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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 Off label use? 1,731 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 1,731 reports of Off label use have been filed in association with ISOTRETINOIN (Amnesteem). This represents 5.0% of all adverse event reports for ISOTRETINOIN.

1,731
Reports of Off label use with ISOTRETINOIN
5.0%
of all ISOTRETINOIN reports
19
Deaths
95
Hospitalizations

How Dangerous Is Off label use From ISOTRETINOIN?

Of the 1,731 reports, 19 (1.1%) resulted in death, 95 (5.5%) required hospitalization, and 16 (0.9%) were considered life-threatening.

Is Off label use Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for ISOTRETINOIN. However, 1,731 reports have been filed with the FAERS database.

What Other Side Effects Does ISOTRETINOIN Cause?

Depression (2,985) Exposure during pregnancy (1,825) 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) Anxiety (1,112)

What Other Drugs Cause Off label use?

RITUXIMAB (39,751) INFLIXIMAB (34,801) DENOSUMAB (34,612) METHOTREXATE (24,020) VEDOLIZUMAB (21,017) ETANERCEPT (20,178) TOCILIZUMAB (18,256) PREDNISONE (17,867) LENALIDOMIDE (17,017) ADALIMUMAB (16,417)

Which ISOTRETINOIN Alternatives Have Lower Off label use Risk?

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

Related Pages

ISOTRETINOIN Full Profile All Off label use Reports All Drugs Causing Off label use ISOTRETINOIN Demographics