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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Therapeutic Areas

Therapeutic Area	MeSH
signs and symptoms pathological conditions	D013568
mental disorders	D001523

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)

Abbreviated New Drug Application (ANDA)

Fluoxetine hydrochloride

Tradename	Company	Number	Date	Products
FLUOXETINE HYDROCHLORIDE	Almatica Pharma	N-202133 RX	2011-10-06	1 products, RLD, RS
PROZAC	Eli Lilly	N-018936 RX	1987-12-29	3 products, RLD

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Fluoxetine hydrochloride

Olanzapine

Tradename	Company	Number	Date	Products
SYMBYAX	Eli Lilly	N-021520 RX	2003-12-24	5 products, RLD

Labels

FDA

EMA

Brand Name	Status	Last Update
fluoxetine	ANDA	2023-06-20
prozac	New Drug Application	2020-04-28
symbyax	New Drug Application	2021-09-20

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
bulimia	—	D002032	F50.2
major depressive disorder	EFO_0003761	D003865	F22
obsessive-compulsive disorder	EFO_0004242	D009771	F42
panic disorder	EFO_0004262	D016584	F41.0

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
Depression	D003863		F33.9	4	8	9	11	12	42
Major depressive disorder	D003865	EFO_0003761	F22	1	6	18	8	6	38
Healthy volunteers/patients	—			10	—	—	1	3	14
Anxiety disorders	D001008	EFO_0006788	F41.1	—	3	3	2	2	10
Obsessive-compulsive disorder	D009771	EFO_0004242	F42	1	2	—	4	3	10
Bipolar disorder	D001714	EFO_0000289	F30.9	—	—	1	7	2	10
Stroke	D020521	EFO_0000712	I63.9	—	5	1	1	2	9
Covid-19	D000086382		U07.1	1	3	3	1	—	6
Human influenza	D007251	EFO_0007328	J11.1	—	—	1	2	3	6
Premenstrual syndrome	D011293		N94.3	—	—	3	1	1	5

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Autistic disorder	D001321	EFO_0003758	F84.0	—	2	2	—	2	6
Post-traumatic stress disorders	D013313	EFO_0001358	F43.1	—	1	1	—	3	5
Treatment-resistant depressive disorder	D061218			—	—	2	—	1	3
Social phobia	D000072861	EFO_1001917	F40.1	—	—	1	—	1	2
Fibromyalgia	D005356	EFO_0005687	M79.1	—	1	1	—	—	2
Epilepsy	D004827	EFO_0000474	G40.9	—	1	1	—	—	2
Severe acute respiratory syndrome-related coronavirus	D045473	NCBITaxon_227859		—	—	1	—	—	1
Dementia	D003704		F03	—	—	1	—	—	1
Psychophysiologic disorders	D011602		F45.9	—	—	1	—	—	1
Attempted suicide	D013406	EFO_0004321	T14.91	—	1	1	—	—	1

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Cerebral infarction	D002544		I63	—	1	—	—	1	2
Multiple system atrophy	D019578			—	1	—	—	1	2
Ischemic stroke	D000083242			—	2	—	—	—	2
Pulmonary arterial hypertension	D000081029			—	2	—	—	—	2
Cocaine-related disorders	D019970		F14	—	1	—	—	1	2
Overweight	D050177		E66.3	—	1	—	—	—	1
Chronic progressive multiple sclerosis	D020528			—	1	—	—	—	1
Back pain	D001416	HP_0003418	M54	—	1	—	—	—	1
Sciatica	D012585	HP_0011868	M54.3	—	1	—	—	—	1
Laron syndrome	D046150	Orphanet_633	E34.321	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Type 1 diabetes mellitus	D003922	EFO_0001359	E10	2	—	—	—	1	3
Cognitive dysfunction	D060825		G31.84	1	—	—	—	2	3
Pure autonomic failure	D054970			1	—	—	—	—	1
Hemorrhagic stroke	D000083302			1	—	—	—	—	1
Brain neoplasms	D001932	EFO_0003833	C71	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Wounds and injuries	D014947		T14.8	—	—	—	—	2	2
Hot flashes	D019584			—	—	—	—	2	2
Drug interactions	D004347			—	—	—	—	1	1
Pain	D010146	EFO_0003843	R52	—	—	—	—	1	1
Chronic disease	D002908			—	—	—	—	1	1
Brain injuries	D001930		S06.9	—	—	—	—	1	1
Suicidal ideation	D059020	EFO_0004320	R45.851	—	—	—	—	1	1
Acute kidney injury	D058186	HP_0001919	N17	—	—	—	—	1	1
Panic disorder	D016584	EFO_0004262	F41.0	—	—	—	—	1	1
Morbid obesity	D009767	EFO_0001074		—	—	—	—	1	1

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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	6S3A
CAS-ID	54910-89-3
RxCUI	4493
ChEMBL ID	CHEMBL41
ChEBI ID	86990
PubChem CID	3386
DrugBank	DB00472
UNII ID	01K63SUP8D (ChemIDplus, GSRS)

Target

Agency Approved

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

ANO1

SLC29A4

KCNC1

KCNJ6

HTR6

HTR2A

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

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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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