Isotretinoin

Common brands: Accutane, Claravis, Zenatane, Amnesteem, Absorica

Top reporter: Jg Pharma Inc.

Retinoid [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Corticosteroid [EPC]Tetracycline-class Drug [EPC]Benzodiazepine [EPC]
48,237
Total Reports
11,143
Serious Reports
881
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (1.83%)

Patient Demographics

Male
14,252
Female
25,348

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Isotretinoin.

# Reaction Reports % of Total
1 DEPRESSION 5,738
10.5%
2 INFLAMMATORY BOWEL DISEASE 5,252
9.6%
3 COLITIS ULCERATIVE 3,801
6.9%
4 DRY SKIN 2,379
4.3%
5 SUICIDAL IDEATION 2,132
3.9%
6 PREGNANCY 2,077
3.8%
7 IRRITABLE BOWEL SYNDROME 2,016
3.7%
8 HEADACHE 1,963
3.6%
9 ARTHRALGIA 1,942
3.5%
10 UNINTENDED PREGNANCY 1,906
3.5%
11 ANXIETY 1,899
3.5%
12 PRODUCT DOSE OMISSION ISSUE 1,746
3.2%
13 CROHN^S DISEASE 1,677
3.1%
14 EXPOSURE DURING PREGNANCY 1,644
3.0%
15 LIP DRY 1,560
2.8%
16 ADVERSE DRUG REACTION 1,481
2.7%
17 BLOOD TRIGLYCERIDES INCREASED 1,449
2.6%
18 ABORTION INDUCED 1,368
2.5%
19 GASTROINTESTINAL INJURY 1,261
2.3%
20 DRUG INEFFECTIVE 1,247
2.3%
21 MOOD ALTERED 1,236
2.3%
22 DRUG EXPOSURE DURING PREGNANCY 1,214
2.2%
23 CROHN'S DISEASE 1,140
2.1%
24 TREATMENT NONCOMPLIANCE 1,108
2.0%
25 NO ADVERSE EFFECT 988
1.8%
26 EPISTAXIS 972
1.8%
27 ACNE 929
1.7%
28 BACK PAIN 928
1.7%
29 ABDOMINAL PAIN 920
1.7%
30 INTESTINAL OBSTRUCTION 878
1.6%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.