Amnesteem: adverse event reports filed with FDA

6,035

reports as suspect product

0% of all reports · about 268 a year

49

reports, 12 months to June 2026

44 in the 12 months before

45.4%

marked serious by the reporter

49.6% across the class

1.5%

record death among outcomes, as reported

88 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 Amnesteem reports recording the termmedian drug in retinoid

1. Inflammatory bowel disease11%664
2. Depressionlow mood9.2%556
3. Blood triglycerides increased6.2%374
4. Headachehead pain6%365
5. Arthralgiajoint pain5.8%350
6. Drug exposure during pregnancythe medicine was taken during pregnancy5.7%345
7. Dry skindry skin5.7%342
8. Suicidal ideationthoughts of suicide4.2%252
9. Lip dry4.2%251
10. Anxietyanxiety3.8%228
11. Pregnancypregnancy3.5%213
12. Maternal exposure during pregnancythe mother took the medicine during pregnancy3.5%210
13. Mood altereda change in mood3.3%199
14. Abortion induced3.2%192
15. Blood cholesterol increasedraised cholesterol2.7%162
16. Colitis ulcerative2.6%158
17. Exposure during pregnancythe medicine was taken during pregnancy2.6%155
18. Myalgiamuscle pain2.6%155
19. Aspartate aminotransferase increasedraised liver enzyme (AST)2.5%152
20. Back painback pain2.4%146
21. Alanine aminotransferase increasedraised liver enzyme (ALT)2.3%137
22. Abdominal painstomach or belly pain2.3%136
23. Epistaxisnosebleed2.2%134
24. Acneacne2%121
25. Mood swingsmood swings1.9%116
26. Nauseafeeling sick1.9%115
27. Fatiguetiredness1.9%114
28. Diarrhoealoose or frequent stools1.8%111
29. Treatment noncompliancethe treatment was not taken as directed1.8%106
30. Drug ineffectivethe medicine did not work as expected1.7%102

Top 30 of 425 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 11 drugs in the retinoid 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 65,827 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. 98.6% 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 6,035 reports.

Drugs most often listed in the same reports

Other products listed in reports where Amnesteem 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 retinoid 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 Amnesteem as a suspect or interacting product; reports listing it only as a concomitant medication (127) 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.