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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 Off label use? 207 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 207 reports of Off label use have been filed in association with PROMETHAZINE (Promethazine Hydrochloride). This represents 2.7% of all adverse event reports for PROMETHAZINE.

207
Reports of Off label use with PROMETHAZINE
2.7%
of all PROMETHAZINE reports
12
Deaths
102
Hospitalizations

How Dangerous Is Off label use From PROMETHAZINE?

Of the 207 reports, 12 (5.8%) resulted in death, 102 (49.3%) required hospitalization, and 11 (5.3%) were considered life-threatening.

Is Off label use Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for PROMETHAZINE. However, 207 reports have been filed with the FAERS database.

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) Somnolence (510) Drug abuse (359) Akathisia (343)

What Other Drugs Cause Off label use?

RITUXIMAB (39,751) INFLIXIMAB (34,801) DENOSUMAB (34,612) METHOTREXATE (24,020) VEDOLIZUMAB (21,017) ETANERCEPT (20,178) TOCILIZUMAB (18,256) PREDNISONE (17,867) LENALIDOMIDE (17,017) ADALIMUMAB (16,417)

Which PROMETHAZINE Alternatives Have Lower Off label use Risk?

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

Related Pages

PROMETHAZINE Full Profile All Off label use Reports All Drugs Causing Off label use PROMETHAZINE Demographics