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

Stem definition	Drug id	CAS RN
	962	469-21-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: doxylamine (+/-)-Doxylamine doxylamine succinate	Histamine H1 antagonist with pronounced sedative properties. It is used in allergies and as an antitussive, antiemetic, and hypnotic. Doxylamine has also been administered in veterinary applications and was formerly used in PARKINSONISM. Molecular weight: 270.38 Formula: C17H22N2O CLOGP: 2.35 LIPINSKI: 0 HAC: 3 HDO: 0 TPSA: 25.36 ALOGS: -2.70 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

doxylamine
(+/-)-Doxylamine
doxylamine succinate

Histamine H1 antagonist with pronounced sedative properties. It is used in allergies and as an antitussive, antiemetic, and hypnotic. Doxylamine has also been administered in veterinary applications and was formerly used in PARKINSONISM.

Molecular weight: 270.38
Formula: C17H22N2O
CLOGP: 2.35
LIPINSKI: 0
HAC: 3
HDO: 0
TPSA: 25.36
ALOGS: -2.70
ROTB: 6

Status: OFP

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

Drug dosage:

Dose	Unit	Route
25	mg	O

ADMET properties:

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Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Bocci G, Oprea TI, Benet LZ
BA (Bioavailability)	24.70 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
S (Water solubility)	100 mg/mL	Bocci G, Oprea TI, Benet LZ
fu (Fraction unbound in plasma)	0.51 %	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
April 7, 1948	FDA	SANOFI AVENTIS US

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
Toxicity to various agents	2319.47	10.11	5447	466901	241803	62774871
Completed suicide	2292.59	10.11	3982	468366	141691	62874983
Infusion related reaction	962.21	10.11	3994	468354	241527	62775147
Exposure to toxic agent	907.12	10.11	548	471800	5039	63011635
Sinusitis	669.45	10.11	3394	468954	223259	62793415
Muscle injury	610.77	10.11	1440	470908	63905	62952769
Folliculitis	594.72	10.11	1491	470857	68826	62947848
Acute hepatic failure	533.33	10.11	670	471678	17657	62999017
Irritable bowel syndrome	527.86	10.11	1578	470770	80834	62935840
Lower respiratory tract infection	521.76	10.11	2158	470190	130149	62886525

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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
Toxicity to various agents	1296.98	10.24	3006	172942	197356	34583627
Completed suicide	1227.19	10.24	1950	173998	96218	34684765
Exposure to toxic agent	560.15	10.24	302	175646	3373	34777610
Infusion related reaction	518.87	10.24	946	175002	52111	34728872
Blood pressure fluctuation	473.03	10.24	609	175339	24640	34756343
Overdose	365.77	10.24	1148	174800	89911	34691072
Acute hepatic failure	306.14	10.24	366	175582	13708	34767275
Intentional product misuse	294.00	10.24	685	175263	44926	34736057
Intentional overdose	277.22	10.24	652	175296	43022	34737961
Drug ineffective	249.90	10.24	1319	174629	455432	34325551

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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	3654.86	9.93	6194	530825	239573	78967796
Toxicity to various agents	3353.34	9.93	8190	528829	413350	78794019
Exposure to toxic agent	1431.65	9.93	846	536173	8312	79199057
Infusion related reaction	1245.65	9.93	3892	533127	226345	78981024
Blood pressure fluctuation	886.73	9.93	1609	535410	65536	79141833
Acute hepatic failure	784.64	9.93	991	536028	29122	79178247
Intentional overdose	769.15	9.93	1993	535026	103967	79103402
Overdose	685.08	9.93	2754	534265	181452	79025917
Intentional product misuse	679.41	9.93	1779	535240	93386	79113983
Rheumatoid arthritis	445.32	9.93	2660	534359	205810	79001559

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	R06AA09	RESPIRATORY SYSTEM ANTIHISTAMINES FOR SYSTEMIC USE ANTIHISTAMINES FOR SYSTEMIC USE Aminoalkyl ethers
ATC	R06AA59	RESPIRATORY SYSTEM ANTIHISTAMINES FOR SYSTEMIC USE ANTIHISTAMINES FOR SYSTEMIC USE Aminoalkyl ethers
CHEBI has role	CHEBI:35717	hypnotics
CHEBI has role	CHEBI:37955	H1 receptor antagonists
CHEBI has role	CHEBI:37956	antihistamines
CHEBI has role	CHEBI:48873	acetylcholine receptor antagonist
CHEBI has role	CHEBI:50857	anti-allergic drugs
CHEBI has role	CHEBI:50919	antiemetico
CHEBI has role	CHEBI:51177	anti-tussive
FDA EPC	N0000175750	Antihistamine

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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
Dermatographic urticaria	indication	7632005	DOID:743
Vasomotor rhinitis	indication	8229003	DOID:4730
Allergic rhinitis	indication	61582004
Nasal discharge	indication	64531003
Nasal congestion	indication	68235000
Sneezing	indication	76067001
Common cold	indication	82272006	DOID:10459
Urticaria	indication	126485001
Influenza-like symptoms	indication	315642008
Seasonal allergic rhinitis	indication	367498001

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🐶 Veterinary Drug Use

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Species	Use	Relation
Cats	Antihistaminic therapy	Indication
Dogs	Antihistaminic therapy	Indication
Horses	Antihistaminic therapy	Indication

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🐶 Veterinary products

Product	Applicant	Ingredients
A-H Injection	Intervet Inc.	2
A-H-Tablets 100 mg, A-H-Tablets 25 mg	Intervet Inc.	1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.83	Basic
pKa2	4.29	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
20MG;20MG	BONJESTA	DUCHESNAY	N209661	Nov. 7, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	9089489	Feb. 18, 2033	TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT
20MG;20MG	BONJESTA	DUCHESNAY	N209661	Nov. 7, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	9375404	Feb. 18, 2033	TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT
20MG;20MG	BONJESTA	DUCHESNAY	N209661	Nov. 7, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	9526703	Feb. 18, 2033	TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT
20MG;20MG	BONJESTA	DUCHESNAY	N209661	Nov. 7, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	9937132	Feb. 18, 2033	TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT

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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])	Mechanism action	Bioact source	MoA source
Histamine H1 receptor	GPCR	P35367	HRH1_HUMAN	ANTAGONIST				CHEMBL	CHEMBL

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External reference:

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ID	Source
003372	NDDF
004789	NDDF
10000	MMSL
1782	INN_ID
23665	RXNORM
3162	PUBCHEM_CID
4019049	VANDF
4019738	VUID
4019738	VANDF
412380009	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Alka-Seltzer Plus Severe Cold Powerfast Fizz Night	HUMAN OTC DRUG LABEL	4	0280-0021	TABLET, EFFERVESCENT	6.25 mg	ORAL	OTC monograph final	16 sections
Basic Care Nighttime	HUMAN OTC DRUG LABEL	3	0113-7459	SOLUTION	12.50 mg	ORAL	OTC monograph final	16 sections
Basic Care Nighttime Cold and Flu	HUMAN OTC DRUG LABEL	3	0113-7056	CAPSULE, LIQUID FILLED	6.25 mg	ORAL	OTC monograph final	16 sections
basic care nighttime cold and flu	HUMAN OTC DRUG LABEL	3	0113-7335	SOLUTION	12.50 mg	ORAL	OTC monograph final	16 sections
basic care nighttime cold and flu	HUMAN OTC DRUG LABEL	4	0113-7501	SOLUTION	12.50 mg	ORAL	OTC monograph final	16 sections
basic care nighttime cold and flu severe	HUMAN OTC DRUG LABEL	4	0113-7763	SOLUTION	12.50 mg	ORAL	OTC monograph final	16 sections
basic care sleep aid	HUMAN OTC DRUG LABEL	1	0113-7441	TABLET	25 mg	ORAL	ANDA	16 sections
Childrens Robitussin Honey Nighttime Cough DM	HUMAN OTC DRUG LABEL	2	0031-8762	SOLUTION	6.25 mg	ORAL	OTC monograph final	17 sections
Childrens Robitussin Honey Nighttime Cough DM	HUMAN OTC DRUG LABEL	2	0031-8762	SOLUTION	6.25 mg	ORAL	OTC monograph final	17 sections
good sense night time	HUMAN OTC DRUG LABEL	3	0113-0056	CAPSULE, LIQUID FILLED	6.25 mg	ORAL	OTC monograph final	15 sections

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