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

Stem definition	Drug id	CAS RN
vasodilators	1814	38304-91-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: minoxidil loniten rogaine	A potent direct-acting peripheral vasodilator (VASODILATOR AGENTS) that reduces peripheral resistance and produces a fall in BLOOD PRESSURE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p371) Molecular weight: 209.25 Formula: C9H15N5O CLOGP: 0.38 LIPINSKI: 0 HAC: 6 HDO: 2 TPSA: 93.63 ALOGS: -1.02 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

minoxidil
loniten
rogaine

A potent direct-acting peripheral vasodilator (VASODILATOR AGENTS) that reduces peripheral resistance and produces a fall in BLOOD PRESSURE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p371)

Molecular weight: 209.25
Formula: C9H15N5O
CLOGP: 0.38
LIPINSKI: 0
HAC: 6
HDO: 2
TPSA: 93.63
ALOGS: -1.02
ROTB: 1

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)	95 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
MRTD (Maximum Recommended Therapeutic Daily Dose)	6.83 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
S (Water solubility)	2.20 mg/mL	Benet LZ, Broccatelli F, Oprea TI
CL (Clearance)	11.50 mL/min/kg	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	10 %	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	1.50 hours	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	1 %	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	0.90 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Oct. 18, 1979	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
Hypertrichosis	304.15	19.50	54	3891	1100	63483977
Product formulation issue	165.27	19.50	29	3916	549	63484528
Hair texture abnormal	54.13	19.50	17	3928	4226	63480851
Hair growth abnormal	51.13	19.50	15	3930	2966	63482111
Application site pruritus	46.84	19.50	15	3930	3969	63481108
Hair colour changes	41.86	19.50	13	3932	3114	63481963
Product use in unapproved indication	37.97	19.50	51	3894	179029	63306048
Wrong patient received product	37.38	19.50	11	3934	2196	63482881
Application site exfoliation	37.22	19.50	8	3937	446	63484631
Injection site alopecia	34.16	19.50	5	3940	27	63485050

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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
Hypertrichosis	348.56	20.23	60	5580	353	34950938
Product formulation issue	284.24	20.23	53	5587	517	34950774
Pericardial effusion	161.57	20.23	79	5561	24583	34926708
Product label on wrong product	51.56	20.23	8	5632	21	34951270
Renal cyst haemorrhage	45.20	20.23	12	5628	627	34950664
Rectal prolapse	43.34	20.23	11	5629	481	34950810
Ceruloplasmin increased	40.51	20.23	6	5634	10	34951281
Nephrogenic systemic fibrosis	39.26	20.23	17	5623	3988	34947303
Blood copper increased	37.84	20.23	6	5634	19	34951272
Intraductal papillary mucinous neoplasm	37.62	20.23	10	5630	525	34950766

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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
Hypertrichosis	641.27	19.09	111	7821	1171	79735285
Product formulation issue	424.49	19.09	75	7857	897	79735559
Pericardial effusion	159.21	19.09	82	7850	46155	79690301
Dermatitis contact	54.28	19.09	25	7907	11008	79725448
Product label on wrong product	53.93	19.09	8	7924	27	79736429
Renal cyst haemorrhage	50.01	19.09	12	7920	680	79735776
Hypertensive crisis	44.50	19.09	27	7905	20743	79715713
Product monitoring error	43.25	19.09	20	7912	8886	79727570
Ceruloplasmin increased	42.38	19.09	6	7926	13	79736443
Cardiac failure congestive	39.47	19.09	59	7873	142343	79594113

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	C02DC01	CARDIOVASCULAR SYSTEM ANTIHYPERTENSIVES ARTERIOLAR SMOOTH MUSCLE, AGENTS ACTING ON Pyrimidine derivatives
ATC	D11AX01	DERMATOLOGICALS OTHER DERMATOLOGICAL PREPARATIONS OTHER DERMATOLOGICAL PREPARATIONS Other dermatologicals
CHEBI has role	CHEBI:35620	vasodilator agents
CHEBI has role	CHEBI:35674	antihypertensive drugs
FDA EPC	N0000175564	Arteriolar Vasodilator
FDA PE	N0000175379	Arteriolar Vasodilation
MeSH PA	D000959	Antihypertensive Agents
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D014665	Vasodilator 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
Hypertensive disorder	indication	38341003	DOID:10763
Alopecia	indication	56317004	DOID:987
Pericarditis	contraindication	3238004	DOID:1787
Myocardial infarction	contraindication	22298006	DOID:5844
Orthostatic hypotension	contraindication	28651003
Cardiac tamponade	contraindication	35304003	DOID:115
Chronic heart failure	contraindication	48447003
Disorder of cardiovascular system	contraindication	49601007	DOID:1287
Cerebrovascular disease	contraindication	62914000	DOID:6713
Kidney disease	contraindication	90708001	DOID:557

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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	4.35	Basic
pKa2	2.62	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])	Mechanism action	Bioact source	MoA source
Sulfonylurea receptor 2, Kir6.2	Ion channel	O60706 Q14654	ABCC9_HUMAN KCJ11_HUMAN	OPENER				CHEMBL	SCIENTIFIC LITERATURE
ATP-sensitive inward rectifier potassium channel 1	Ion channel	P48048	KCNJ1_HUMAN		IC50	6.97		WOMBAT-PK

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External reference:

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ID	Source
MXD	PDB_CHEM_ID
000637	NDDF
1335	MMSL
202706	RXNORM
2064	MMSL
2987	INN_ID
387272001	SNOMEDCT_US
4018077	VUID
4018077	VANDF
4201	PUBCHEM_CID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Basic Care Hair Regrowth	HUMAN OTC DRUG LABEL	1	0113-7798	SOLUTION	3 g	TOPICAL	ANDA	16 sections
basic care hair regrowth treatment	HUMAN OTC DRUG LABEL	1	0113-7032	SOLUTION	5 g	TOPICAL	ANDA	16 sections
basic care hair regrowth treatment	HUMAN OTC DRUG LABEL	1	0113-7129	AEROSOL, FOAM	50 mg	TOPICAL	ANDA	16 sections
basic care hair regrowth treatment	HUMAN OTC DRUG LABEL	1	0113-7202	SOLUTION	2 g	TOPICAL	ANDA	16 sections
basic care hair regrowth treatment	HUMAN OTC DRUG LABEL	1	0113-7294	AEROSOL, FOAM	5 g	TOPICAL	ANDA	16 sections
good sense hair regrowth treatment	HUMAN OTC DRUG LABEL	1	0113-0294	AEROSOL, FOAM	5 g	TOPICAL	ANDA	16 sections
good sense hair regrowth treatment	HUMAN OTC DRUG LABEL	1	0113-0294	AEROSOL, FOAM	5 g	TOPICAL	ANDA	16 sections
Good Sense Hair Regrowth Treatment	HUMAN OTC DRUG LABEL	1	0113-1032	SOLUTION	5 g	TOPICAL	ANDA	16 sections
Good Sense Hair Regrowth Treatment	HUMAN OTC DRUG LABEL	1	0113-1032	SOLUTION	5 g	TOPICAL	ANDA	16 sections
Good Sense Hair Regrowth Treatment	HUMAN OTC DRUG LABEL	1	0113-1129	AEROSOL, FOAM	50 mg	TOPICAL	ANDA	16 sections

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