Does ISOTRETINOIN Cause Proctitis? 34 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 34 reports of Proctitis have been filed in association with ISOTRETINOIN (Amnesteem). This represents 0.1% of all adverse event reports for ISOTRETINOIN.
34
Reports of Proctitis with ISOTRETINOIN
0.1%
of all ISOTRETINOIN reports
0
Deaths
8
Hospitalizations
How Dangerous Is Proctitis From ISOTRETINOIN?
Of the 34 reports, 8 (23.5%) required hospitalization.
Is Proctitis Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for ISOTRETINOIN. However, 34 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 Proctitis?
ADALIMUMAB (494)
VEDOLIZUMAB (356)
INFLIXIMAB (296)
MESALAMINE (275)
METRONIDAZOLE (230)
HYDROMORPHONE (226)
PREDNISONE (224)
ACETAMINOPHEN (223)
SULFAMETHOXAZOLE\TRIMETHOPRIM (207)
BUDESONIDE (204)
Which ISOTRETINOIN Alternatives Have Lower Proctitis Risk?
ISOTRETINOIN vs ISRADIPINE
ISOTRETINOIN vs ISTRADEFYLLINE
ISOTRETINOIN vs ITACITINIB
ISOTRETINOIN vs ITRACONAZOLE
ISOTRETINOIN vs ITRACONAZOLE\SODIUM