Linaclotide: uses, dosing, side effects & brands
Linaclotide is a guanylate cyclase-c agonist sold in the U.S. under one brand, for constipation and irritable bowel syndrome. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Guanylate Cyclase-C Agonist
- Treats
- Constipation and Irritable Bowel Syndrome
- Available as
- Capsule
- Sold as
- Linzess
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How linaclotide is dosed
From the FDA label for Linzess (application NDA202811). Other linaclotide products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The recommended dosage in adults is: IBS-C : 290 mcg orally once daily. ( 2.1 ) CIC : 145 mcg orally once daily or 72 mcg orally once daily based on individual presentation or tolerability. ( 2.1 ) The recommended dosage in pediatric patients: 7 years of age and older with IBS-C : 145 mcg orally once daily. ( 2.1 ) 2 years of age and older with FC : 72 mcg orally once daily. ( 2.1 ) Administration Instructions ( 2.2 ): Take on empty stomach at least 30 minutes prior to a meal at approximately the same time each day. Do not crush or chew LINZESS capsule or capsule contents. For patients who have difficulty swallowing capsules whole or those with a nasogastric or gastrostomy tube, see full prescribing information for instructions for opening the capsule and administering with applesauce or water. 2.1 Recommended Dosage Irritable Bowel Syndrome with Constipation (IBS-C) : The recommended dosage of LINZESS is: • Adults : 290 mcg orally once daily • Pediatric patients 7 years of age and older : 145 mcg orally once daily Chronic Idiopathic Constipation (CIC) in Adults The recommended dosage of LINZESS in adults is 145 mcg orally once daily. A dosage of 72 mcg once daily may be used based on individual presentation or tolerability. Functional Constipation (FC) in Pediatric Patients 2 Years of Age and Older The recommended dosage of LINZESS in pediatric patients 2 years of age and…
Linaclotide side effects
Most common adverse reactions (≥2%) reported in adult patients with IBS-C or CIC are: diarrhea, abdominal pain, flatulence and abdominal distension. ( 6.1 ) Most common adverse reaction (≥2%) reported in pediatric patients 7 to 17 years of age with IBS-C and 6 to 17 years of age with FC is diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie, Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Demographic characteristics were comparable between treatment groups in all studies [see Clinical Studies ( 14.1 , 14.2 , 14.3 , 14.4 , 14.5 )] . Irritable Bowel Syndrome with Constipation (IBS-C) in Adults Most Common Adverse Reactions The data described below reflect exposure to LINZESS in the two placebo-controlled clinical trials involving 1605 adult patients with IBS-C (Trials 1 and 2) [see Clinical Studies ( 14.1 )] . Patients were randomized to receive placebo or 290 mcg LINZESS once daily on an empty stomach for up to 26 weeks. Table 1 provides the incidence of adverse reactions reported in at least 2% of IBS-C patients in the LINZESS treatment…
Who shouldn’t take linaclotide
LINZESS is contraindicated in: Patients less than 2 years of age due to the risk of serious dehydration [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )] . Patients with known or suspected mechanical gastrointestinal obstruction. Patients less than 2 years of age. ( 4 , 5.1 , 8.4 ) Patients with known or suspected mechanical gastrointestinal obstruction. ( 4 )
Every linaclotide product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Linzess.
What linaclotide pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Can you crush or split linaclotide?
At least one linaclotideproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each linaclotide label says about crushing, splitting and chewingLinaclotide and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for linaclotide: levels in milk, effects in breastfed infants, and the drugs it would consider insteadLinaclotide is minimally absorbed from the gastrointestinal tract and the drug and its active metabolite are not measurable in milk following administration of doses up to 290 mcg daily. Linaclotide appears to be acceptable in nursing mothers and no special precautions are required.
National Institute of Child Health and Human Development, record revised June 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about linaclotide
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2,877 reports naming linaclotide, and the FDA flagged 56% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- diarrhoea609 reports
- constipation215 reports
- abdominal pain182 reports
- nausea153 reports
- abdominal distension123 reports
- headache123 reports
- dizziness97 reports
- fatigue91 reports
Read these as a signal, not a rate. A report does not mean linaclotide caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
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Frequently asked questions
What is linaclotide?
Linzess (Linaclotide) is a guanylate cyclase-c agonist used to treat Constipation, Irritable Bowel Syndrome.
What kind of drug is linaclotide?
The FDA classifies linaclotide as a guanylate cyclase-c agonist. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take linaclotide with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run linaclotide against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does linaclotide come in?
Across the brands we track, linaclotide is currently marketed as capsule, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic linaclotide?
We do not currently list a generic-labelled linaclotide product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Linaclotide: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/linaclotide
- MLA
- “Linaclotide: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/linaclotide.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for linaclotide on DailyMed (NIH) ↗ — including its boxed warning in full.