Accutane: adverse event reports filed with FDA

12,317

reports as suspect product

0.1% of all reports · about 548 a year

406

reports, 12 months to June 2026

627 in the 12 months before

77%

marked serious by the reporter

49.6% across the class

1.2%

record death among outcomes, as reported

148 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 Accutane reports recording the termmedian drug in retinoid

1. Inflammatory bowel disease40.1%4,934
2. Colitis ulcerative29.7%3,654
3. Depressionlow mood25.2%3,099
4. Irritable bowel syndrome15.7%1,935
5. Crohn's disease13%1,602
6. Gastrointestinal injury10.2%1,256
7. Crohn's diseaseCrohn's disease, an inflammatory bowel disease9%1,110
8. Dry skindry skin8.8%1,086
9. Anxietyanxiety7.8%960
10. Intestinal obstructiona blocked bowel7%860
11. Lip dry6.7%828
12. Suicidal ideationthoughts of suicide6.6%810
13. Injurya physical injury6%737
14. Pregnancypregnancy5.9%727
15. Intestinal haemorrhage5.7%704
16. Product dose omission issuea dose was missed5.5%683
17. Colitisinflamed bowel5.4%662
18. Emotional distressemotional distress5.2%644
19. Blood triglycerides increased5.1%624
20. No adverse effect5%620
21. Arthralgiajoint pain4.6%563
22. Rectal haemorrhage4.4%536
23. Headachehead pain4.1%500
24. Blood cholesterol increasedraised cholesterol3.6%449
25. Abdominal painstomach or belly pain3.6%443
26. Epistaxisnosebleed3.2%397
27. Haemorrhoids3.2%388
28. Stressstress3.1%378
29. Product administration interrupted2.9%359
30. Acneacne2.9%358

Top 30 of 1,142 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. 89.4% 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 12,317 reports.

Drugs most often listed in the same reports

Other products listed in reports where Accutane 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 Accutane as a suspect or interacting product; reports listing it only as a concomitant medication (927) 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.