Duloxetine: US FDA label indications

Indications and usage (label excerpt)

1 INDICATIONS AND USAGE Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: Major Depressive Disorder (MDD) ( 1.1 ) Generalized Anxiety Disorder (GAD) ( 1.2 ) Diabetic Peripheral Neuropathic Pain (DPNP) ( 1.3 ) Fibromyalgia (FM) ( 1.4 ) Chronic Musculoskeletal Pain ( 1.5 ) 1.1 Major Depressive Disorder Duloxetine is indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine was established in four short-term and one maintenance trial in adults [see Clinical Studies ( 14.1 )] . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation. 1.2 Generalized Anxiety Disorder Duloxetine is indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of duloxetine was established in three short-term trials and one maintenance trial in adults [see Clinical Studies ( 14.2 )] . Generalized anxiety disorder is defined by the DSM-IV as excessive anxiety and worry, present more days than not, for at least 6 months. The ex…

Warnings (label excerpt)

5 WARNINGS AND PRECAUTIONS Suicidality: Monitor for clinical worsening and suicide risk ( 5.1 ) Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with duloxetine. Duloxetine should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Duloxetine should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease ( 5.2 ) Orthostatic Hypotension and Syncope: Cases have been reported with duloxetine therapy ( 5.3 ) Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including with duloxetine, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone and St. John's Wort). If such symptoms occur, discontinue duloxetine and initiate supportive…

Excerpts are shortened. Read the full label, and ask a pharmacist or prescriber about any medicine. Full label on DailyMed(opens in a new tab) For products sold in Canada, see the Health Canada Drug Product Database(opens in a new tab).

Trials whose interventions mention this drug

Canadian trials first. A match on the drug name does not mean the trial studied this specific product.