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Prozac (fluoxetine)
Fluoxetine inhibits CNS neuronal uptake of serotonin, though exact mechanism unknown.
Fluoxetine is an SSRI indicated for major depressive disorder, OCD, bulimia nervosa, panic disorder, and bipolar I depression (in combination with olanzapine). It potently inhibits serotonin reuptake with peak plasma concentrations 6-8 hours after dosing and 94.5% protein binding. Major contraindications include MAOIs, linezolid, methylene blue, pimozide, and thioridazine due to serotonin syndrome and QT prolongation risks. Significant CYP2D6 inhibition requires careful monitoring with TCAs, antipsychotics, and anticonvulsants.
At a glance
| Generic name | fluoxetine |
|---|---|
| Also known as | Prozac, Sarafem |
| Sponsor | Eli Lilly and Company |
| Drug class | Selective Serotonin Reuptake Inhibitor (SSRI) |
| Target | Serotonin reuptake transporter |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1987-12-29 (United States) |
| Annual revenue | 1000 |
Mechanism of action
Fluoxetine is presumed to exert its therapeutic effects through inhibition of CNS neuronal uptake of serotonin. The drug is a racemic mixture of R-fluoxetine and S-fluoxetine enantiomers, with both demonstrating specific and potent serotonin uptake inhibition with essentially equivalent pharmacologic activity in animal models. The S-fluoxetine enantiomer is eliminated more slowly and becomes the predominant enantiomer at steady state.
Approved indications
- Bipolar affective disorder, current episode depression
- Bulimia nervosa
- Depressive disorder
- Major depressive disorder
- Obsessive-compulsive disorder
- Panic disorder
- Premenstrual dysphoric disorder
Common side effects
- Nausea
- Insomnia
- Diarrhea
- Somnolence
- Tremor
- Sweating
- Anxiety
- Nervousness
- Abnormal ejaculation
- Libido decreased
- Impotence
- Dry mouth
Drug interactions
- Monoamine Oxidase Inhibitors (MAOIs)
- Drugs metabolized by CYP2D6
- Tricyclic Antidepressants (TCAs)
- Benzodiazepines (Diazepam, Alprazolam)
- Antipsychotics (Haloperidol, Clozapine)
- Anticonvulsants (Phenytoin, Carbamazepine)
- Serotonergic drugs
- Drugs that interfere with hemostasis (NSAIDs, Aspirin, Warfarin)
- Drugs tightly bound to plasma proteins
- Drugs that prolong QT interval (Thioridazine, Pimozide)
- CNS acting drugs
Key clinical trials
- Assessing Tolerability and Efficacy of Vortioxetine Versus SSRIs in Elderly Patients With Depression: a Pragmatic, Multicenter, Open-label, Parallel-group, Superiority, Randomized Trial (Phase 4)
- Evaluating the Results of Physician and Parent Decisions to Treat Selective Mutism With Fluoxetine (Phase 2)
- Continuation Phase CBT for Youth With MDD (NA)
- A 12-Week Open-Label Trial of Once-Weekly Fluoxetine for the Treatment of Depression in Patients With End-Stage Renal Disease (Phase 4)
- A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY110140 in Healthy Japanese Male Subjects (Phase 1)
- Evaluation of the Efficacy of Serotoninergic Antidepressants in Bulimia Nervosa, According to Brain Serotonin Profile Determined by Positron Emission Tomography With [18F] MPPF - a Multicenter Study (Phase 4)
- Efficacy of Fluoxetine in Reducing Ictal Hypoventilation in Patients With Partial Epilepsy (NA)
- The Role of Antidepressants or Antipsychotics in Preventing Psychosis (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Prozac CI brief — competitive landscape report
- Prozac updates RSS · CI watch RSS
- Eli Lilly and Company portfolio CI