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 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
Off label use 33.86 19.50 105 3840 674357 62810720
Product preparation error 33.37 19.50 13 3932 6079 63478998
Dermatitis contact 32.03 19.50 15 3930 10993 63474084
Cardiac hypertrophy 30.58 19.50 8 3937 1037 63484040
Drug ineffective for unapproved indication 29.35 19.50 21 3924 34042 63451035
Tachycardia 28.68 19.50 36 3909 118120 63366957
Dermatitis 25.91 19.50 15 3930 16943 63468134
Arrhythmia 25.07 19.50 20 3925 38120 63446957
Product use issue 24.78 19.50 47 3898 220473 63264604
Dandruff 23.77 19.50 5 3940 251 63484826
Vanishing bile duct syndrome 23.34 19.50 6 3939 726 63484351
Application site pain 23.17 19.50 9 3936 4173 63480904
Product administration error 22.08 19.50 15 3930 22382 63462695
Hypertensive crisis 21.98 19.50 13 3932 15273 63469804
Glomerulonephritis acute 21.84 19.50 4 3941 97 63484980
Hypertension 20.40 19.50 50 3895 279253 63205824
Pericardial effusion 20.26 19.50 16 3929 30042 63455035
Occupational asthma 20.00 19.50 4 3941 156 63484921
Hirsutism 19.52 19.50 6 3939 1389 63483688

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 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
Swelling of eyelid 34.48 20.23 11 5629 1100 34950191
Oedema peripheral 33.34 20.23 65 5575 119747 34831544
Vascular anastomotic haemorrhage 33.27 20.23 8 5632 279 34951012
Aortic dilatation 31.97 20.23 11 5629 1390 34949901
Vascular compression 31.12 20.23 8 5632 368 34950923
Delayed graft function 30.51 20.23 12 5628 2209 34949082
Hypervolaemia 29.77 20.23 25 5615 19684 34931607
Scrotal oedema 29.13 20.23 11 5629 1815 34949476
Abdominal wall haemorrhage 29.02 20.23 8 5632 482 34950809
Carotid arteriosclerosis 28.94 20.23 11 5629 1847 34949444
Cardiac tamponade 28.93 20.23 15 5625 5251 34946040
Perineal cyst 28.55 20.23 7 5633 265 34951026
Product monitoring error 28.53 20.23 14 5626 4367 34946924
Dermatitis contact 28.19 20.23 13 5627 3533 34947758
Cardiac failure congestive 27.95 20.23 49 5591 83221 34868070
Left ventricular hypertrophy 27.89 20.23 17 5623 8113 34943178
Dizziness 27.08 20.23 87 5553 218434 34732857
Hyperparathyroidism secondary 27.03 20.23 10 5630 1558 34949733
Vena cava injury 27.00 20.23 7 5633 333 34950958
Renal artery stenosis 26.84 20.23 11 5629 2250 34949041
Erectile dysfunction 26.77 20.23 24 5616 20613 34930678
Hypertensive crisis 26.73 20.23 17 5623 8734 34942557
Complications of transplanted kidney 24.95 20.23 13 5627 4596 34946695
Libido decreased 24.72 20.23 13 5627 4683 34946608
Myocardial necrosis 23.99 20.23 6 5634 247 34951044
Blood 25-hydroxycholecalciferol decreased 23.62 20.23 6 5634 263 34951028
Spinal stenosis 23.32 20.23 13 5627 5256 34946035
Mean cell volume increased 23.28 20.23 11 5629 3158 34948133
Intervertebral disc space narrowing 22.98 20.23 8 5632 1047 34950244
Restless legs syndrome 22.51 20.23 15 5625 8339 34942952
Actinic keratosis 22.23 20.23 12 5628 4555 34946736
Application site pain 21.69 20.23 9 5631 1899 34949392
Hypertension 21.30 20.23 59 5581 136384 34814907
SARS-CoV-2 antibody test positive 20.92 20.23 6 5634 418 34950873
Diverticulum intestinal 20.80 20.23 11 5629 4010 34947281
Skin induration 20.65 20.23 9 5631 2142 34949149
Hepatosplenomegaly 20.42 20.23 11 5629 4158 34947133
Chorioretinopathy 20.27 20.23 8 5632 1485 34949806

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 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
Blood copper increased 39.26 19.09 6 7926 26 79736430
Intraductal papillary mucinous neoplasm 38.45 19.09 10 7922 788 79735668
Hair growth abnormal 37.32 19.09 13 7919 2771 79733685
Vascular anastomotic haemorrhage 37.12 19.09 8 7924 279 79736177
Application site pruritus 36.92 19.09 14 7918 3796 79732660
Left ventricular hypertrophy 36.04 19.09 19 7913 11172 79725284
Scrotal oedema 35.86 19.09 11 7921 1574 79734882
Hypertension 34.66 19.09 91 7841 330901 79405555
Aortic dilatation 34.41 19.09 11 7921 1801 79734655
Rectal prolapse 32.43 19.09 11 7921 2167 79734289
Oedema peripheral 32.37 19.09 75 7857 252213 79484243
Application site exfoliation 32.15 19.09 8 7924 528 79735928
Perineal cyst 32.00 19.09 7 7925 262 79736194
Vascular compression 31.60 19.09 8 7924 566 79735890
Cardiac hypertrophy 31.39 19.09 10 7922 1620 79734836
Renal artery stenosis 30.90 19.09 12 7920 3470 79732986
Delayed graft function 30.81 19.09 12 7920 3495 79732961
Hair texture abnormal 30.73 19.09 12 7920 3522 79732934
Carotid arteriosclerosis 30.29 19.09 11 7921 2645 79733811
Hyperparathyroidism secondary 30.27 19.09 11 7921 2649 79733807
Vena cava injury 30.12 19.09 7 7925 345 79736111
Abdominal wall haemorrhage 30.09 19.09 8 7924 686 79735770
Complications of transplanted kidney 29.99 19.09 14 7918 6352 79730104
Swelling of eyelid 29.85 19.09 12 7920 3799 79732657
Occupational asthma 29.20 19.09 4 7928 6 79736450
Hypotension 29.10 19.09 103 7829 440214 79296242
Hypervolaemia 29.09 19.09 28 7904 42662 79693794
Product preparation error 28.10 19.09 13 7919 5780 79730676
Cardiac tamponade 27.76 19.09 15 7917 9261 79727195
Actinic keratosis 27.57 19.09 13 7919 6029 79730427
Application site pain 27.30 19.09 12 7920 4735 79731721
Tachycardia 26.33 19.09 56 7876 177712 79558744
Nephrogenic systemic fibrosis 24.32 19.09 12 7920 6148 79730308
Blood 25-hydroxycholecalciferol decreased 24.30 19.09 6 7926 383 79736073
Dandruff 24.15 19.09 6 7926 393 79736063
Electrocardiogram ST segment depression 23.82 19.09 11 7921 4867 79731589
SARS-CoV-2 antibody test positive 23.58 19.09 6 7926 433 79736023
Intervertebral disc space narrowing 22.87 19.09 8 7924 1727 79734729
Myocardial necrosis 22.80 19.09 6 7926 495 79735961
Hepatosplenomegaly 21.54 19.09 11 7921 6058 79730398
Mean cell volume increased 21.23 19.09 11 7921 6242 79730214
Kidney transplant rejection 21.13 19.09 13 7919 10233 79726223
Chorioretinopathy 20.91 19.09 8 7924 2223 79734233
Product prescribing error 20.89 19.09 24 7908 44789 79691667
Chronic kidney disease 20.63 19.09 29 7903 66125 79670331
Face oedema 20.21 19.09 19 7913 28117 79708339
Palpitations 20.04 19.09 41 7891 126569 79609887
Blood potassium increased 19.57 19.09 19 7913 29256 79707200
Restless legs syndrome 19.29 19.09 16 7916 20076 79716380
Hypertensive emergency 19.19 19.09 8 7924 2777 79733679

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 | Suggest Off label Use Form| |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
4254 IUPHAR_LIGAND_ID
2987 INN_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 0113-1032 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 0363-0032 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
Minoxidil (For Men) HUMAN OTC DRUG LABEL 1 0363-9090 AEROSOL, FOAM 50 mg TOPICAL ANDA 16 sections
Minoxidil (For Women) HUMAN OTC DRUG LABEL 1 0363-9091 AEROSOL, FOAM 50 mg TOPICAL ANDA 16 sections
Minoxidil HUMAN OTC DRUG LABEL 1 0363-9970 SOLUTION 2 g TOPICAL ANDA 15 sections
Minoxidil HUMAN OTC DRUG LABEL 1 0363-9971 SOLUTION 50 mg TOPICAL ANDA 16 sections
Minoxidil HUMAN OTC DRUG LABEL 1 0363-9972 SOLUTION 2 g TOPICAL ANDA 15 sections
Minoxidil HUMAN OTC DRUG LABEL 1 0363-9972 SOLUTION 2 g TOPICAL ANDA 15 sections
Minoxidil HUMAN OTC DRUG LABEL 1 0363-9973 SOLUTION 50 mg TOPICAL ANDA 16 sections
Minoxidil HUMAN OTC DRUG LABEL 1 0363-9973 SOLUTION 50 mg TOPICAL ANDA 16 sections
MinoxidilRegular Strength for Men HUMAN OTC DRUG LABEL 1 0472-0066 SOLUTION 2 g TOPICAL ANDA 15 sections