Linzesslinaclotide
According to the FDA label: LINZESS is indicated for the treatment of: • irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older • chronic idiopathic constipation (CIC) in adults • functional constipation (FC) in pediatric patients 2 years of age and older LINZESS is a guanylate cyclase-C agonist indicated for treatment of: Irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older.
25,697 adverse event reports submitted to the FDA (2012–2026)
Top Reported Adverse Events
The most frequently reported events in association with Linzess in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
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Diarrhoea 4,580 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 4,430 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Off Label Use 3,279 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Constipation 1,937 reports
Difficulty passing stool, or having fewer bowel movements than usual.
Full definition in the glossary → See all drugs reporting this event →Nausea 1,414 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Fatigue 1,143 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Abdominal Distension 1,134 reports
A swelling or bloating of the belly.
Full definition in the glossary → See all drugs reporting this event →Abdominal Pain 1,041 reports
Pain in the belly or stomach area.
Full definition in the glossary → See all drugs reporting this event →Headache 1,007 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Pain 928 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Abdominal Pain Upper 908 reports
Pain in the upper part of the belly, above the navel.
Full definition in the glossary →Dizziness 818 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Inappropriate Schedule of Product Administration 739 reports
A report that the medication was taken on the wrong schedule, such as too often, not often enough, or at the wrong time. This is a usage category, not a sign of a problem with the drug.
Full definition in the glossary →Flatulence 688 reports
Excess gas in the digestive system, commonly called passing gas.
Full definition in the glossary →Fall 679 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 17,031 |
| Male | 6,337 |
| Unknown | 61 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 312 |
| 18-34 | 742 |
| 35-49 | 1,675 |
| 50-64 | 3,473 |
| 65-74 | 2,777 |
| 75+ | 2,897 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Linzess. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 16,472 |
| Other Serious | 6,542 |
| Hospitalization | 3,771 |
| Death | 1,036 |
| Disability | 334 |
| Life-Threatening | 249 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Linzess. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2012 | 9 |
| 2013 | 597 |
| 2014 | 1,295 |
| 2015 | 1,290 |
| 2016 | 2,129 |
| 2017 | 2,256 |
| 2018 | 2,579 |
| 2019 | 2,374 |
| 2020 | 2,224 |
| 2021 | 1,937 |
| 2022 | 1,882 |
| 2023 | 1,991 |
| 2024 | 2,046 |
| 2025 | 2,438 |
| 2026 (partial) | 650 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Linzess
In FDA adverse event reports that mention Linzess, these medications appeared most often in the same report.
- Ergocalciferol (3,027 reports)
- Gabapentin (2,832 reports)
- Omeprazole (2,629 reports)
- Aspirin (1,993 reports)
- Polyethylene Glycol (1,791 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026