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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 PROMETHAZINE Cause Somnolence? 510 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 510 reports of Somnolence have been filed in association with PROMETHAZINE (Promethazine Hydrochloride). This represents 6.5% of all adverse event reports for PROMETHAZINE.

510
Reports of Somnolence with PROMETHAZINE
6.5%
of all PROMETHAZINE reports
26
Deaths
393
Hospitalizations

How Dangerous Is Somnolence From PROMETHAZINE?

Of the 510 reports, 26 (5.1%) resulted in death, 393 (77.1%) required hospitalization, and 9 (1.8%) were considered life-threatening.

Is Somnolence Listed in the Official Label?

Yes, Somnolence is listed as a known adverse reaction in the official FDA drug label for PROMETHAZINE.

What Other Side Effects Does PROMETHAZINE Cause?

Intentional overdose (3,193) Intentional self-injury (2,869) Toxicity to various agents (742) Tachycardia (653) Drug hypersensitivity (627) Fatigue (617) Depressed level of consciousness (522) Drug abuse (359) Akathisia (343) Nausea (314)

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 PROMETHAZINE Alternatives Have Lower Somnolence Risk?

PROMETHAZINE vs PROMETHAZINE\PROMETHAZINE PROMETHAZINE vs PROMETHAZINE\THIOUREA PROMETHAZINE vs PROPAFENONE PROMETHAZINE vs PROPARACAINE PROMETHAZINE vs PROPECIA

Related Pages

PROMETHAZINE Full Profile All Somnolence Reports All Drugs Causing Somnolence PROMETHAZINE Demographics