Does ISOTRETINOIN Cause Somnolence? 73 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 73 reports of Somnolence have been filed in association with ISOTRETINOIN (Amnesteem). This represents 0.2% of all adverse event reports for ISOTRETINOIN.
73
Reports of Somnolence with ISOTRETINOIN
0.2%
of all ISOTRETINOIN reports
1
Deaths
7
Hospitalizations
How Dangerous Is Somnolence From ISOTRETINOIN?
Of the 73 reports, 1 (1.4%) resulted in death, 7 (9.6%) required hospitalization, and 2 (2.7%) were considered life-threatening.
Is Somnolence Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for ISOTRETINOIN. However, 73 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 Somnolence?
PREGABALIN (5,528)
QUETIAPINE (4,394)
ACETAMINOPHEN (3,923)
GABAPENTIN (3,798)
SODIUM OXYBATE (3,642)
CETIRIZINE (3,058)
OLANZAPINE (2,612)
DIAZEPAM (2,547)
RISPERIDONE (2,496)
OXYCODONE (2,494)
Which ISOTRETINOIN Alternatives Have Lower Somnolence Risk?
ISOTRETINOIN vs ISRADIPINE
ISOTRETINOIN vs ISTRADEFYLLINE
ISOTRETINOIN vs ITACITINIB
ISOTRETINOIN vs ITRACONAZOLE
ISOTRETINOIN vs ITRACONAZOLE\SODIUM