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

Stem definition	Drug id	CAS RN
	1230	54739-18-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: fluvoxamine fluvoxamine maleate depromel	A selective serotonin reuptake inhibitor that is used in the treatment of DEPRESSION and a variety of ANXIETY DISORDERS. Because of its high affinity at the sigma-1 receptor, the drug was evaluated whether could prevent clinical deterioration in patients with COVID-19. At the moment, there are insufficient data to recommend either for or against use of fluvoxamine for the treatment of COVID-19. Molecular weight: 318.34 Formula: C15H21F3N2O2 CLOGP: 2.77 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 56.84 ALOGS: -4.64 ROTB: 10 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

fluvoxamine
fluvoxamine maleate
depromel

A selective serotonin reuptake inhibitor that is used in the treatment of DEPRESSION and a variety of ANXIETY DISORDERS. Because of its high affinity at the sigma-1 receptor, the drug was evaluated whether could prevent clinical deterioration in patients with COVID-19. At the moment, there are insufficient data to recommend either for or against use of fluvoxamine for the treatment of COVID-19.

Molecular weight: 318.34
Formula: C15H21F3N2O2
CLOGP: 2.77
LIPINSKI: 0
HAC: 4
HDO: 1
TPSA: 56.84
ALOGS: -4.64
ROTB: 10

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.10	g	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	53 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
CL (Clearance)	31.95 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	23.50 L/kg	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	2 %	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	14.87 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	13.46 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
t_half (Half-life)	12.50 hours	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	0.20 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Dec. 5, 1994	FDA

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
Drug interaction	344.34	18.75	243	6493	228888	63253398
Myoglobin urine present	283.86	18.75	52	6684	720	63481566
Serotonin syndrome	218.43	18.75	90	6646	28592	63453694
Toxic encephalopathy	194.88	18.75	57	6679	6522	63475764
Amylase increased	174.91	18.75	52	6684	6293	63475993
Suicide attempt	159.33	18.75	92	6644	60826	63421460
Troponin increased	158.84	18.75	54	6682	10067	63472219
Blood creatine phosphokinase increased	152.01	18.75	71	6665	30359	63451927
Intentional overdose	145.11	18.75	93	6643	74059	63408227
Blood potassium increased	131.04	18.75	55	6681	18254	63464032

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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
Loss of libido	211.93	22.45	55	5897	2497	34948482
Drug interaction	158.78	22.45	193	5759	225753	34725226
Apathy	153.87	22.45	54	5898	6878	34944101
Sedation	142.13	22.45	70	5882	20936	34930043
Schizophrenia	131.37	22.45	51	5901	8615	34942364
Psychotic disorder	126.44	22.45	68	5884	24384	34926595
Suicidal ideation	121.18	22.45	79	5873	40309	34910670
Serotonin syndrome	99.03	22.45	54	5898	19879	34931100
Neuroleptic malignant syndrome	76.58	22.45	44	5908	17890	34933089
Persecutory delusion	76.53	22.45	25	5927	2555	34948424

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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
Drug interaction	407.39	17.13	382	10540	414801	79318665
Serotonin syndrome	291.65	17.13	136	10786	44891	79688575
Myoglobin urine present	242.02	17.13	49	10873	898	79732568
Intentional overdose	185.76	17.13	137	10785	105823	79627643
Suicide attempt	174.80	17.13	120	10802	82812	79650654
Toxic encephalopathy	135.31	17.13	53	10869	11387	79722079
Intentional self-injury	133.24	17.13	72	10850	32347	79701119
Troponin increased	127.14	17.13	59	10863	19196	79714270
Blood creatine phosphokinase increased	123.77	17.13	89	10833	66001	79667465
Neuroleptic malignant syndrome	121.10	17.13	64	10858	27495	79705971

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N06AB08	NERVOUS SYSTEM PSYCHOANALEPTICS ANTIDEPRESSANTS Selective serotonin reuptake inhibitors
CHEBI has role	CHEBI:35469	antidepressants
CHEBI has role	CHEBI:35474	anti-anxiety agents
CHEBI has role	CHEBI:50949	SSRI
FDA EPC	N0000175696	Serotonin Reuptake Inhibitor
FDA MoA	N0000000109	Serotonin Uptake Inhibitors
MeSH PA	D014151	Anti-Anxiety Agents
MeSH PA	D000928	Antidepressive Agents
MeSH PA	D018687	Antidepressive Agents, Second-Generation
MeSH PA	D002491	Central Nervous System 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
Social phobia	indication	25501002	DOID:11257
Obsessive-compulsive disorder	indication	191736004	DOID:10933
Depressive disorder	off-label use	35489007
Posttraumatic stress disorder	off-label use	47505003	DOID:2055
Bipolar affective disorder, current episode depression	off-label use	191627008	DOID:3312
Suicidal thoughts	contraindication	6471006
Bipolar disorder	contraindication	13746004	DOID:3312
Neuroleptic malignant syndrome	contraindication	15244003	DOID:14464
Upper gastrointestinal hemorrhage	contraindication	37372002
Syndrome of inappropriate vasopressin secretion	contraindication	55004003	DOID:3401

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.36	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	Ki	8.51	WOMBAT-PK	CHEMBL
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		Ki	5.95	PDSP
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN		Ki	8.84	CHEMBL
Cytochrome P450 1A2	Enzyme	P05177	CP1A2_HUMAN		Ki	5.07	WOMBAT-PK
Sigma non-opioid intracellular receptor 1	Membrane receptor	Q99720	SGMR1_HUMAN		Ki	7.44	CHEMBL
Sodium-dependent serotonin transporter	Transporter		SC6A4_RAT	INHIBITOR	Ki	8.19	IUPHAR
Sigma non-opioid intracellular receptor 1	Membrane receptor		SGMR1_RAT		Ki	7.44	CHEMBL
Sigma intracellular receptor 2	Unclassified		SGMR2_RAT		Ki	5.07	CHEMBL

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External reference:

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ID	Source
FVX	PDB_CHEM_ID
003633	NDDF
003634	NDDF
116522003	SNOMEDCT_US
203143	RXNORM
372905008	SNOMEDCT_US
3879	INN_ID
4020892	VANDF
4023976	VUID
4023976	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Fluvoxamine Maleate	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2848	CAPSULE, EXTENDED RELEASE	100 mg	ORAL	ANDA	21 sections
Fluvoxamine Maleate	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2848	CAPSULE, EXTENDED RELEASE	100 mg	ORAL	ANDA	21 sections
Fluvoxamine Maleate	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2849	CAPSULE, EXTENDED RELEASE	150 mg	ORAL	ANDA	21 sections
Fluvoxamine Maleate	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2849	CAPSULE, EXTENDED RELEASE	150 mg	ORAL	ANDA	21 sections
Fluvoxamine maleate	HUMAN PRESCRIPTION DRUG LABEL	1	0832-1670	TABLET, FILM COATED	25 mg	ORAL	ANDA	34 sections
Fluvoxamine maleate	HUMAN PRESCRIPTION DRUG LABEL	1	0832-1670	TABLET, FILM COATED	25 mg	ORAL	ANDA	34 sections
Fluvoxamine maleate	HUMAN PRESCRIPTION DRUG LABEL	1	0832-1671	TABLET, FILM COATED	50 mg	ORAL	ANDA	34 sections
Fluvoxamine maleate	HUMAN PRESCRIPTION DRUG LABEL	1	0832-1671	TABLET, FILM COATED	50 mg	ORAL	ANDA	34 sections
Fluvoxamine maleate	HUMAN PRESCRIPTION DRUG LABEL	1	0832-1672	TABLET, FILM COATED	100 mg	ORAL	ANDA	34 sections
Fluvoxamine maleate	HUMAN PRESCRIPTION DRUG LABEL	1	0832-1672	TABLET, FILM COATED	100 mg	ORAL	ANDA	34 sections

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