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paroxetine 🐶 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	2068	61869-08-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: BRL 29060A BRL-29060A paroxetine hydrochloride hydrate brisdelle paroxetine paxetil paxil paroxetine hydrochloride paroxetine mesylate paroxetine hydrochloride hemihydrate paroxetine hydrochloride anhydrous paroxetine mesilate paroxetine HCl	A serotonin uptake inhibitor that is effective in the treatment of depression. Molecular weight: 329.37 Formula: C19H20FNO3 CLOGP: 4.24 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 39.72 ALOGS: -4.59 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

BRL 29060A
BRL-29060A
paroxetine hydrochloride hydrate
brisdelle
paroxetine
paxetil
paxil
paroxetine hydrochloride
paroxetine mesylate
paroxetine hydrochloride hemihydrate
paroxetine hydrochloride anhydrous
paroxetine mesilate
paroxetine HCl

A serotonin uptake inhibitor that is effective in the treatment of depression.

Molecular weight: 329.37
Formula: C19H20FNO3
CLOGP: 4.24
LIPINSKI: 0
HAC: 4
HDO: 1
TPSA: 39.72
ALOGS: -4.59
ROTB: 4

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)	50 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
S (Water solubility)	5.40 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	2.53 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
EoM (Fraction excreted unchanged in urine)	2 %	Benet LZ, Broccatelli F, Oprea TI
CL (Clearance)	18 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	18 L/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	13 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)	0.06 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Dec. 29, 1992	FDA	APOTEX TECHNOLOGIES

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 withdrawal syndrome	939.65	10.27	585	108886	26609	63352942
Serotonin syndrome	770.45	10.27	527	108944	28155	63351396
Atrial septal defect	763.87	10.27	326	109145	6612	63372939
Suicidal ideation	498.82	10.27	576	108895	61845	63317706
Ventricular septal defect	427.35	10.27	189	109282	4189	63375362
Sopor	396.47	10.27	319	109152	21845	63357706
Patent ductus arteriosus	394.11	10.27	177	109294	4073	63375478
Drug abuse	380.23	10.27	543	108928	71975	63307576
Suicide attempt	356.55	10.27	481	108990	60437	63319114
Exposure during pregnancy	317.82	10.27	776	108695	154771	63224780

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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
Exposure during pregnancy	1837.68	11.53	641	53284	8293	34894713
Atrial septal defect	826.73	11.53	340	53585	7052	34895954
Ventricular septal defect	554.96	11.53	215	53710	3786	34899220
Patent ductus arteriosus	496.53	11.53	189	53736	3165	34899841
Foetal exposure during pregnancy	446.32	11.53	410	53515	37691	34865315
Drug withdrawal syndrome	411.57	11.53	298	53627	19536	34883470
Cardiac murmur	345.78	11.53	190	53735	7647	34895359
Congenital anomaly	309.49	11.53	106	53819	1287	34901719
Suicidal ideation	305.10	11.53	343	53582	40045	34862961
Serotonin syndrome	300.91	11.53	248	53677	19685	34883321

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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
Serotonin syndrome	976.89	10.33	701	125014	44326	79574347
Drug withdrawal syndrome	779.44	10.33	552	125163	34166	79584507
Suicidal ideation	615.69	10.33	678	125037	75662	79543011
Suicide attempt	532.32	10.33	655	125060	82277	79536396
Sopor	511.74	10.33	421	125294	32589	79586084
Drug abuse	436.01	10.33	858	124857	161833	79456840
Anxiety	428.36	10.33	1099	124616	247413	79371260
Agitation	357.61	10.33	597	125118	99118	79519555
Tremor	339.39	10.33	796	124919	169287	79449386
Completed suicide	296.18	10.33	956	124759	244811	79373862

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N06AB05	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:50183	P450 inhibitors
CHEBI has role	CHEBI:50908	agente hepatotoxico
CHEBI has role	CHEBI:50949	SSRI
FDA EPC	N0000175696	Serotonin Reuptake Inhibitor
FDA MoA	N0000000109	Serotonin Uptake Inhibitors
MeSH PA	D000928	Antidepressive Agents
MeSH PA	D018687	Antidepressive Agents, Second-Generation

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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
Generalized anxiety disorder	indication	21897009	DOID:14320
Social phobia	indication	25501002	DOID:11257
Depressive disorder	indication	35489007
Posttraumatic stress disorder	indication	47505003	DOID:2055
Obsessive-compulsive disorder	indication	191736004	DOID:10933
Menopausal flushing	indication	198436008
Major depressive disorder	indication	370143000
Panic disorder	indication	371631005	DOID:594
Bipolar affective disorder, current episode depression	off-label use	191627008	DOID:3312

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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	9.51	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 7.5MG BASE	BRISDELLE	SEBELA IRELAND LTD	N204516	June 28, 2013	RX	CAPSULE	ORAL	8946251	Aug. 4, 2026	TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
EQ 7.5MG BASE	BRISDELLE	SEBELA IRELAND LTD	N204516	June 28, 2013	RX	CAPSULE	ORAL	9393237	Aug. 4, 2026	TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
EQ 7.5MG BASE	BRISDELLE	SEBELA IRELAND LTD	N204516	June 28, 2013	RX	CAPSULE	ORAL	8658663	April 6, 2029	TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

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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	10.40	CHEMBL	CHEMBL
Sigma non-opioid intracellular receptor 1	Membrane receptor	Q99720	SGMR1_HUMAN		Ki	5.65	DRUG MATRIX
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		Ki	5.07	DRUG MATRIX
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		Kd	7.40	WOMBAT-PK
5-hydroxytryptamine receptor 1A	GPCR	P08908	5HT1A_HUMAN		Kd	4.52	CHEMBL
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	5.42	WOMBAT-PK
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN		Ki	7.46	DRUG MATRIX
Muscarinic acetylcholine receptor M2	GPCR	P08172	ACM2_HUMAN		Ki	6.72	DRUG MATRIX
Muscarinic acetylcholine receptor M3	GPCR	P20309	ACM3_HUMAN		Ki	7.42	DRUG MATRIX
Muscarinic acetylcholine receptor M4	GPCR	P08173	ACM4_HUMAN		Ki	7.47	DRUG MATRIX

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External reference:

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ID	Source
8PR	PDB_CHEM_ID
004016	NDDF
004017	NDDF
008361	NDDF
110429-35-1	SECONDARY_CAS_RN
114228	RXNORM
1269153001	SNOMEDCT_US
18339	MMSL
205288	MMSL
217797-14-3	SECONDARY_CAS_RN

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Paroxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-7001	TABLET, FILM COATED	10 mg	ORAL	ANDA	28 sections
Paroxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-7001	TABLET, FILM COATED	10 mg	ORAL	ANDA	28 sections
Paroxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-7002	TABLET, FILM COATED	20 mg	ORAL	ANDA	28 sections
Paroxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-7002	TABLET, FILM COATED	20 mg	ORAL	ANDA	28 sections
Paroxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-7003	TABLET, FILM COATED	30 mg	ORAL	ANDA	28 sections
Paroxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-7003	TABLET, FILM COATED	30 mg	ORAL	ANDA	28 sections
Paroxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-7004	TABLET, FILM COATED	40 mg	ORAL	ANDA	28 sections
Paroxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-7004	TABLET, FILM COATED	40 mg	ORAL	ANDA	28 sections
Paroxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0574-0279	CAPSULE	7.50 mg	ORAL	NDA	28 sections
Paroxetine	HUMAN PRESCRIPTION DRUG LABEL	1	0574-0279	CAPSULE	7.50 mg	ORAL	NDA	28 sections

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