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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 Fistula? 27 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 27 reports of Fistula have been filed in association with ISOTRETINOIN (Amnesteem). This represents 0.1% of all adverse event reports for ISOTRETINOIN.

27
Reports of Fistula with ISOTRETINOIN
0.1%
of all ISOTRETINOIN reports
0
Deaths
5
Hospitalizations

How Dangerous Is Fistula From ISOTRETINOIN?

Of the 27 reports, 5 (18.5%) required hospitalization.

Is Fistula Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for ISOTRETINOIN. However, 27 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 Fistula?

ADALIMUMAB (1,882) INFLIXIMAB (1,170) INFLIXIMAB-DYYB (866) VEDOLIZUMAB (589) USTEKINUMAB (316) BEVACIZUMAB (215) METHOTREXATE (197) RISANKIZUMAB-RZAA (190) ZOLEDRONIC ACID (189) UPADACITINIB (124)

Which ISOTRETINOIN Alternatives Have Lower Fistula Risk?

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

Related Pages

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