DULOXETINE
According to the FDA label: Duloxetine delayed-release capsules, USP are indicated for the treatment of: • Major depressive disorder in adults • Generalized anxiety disorder in adults and pediatric patients 7 years of age and older • Diabetic peripheral neuropathic pain in adults • Fibromyalgia in adults and pediatric patients 13 years of age and older • Chronic musculoskeletal pain in adults Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: •…
67,126 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with DULOXETINE 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 DULOXETINE. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
Report Volume Over Time
Number of FAERS reports received per quarter for DULOXETINE. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior — not changes in the medication's safety profile.
Related Drugs
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 →