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fluoxetine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
serotonin and/or norepinephrine reuptake inhibitors, fluoxetine derivatives	1209	54910-89-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: prozac fluoxetine fluoxetine hydrochloride fluoxetin fluoxetine HCl	The first highly specific serotonin uptake inhibitor. It is used as an antidepressant and often has a more acceptable side-effects profile than traditional antidepressants. Molecular weight: 309.33 Formula: C17H18F3NO CLOGP: 4.57 LIPINSKI: 0 HAC: 2 HDO: 1 TPSA: 21.26 ALOGS: -5.26 ROTB: 7 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

prozac
fluoxetine
fluoxetine hydrochloride
fluoxetin
fluoxetine HCl

The first highly specific serotonin uptake inhibitor. It is used as an antidepressant and often has a more acceptable side-effects profile than traditional antidepressants.

Molecular weight: 309.33
Formula: C17H18F3NO
CLOGP: 4.57
LIPINSKI: 0
HAC: 2
HDO: 1
TPSA: 21.26
ALOGS: -5.26
ROTB: 7

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
20	mg	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	60 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
MRTD (Maximum Recommended Therapeutic Daily Dose)	4.30 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
S (Water solubility)	14 mg/mL	Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine)	1.25 %	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	0.02 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

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Approvals:

Date	Agency	Company	Orphan
Dec. 29, 1987	FDA	ELI LILLY AND CO

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Completed suicide	1679.45	9.67	1886	147625	143787	63195724
Intentional overdose	1039.73	9.67	1066	148445	73086	63266425
Toxicity to various agents	982.12	9.67	1939	147572	245311	63094200
Suicidal ideation	879.69	9.67	900	148611	61521	63277990
Drug abuse	610.62	9.67	802	148709	71716	63267795
Serotonin syndrome	591.26	9.67	511	149000	28171	63311340
Suicide attempt	589.33	9.67	722	148789	60196	63279315
Intentional self-injury	585.70	9.67	485	149026	25202	63314309
Drug interaction	557.91	9.67	1482	148029	227649	63111862
Electrocardiogram QT prolonged	404.55	9.67	594	148917	58936	63280575

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Serotonin syndrome	998.34	11.13	554	62608	19379	34874390
Suicidal ideation	461.07	11.13	460	62702	39928	34853841
Completed suicide	428.15	11.13	691	62471	97477	34796292
Toxicity to various agents	421.04	11.13	1038	62124	199324	34694445
Suicide attempt	414.52	11.13	428	62734	38688	34855081
Intentional overdose	350.36	11.13	413	62749	43261	34850508
Drug interaction	325.23	11.13	1020	62142	224926	34668843
Obsessive-compulsive disorder	321.00	11.13	170	62992	5394	34888375
Akathisia	286.38	11.13	180	62982	7929	34885840
Euphoric mood	218.95	11.13	133	63029	5508	34888261

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Completed suicide	2158.64	9.71	2636	167475	243131	79331146
Serotonin syndrome	1420.23	9.71	991	169120	44036	79530241
Toxicity to various agents	1297.17	9.71	2806	167305	418734	79155543
Intentional overdose	1288.86	9.71	1348	168763	104612	79469665
Suicidal ideation	1055.30	9.71	1041	169070	75299	79498978
Suicide attempt	785.31	9.71	926	169185	82006	79492271
Drug interaction	776.93	9.71	2290	167821	412893	79161384
Drug abuse	668.05	9.71	1224	168887	161467	79412810
Intentional self-injury	566.76	9.71	504	169607	31915	79542362
Electrocardiogram QT prolonged	487.22	9.71	768	169343	89618	79484659

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FDA Adverse Event Reporting System (Pediatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Feeling jittery	45.63	22.91	18	774	44	88956
Exposure during pregnancy	32.11	22.91	48	744	1286	87714
Hypertonia neonatal	27.90	22.91	23	769	304	88696
Tremor neonatal	22.95	22.91	13	779	87	88913

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Pharmacologic Action:

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Source	Code	Description
ATC	N06AB03	NERVOUS SYSTEM PSYCHOANALEPTICS ANTIDEPRESSANTS Selective serotonin reuptake inhibitors
ATC	N06CA03	NERVOUS SYSTEM PSYCHOANALEPTICS PSYCHOLEPTICS AND PSYCHOANALEPTICS IN COMBINATION Antidepressants in combination with psycholeptics
CHEBI has role	CHEBI:35469	antidepressants
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:50949	SSRI
CHEBI has role	CHEBI:78298	environmental contaminants
CHEBI has role	CHEBI:88188	allergenic drug
FDA EPC	N0000175696	Serotonin Reuptake Inhibitor
FDA MoA	N0000000109	Serotonin Uptake Inhibitors
MeSH PA	D000928	Antidepressive Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Premenstrual dysphoric disorder	indication	596004
Depressive disorder	indication	35489007
Bulimia nervosa	indication	78004001
Bipolar affective disorder, current episode depression	indication	191627008	DOID:3312
Obsessive-compulsive disorder	indication	191736004	DOID:10933
Major depressive disorder	indication	370143000
Panic disorder	indication	371631005	DOID:594
Posttraumatic stress disorder	off-label use	47505003	DOID:2055
Postpartum depression	off-label use	58703003	DOID:9478
Cataplexy and narcolepsy	off-label use	193042000

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🐶 Veterinary Drug Use

Species	Use	Relation
Dogs	Separation anxiety	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Reconcile	Pegasus Laboratories Inc.	1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.32	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN	INHIBITOR	Kd	9.09	WOMBAT-PK	CHEMBL
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN		Ki	8.20	CHEMBL
Sigma non-opioid intracellular receptor 1	Membrane receptor	Q99720	SGMR1_HUMAN		IC50	6.07	CHEMBL
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	6.16	WOMBAT-PK
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		Kd	6.62	WOMBAT-PK
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN		Ki	6.61	WOMBAT-PK
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN	ANTAGONIST	Ki	5.30	IUPHAR
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN		Ki	6.40	WOMBAT-PK
5-hydroxytryptamine receptor 6	GPCR	P50406	5HT6R_HUMAN		Ki	6.11	CHEMBL
Alpha-1A adrenergic receptor	GPCR	P35348	ADA1A_HUMAN		Ki	5.70	PDSP

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External reference:

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ID	Source
RFX	PDB_CHEM_ID
001514	NDDF
004613	NDDF
01K63SUP8D	UNII
17711	MMSL
203	IUPHAR_LIGAND_ID
227224	RXNORM
28237	MMSL
3386	PUBCHEM_CID
372767007	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Fluoxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-0807	TABLET, FILM COATED	20 mg	ORAL	ANDA	32 sections
Fluoxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-0807	TABLET, FILM COATED	20 mg	ORAL	ANDA	32 sections
Fluoxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-0807	TABLET, FILM COATED	20 mg	ORAL	ANDA	32 sections
Fluoxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5262	TABLET, FILM COATED	60 mg	ORAL	ANDA	32 sections
Fluoxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5262	TABLET, FILM COATED	60 mg	ORAL	ANDA	32 sections
Fluoxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7188	TABLET, FILM COATED	10 mg	ORAL	ANDA	32 sections
Fluoxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7188	TABLET, FILM COATED	10 mg	ORAL	ANDA	32 sections
Fluoxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7188	TABLET, FILM COATED	10 mg	ORAL	ANDA	32 sections
Fluoxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7198	CAPSULE	40 mg	ORAL	ANDA	31 sections
Fluoxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7198	CAPSULE	40 mg	ORAL	ANDA	31 sections

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