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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 5-hydroxytryptamine receptor 2B, anoctamin-1, equilibrative nucleoside transporter 4, potassium voltage-gated channel subfamily C member 1, G protein-activated inward rectifier potassium channel 2, 5-hydroxytryptamine receptor 6, 5-hydroxytryptamine receptor 2A, and 5-hydroxytryptamine receptor 2C.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
mental disordersD001523
Trade Name
FDA
EMA
Prozac (generic drugs available since 2001-08-02, discontinued: Sarafem, Selfemra)
Combinations
Symbyax (generic drugs available since 2001-08-02)
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
FLUOXETINE HYDROCHLORIDEAlmatica PharmaN-202133 RX2011-10-06
1 products, RLD, RS
PROZACEli LillyN-018936 RX1987-12-29
3 products, RLD
Show 6 discontinued
Fluoxetine hydrochloride
+
Olanzapine
Tradename
Company
Number
Date
Products
SYMBYAXEli LillyN-021520 RX2003-12-24
5 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
fluoxetineANDA2023-06-20
prozacNew Drug Application2020-04-28
symbyaxNew Drug Application2021-09-20
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bulimia—D002032F50.2
major depressive disorderEFO_0003761D003865F22
obsessive-compulsive disorderEFO_0004242D009771F42
panic disorderEFO_0004262D016584F41.0
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
220 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DepressionD003863F33.9489111242
Major depressive disorderD003865EFO_0003761F2216188638
Healthy volunteers/patients—10——1314
Anxiety disordersD001008EFO_0006788F41.1—332210
Obsessive-compulsive disorderD009771EFO_0004242F4212—4310
Bipolar disorderD001714EFO_0000289F30.9——17210
StrokeD020521EFO_0000712I63.9—51129
Covid-19D000086382U07.11331—6
Human influenzaD007251EFO_0007328J11.1——1236
Premenstrual syndromeD011293N94.3——3115
Show 24 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Autistic disorderD001321EFO_0003758F84.0—22—26
Post-traumatic stress disordersD013313EFO_0001358F43.1—11—35
Treatment-resistant depressive disorderD061218——2—13
Social phobiaD000072861EFO_1001917F40.1——1—12
FibromyalgiaD005356EFO_0005687M79.1—11——2
EpilepsyD004827EFO_0000474G40.9—11——2
Severe acute respiratory syndrome-related coronavirusD045473NCBITaxon_227859——1——1
DementiaD003704F03——1——1
Psychophysiologic disordersD011602F45.9——1——1
Attempted suicideD013406EFO_0004321T14.91—11——1
Show 7 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cerebral infarctionD002544I63—1——12
Multiple system atrophyD019578—1——12
Ischemic strokeD000083242—2———2
Pulmonary arterial hypertensionD000081029—2———2
Cocaine-related disordersD019970F14—1——12
OverweightD050177E66.3—1———1
Chronic progressive multiple sclerosisD020528—1———1
Back painD001416HP_0003418M54—1———1
SciaticaD012585HP_0011868M54.3—1———1
Laron syndromeD046150Orphanet_633E34.321—1———1
Show 17 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Type 1 diabetes mellitusD003922EFO_0001359E102———13
Cognitive dysfunctionD060825G31.841———23
Pure autonomic failureD0549701————1
Hemorrhagic strokeD0000833021————1
Brain neoplasmsD001932EFO_0003833C711————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Wounds and injuriesD014947T14.8————22
Hot flashesD019584————22
Drug interactionsD004347————11
PainD010146EFO_0003843R52————11
Chronic diseaseD002908————11
Brain injuriesD001930S06.9————11
Suicidal ideationD059020EFO_0004320R45.851————11
Acute kidney injuryD058186HP_0001919N17————11
Panic disorderD016584EFO_0004262F41.0————11
Morbid obesityD009767EFO_0001074————11
Show 7 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFLUOXETINE
INNfluoxetine
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 classantidepressants (fluoxetine type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Identifiers
PDB6S3A
CAS-ID54910-89-3
RxCUI4493
ChEMBL IDCHEMBL41
ChEBI ID86990
PubChem CID3386
DrugBankDB00472
UNII ID01K63SUP8D (ChemIDplus, GSRS)
Target
Agency Approved
SLC6A4
SLC6A4
Organism
Homo sapiens
Gene name
SLC6A4
Gene synonyms
HTT, SERT
NCBI Gene ID
6532
Protein name
sodium-dependent serotonin transporter
Protein synonyms
5-hydroxytryptamine (serotonin) transporter, 5HT transporter, 5HTT, Na+/Cl- dependent serotonin transporter, serotonin transporter 1, solute carrier family 6 (neurotransmitter transporter), member 4, solute carrier family 6 (neurotransmitter transporter, serotonin), member 4, Solute carrier family 6 member 4
Uniprot ID
Q5EE02
Mouse ortholog
Slc6a4 (15567)
sodium-dependent serotonin transporter (Q60857)
Alternate
HTR2B
HTR2B
ANO1
ANO1
SLC29A4
SLC29A4
KCNC1
KCNC1
KCNJ6
KCNJ6
HTR6
HTR6
HTR2A
HTR2A
HTR2C
HTR2C
Organism
Homo sapiens
Gene name
HTR2B
Gene synonyms
NCBI Gene ID
3357
Protein name
5-hydroxytryptamine receptor 2B
Protein synonyms
5-HT 2B receptor, 5-hydroxytryptamine (serotonin) receptor 2B, G protein-coupled, 5-hydroxytryptamine 2B receptor, Serotonin receptor 2B
Uniprot ID
Q6P523
Mouse ortholog
Htr2b (15559)
5-hydroxytryptamine receptor 2B (Q9QWS2)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 38,862 documents
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Safety
Black-box Warning
Black-box warning for: Fluoxetine, Prozac, Symbyax
Adverse Events
Top Adverse Reactions
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15,674 adverse events reported
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