FDA-Approved Indications for Prozac (Fluoxetine)
Prozac is FDA-approved for five specific indications: major depressive disorder (both adults and pediatric patients), obsessive-compulsive disorder (both adults and pediatric patients), bulimia nervosa (adults only), and panic disorder with or without agoraphobia (adults only). 1
Detailed Breakdown by Indication
Major Depressive Disorder (MDD)
- Adults: Approved for acute treatment (established in 5-6 week trials) and maintenance therapy (up to 38 weeks demonstrated efficacy). Prozac Weekly formulation is also approved for once-weekly maintenance dosing after acute stabilization 1
- Pediatric (children and adolescents): Approved based on two 8-9 week placebo-controlled trials in depressed outpatients meeting DSM-III-R or DSM-IV criteria 1
Obsessive-Compulsive Disorder (OCD)
- Adults: Approved for treatment of obsessions and compulsions causing marked distress or functional impairment, established in 13-week trials. The optimal dose range is 40-60 mg daily 1, 2
- Pediatric (children and adolescents): Approved based on a 13-week dose titration trial in patients meeting DSM-IV criteria for OCD 1
Bulimia Nervosa
- Adults only: Approved for treatment of binge-eating and vomiting behaviors in moderate to severe bulimia nervosa (defined as ≥3 bulimic episodes per week for 6 months). Efficacy established in 8-16 week trials, with 60 mg/day demonstrating maintenance of response for up to 52 weeks 1, 3
Panic Disorder
- Adults only: Approved for panic disorder with or without agoraphobia as defined in DSM-IV. Efficacy established in two 12-week clinical trials 1
Critical Clinical Considerations
Important limitation: Prozac is NOT approved for use in hospitalized depressed patients, as effects in this population have not been adequately studied 1. Additionally, Prozac is not approved for bipolar depression, though olanzapine-fluoxetine combination is FDA-approved for this indication 4.
The FDA label emphasizes that only MDD and OCD are approved indications in the pediatric population—the other three indications are adult-only 1.