VENLAFAXINE

According to the FDA label: INDICATIONS & USAGE Venlafaxine tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS ).

69,658 adverse event reports submitted to the FDA (2002–2026)

This data reflects voluntary reports submitted to the FDA's Adverse Event Reporting System (FAERS). A report does not mean the medication caused the event. Data may be incomplete or contain errors. Learn more about FAERS.

Top Reported Adverse Events

The most frequently reported events in association with VENLAFAXINE in the FAERS database. These are events reported by patients taking this medication — not necessarily caused by it. A single report may include multiple events.

Who Is Reporting

Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.

By Sex

By Age Group

Reported Outcomes

Outcomes recorded in FAERS reports that included VENLAFAXINE. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.

Number of FAERS reports received per quarter for VENLAFAXINE. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior — not changes in the medication's safety profile.

Other medications with similar adverse event profiles in FDA FAERS reports.

Data Source

This data is sourced from the FDA Adverse Event Reporting System (FAERS) via the OpenFDA API. PillSignal is not affiliated with the FDA.

View this data on the FDA website →