minoxidil ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
vasodilators 1814 38304-91-5

Description:

MoleculeDescription

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:

DoseUnitRoute
20 mg O

ADMET properties:

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

Approvals:

DateAgencyCompanyOrphan
Oct. 18, 1979 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hypertrichosis 306.69 20.59 54 3380 955 50600735
Product formulation issue 164.43 20.59 29 3405 516 50601174
Hair texture abnormal 55.15 20.59 17 3417 3639 50598051
Hair growth abnormal 47.65 20.59 14 3420 2547 50599143
Application site pruritus 46.40 20.59 15 3419 3744 50597946
Application site exfoliation 39.85 20.59 8 3426 291 50601399
Product use in unapproved indication 39.84 20.59 44 3390 115775 50485915
Wrong patient received product 39.27 20.59 11 3423 1689 50600001
Hair colour changes 38.28 20.59 12 3422 2712 50598978
Dermatitis contact 31.03 20.59 14 3420 8632 50593058
Cardiac hypertrophy 30.32 20.59 8 3426 981 50600709
Product use issue 26.55 20.59 41 3393 149434 50452256
Hypertension 24.52 20.59 48 3386 211155 50390535
Dandruff 24.42 20.59 5 3429 201 50601489
Vanishing bile duct syndrome 23.65 20.59 6 3428 631 50601059
Application site pain 23.25 20.59 9 3425 3789 50597901
Hypertensive crisis 22.74 20.59 13 3421 13141 50588549
Hirsutism 20.95 20.59 6 3428 997 50600693

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hypertrichosis 363.82 18.41 60 4413 282 29569772
Product formulation issue 297.27 18.41 53 4420 423 29569631
Pericardial effusion 152.62 18.41 71 4402 21137 29548917
Product label on wrong product 56.35 18.41 8 4465 9 29570045
Ceruloplasmin increased 42.63 18.41 6 4467 6 29570048
Nephrogenic systemic fibrosis 40.58 18.41 17 4456 3925 29566129
Blood copper increased 39.87 18.41 6 4467 13 29570041
Hypervolaemia 33.78 18.41 25 4448 17520 29552534
Scrotal oedema 32.20 18.41 11 4462 1453 29568601
Dermatitis contact 31.12 18.41 13 4460 2979 29567075
Cardiac failure congestive 29.16 18.41 46 4427 76535 29493519
Dizziness 27.97 18.41 77 4396 189607 29380447
Cardiac tamponade 25.68 18.41 13 4460 4622 29565432
Erectile dysfunction 24.65 18.41 21 4452 17988 29552066
Affective disorder 24.10 18.41 11 4462 3115 29566939
Oedema peripheral 23.83 18.41 50 4423 103507 29466547
Libido decreased 23.65 18.41 12 4461 4286 29565768
Skin induration 21.62 18.41 9 4464 2045 29568009
Chorioretinopathy 21.19 18.41 8 4465 1408 29568646
Palpitations 20.56 18.41 25 4448 32579 29537475
Skin fibrosis 19.95 18.41 7 4466 1000 29569054
Skin hyperpigmentation 18.75 18.41 9 4464 2855 29567199
Skin tightness 18.65 18.41 8 4465 1956 29568098

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hypertrichosis 645.12 17.26 110 6404 1038 64491180
Product formulation issue 434.54 17.26 75 6439 763 64491455
Pericardial effusion 146.92 17.26 74 6440 39180 64453038
Dermatitis contact 58.81 17.26 25 6489 8975 64483243
Product label on wrong product 57.16 17.26 8 6506 15 64492203
Ceruloplasmin increased 43.71 17.26 6 6508 9 64492209
Blood copper increased 40.41 17.26 6 6508 20 64492198
Scrotal oedema 38.66 17.26 11 6503 1196 64491022
Cardiac failure congestive 38.31 17.26 56 6458 130524 64361694
Hair growth abnormal 35.32 17.26 12 6502 2340 64489878
Cardiac hypertrophy 32.25 17.26 10 6504 1461 64490757
Hypertensive crisis 31.97 17.26 21 6493 18227 64473991
Hypervolaemia 31.35 17.26 28 6486 38257 64453961
Hypotension 30.51 17.26 96 6418 380878 64111340
Application site exfoliation 30.45 17.26 7 6507 324 64491894
Hypertension 29.24 17.26 74 6440 259187 64233031
Occupational asthma 29.14 17.26 4 6510 6 64492212
Hair texture abnormal 28.81 17.26 11 6503 2993 64489225
Dandruff 25.47 17.26 6 6508 309 64491909
Palpitations 25.27 17.26 41 6473 104447 64387771
Application site pain 25.12 17.26 11 6503 4237 64487981
Electrocardiogram ST segment depression 24.78 17.26 11 6503 4378 64487840
Nephrogenic systemic fibrosis 24.65 17.26 12 6502 5880 64486338
Cardiac tamponade 23.69 17.26 13 6501 8151 64484067
Application site pruritus 23.68 17.26 10 6504 3529 64488689
Oedema peripheral 23.66 17.26 60 6454 210257 64281961
Face oedema 22.05 17.26 19 6495 24742 64467476
Kidney transplant rejection 21.84 17.26 13 6501 9498 64482720
Chorioretinopathy 20.91 17.26 8 6506 2189 64490029
Hypertensive emergency 20.63 17.26 8 6506 2268 64489950
Tachycardia 20.40 17.26 46 6468 149533 64342685
Dizziness 19.16 17.26 90 6424 430073 64062145
Skin test positive 18.31 17.26 6 6508 1047 64491171
Skin hyperpigmentation 17.83 17.26 10 6504 6541 64485677
Affective disorder 17.78 17.26 10 6504 6570 64485648
Peritonitis bacterial 17.30 17.26 11 6503 9032 64483186

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C02DC01 CARDIOVASCULAR SYSTEM
ANTIHYPERTENSIVES
ARTERIOLAR SMOOTH MUSCLE, AGENTS ACTING ON
Pyrimidine derivatives
ATC D11AX01 DERMATOLOGICALS
OTHER DERMATOLOGICAL PREPARATIONS
OTHER DERMATOLOGICAL PREPARATIONS
Other dermatologicals
FDA PE N0000175379 Arteriolar Vasodilation
FDA EPC N0000175564 Arteriolar Vasodilator
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D014665 Vasodilator Agents
CHEBI has role CHEBI:35620 vasodilator agents
CHEBI has role CHEBI:35674 antihypertensive drugs

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
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
Angina pectoris contraindication 194828000
Cerebrovascular accident contraindication 230690007
Pheochromocytoma contraindication 302835009
Pericardial effusion contraindication 373945007 DOID:118
Dermatosis of scalp contraindication 402694007 DOID:3136




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sulfonylurea receptor 2, Kir6.2 Ion channel OPENER CHEMBL SCIENTIFIC LITERATURE
ATP-sensitive inward rectifier potassium channel 1 Ion channel IC50 6.97 WOMBAT-PK

External reference:

IDSource
4018077 VUID
N0000146416 NUI
D00418 KEGG_DRUG
4018077 VANDF
C0026196 UMLSCUI
CHEBI:6942 CHEBI
MXD PDB_CHEM_ID
CHEMBL802 ChEMBL_ID
DB00350 DRUGBANK_ID
D008914 MESH_DESCRIPTOR_UI
4201 PUBCHEM_CID
2987 INN_ID
4254 IUPHAR_LIGAND_ID
5965120SH1 UNII
202706 RXNORM
1335 MMSL
2064 MMSL
5119 MMSL
7147 MMSL
d00135 MMSL
000637 NDDF
387272001 SNOMEDCT_US
49577002 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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 Treatmentfor Men HUMAN OTC DRUG LABEL 1 0113-0798 SOLUTION 3 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
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
Basic Care Hair Regrowth HUMAN OTC DRUG LABEL 1 0113-7798 SOLUTION 3 g TOPICAL ANDA 16 sections
hair regrowth treatment HUMAN OTC DRUG LABEL 1 0363-0032 SOLUTION 5 g TOPICAL ANDA 16 sections
hair regrowth treatment HUMAN OTC DRUG LABEL 1 0363-0703 SOLUTION 2 g TOPICAL ANDA 16 sections
hair regrowth treatment HUMAN OTC DRUG LABEL 1 0363-1129 AEROSOL, FOAM 50 mg TOPICAL ANDA 16 sections
Solution HUMAN OTC DRUG LABEL 1 0363-2173 SOLUTION 0.02 g TOPICAL ANDA 13 sections
Solution HUMAN OTC DRUG LABEL 1 0363-2173 SOLUTION 0.02 g TOPICAL ANDA 13 sections
hair regrowth treatment HUMAN OTC DRUG LABEL 1 0363-2294 AEROSOL, FOAM 5 g TOPICAL ANDA 16 sections
hair regrowth treatment HUMAN OTC DRUG LABEL 1 0363-2294 AEROSOL, FOAM 5 g TOPICAL ANDA 16 sections
hair regrowth treatment HUMAN OTC DRUG LABEL 1 0363-2798 SOLUTION 3 g TOPICAL ANDA 16 sections
hair regrowth treatment HUMAN OTC DRUG LABEL 1 0363-7202 SOLUTION 2 g TOPICAL ANDA 16 sections
MinoxidilRegular Strength for Men HUMAN OTC DRUG LABEL 1 0472-0066 SOLUTION 2 g TOPICAL ANDA 15 sections
Minoxidil HUMAN PRESCRIPTION DRUG LABEL 1 0591-5642 TABLET 2.50 mg ORAL ANDA 26 sections
Minoxidil HUMAN PRESCRIPTION DRUG LABEL 1 0591-5643 TABLET 10 mg ORAL ANDA 26 sections
just for men minoxidil HUMAN OTC DRUG LABEL 1 11509-0798 SOLUTION 3 g TOPICAL ANDA 16 sections
up and up hair regrowth treatment for women HUMAN OTC DRUG LABEL 1 11673-189 SOLUTION 2 g TOPICAL ANDA 16 sections
up and up hair regrowth treatment for men HUMAN OTC DRUG LABEL 1 11673-317 SOLUTION 5 g TOPICAL ANDA 16 sections
up and up hair regrowth treatment for women HUMAN OTC DRUG LABEL 1 11673-382 SOLUTION 2 g TOPICAL ANDA 16 sections
up and up hair regrowth treatment for women HUMAN OTC DRUG LABEL 1 11673-431 AEROSOL, FOAM 50 mg TOPICAL ANDA 16 sections
up and up hair regrowth treatment for women HUMAN OTC DRUG LABEL 1 11673-431 AEROSOL, FOAM 50 mg TOPICAL ANDA 16 sections
up and up hair regrowth treatment for men HUMAN OTC DRUG LABEL 1 11673-632 SOLUTION 5 g TOPICAL ANDA 16 sections
up and up hair regrowth treatment for men HUMAN OTC DRUG LABEL 1 11673-707 AEROSOL, FOAM 5 g TOPICAL ANDA 16 sections