Tretinoin: adverse event reports filed with FDA

3,415

reports as suspect product

0% of all reports · about 152 a year

365

reports, 12 months to June 2026

343 in the 12 months before

72.4%

marked serious by the reporter

49.6% across the class

21%

record death among outcomes, as reported

716 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 Tretinoin reports recording the termmedian drug in retinoid

1. Off label useused for a purpose or in a way not on the label18.7%640
2. Drug ineffectivethe medicine did not work as expected13.7%469
3. Product use in unapproved indicationused for a purpose not on the label10.7%364
4. Vomitingbeing sick9.3%316
5. Paraesthesiatingling or pins and needles8.9%305
6. Maternal exposure during pregnancythe mother took the medicine during pregnancy8.9%303
7. Painpain, site not specified8.9%303
8. Taste disorder8.8%299
9. Abdominal pain upperupper stomach pain8.6%294
10. Drug intolerancethe medicine was not tolerated8.4%287
11. Epilepsy8.3%283
12. Blepharospasm8.1%277
13. Gastrooesophageal reflux diseaseacid reflux8%272
14. Hypoaesthesianumbness7.8%268
15. Memory impairmentmemory problems7.7%262
16. Differentiation syndrome6.6%225
17. Migrainemigraine6.4%217
18. Rashskin rash6.4%217
19. Treatment failurethe treatment did not work5.7%196
20. Pneumonialung infection5.7%193
21. Product use issuea problem in how the product was used5.6%192
22. Product quality issuea problem with the product itself5.6%191
23. Condition aggravatedthe condition being treated got worse5.5%188
24. Contraindicated product administered5.2%178
25. Diarrhoealoose or frequent stools5.1%175
26. Pericarditisinflammation of the sac around the heart5.1%174
27. Weight increasedweight gain5.1%173
28. Synovitis5%172
29. Arthralgiajoint pain4.8%164
30. Alopeciahair loss4.8%163

Top 30 of 722 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. 46.7% 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 3,415 reports.

Drugs most often listed in the same reports

Other products listed in reports where Tretinoin 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 Tretinoin as a suspect or interacting product; reports listing it only as a concomitant medication (2,995) 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.