ISOTRETINOIN: 34,934 Adverse Event Reports & Safety Profile

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34,934

Total FAERS Reports

301 (0.9%)

Deaths Reported

1,450

Hospitalizations

34,934

As Primary/Secondary Suspect

266

Life-Threatening

437

Disabilities

Apr 11, 2003

FDA Approved

Mylan Pharmaceuticals Inc.

Manufacturer

Discontinued

Status

Yes

Generic Available

Drug Class: Retinoid [EPC] · Route: ORAL · Manufacturer: Mylan Pharmaceuticals Inc. · FDA Application: 018662 · HUMAN PRESCRIPTION DRUG · FDA Label: Available

Patent Expires: May 29, 2035 · First Report: 1980 · Latest Report: 20250925

What Are the Most Common ISOTRETINOIN Side Effects?

#1 Most Reported

Depression

2,985 reports (8.5%)

#2 Most Reported

Exposure during pregnancy

1,825 reports (5.2%)

#3 Most Reported

Off label use

1,731 reports (5.0%)

All ISOTRETINOIN Side Effects by Frequency

Side Effect	Reports	% of Total	Deaths	Hosp.
Depression	2,985	8.5%	34	237
Exposure during pregnancy	1,825	5.2%	0	19
Off label use	1,731	5.0%	19	95
Headache	1,693	4.9%	5	61
Dry skin	1,688	4.8%	11	62
Product dose omission issue	1,673	4.8%	0	5
Arthralgia	1,616	4.6%	1	64
Mood altered	1,367	3.9%	4	13
Adverse drug reaction	1,269	3.6%	1	4
Suicidal ideation	1,120	3.2%	13	147
Anxiety	1,112	3.2%	14	59
Drug ineffective	1,074	3.1%	6	53
Unintended pregnancy	1,011	2.9%	0	7
Lip dry	946	2.7%	11	48
Colitis ulcerative	932	2.7%	3	200
Blood triglycerides increased	927	2.7%	0	39
Treatment noncompliance	905	2.6%	0	7
Myalgia	750	2.2%	0	44
Epistaxis	728	2.1%	2	28
Back pain	707	2.0%	1	31

Who Reports ISOTRETINOIN Side Effects? Age & Gender Data

Gender: 65.8% female, 34.2% male. Average age: 23.5 years. Most reports from: US. View detailed demographics →

Is ISOTRETINOIN Getting Safer? Reports by Year

Year	Reports	Deaths	Hosp.
2000	60	1	15
2001	46	0