Does ISOTRETINOIN Cause Cheilitis? 300 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 300 reports of Cheilitis have been filed in association with ISOTRETINOIN (Amnesteem). This represents 0.9% of all adverse event reports for ISOTRETINOIN.
300
Reports of Cheilitis with ISOTRETINOIN
0.9%
of all ISOTRETINOIN reports
3
Deaths
11
Hospitalizations
How Dangerous Is Cheilitis From ISOTRETINOIN?
Of the 300 reports, 3 (1.0%) resulted in death, 11 (3.7%) required hospitalization.
Is Cheilitis Listed in the Official Label?
Yes, Cheilitis 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 Cheilitis?
DUPILUMAB (183)
METHOTREXATE (101)
ADALIMUMAB (82)
CAPECITABINE (69)
EVEROLIMUS (63)
DOCOSANOL (61)
LAMOTRIGINE (59)
SULFAMETHOXAZOLE\TRIMETHOPRIM (59)
PALBOCICLIB (56)
IBUPROFEN (50)
Which ISOTRETINOIN Alternatives Have Lower Cheilitis Risk?
ISOTRETINOIN vs ISRADIPINE
ISOTRETINOIN vs ISTRADEFYLLINE
ISOTRETINOIN vs ITACITINIB
ISOTRETINOIN vs ITRACONAZOLE
ISOTRETINOIN vs ITRACONAZOLE\SODIUM