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

Stem definition	Drug id	CAS RN
	1053	128196-01-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: escitalopram (+)-(S)-Citalopram (+)-Citalopram (S)-Citalopram S-(+)-Citalopram seroplex escitalopram oxalate	Molecular weight: 324.40 Formula: C20H21FN2O CLOGP: 3.13 LIPINSKI: 0 HAC: 3 HDO: 0 TPSA: 36.26 ALOGS: -4.74 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

escitalopram
(+)-(S)-Citalopram
(+)-Citalopram
(S)-Citalopram
S-(+)-Citalopram
seroplex
escitalopram oxalate

Molecular weight: 324.40
Formula: C20H21FN2O
CLOGP: 3.13
LIPINSKI: 0
HAC: 3
HDO: 0
TPSA: 36.26
ALOGS: -4.74
ROTB: 5

Status: OFP

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

Drug dosage:

Dose	Unit	Route
10	mg	O

ADMET properties:

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Property	Value	Reference
EoM (Fraction excreted unchanged in urine)	8 %	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.88 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
fu (Fraction unbound in plasma)	0.36 %	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
Aug. 14, 2002	FDA	FOREST LABS

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
Suicide attempt	559.73	9.60	760	173267	60158	63254837
Suicidal ideation	540.84	9.60	757	173270	61664	63253331
Intentional overdose	486.73	9.60	790	173237	73362	63241633
Pemphigus	480.98	9.60	4	174023	183722	63131273
Electrocardiogram QT prolonged	464.54	9.60	687	173340	58843	63256152
Serotonin syndrome	405.40	9.60	445	173582	28237	63286758
Hand deformity	382.46	9.60	12	174015	159445	63155550
Contraindicated product administered	375.26	9.60	71	173956	217577	63097418
Synovitis	368.45	9.60	41	173986	186877	63128118
Sopor	354.09	9.60	367	173660	21797	63293198

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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	446.53	10.29	363	77075	19570	34859923
Completed suicide	329.11	10.29	693	76745	97475	34782018
Suicidal ideation	319.65	10.29	420	77018	39968	34839525
Suicide attempt	317.70	10.29	412	77026	38704	34840789
Intentional overdose	269.37	10.29	403	77035	43271	34836222
Agitation	189.53	10.29	403	77035	56996	34822497
Anxiety	166.08	10.29	541	76897	98887	34780606
Aggression	155.38	10.29	296	77142	38668	34840825
Foetal exposure during pregnancy	152.62	10.29	290	77148	37811	34841682
Somnolence	150.43	10.29	564	76874	110552	34768941

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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
Suicide attempt	687.03	9.64	935	197055	81997	79464401
Serotonin syndrome	656.70	9.64	678	197312	44349	79502049
Suicidal ideation	655.69	9.64	876	197114	75464	79470934
Completed suicide	600.29	9.64	1646	196344	244121	79302277
Intentional overdose	581.11	9.64	986	197004	104974	79441424
Sopor	440.22	9.64	474	197516	32536	79513862
Electrocardiogram QT prolonged	439.61	9.64	798	197192	89588	79456810
Somnolence	383.97	9.64	1385	196605	237596	79308802
Anxiety	342.08	9.64	1371	196619	247141	79299257
Overdose	299.47	9.64	1072	196918	183134	79363264

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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
Human herpesvirus 6 infection	34.80	32.07	15	835	45	88897

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Pharmacologic Action:

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Source	Code	Description
ATC	N06AB10	NERVOUS SYSTEM PSYCHOANALEPTICS ANTIDEPRESSANTS Selective serotonin reuptake inhibitors
CHEBI has role	CHEBI:35469	antidepressants
CHEBI has role	CHEBI:76779	post-proline endopeptidase inhibitors
FDA EPC	N0000175696	Serotonin Reuptake Inhibitor
FDA MoA	N0000000109	Serotonin Uptake Inhibitors
MeSH PA	D049990	Membrane Transport Modulators
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D014179	Neurotransmitter Uptake Inhibitors
MeSH PA	D017367	Selective Serotonin Reuptake Inhibitors
MeSH PA	D018490	Serotonin 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
Generalized anxiety disorder	indication	21897009	DOID:14320
Major depressive disorder	indication	370143000
Posttraumatic stress disorder	off-label use	47505003	DOID:2055
Bipolar affective disorder, current episode depression	off-label use	191627008	DOID:3312
Obsessive-compulsive disorder	off-label use	191736004	DOID:10933
Menopausal flushing	off-label use	198436008
Panic disorder	off-label use	371631005	DOID:594
Suicidal thoughts	contraindication	6471006
Bipolar disorder	contraindication	13746004	DOID:3312
Neuroleptic malignant syndrome	contraindication	15244003	DOID:14464

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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	9.33	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 10MG BASE	LEXAPRO	ABBVIE	N021323	Aug. 14, 2002	RX	TABLET	ORAL	May 12, 2026	NEW PATIENT POPULATION
EQ 20MG BASE	LEXAPRO	ABBVIE	N021323	Aug. 14, 2002	RX	TABLET	ORAL	May 12, 2026	NEW PATIENT POPULATION
EQ 5MG BASE	LEXAPRO	ABBVIE	N021323	Aug. 14, 2002	RX	TABLET	ORAL	May 12, 2026	NEW PATIENT POPULATION
EQ 5MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LEXAPRO	ABBVIE	N021365	Nov. 27, 2002	DISCN	SOLUTION	ORAL	May 12, 2026	NEW PATIENT POPULATION

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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	8.96	WOMBAT-PK	CHEMBL
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		Ki	5.19	PDSP
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN		Ki	5.60	PDSP
Alpha-1A adrenergic receptor	GPCR	P35348	ADA1A_HUMAN		Ki	5.41	PDSP
Histamine H1 receptor	GPCR	P35367	HRH1_HUMAN		Ki	5.71	PDSP
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN		Ki	5.91	PDSP
Sodium-dependent serotonin transporter	Transporter		SC6A4_RAT		Ki	9.05	CHEMBL
Sodium-dependent dopamine transporter	Transporter		SC6A3_RAT		Ki	5.09	CHEMBL
Transporter	Transporter		Q63380_RAT		Ki	4.98	CHEMBL

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External reference:

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ID	Source
009709	NDDF
009710	NDDF
146570	PUBCHEM_CID
158618	MMSL
16927	MMSL
187848	MMSL
219861-08-2	SECONDARY_CAS_RN
321988	RXNORM
395246009	SNOMEDCT_US
400447003	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Escitalopram	HUMAN PRESCRIPTION DRUG LABEL	1	0615-7953	TABLET	5 mg	ORAL	ANDA	31 sections
Escitalopram	HUMAN PRESCRIPTION DRUG LABEL	1	0615-7954	TABLET	10 mg	ORAL	ANDA	31 sections
Escitalopram	HUMAN PRESCRIPTION DRUG LABEL	1	0615-7955	TABLET	20 mg	ORAL	ANDA	31 sections
Escitalopram	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8348	TABLET, FILM COATED	5 mg	ORAL	ANDA	31 sections
Escitalopram	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8349	TABLET, FILM COATED	10 mg	ORAL	ANDA	31 sections
Escitalopram	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8350	TABLET, FILM COATED	20 mg	ORAL	ANDA	31 sections
Escitalopram	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8365	TABLET, FILM COATED	10 mg	ORAL	ANDA	31 sections
Escitalopram	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8366	TABLET, FILM COATED	20 mg	ORAL	ANDA	31 sections
Escitalopram	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8475	TABLET, FILM COATED	5 mg	ORAL	ANDA	31 sections
Escitalopram	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8476	TABLET, FILM COATED	10 mg	ORAL	ANDA	31 sections

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