Isotretinoin: adverse event reports filed with FDA

14,852

reports as suspect product

0.1% of all reports · about 660 a year

2,177

reports, 12 months to June 2026

2,554 in the 12 months before

53.4%

marked serious by the reporter

49.6% across the class

2.5%

record death among outcomes, as reported

378 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 Isotretinoin reports recording the termmedian drug in retinoid

1. Depressionlow mood6.7%1,001
2. Pregnancypregnancy6.7%998
3. Exposure during pregnancythe medicine was taken during pregnancy4.8%710
4. Abortion induced4.4%658
5. Adverse drug reactiona harmful or unpleasant reaction reported to a medicine4.2%627
6. Product dose omission issuea dose was missed3.8%570
7. Dry skindry skin3.7%554
8. Headachehead pain3.6%533
9. Arthralgiajoint pain3.5%523
10. Suicidal ideationthoughts of suicide3.4%499
11. Drug ineffectivethe medicine did not work as expected3%442
12. Mood altereda change in mood3%440
13. Anxietyanxiety2.6%385
14. Lip dry2.1%308
15. Myalgiamuscle pain2%303
16. Drug exposure during pregnancythe medicine was taken during pregnancy2%296
17. Off label useused for a purpose or in a way not on the label2%291
18. Maternal exposure during pregnancythe mother took the medicine during pregnancy1.9%283
19. No adverse effect1.8%266
20. No adverse eventno adverse event was reported1.7%250
21. Abdominal painstomach or belly pain1.6%244
22. Epistaxisnosebleed1.6%242
23. Blood triglycerides increased1.6%233
24. Dry eyedry eye1.6%233
25. Product use issuea problem in how the product was used1.6%232
26. Back painback pain1.5%224
27. Diarrhoealoose or frequent stools1.5%222
28. Acneacne1.5%218
29. Abortion spontaneousmiscarriage1.4%215
30. Fatiguetiredness1.4%211

Top 30 of 1,151 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. 70.5% 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 14,852 reports.

Drugs most often listed in the same reports

Other products listed in reports where Isotretinoin 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 Isotretinoin as a suspect or interacting product; reports listing it only as a concomitant medication (732) 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.