Fluoxetine
Fluoxetine, Prozac, Symbyax (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, Symbyax
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fluoxetine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PROZAC | Eli Lilly | N-018936 RX | 1987-12-29 | 3 products, RLD |
| FLUOXETINE HYDROCHLORIDE | TWi Pharmaceuticals | N-202133 RX | 2011-10-06 | 1 products, RLD, RS |
Show 6 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fluoxetine | ANDA | 2024-10-20 |
| fluoxetine hcl | New Drug Application | 2024-05-01 |
| fluoxetine hydrochloride | ANDA | 2024-09-18 |
| gaboxetine | unapproved drug other | 2011-08-01 |
| olanzapine and fluoxetine | ANDA | 2024-04-19 |
| prozac | New Drug Application | 2023-08-18 |
| sentraflox am-10 | unapproved drug other | 2011-08-17 |
| sentroxatine | unapproved drug other | 2011-08-01 |
| symbyax | New Drug Application | 2023-08-18 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
HCPCS
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Clinical
Clinical Trials
362 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | — | F33.9 | 12 | 31 | 31 | 40 | 58 | 163 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 12 | 31 | 31 | 40 | 44 | 148 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 8 | 20 | 23 | 22 | 27 | 94 |
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | 1 | 3 | 1 | 8 | 7 | 19 |
| Healthy volunteers/patients | — | — | — | 11 | — | — | 1 | 4 | 16 |
| Compulsive personality disorder | D003193 | — | F60.5 | — | 1 | 1 | 8 | 6 | 16 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | 3 | 4 | 3 | 4 | 14 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 1 | 1 | 1 | 10 | 2 | 14 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 8 | 1 | 1 | 3 | 13 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | 2 | 2 | 1 | 2 | 4 | 11 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | 1 | 1 | — | 5 | 7 |
| Autistic disorder | D001321 | HP_0000717 | F84.0 | — | 2 | 2 | — | 2 | 6 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | 1 | 1 | — | 1 | 3 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | — | 1 | 2 | — | — | 2 |
| Somatoform disorders | D013001 | — | F45 | — | 1 | 1 | — | — | 2 |
| Social phobia | D000072861 | EFO_1001917 | F40.1 | — | — | 1 | — | 1 | 2 |
| Urinary incontinence | D014549 | HP_0000020 | R32 | — | — | 1 | — | 1 | 2 |
| Nocturnal enuresis | D053206 | — | N39.44 | — | — | 1 | — | 1 | 2 |
| Enuresis | D004775 | — | R32 | — | — | 1 | — | 1 | 2 |
| Seizures | D012640 | HP_0002069 | G40.4 | — | 1 | 1 | — | — | 2 |
Show 22 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 1 | — | — | 2 | 3 |
| Cerebral infarction | D002544 | — | I63 | — | 2 | — | — | 1 | 3 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | 2 | 3 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | 1 | — | — | 1 | 2 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | — | — | 1 | 2 |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | 2 | — | — | — | 2 |
| Sleep deprivation | D012892 | — | F51.12 | 1 | 2 | — | — | — | 2 |
| Infarction | D007238 | EFO_0009463 | — | — | 1 | — | — | 1 | 2 |
| Shy-drager syndrome | D012791 | EFO_1001050 | — | — | 1 | — | — | 1 | 2 |
| Multiple system atrophy | D019578 | — | — | — | 1 | — | — | 1 | 2 |
Show 38 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 2 | — | — | — | 6 | 8 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 2 | — | — | — | 2 | 4 |
| Hypoglycemia | D007003 | HP_0001943 | E16.2 | 1 | — | — | — | 3 | 4 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | 1 | — | — | — | 2 | 3 |
| Pure autonomic failure | D054970 | — | — | 1 | — | — | — | 1 | 2 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 2 | — | — | — | — | 2 |
| Body weight | D001835 | EFO_0004338 | — | 1 | — | — | — | — | 1 |
| Weight loss | D015431 | HP_0001824 | — | 1 | — | — | — | — | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | — | 1 | — | — | — | — | 1 |
Show 1 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 4 | 4 |
| Taste disorders | D013651 | — | — | — | — | — | — | 3 | 3 |
| Drug interactions | D004347 | — | — | — | — | — | — | 2 | 2 |
| Chronic pain | D059350 | HP_0012532 | — | — | — | — | — | 2 | 2 |
| Suicidal ideation | D059020 | EFO_0004320 | R45.851 | — | — | — | — | 2 | 2 |
| Hot flashes | D019584 | — | — | — | — | — | — | 2 | 2 |
| Cardiac surgical procedures | D006348 | — | — | — | — | — | — | 2 | 2 |
| Orthopedic procedures | D019637 | — | — | — | — | — | — | 2 | 2 |
| Magnetic resonance imaging | D008279 | — | — | — | — | — | — | 2 | 2 |
| Sleep wake disorders | D012893 | — | G47 | — | — | — | — | 1 | 1 |
Show 39 more
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
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Financial
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Estimated US medical usage
Fluoxetine
Total medical expenditures per year (USD, in millions)
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Fluoxetine
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Olanzapine
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 43,945 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, Symbyax
Adverse Events
Top Adverse Reactions
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46,151 adverse events reported
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