Loperamide hydrochloride: adverse event reports filed with FDA

5,180

reports as suspect product

0% of all reports · about 234 a year

707

reports, 12 months to June 2026

687 in the 12 months before

41.4%

marked serious by the reporter

91.7% across the class

6.7%

record death among outcomes, as reported

345 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 Loperamide hydrochloride reports recording the termmedian drug in opioid agonist

1. Drug ineffectivethe medicine did not work as expected20.1%1,041
2. Intentional product use issuedeliberate use not as intended15.3%791
3. Off label useused for a purpose or in a way not on the label11.2%580
4. Incorrect product administration duration8.6%443
5. Constipationconstipation7.6%393
6. Diarrhoealoose or frequent stools6.1%314
7. Nauseafeeling sick5.2%267
8. Macular degenerationa disease of the central retina4.7%246
9. Overdosea dose above the recommended amount4.5%235
10. Expired product administeredthe product was used past its expiry date4.4%229
11. Malaisegeneral feeling of being unwell4.2%216
12. Abdominal painstomach or belly pain4%208
13. Drug abusemisuse of a medicine3.8%198
14. Incorrect dose administeredthe wrong dose was given3.8%197
15. Weight decreasedweight loss3.8%196
16. Intentional product misusedeliberate use not as intended3.7%194
17. Pyrexiafever3.7%193
18. Inappropriate schedule of product administrationthe product was taken at the wrong times3.7%190
19. Incorrect drug administration duration3.6%186
20. Painpain, site not specified3.5%180
21. Headachehead pain3.4%177
22. Therapeutic product effect incomplete3.2%168
23. Electrocardiogram QT prolongeda QT prolongation on the ECG3.1%162
24. Dyspepsiaindigestion2.9%151
25. Toxicity to various agentspoisoning or toxic effect of one or more substances2.9%150
26. Anaemialow red blood cells2.8%146
27. Fatiguetiredness2.7%142
28. Chronic sinusitis2.5%130
29. Haematocheziablood in the stool2.4%124
30. Drug interactionan interaction between medicines2.4%123

Top 30 of 801 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. 70.4% 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 5,180 reports.

Drugs most often listed in the same reports

Other products listed in reports where Loperamide hydrochloride 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 Loperamide hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (5,002) 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.