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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ACCUTANE: 273 Adverse Event Reports & Safety Profile

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273
Total FAERS Reports
1 (0.4%)
Deaths Reported
109
Hospitalizations
273
As Primary/Secondary Suspect
2
Life-Threatening
14
Disabilities

First Report: 1980 · Latest Report: 20140617

What Are the Most Common ACCUTANE Side Effects?

#1 Most Reported
Inflammatory bowel disease
223 reports (81.7%)
#2 Most Reported
Colitis ulcerative
163 reports (59.7%)
#3 Most Reported
Depression
154 reports (56.4%)

All ACCUTANE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Inflammatory bowel disease 223 81.7% 1 94
Colitis ulcerative 163 59.7% 1 59
Depression 154 56.4% 1 72
Crohn's disease 150 55.0% 0 75
Irritable bowel syndrome 118 43.2% 1 36
Gastrointestinal injury 59 21.6% 0 29
Dry skin 58 21.3% 0 22
Intestinal obstruction 52 19.1% 0 32
Lip dry 42 15.4% 0 17
Blood triglycerides increased 40 14.7% 0 21
Large intestine polyp 39 14.3% 1 17
Suicidal ideation 38 13.9% 1 17
Blood cholesterol increased 35 12.8% 0 14
Emotional distress 32 11.7% 0 12
Injury 31 11.4% 0 12
Anal fistula 29 10.6% 0 15
Anxiety 28 10.3% 0 11
Anal fissure 25 9.2% 0 11
Arthralgia 23 8.4% 0 11
Intestinal haemorrhage 23 8.4% 0 11

Who Reports ACCUTANE Side Effects? Age & Gender Data

Average age: 25.3 years. Most reports from: US. View detailed demographics →

Is ACCUTANE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 15 0 2
2001 16 0 6
2002 15 0 5
2003 14 0 6
2004 12 0 6
2005 11 0 4
2006 6 0 1
2007 1 0 0
2008 7 0 3
2009 2 0 0
2011 1 0 0
2012 3 0 1
2013 1 0 1
2014 6 0 1

View full timeline →

What Is ACCUTANE Used For?

IndicationReports
Acne 220
Acne cystic 33
Product used for unknown indication 7

ACCUTANE vs Alternatives: Which Is Safer?

ACCUTANE vs ACEBUTOLOL ACCUTANE vs ACECLOFENAC ACCUTANE vs ACEMETACIN ACCUTANE vs ACENOCOUMAROL ACCUTANE vs ACEON ACCUTANE vs ACETAMINOPHEN ACCUTANE vs ACETAMINOPHEN AND OR DEXTROMETHORPHAN AND OR DIPHENHYDRAMINE AND OR GUAIFENESIN AND OR PHENYLEPHRINE AND OR PSEUDOEPHEDRINE ACCUTANE vs ACETAMINOPHEN W/HYDROCODONE ACCUTANE vs ACETAMINOPHEN\ASPIRIN\CAFFEINE ACCUTANE vs ACETAMINOPHEN\ASPIRIN\CAFFEINE\SALICYLAMIDE

Official FDA Label for ACCUTANE

Official prescribing information from the FDA-approved drug label.