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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 SERTRALINE Cause Off label use? 1,865 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 1,865 reports of Off label use have been filed in association with SERTRALINE (Sertraline Hydrochloride). This represents 3.1% of all adverse event reports for SERTRALINE.

1,865
Reports of Off label use with SERTRALINE
3.1%
of all SERTRALINE reports
122
Deaths
661
Hospitalizations

How Dangerous Is Off label use From SERTRALINE?

Of the 1,865 reports, 122 (6.5%) resulted in death, 661 (35.4%) required hospitalization, and 99 (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 SERTRALINE. However, 1,865 reports have been filed with the FAERS database.

What Other Side Effects Does SERTRALINE Cause?

Drug ineffective (4,439) Toxicity to various agents (3,110) Nausea (3,105) Anxiety (2,981) Dizziness (2,697) Headache (2,597) Intentional overdose (2,540) Drug interaction (2,504) Diarrhoea (2,424) Fatigue (2,349)

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 SERTRALINE Alternatives Have Lower Off label use Risk?

SERTRALINE vs SETMELANOTIDE SERTRALINE vs SEVELAMER SERTRALINE vs SEVOFLURANE SERTRALINE vs SIBUTRAMINE SERTRALINE vs SILDENAFIL

Related Pages

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