Imodium: adverse event reports filed with FDA

5,968

reports as suspect product

0% of all reports · about 265 a year

326

reports, 12 months to June 2026

500 in the 12 months before

49.1%

marked serious by the reporter

91.7% across the class

6.4%

record death among outcomes, as reported

383 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 Imodium reports recording the termmedian drug in opioid agonist

1. Diarrhoealoose or frequent stools19.5%1,162
2. Drug ineffectivethe medicine did not work as expected16.3%971
3. Constipationconstipation14.9%889
4. Nauseafeeling sick7.8%463
5. Somnolencedrowsiness6.5%387
6. Off label useused for a purpose or in a way not on the label6.5%386
7. Gastrooesophageal reflux diseaseacid reflux5.6%335
8. Vomitingbeing sick5.5%326
9. Coma5.3%318
10. Fatiguetiredness5%296
11. Pneumonia aspirationlung infection from breathing in material4.9%294
12. Incorrect dose administeredthe wrong dose was given4.6%277
13. Weight decreasedweight loss4.1%246
14. Abdominal painstomach or belly pain4.1%242
15. Dyspnoeashortness of breath3.6%214
16. Abdominal pain upperupper stomach pain3.5%211
17. Decreased appetitereduced appetite3.4%205
18. Dizzinesslight-headedness or unsteadiness3.4%200
19. Headachehead pain3.4%200
20. Product use in unapproved indicationused for a purpose not on the label3.2%188
21. Malaisegeneral feeling of being unwell3.1%184
22. Overdosea dose above the recommended amount2.9%174
23. Pyrexiafever2.9%172
24. Painpain, site not specified2.8%170
25. Astheniaweakness or lack of energy2.5%147
26. Abdominal discomfortstomach discomfort2.4%146
27. Drug abusemisuse of a medicine2.4%145
28. Abdominal distensiona bloated abdomen2.4%143
29. Coughcough2.4%141
30. Therapeutic product effect incomplete2.3%139

Top 30 of 879 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 42 drugs in the opioid 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 965,051 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. 65.4% 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 5,968 reports.

Drugs most often listed in the same reports

Other products listed in reports where Imodium 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 opioid 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 Imodium as a suspect or interacting product; reports listing it only as a concomitant medication (20,381) 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.