Fluoxetine: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Fluoxetine appears in the FDA drug-label database. Marketed as Fluoxetine.
- Boxed warning
- The FDA label for Fluoxetine carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
& USAGE Fluoxetine capsules are indicated for the treatment of: • Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. • Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2 )]. • Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3 )]. • Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4 ) ]. Fluoxetine capsules and Olanzapine in Combination is indicated for the treatment of: • Acute treatment of depressive episodes associated with Bipolar I Disorder. • Treatment Resistant Depression (Major Depressive Disorder in patient, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies se…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity. — Teva Pharmaceuticals USA | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2015-04-13 |
| CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. — Torrent Pharma Inc. | Class II (FDA: may cause temporary or reversible harm) | Completed | 2025-05-27 |
| Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. — Teva Pharmaceuticals USA | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2014-02-12 |
| Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. — Teva Pharmaceuticals USA | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2014-02-12 |
| Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor. — Legacy Pharmaceutical Packaging | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2014-02-14 |
Phase breakdown
Conditions being studied
Recruiting trials involving Fluoxetine
- Bariatric Surgery and Pharmacokinetics of Fluoxetine
- Dapagliflozin in Depression
- Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer
- Fluoxetine on Emotional Experience (FLEX) Study
- Psilocybe Cubensis Mushrooms With or Without Fluoxetine for Refractory Depression
- Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients
- Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)
- Study of Dextromethorphan in OCD and Related Disorders
- Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
- TDM-Guided Treatment With SSRIs in Hospitalized Adults and Children
- The Friendship Bench Plus Trial
Common questions
Is Fluoxetine FDA-approved?
Yes, marketed as Fluoxetine. Its FDA label carries a boxed warning.
How many recruiting trials involve Fluoxetine?
11 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.