Linzess: adverse event reports filed with FDA

14,346

reports as suspect product

0.1% of all reports · about 1,031 a year

1,034

reports, 12 months to June 2026

685 in the 12 months before

17.9%

marked serious by the reporter

20.3% across the class

1.3%

record death among outcomes, as reported

184 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Linzess reports recording the termmedian drug in guanylate cyclase-c agonist

1. Diarrhoealoose or frequent stools29.2%4,194
2. Drug ineffectivethe medicine did not work as expected26.6%3,813
3. Off label useused for a purpose or in a way not on the label17.8%2,554
4. Constipationconstipation8.1%1,160
5. Abdominal distensiona bloated abdomen6.7%967
6. Abdominal painstomach or belly pain5.5%787
7. Abdominal pain upperupper stomach pain4.5%644
8. Flatulencewind4.3%623
9. Inappropriate schedule of product administrationthe product was taken at the wrong times3.8%545
10. Nauseafeeling sick3.4%488
11. Intentional product misusedeliberate use not as intended3.1%450
12. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times2.4%348
13. Product storage errorthe product was stored wrongly2.4%342
14. Dizzinesslight-headedness or unsteadiness2.3%337
15. Incorrect dose administeredthe wrong dose was given2.2%309
16. Abdominal discomfortstomach discomfort1.9%272
17. Headachehead pain1.8%260
18. Wrong technique in product usage processthe product was used in the wrong way1.8%259
19. Malaisegeneral feeling of being unwell1.6%228
20. Painpain, site not specified1.6%228
21. Product dispensing error1.6%225
22. Fatiguetiredness1.5%220
23. Therapeutic response decreasedthe medicine worked less well1.5%219
24. Drug dose omissiona dose was missed1.5%215
25. Astheniaweakness or lack of energy1.5%209
26. Muscle spasmsmuscle cramps1.4%201
27. Dehydrationdehydration1.4%197
28. Weight decreasedweight loss1.3%181
29. Vomitingbeing sick1.2%172
30. Feeling abnormalfeeling odd or not right1.1%163

Top 30 of 763 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the guanylate cyclase-c agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 16,496 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 14,346 reports.

Drugs most often listed in the same reports

Other products listed in reports where Linzess is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the guanylate cyclase-c agonist class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Linzess as a suspect or interacting product; reports listing it only as a concomitant medication (11,038) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.