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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CYMBALTA safely and effectively. See full prescribing information for CYMBALTA. CYMBALTA (duloxetine hydrochloride) capsule, delayed release for oral use Initial U.S. Approval: 2004
Medication labelWhy this: Advisory · dailymed-prescription
Cymbalta is indicated for the treatment of major depressive disorder (MDD). The efficacy of Cymbalta 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. Cymbalta is indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of Cymbalta 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 excessive anxiety and worry must be difficult to control and must cause significant distress or impairment in normal functioning. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and/or sleep disturbance. Cymbalta is indicated for the management of neuropathic pain (DPNP) associated with diabetic peripheral neuropathy [see Clinical Studies (14.3)]. Cymbalta is indicated for the management of fibromyalgia (FM) [see Clinical Studies (14.4)].
- generic_name
- duloxetine hydrochloride
- product_names
- Duloxetine hydrochloride
- ndc
- 54868-5215, 0002-3235, 54868-5215-0, 54868-5215-1, 54868-5215-2, 54868-5315, 0002-3240, 54868-5315-0, 54868-5315-1, 54868-5315-2, 54868-5192, 0002-3237, 54868-5192-0, 54868-5192-1, 54868-5192-2, 54868-5192-3
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en