WARNINGS
What is the most important information I should know about LINZESS?
• Do not give LINZESS to children who are less than 2 years of age. It may harm them.
See the section “What are the possible side effects of LINZESS?” for more information about side effects.
Who should not take LINZESS?
• Do not give LINZESS to children who are less than 2 years of age. LINZESS can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt).
• Do not take LINZESS if a healthcare provider has told you that you have a bowel blockage (intestinal obstruction).
Before you take LINZESS, tell your healthcare provider about all of your medical conditions, including
if you:
• are pregnant or plan to become pregnant. It is not known if LINZESS will harm your unborn baby.
• are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take LINZESS and breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
USES
What is LINZESS?
LINZESS is a prescription medicine used to treat:
• irritable bowel syndrome with constipation (IBS-C) in adults and in children and adolescents 7 years of age and older.
• a type of constipation called chronic idiopathic constipation (CIC) in adults. “Idiopathic” means the cause of the constipation is unknown.
• functional constipation in children and adolescents 6 years of age and older.
It is not known if LINZESS is safe and effective in children with functional constipation less than 6 years of age or in children with IBS-C less than 7 years of age.
HOW TO USE
How should I take LINZESS?
• Take LINZESS exactly as your healthcare provider tells you to take it.
• Take LINZESS 1 time each day on an empty stomach, at least 30 minutes before a meal, at approximately the same time each day. You should also wait 30 minutes before eating a meal if you take LINZESS with applesauce or mixed with water.
• If you miss a dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 doses at the same time.
• LINZESS capsules should be swallowed whole. Do not crush or chew LINZESS.
o If you cannot swallow LINZESS capsules whole, you may open the LINZESS capsule and sprinkle the LINZESS beads over applesauce or mix LINZESS with bottled water before swallowing.
It is not known if LINZESS is safe and effective when sprinkled on other foods or mixed with other liquids.
Taking LINZESS in applesauce:
• Place 1 teaspoon of room temperature applesauce into a clean container. Open the LINZESS capsule and sprinkle all of the LINZESS beads onto the applesauce.
• Swallow all of the LINZESS beads and applesauce right away. Do not keep the applesauce for later use.
• Do not chew the LINZESS beads.
Taking LINZESS in water:
• Pour 1 ounce (30 mL) of room temperature bottled water into a clean cup. Open the LINZESS capsule and sprinkle all of the LINZESS beads into the cup of water.
• Gently swirl the beads and water for at least 20 seconds.
• Swallow all of the LINZESS beads and water mixture right away. Do not keep the mixture for later use.
• If you see any LINZESS beads left in the cup, add another 1 ounce (30 mL) of water to the beads in the cup, swirl for at least 20 seconds, and swallow right away.
Taking LINZESS in a nasogastric or gastrostomy feeding tube:
Gather the supplies you will need to take your LINZESS dose. Your healthcare provider should tell you what size catheter tipped syringe you will need for your dose. Ask your healthcare provider if you have any questions about how to give LINZESS the right way.
• Open the LINZESS capsule and pour all of the LINZESS beads into a clean container with 1 ounce (30 mL) of room temperature bottled water.
• Gently swirl the beads and water for at least 20 seconds.
• Remove the plunger from the catheter tipped syringe, and then pour the LINZESS bead and water mixture into the syringe and replace the plunger.
• Remove the cap from the syringe, insert the tip of the syringe into the nasogastric or gastrostomy feeding tube and push the plunger all the way in to give the dose.
• If you see any LINZESS beads left in the container, add another 1 ounce (30 mL) of water to the beads in the container and repeat the process.
• After giving the LINZESS dose, flush the nasogastric or gastrostomy feeding tube with at least 10 mL of water.
What are the possible side effects of LINZESS?
LINZESS can cause serious side effects, including:
• See “What is the most important information I should know about LINZESS?”
• Diarrhea is the most common side effect of LINZESS, and it can sometimes be severe.
o Diarrhea often begins within the first 2 weeks of LINZESS treatment.
o Stop taking LINZESS and call your healthcare provider right away if you get severe diarrhea during treatment with LINZESS.
Other common side effects of LINZESS in people with IBS-C and CIC include:
• gas
• stomach-area (abdomen) pain
• swelling, or a feeling of fullness or pressure in your abdomen (distention)
Call your healthcare provider or go to the nearest hospital emergency room right away, if you develop unusual or severe stomach-area (abdomen) 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.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of LINZESS.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use LINZESS for a condition for which it was not prescribed. Do not give LINZESS to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your healthcare provider or pharmacist for information about LINZESS that is written for health professionals.
OVERDOSE
Please call your healthcare provider for more information.
MISSED DOSE
If you miss a dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 doses at the same time.
STORAGE
How should I store LINZESS?
• Store LINZESS at room temperature between 68-degrees F to 77-degrees F (20-degrees C to 25-degrees C).
• Keep LINZESS in the bottle that it comes in.
• The LINZESS bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture).
Do not remove the desiccant packet from the bottle.
• Keep the bottle of LINZESS tightly closed and in a dry place.
Keep LINZESS and all medicines out of the reach of children
NOTES
Medication Guide: revision date 11/2025
Prescribing Information: revision date 11/2025
No drug-drug interaction studies have been conducted with LINZESS. Systemic exposures of drug and active metabolite are negligible following oral administration. Linaclotide does not interact with the cytochrome P450 enzyme system based on the results of in vitro studies. In addition, linaclotide does not interact with common efflux and uptake transporters (including the efflux transporter P-glycoprotein (P-gp)). Based on these in vitro data no drug-drug interactions through modulation of CYP enzymes or common transporters are anticipated.
See the section WARNINGS above.
