Duloxetine

What it is and how it works

Mechanism of Action Although the exact mechanisms of the antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.

Indications

Duloxetine delayed-release capsules 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 delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: Major depressive disorder (MDD) in adults Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older Diabetic peripheral neuropathic pain (DPNP) in adults Fibromyalgia (FM) in adults and pediatric patients 13 years of age and older Chronic musculoskeletal pain in adults

Dosage and administration (summary)

Take duloxetine delayed-release capsules once daily, with or without food. Swallow whole; do not crush, or chew, or open capsule Indication Starting Dose Target Dose Maximum Dose MDD 40 mg/day to 60 mg/day Acute Treatment: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance Treatment: 60 mg/day 120 mg/day GAD Adults 60 mg/day 60 mg/day (once daily) 120 mg/day Geriatric 30 mg/day 60 mg/day (once daily) 120 mg/day Pediatrics (7 years to 17 years of age) 30 mg/day 30 to 60 mg/day (once daily) 120 mg/day DPNP 60 mg/day 60 mg/day (once daily) 60 mg/day FM Adults and Pediatrics (13 years to 17 years of age) 30 mg/day 60 mg/day (once daily) 60 mg/day Chronic…

Contraindications

The use of MAOIs intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine is contraindicated because of an increased risk of serotonin syndrome. The use of duloxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders is contraindicated .

Warnings and precautions

Hepatotoxicity : Hepatic failure, sometimes fatal, has been reported. Discontinue duloxetine in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Avoid use in patients with substantial alcohol use or evidence of chronic liver disease Orthostatic Hypotension, Falls and Syncope : Consider dosage reduction or discontinuation if these events occur Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents but also when taken alone.

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors the pregnancy outcomes in women exposed to antidepressants, including duloxetine, during pregnancy.

Storage and supply

How Supplied Duloxetine delayed-release capsules are available in the following strengths, colors, imprints, and presentations: NDC 68071-3519-3 BOTTLES OF 30 a equivalent to duloxetine base Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [ see USP Controlled Room Temperature].

Source: Duloxetine (Duloxetine) — US FDA prescribing information, 2026-03-19, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.