Fluoxetine
Fluoxetine, Prozac (fluoxetine) is a small molecule pharmaceutical. Fluoxetine was first approved as Prozac on 1987-12-29. It is used to treat bulimia, major depressive disorder, obsessive-compulsive disorder, and panic disorder in the USA. The pharmaceutical is active against sodium-dependent serotonin transporter. In addition, it is known to target anoctamin-1, voltage-gated potassium channel KCNC1, G protein-activated inward rectifier potassium channel 2, 5-hydroxytryptamine receptor 6, 5-hydroxytryptamine receptor 2B, equilibrative nucleoside transporter 4, 5-hydroxytryptamine receptor 2A, and 5-hydroxytryptamine receptor 2C.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| signs and symptoms pathological conditions | D013568 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
Fluoxetine, Sarafem (discontinued: Fluoxetine, Prozac, Sarafem, Selfemra)
CombinationsOlanzapine fluoxetine (discontinued: Symbyax)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fluoxetine | ANDA | 2026-02-17 |
| fluoxetine hcl | ANDA | 2026-01-27 |
| fluoxetine hydrochloride | ANDA | 2026-01-05 |
| gaboxetine | unapproved drug other | 2011-08-01 |
| olanzapine and fluoxetine | ANDA | 2025-10-15 |
| prozac | New Drug Application | 2026-01-08 |
| sentraflox am-10 | unapproved drug other | 2011-08-17 |
| sentroxatine | unapproved drug other | 2011-08-01 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N06: Psychoanaleptics
— N06A: Antidepressants
— N06AB: Selective serotonin reuptake inhibitors
— N06AB03: Fluoxetine
— N06C: Psycholeptics and psychoanaleptics in combination
— N06CA: Antidepressants in combination with psycholeptics
— N06CA03: Fluoxetine and psycholeptics
HCPCS
No data
Clinical
Clinical Trials
388 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 1 | — | 6 | 3 | 1 | 11 |
| Depression | D003863 | — | F33.9 | — | — | 5 | 5 | — | 10 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | — | 5 | 1 | 1 | 8 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | 1 | 1 | 3 | — | 5 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | 1 | 3 | — | 4 |
| Dysthymic disorder | D019263 | EFO_0008623 | F34.1 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Treatment-resistant depressive disorder | D061218 | — | — | — | — | 3 | — | — | 3 |
| Smoking | D012907 | EFO_0004318 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fluoxetine |
| INN | fluoxetine |
| Description | N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine is an aromatic ether consisting of 4-trifluoromethylphenol in which the hydrogen of the phenolic hydroxy group is replaced by a 3-(methylamino)-1-phenylpropyl group. It is a member of (trifluoromethyl)benzenes, an aromatic ether and a secondary amino compound. |
| Classification | Small molecule |
| Drug class | antidepressants (fluoxetine type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1 |
Identifiers
| PDB | — |
| CAS-ID | 54910-89-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL41 |
| ChEBI ID | 86990 |
| PubChem CID | 3386 |
| DrugBank | DB00472 |
| UNII ID | 01K63SUP8D (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
KCNC1
KCNC1
Organism
Homo sapiens
Gene name
KCNC1
Gene synonyms
NCBI Gene ID
Protein name
potassium voltage-gated channel subfamily C member 1
Protein synonyms
NGK2, potassium channel, voltage gated Shaw related subfamily C, member 1, voltage-gated potassium channel protein KV3.1, Voltage-gated potassium channel subunit Kv3.1, Voltage-gated potassium channel subunit Kv4
Uniprot ID
Mouse ortholog
Kcnc1 (16502)
potassium voltage-gated channel subfamily C member 1 (P15388)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Fluoxetine
Total medical expenditures per year (USD, in millions)
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Fluoxetine
+
Olanzapine
Total medical expenditures per year (USD, in millions)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,999 documents
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Safety
Black-box Warning
Black-box warning for: Fluoxetine, Fluoxetine hcl, Fluoxetine hydrochloride, Gaboxetine, Olanzapine and fluoxetine, Prozac, Sentraflox am-10, Sentroxatine
Adverse Events
Top Adverse Reactions
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50,756 adverse events reported
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