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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.

Does ISOTRETINOIN Cause Acne? 678 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 678 reports of Acne have been filed in association with ISOTRETINOIN (Amnesteem). This represents 1.9% of all adverse event reports for ISOTRETINOIN.

678
Reports of Acne with ISOTRETINOIN
1.9%
of all ISOTRETINOIN reports
1
Deaths
39
Hospitalizations

How Dangerous Is Acne From ISOTRETINOIN?

Of the 678 reports, 1 (0.1%) resulted in death, 39 (5.8%) required hospitalization, and 5 (0.7%) were considered life-threatening.

Is Acne Listed in the Official Label?

Yes, Acne is listed as a known adverse reaction in the official FDA drug label for ISOTRETINOIN.

What Other Side Effects Does ISOTRETINOIN Cause?

Depression (2,985) Exposure during pregnancy (1,825) Off label use (1,731) Headache (1,693) Dry skin (1,688) Product dose omission issue (1,673) Arthralgia (1,616) Mood altered (1,367) Adverse drug reaction (1,269) Suicidal ideation (1,120)

What Other Drugs Cause Acne?

ADAPALENE (40,188) AVOBENZONE\OCTISALATE\OCTOCRYLENE (31,405) AVOBENZONE\HOMOSALATE\OCTINOXATE\OCTISALATE\OXYBENZONE (2,679) DUPILUMAB (1,305) ADALIMUMAB (1,227) LEVONORGESTREL (1,212) UPADACITINIB (1,203) INFLIXIMAB (946) TOFACITINIB (915) ETANERCEPT (847)

Which ISOTRETINOIN Alternatives Have Lower Acne Risk?

ISOTRETINOIN vs ISRADIPINE ISOTRETINOIN vs ISTRADEFYLLINE ISOTRETINOIN vs ITACITINIB ISOTRETINOIN vs ITRACONAZOLE ISOTRETINOIN vs ITRACONAZOLE\SODIUM

Related Pages

ISOTRETINOIN Full Profile All Acne Reports All Drugs Causing Acne ISOTRETINOIN Demographics