Does ISOTRETINOIN Cause Adverse event? 311 Reports in FDA Database

Q: Does ISOTRETINOIN cause Adverse event?

311 reports of Adverse event have been filed with the FDA for ISOTRETINOIN, representing 0.9% of all ISOTRETINOIN adverse event reports.

Q: How dangerous is Adverse event from ISOTRETINOIN?

Of 311 reports, 11 (3.5%) resulted in death and 6 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 311 reports of Adverse event have been filed in association with ISOTRETINOIN (Amnesteem). This represents 0.9% of all adverse event reports for ISOTRETINOIN.

311

Reports of Adverse event with ISOTRETINOIN

0.9%

of all ISOTRETINOIN reports

Deaths

Hospitalizations

How Dangerous Is Adverse event From ISOTRETINOIN?

Of the 311 reports, 11 (3.5%) resulted in death, 6 (1.9%) required hospitalization.

Is Adverse event Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for ISOTRETINOIN. However, 311 reports have been filed with the FAERS database.

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 Adverse event?

ABATACEPT (4,028) APIXABAN (3,871) ETANERCEPT (3,096) LENALIDOMIDE (2,426) INFLIXIMAB (2,269) ADALIMUMAB (2,121) METHOTREXATE (1,846) LEFLUNOMIDE (1,476) RIVAROXABAN (1,465) ALENDRONATE (1,462)

Which ISOTRETINOIN Alternatives Have Lower Adverse event Risk?

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

ISOTRETINOIN Full Profile All Adverse event Reports All Drugs Causing Adverse event ISOTRETINOIN Demographics