: 145 and 290 mcg
How should I keep linaclotide (Linzess) stored?
Linaclotide should be stored at room temperature, 15 C to 30 C (59 F to 86 F). It should be kept in the original container and protected from moisture. The dessicant (drying agent) should not be removed from the container.
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Summary
Linaclotide (Linzess) is a guanylate cyclase-C agnoist drug prescribed for the relief of symptoms of irritable bowel syndrome with constipation and for the treatment of chronic constipation of unknown cause. Side effects, drug interactions, dosage, and pregnancy safety information should be reviewed prior to taking this medication.
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Related Disease Conditions
Irritable Bowel Syndrome (IBS)
Irritable bowel syndrome (IBS) is a GI (gastrointestinal) disorder with signs and symptoms that include abdominal pain, bloating, increased gas (flatulence), abdominal cramping, diarrhea, constipation, and food intolerance.Two new tests are now available that may help diagnose irritable bowel syndrome with diarrhea and constipation (IBS-M) irritable bowel syndrome with diarrhea (IBS-D), and irritable bowel syndrome with constipation (IBS-C). Treatment for IBS includes diet changes, medications, and other lifestyle changes to manage symptoms.
Constipation
Constipation is defined medically as fewer than three stools per week and severe constipation as less than one stool per week. Constipation usually is caused by the slow movement of stool through the colon. There are many causes of constipation including medications, poor bowel habits, low fiber diets, laxative abuse, and hormonal disorders, and diseases primarily of other parts of the body that also affect the colon.
IBS-D (Irritable Bowel Syndrome with Diarrhea)
IBS-D or irritable bowel syndrome with diarrhea refers to IBS with diarrhea. Symptoms of IBS-D include intestinal gas (flatulence), loose stools, frequent stools, abdominal pain, diarrhea, and nausea. New non-FDA approved IBS tests may help diagnose IBS and IBS-D. Treatment of IBS-D is geared to toward managing symptoms with diet, medication, and lifestyle changes.
IBS Triggers (Prevention)
Irritable bowel syndrome (IBS) is a functional disease that can affect the quality of those who suffer from this condition. People with IBS can make lifestyle changes that may modify or control the number and severity of episodes. Certain foods, medications, and hormone levels may trigger IBS episodes, for example fatty foods, dairy products, eating foods in large quantities, foods that contain high levels of sorbitol, foods that produce intestinal gas (broccoli, onions, cabbage, and beans), chocolate, caffeine, physiological stress, some antibiotics, some antidepressants, medicine with sorbitol, and menstrual pain. Exercise, diet, and other lifestyle changes can decrease IBS flares, and prevent the number and severity of IBS episodes of diarrhea and constipation.
#1 Displaced
I’ve been on Linzess for about six months. I’ve had IBS for years and tried lots of things: Miralax, fiber supplements of various kinds, probiotics, Amitiza, Linzess once before at a higher dose (started at 72 mcg this time). Nothing really solves all my problems, unfortunately. It’s hard to sort out what, if anything, is going on: is the Linzess causing side effects such as a lot of abdominal discomfort and nausea? Or is my IBS just getting worse? Am I overly stressed out BECAUSE I’m worried about IBS and what the drug is or isn’t doing, thus aggravating the IBS? All of the above? Probably no one can answer that. All I can say is that I feel miserable, although in different ways, almost every day and often have trouble sleeping, which also isn’t good for one’s health. Since I began taking Linzess reluctantly, based on a very negative experience with a higher dose, perhaps I set myself up to fail and have been looking for an excuse to stop. However, if diarrhea about half the days of the week, usually leaving me nauseous and tired, and no activity the other days, also often causing discomfort and frequent insomnia, is considering an “effective” treatment, then I don’t want to continue. I’m not likely to find some “miracle cure,” but perhaps either temporarily or permanently stopping Linzess will make things a little better. Should I just go cold turkey and stop completely or taper off? For about a month I’ve been alternating 72mcg and 145 mcg doses, since my doctor thought that might make things better. If anything, I feel worse, although I can’t discount the psychological aspect of expecting bad results and then getting them. I might consider going back to just the lower dose for a while, then if that doesn’t help stopping altogether. Any advice on stopping this medication?
#2 annie7
- Country: United States
if linzess isn’t helping you and is making you miserable, just stop it cold turkey. that’s what i did. or just stay with the 72 mcg if you feel that was helping you somewhat and see how that goes.
why don’t you give trulance a try. a number of people have had success with it. it doesn’t cause as much D as linzess does.
good luck. hope you can find some relief.
these are just my own thoughts. for expert medical advice please contact a health care professional.
#3 flossy
Very Prolific Member
- Country: United States
I’d order some of this, which I recommended to you before:
. And as soon as you get it? Start to ween off the Linzess – or – just stop the Linzess altogether and try I.F. right from the get-go.
If you order some? I would get the I.F. # 1 and also the I.F. # 1 maximum strength together.
Good luck & keep us posted!
#4 sjw596
- Country: United States
You can review my history here: “ tarted-amitiza/” In sum,. Linzess was great for about 1.5 years. When it abruptly quit, I was taking the 290 mcg dose. Amitiza never really worked at all.
I’ve tried them all, and still am taking Trulance since September. I found that taking it upon getting up in the morning worked best, always within 2.5 hours after breakfast. Of late, I’m finding that Trulance also may be diminishing in effectiveness, also rather abruptly. My GI said that supplementing the Trulance with Miralax is fine, particularly as I drink tons of liquids. I may try to supplement with milk of magnesia, instead. I’m hoping that the Trulance will get going again soon. Even when Linzess was working, I had brief spells when it seemed to stop, before it actually did. I haven’t heard any explanations of why these drugs may stop so suddenly.
Brand Name Choices
Generic Choices
No generic medication is available for Linzess (Linaclotide)
What Linzess is and what it is used for
What Constella is used for Constella contains the active substance linaclotide. It is used to treat the symptoms of moderate to severe irritable bowel syndrome (often just called “IBS”) with constipation in adult patients. IBS is a common gut disorder. The main symptoms of IBS with constipation include:
• stomach or abdominal pain,
• feeling bloated,
• infrequent, hard, small or pellet-like stools (faeces). These symptoms may vary from person to person. How Constella works Constella acts locally in your gut, helping you to feel less pain and less bloated, and to restore the normal functioning of your bowels. It is not absorbed into the body, but attaches to receptor called guanylate cyclase C on the surface of your gut. By attaching to this receptor, it blocks the sensation of pain and allows liquid to enter from the body into the gut, thereby loosening the stools and increasing your bowel movements.
How to take Linzess
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one capsule (i.e. 290 micrograms of linaclotide) taken orally once a day. The capsule should be taken at least 30 minutes before a meal. 3 If you have not experienced improvement in your symptoms after 4 weeks of treatment, you should contact your doctor. If you take more Constella than you should The most likely effect of taking too much Constella is diarrhoea. Contact your doctor or pharmacist if you have taken too much of this medicine. If you forget to take Constella Do not take a double dose to make up for a forgotten dose. Just take the next dose at the scheduled time and continue as normal. If you stop taking Constella It is preferable to discuss stopping treatment with your doctor before actually doing so. However, treatment with Constella can be safely stopped at any time. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (may affect more than 1 in 10 people):
• diarrhoea Diarrhoea is normally short lived; however, if you experience severe or prolonged diarrhoea (passing frequent or watery stools for 7 days or more) and feel lightheaded, dizzy or faint, stop taking Constella and contact your doctor.
Common side effects (may affect up to 1 in 10 people):
• stomach or abdominal pain
• feeling bloated
• wind
• stomach flu (viral gastroenteritis)
• feeling dizzy
Uncommon side effects (may affect up to 1 in 100 people):
• lack of control over passing stools (faecal incontinence)
• urgency to pass stools
• feeling lightheaded after standing up quickly
• dehydration
• low level of potassium in your blood
• decreased appetite
• rectal bleeding
• bleeding from the bowel or rectum including bleeding from piles/haemorrhoids
• nausea
• vomiting
Rare side effects (may affect up to 1 in 1,000 people):
• bicarbonate decrease in your blood Side effects with frequency not known (frequency cannot be estimated from the available data): 4
• Rash
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme, Website: Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL
•Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: e-mail: [email protected]
How to Store Linzess
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and the bottle after ¨EXP¨. The expiry date refers to the last day of that month. Once the bottle is opened, the capsules should be used within 18-weeks. Do not store above 30ºC. Keep the bottle tightly closed in order to protect from moisture. Warning: The bottle contains one or more sealed canisters containing silica gel to keep the capsules dry. Keep the canisters in the bottle. Do not swallow them. Do not use this medicine if you notice any signs of damage to the bottle or any change in the appearance of the capsules. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment
How Does Linzess Work For Constipation
Linzess is used to treat Irritable Bowel Syndrome with Constipation and Chronic Idiopathic Constipation
How Linzess works?
Linzess works on a body by increasing the secretion of both chlorine and water in the intestine. This, therefore, smoothens stools and helps to accelerate bowel movements. Linzess is FDA is appropriate to treat IBS‑C condition in both men and women.
How should one take Linzess?
Take the medicine as prescribed by your doctor by following the prescriptions given on the label. If you cannot swallow the capsule then it is advised to break it open and squeeze the medicine out of it. Then mix it with a spoonful of water and swallow it directly. Most importantly, never store or preserve the medicine for later use.
Purpose of linzess Constipation:
Linzess is used to treat some type of bowel problems or constipation. People suffering from these issues can use this capsule that works by increasing fluid intestine. And it will even speed up the movement of food through the gut.
Precautions:
- People suffering from intestine blockage should not use Linzess
- It should not be used by children below 6 years as it causes dehydration.
- The medicine should be taken early in the morning with an empty stomach or half an hour before the first meal.
- If you are feeling discomfort, stomach pain, bloody or tarry stools then it’s better to consult the doctor immediately.
- People allergic to linaclotide should avoid using linzess.
- Store the medicine at room temperature away from heat.
Linzess Constipation dosing information
- Usual Adult Dose for Irritable Bowel Syndrome: 290 mcg orally once a day
- Usual Adult Dose for Constipation: 145 mcg orally once a day
It is also recommended to always consult with a doctor if issue even then persist. There are many best hospitals in the US.
Read user comments about the side effects, benefits, and effectiveness of Linzess oral.
Overall User Ratings
Current Rating: 0
Current Rating: 0
Current Rating: 0
User Reviews
Reviewer: 55-64 Female on Treatment for less than 1 month (Patient)
Current Rating: 1
Current Rating: 1
Current Rating: 1
Comment:
The first two days using Linzess- explosion bowel movements, day 3-7 no bowel movements at all. I am disappointed in this treatment. Drug is not effective for me at all.
Comment:
The first two days using Linzess- explosion bowel movements, day 3-7 no bowel movements at all. I am disappointed in this treatment. Drug is not effective for me at all.
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1 person found this review helpful.
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Reviewer: 35-44 Female on Treatment for 6 months to less than 1 year (Patient)
Current Rating: 5
Current Rating: 5
Current Rating: 5
Comment:
I have been taking Linzess for 9 months. As far as I am concerned, it is a miracle medication. I have been dealing with IBS-C for 18 years. I used to take Zelnorm until it was discontinued, but that only treated the horrible belly pain. To regulate my bowels I would take daily probiotics, intermittent laxatives, daily fiber supplements, a morning spinach/fruit smoothie, one meal with beans, an . Show Full Comment
Comment:
I have been taking Linzess for 9 months. As far as I am concerned, it is a miracle medication. I have been dealing with IBS-C for 18 years. I used to take Zelnorm until it was discontinued, but that only treated the horrible belly pain. To regulate my bowels I would take daily probiotics, intermittent laxatives, daily fiber supplements, a morning spinach/fruit smoothie, one meal with beans, and I would still only have 2-3 bowel movements a week. Since day one of starting Linzess, I have daily bowel movements and I have stopped taking the extra supplements and can eat well balanced meals instead of overdoing the fiber. It has changed my life.
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1 person found this review helpful.
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Reviewer: 25-34 on Treatment for 1 to less than 2 years (Patient)
Current Rating: 5
Current Rating: 5
Current Rating: 5
Comment:
While I know that Linzess doesn’t work for everyone, or works differently for others, I will tell you about my experience. I’ve been cursed with constipation since I was about 6 (I’m 28 now). In college I was on Adderall and had no problem being regular. But that stuff is deadly and I got off the medication only to find the “safer” meds actually worsened my IBS. I went to a g . Show Full Comment
Comment:
While I know that Linzess doesn’t work for everyone, or works differently for others, I will tell you about my experience. I’ve been cursed with constipation since I was about 6 (I’m 28 now). In college I was on Adderall and had no problem being regular. But that stuff is deadly and I got off the medication only to find the “safer” meds actually worsened my IBS. I went to a gastroenterologist and got a colonoscopy at the age of 26 and a script of Linzess. Linzess has been a godsend. Yeah, you’d better be near a toilet after taking it and better cancel all plans for the night but I promise if you suffer the same as me, its well worth it. I was instructed to take it in the morning on an empty stomach but when I got to work, all bets were off. So I learned it was best (for me, everyone is different) to take it when I got home, or on the days I didn’t have to work. Also, drinking alcohol can cancel out the effectiveness of Linzess (again, JUST my personal experience) Basically if you take this medication you should 1)be at home with nowhere you need to be 2)have plenty of toilet paper 3)prepare for uncontrollable urges to poop. and finally 4)it WILL be liquid and that is OK.
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3 people found this review helpful.
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Reviewer: Jameson , 45-54 on Treatment for 1 to 6 months (Patient)
Current Rating: 1
Current Rating: 1
Current Rating: 1
Comment:
I took this medication for a number of month. It gives you pass alotta gas. Also it will make you use the bathroom. But you still feel bloated and didn’t seem to be clean me out. In comparison to my food intake. I discontinue and now usin Laculose Solution USP. Which I Love..
Comment:
I took this medication for a number of month. It gives you pass alotta gas. Also it will make you use the bathroom. But you still feel bloated and didn’t seem to be clean me out. In comparison to my food intake. I discontinue and now usin Laculose Solution USP. Which I Love..
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1 person found this review helpful.
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Reviewer: Pat, 65-74 Female on Treatment for less than 1 month (Patient)
Guest over a year ago
I’ve been suffering from irritable bowel syndrome for 4 years now, and ever since I was diagnosed all I ever used for treatment was Metamucil and even with cutting off milk and dairy completely out of my diet and watching out after everything I eat. Since IBS started I haven’t been able to gain any weight, instead I was losing it when the symptoms would be at their worst. So when my doctor suggested I try the new medication Linzess that’s been effective in eliminating IBS symptoms and is used only for that purpose, I really hoped it will work.
And I can’t say Linzess doesn’t work, but I’m having some pretty big problems while using it. When I use a larger dose, the diarrhea I get can last for hours. I’ve been taking it for 5 days now, and I’ve lost weight, I’m exhausted and tired and what’s worse, bloating and gas pains still come back at night.
Nikols169605 over a year ago
since you’re suffering from IBS I’m sure you’re aware that prolonged diarrhea could lead to severe dehydration, which will then start to cause you even more problems – headache, tiredness, dizziness. all those are the symptoms of dehydration. If you can’t eat and drink properly because everything gets expelled immediately, you’re not getting nutrients and electrolytes your organs need to function normally. I can’t say how tough your IBS symptoms were before this, but it sounds to me more like you’re having some relief with this medication, accompanied by quite severe side effects. I think you should talk both to your pharmacist and your doctor about this – it definitely sounds like your medication dosage needs to be lower, or if it doesn’t help with the IVBS symptoms at all – then there’s little point in taking it
Wish you all the best,
Guest over a year ago
AbbNor339199 over a year ago
Guest over a year ago
Guest over a year ago
Hi, I started taking Linzess 145mcg about 3 weeks ago and it has worked well for me. My Dr recommend that I take it right before bed away from meals and that has seem to work great. I have taken it twice close to meals and had diarrhea however every time I take It 2 to 3 hours away from a meal it works without diarrhea. Hope this helps
#1 anne72
- Country: United States
I’ve been taking 290mg Linzess for about 2 weeks now and I’m still waiting to have a bowel movement. My gastro doctor told me LInzess works best if you “clean out” first. Only thing I’ve had with the LInzess is a whole lot of bloating and painful gas. When is this going to start working? I’m concerned as I also have a rectocele and cystocele, need to get things moving before surgery. If I can’t get it cleared up, it makes no sense to have them repaired because they will most likely reoccur with the constipation. I’m also using miralax, align and fibercon. Still nothing. Should I continue the Linzess in the hopes that eventually it will work?
Thanks for any advice!
#2 annie7
- Country: United States
Anne–sorry linzess doesn’t seem to be working for you.
from what i’ve read in reports and clinical studies on linzess, “improvements started within the first week of treatment”. of course we’re all so different in how our bodies react to meds, so your mileage may vary somewhat.
and yes your gastro is right about the advice that it works best if you do a cleanout first.
some people find they have to do some tweaking with it to get it to work. like taking it with miralax (which it sounds like you’re doing) or even taking it with a stimulant laxative like senna (start with a small dose of the stimulant). taking it with coffee, taking it different times of the day–at lunch or at night. etc.
i personally found that for the first few days it did work for me then it quit. i did quite a bit of experimentation with it and finally found that taking it WITH food–a warm meal with some healthy fat in it–instead of taking it as directed–a half hour or more before eating–makes it work for me. i’d read about this in the prescribing information on the linzess website–that taking it with food with some fat in it increases the diarrhea effect. anyway- when i take it this way i go about four or five times during the day–once every three or four hours. so that means i have to stay home all day. i also have a lot of gas, abdominal pain and bloating during all this for the entire day so it certainly isn’t optimal to say the least. so because of all this, i only take it when i need to do a cleanout.
another thing–as many people say, it does help to drink a lot of water with it too.
good luck to you. i do hope you can get linzess to work for you. it has helped some people but unfortunately not all of us. take care.
these are just my own thoughts. for expert medical advice please contact a health care professional.
#3 ABNormal
As Annie7 wrote, one has to experiment with it. I take it 1/2 hour before breakfast with a glass of Miralax. It works most days, but my issue has been incomplete evacuation.
When I first started taking Linzess, I took it at night. It was working like gangbusters, but that lasted about 2 weeks. Then nothing. I was ready to give up, but then saw a post that recommended using it with Miralax in the morning.
So, don’t give up Anne72 because we are all different. Try what Annie7 wrote or try what I wrote. Good luck.
Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
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Suffering from IBS-C. Public relations executive, mother of 2, enjoys walking
“I feel like I have tried everything…but I still have symptoms.”
Treatment history:
- Has seen physician 3 times in the last 3 months for her chronic constipation and belly pain
- Has tried over-the-counter laxatives, fiber, and stool softeners
Symptoms:
Abdominal pain score: 8
Suffering from CIC. Transportation dispatcher, home chef, grandfather of 2
“I’ve tried laxatives…I just wish there was something else I could try.”
Treatment history:
- Has been to physician a few times in the last 12 months
- Self-treats with over-the-counter laxatives and stool softeners; was recently prescribed a prescription laxative
Symptoms:
CSBMs/week:
Suffering from CIC. Office manager, active social life, avid traveler
“Even when I’m able to go, I never feel like I’m finished.”
Treatment history:
- Has a history of using multiple over-the-counter (OTC) remedies; tries a different OTC therapy, on average, every 2 months
- Went to physician and was given another OTC medication to try
Symptoms:
CSBMs/week:
*Not actual patients. For illustrative purposes only.
Disease Information
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
LINZESS is contraindicated in patients less than 6 years of age. In nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration. Use of LINZESS should be avoided in patients 6 years to less than 18 years of age. The safety and effectiveness of LINZESS have not been established in patients less than 18 years of age.
- LINZESS is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
- LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Pediatric Risk
- LINZESS is contraindicated in patients less than 6 years of age. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established. In neonatal mice, linaclotide increased fluid secretion as a consequence of GC-C agonism resulting in mortality within the first 24 hours due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than patients 6 years of age and older to develop severe diarrhea and its potentially serious consequences.
- Use of LINZESS should be avoided in pediatric patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in young juvenile mice and the lack of clinical safety and efficacy data in pediatric patients, use of LINZESS should be avoided in pediatric patients 6 years to less than 18 years of age.
Diarrhea
- Diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of 145 mcg and 290 mcg LINZESS-treated patients, and in (incidence ≥2% and greater than placebo)
- In IBS-C clinical trials: diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%).
- In CIC trials of a 145 mcg dose: diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal distension (3% vs 2%). In a CIC trial of a 72 mcg dose: diarrhea (19% vs 7% placebo) and abdominal distension (2% vs ® (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS‑C) and chronic idiopathic constipation (CIC).
If you are a patient, and have any questions, please discuss them with your doctor or healthcare professional. For additional information about LINZESS, call Allergan Medical Information at 1.800.678.1605.
Please see below and full Prescribing Information for LINZESS.
Allergan ® and its design are trademarks of Allergan, Inc.
Ironwood ® and its three-leaf design are registered trademarks of Ironwood Pharmaceuticals, Inc.
LINZESS ® and its design are registered trademarks of Ironwood Pharmaceuticals, Inc.
© 2020 Allergan and Ironwood Pharmaceuticals, Inc. All rights reserved.
Linzess for chronic constipation is safe or not depending on what you believe about it’s mechanism of action and that it is not a long term solution. Linzess (linaclotide) is a new medication for constipation predominant IBS (IBS-C) and chronic idiopathic constipation (CIC).
Like any medication, Linzess doesn’t work for everyone but many had significant improvement in their symptoms with either IBS-C or CIC. It should not be used by anyone 17 years of age or younger.
The design of the medication came from the identification of a receptor in the gastrointestinal tract that when stimulated, increases water secretion into the bowel lumen. It also decreases abdominal pain associated with IBS-C.
But, as with all medications that never solve the problem and only mask symptoms, there are side effects you may not want. And, the medication doesn’t work for everyone.
The main side effects is an over-loosening of the bowel causing diarrhea. What a great concept. Let’s go from being an IBS patient with constipation to becoming an IBS patent with diarrhea. Brilliant!
Other side effects include gas, swelling, abdominal pressure and feeling of fullness and abdominal pain. Wait, I thought this medication decreased abdominal pain? Only if the abdominal pain originates in specific cells in the gastrointestinal system. Pain associated with IBS can come from many places. Additionally, why do we want to take a medication that “numbs” any part of our body?
And, there are no long term studies of the safety of Linzess. Wouldn’t it be better to try an all natural treatment plan to restore the health, balance and efficiency of your gastrointestinal system?
For a complete all natural treatment plan that includes an IBS with constipation diet, please fill out the form below to receive a copy of Dr. Dahlman’s free report about IBS utilizing his step-by-step process and an all natural supplement program.
Remember, Dr. Dahlman will personally design the exact diet for you that is necessary to treat this condition. Don’t suffer!*
To find the costs of his program, please click here: “Do It Yourself Program” and solve irritable bowel syndrome on your own or “Phone Consultation Program” to learn about how he can guide you through the step-by-step process to help you conquer this condition.*
Download our complete descriptions of the protocols used by Dr. Dahlman.
Ask Dr. Dahlman any question, but realize that the answer to many questions such as the cause, symptoms, treatments and dietary information related to your specific concern may be found in the report you are about to download:
IMPORTANT WARNING:
Linaclotide may cause life-threatening dehydration in young laboratory mice. Children younger than 6 years of age should never take linaclotide. Children 6 to 17 years of age should not take linaclotide.
Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with linaclotide and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website () or the manufacturer’s website to obtain the Medication Guide.
Talk to your doctor about the risks of taking linaclotide.
Why is this medication prescribed?
Linaclotide is used in adults to treat irritable bowel syndrome with constipation (IBS-C; a condition that causes stomach pain or cramps, bloating, and infrequent or difficult passage of stools) and chronic idiopathic constipation (CIC; difficult or infrequent passage of stools that lasts for 3 months or longer and is not caused by a disease or a medication). Linaclotide is in a class of medications called guanylate cyclase-C agonists. It works by increasing the movement of food and waste through the stomach and intestines.
How should this medicine be used?
Linaclotide comes as a capsule to take by mouth. It is usually taken once a day on an empty stomach, at least thirty minutes before the first meal of the day. Take linaclotide at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take linaclotide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the capsules whole; do not split, chew, or crush them.
Linaclotide controls the symptoms of IBS-C and CIC, but does not cure these conditions. Your constipation symptoms may improve in 1 week, and it may take slightly longer for your stomach pain to improve. Continue to take linaclotide even if you feel well. Do not stop taking linaclotide without talking to your doctor. If you stop taking linaclotide, your symptoms may return in about 1 week.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking linaclotide,
- tell your doctor and pharmacist if you are allergic to linaclotide, any other medications, or any of the ingredients in linaclotide capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have a blockage in your stomach or intestines. Your doctor will probably tell you not to take linaclotide.
- tell your doctor if you have or have ever had any other medical conditions.
tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking linaclotide, call your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
If you remember the missed dose before eating, take the missed dose as soon as you remember it. If you have already eaten, check with your doctor before taking the missed dose. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Linaclotide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- diarrhea
- stomach pain
- swelling or feeling of fullness or pressure in the stomach area
- gas
- headache
Some side effects can be serious. If you experience any of these symptoms, stop taking linaclotide and call your doctor immediately or get emergency medical treatment:
- unusual or severe stomach pain
- bright red or black, tarry stools
- hives
Linaclotide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online () or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (drying agent) from the bottle, if one has been provided.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website () for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach.
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Brand names
AHFS В® Patient Medication Informationв„ў. В© Copyright, 2020. The American Society of Health-System Pharmacists В® , 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.