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

Stem definitionDrug idCAS RN
1722 1665-48-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • metaxalone
  • metaxalon
  • metazalone
  • metazolone
  • skelaxin
  • zorane
  • AHR 438
muscle spasm relaxant; structure
  • Molecular weight: 221.26
  • Formula: C12H15NO3
  • CLOGP: 2.15
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 47.56
  • ALOGS: -2.24
  • ROTB: 3

  • Status: OFP

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

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.30 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 206.61 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
Aug. 13, 1962 FDA KING PHARMS

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
Accidental death 242.73 14.31 59 11435 1917 63475611
Completed suicide 226.79 14.31 197 11297 145476 63332052
Drug hypersensitivity 185.37 14.31 253 11241 310434 63167094
Toxicity to various agents 170.02 14.31 216 11278 247034 63230494
Serotonin syndrome 61.81 14.31 47 11447 28635 63448893
Deep vein thrombosis 43.40 14.31 64 11430 83736 63393792
Anxiety 40.54 14.31 108 11386 217433 63260095
Overdose 38.24 14.31 72 11422 115006 63362522
Depression 38.08 14.31 99 11395 196393 63281135
Purpura senile 35.97 14.31 10 11484 553 63476975
Clonus 34.99 14.31 17 11477 4619 63472909
Tarsal tunnel syndrome 31.26 14.31 9 11485 565 63476963
Drug ineffective 27.07 14.31 98 11396 1044667 62432861
Off label use 26.80 14.31 51 11443 674411 62803117
Injury 25.78 14.31 47 11447 73200 63404328
Ankle fracture 25.38 14.31 23 11471 17832 63459696
Intervertebral disc protrusion 25.15 14.31 26 11468 23683 63453845
Muscle rigidity 25.11 14.31 19 11475 11481 63466047
Foot fracture 24.96 14.31 26 11468 23888 63453640
Resorption bone increased 24.21 14.31 9 11485 1265 63476263
Neck pain 23.79 14.31 44 11450 69274 63408254
Autonomic nervous system imbalance 23.30 14.31 11 11483 2807 63474721
Vestibular disorder 23.19 14.31 9 11485 1422 63476106
Infusion related reaction 22.79 14.31 8 11486 245513 63232015
Suicidal behaviour 20.89 14.31 10 11484 2629 63474899
Fibromyalgia 20.38 14.31 45 11449 80375 63397153
Vertigo positional 20.17 14.31 10 11484 2839 63474689
Joint swelling 19.93 14.31 18 11476 327648 63149880
Migraine 19.91 14.31 52 11442 103294 63374234
Treatment failure 19.32 14.31 6 11488 199037 63278491
Drug withdrawal syndrome 18.96 14.31 24 11470 27170 63450358
Respiratory arrest 18.45 14.31 26 11468 32619 63444909
Muscle spasms 18.29 14.31 66 11428 156084 63321444
Product use issue 17.56 14.31 9 11485 220511 63257017
Synovitis 17.49 14.31 6 11488 186912 63290616
Neutropenia 17.48 14.31 5 11489 175000 63302528
Systemic lupus erythematosus 17.43 14.31 8 11486 208910 63268618
Concussion 17.42 14.31 14 11480 9230 63468298
Myocardial infarction 16.98 14.31 48 11446 99845 63377683
Spinal stenosis 16.98 14.31 17 11477 14908 63462620
Temporomandibular joint syndrome 16.78 14.31 10 11484 4079 63473449
Drug abuse 16.62 14.31 39 11455 72479 63405049
Drug intolerance 16.44 14.31 19 11475 308642 63168886
Mydriasis 16.21 14.31 15 11479 11941 63465587
Coronary artery disease 15.71 14.31 24 11470 32353 63445175
Alopecia 15.70 14.31 23 11471 337513 63140015
Cerebrovascular accident 14.69 14.31 48 11446 107976 63369552
Respiratory depression 14.47 14.31 15 11479 13700 63463828
Fear 14.44 14.31 16 11478 15750 63461778

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
Completed suicide 91.13 19.93 75 3256 98093 34855507
Toxicity to various agents 87.36 19.93 101 3230 200261 34753339
Accidental death 64.83 19.93 19 3312 2437 34951163
Drug hypersensitivity 46.09 19.93 47 3284 80482 34873118
Coronary artery disease 38.72 19.93 34 3297 48271 34905329
Back pain 26.40 19.93 44 3287 121745 34831855
Overdose 25.46 19.93 37 3294 91022 34862578
Drug withdrawal syndrome 24.50 19.93 18 3313 19816 34933784
Depression 23.65 19.93 37 3294 97061 34856539
Body height decreased 23.45 19.93 10 3321 3833 34949767
Back injury 22.97 19.93 10 3321 4031 34949569
Cerebral vasoconstriction 21.74 19.93 5 3326 246 34953354
Emotional distress 21.70 19.93 15 3316 15011 34938589
Myocardial infarction 21.39 19.93 40 3291 121045 34832555
Anxiety 20.31 19.93 35 3296 99393 34854207

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
Completed suicide 366.58 15.06 292 11013 245475 79487608
Accidental death 296.61 15.06 77 11228 4214 79728869
Toxicity to various agents 261.23 15.06 309 10996 421231 79311852
Drug hypersensitivity 222.05 15.06 241 11064 298675 79434408
Serotonin syndrome 76.49 15.06 58 11247 44969 79688114
Overdose 73.17 15.06 109 11196 184097 79548986
Anxiety 54.20 15.06 113 11192 248399 79484684
Coronary artery disease 46.97 15.06 52 11253 65422 79667661
Depression 45.42 15.06 97 11208 216693 79516390
Clonus 41.52 15.06 20 11285 6820 79726263
Deep vein thrombosis 40.22 15.06 66 11239 120853 79612230
Injury 35.31 15.06 49 11256 77447 79655636
Purpura senile 34.15 15.06 9 11296 521 79732562
Tarsal tunnel syndrome 34.05 15.06 9 11296 527 79732556
Myocardial infarction 32.51 15.06 77 11228 184052 79549031
Off label use 31.65 15.06 50 11255 907165 78825918
Drug withdrawal syndrome 31.00 15.06 31 11274 34687 79698396
Hyperlipidaemia 30.39 15.06 27 11278 26066 79707017
Emotional distress 29.10 15.06 32 11273 39937 79693146
Muscle rigidity 28.12 15.06 23 11282 19859 79713224
Neutropenia 27.56 15.06 4 11301 287706 79445377
Hyperreflexia 26.79 15.06 16 11289 8369 79724714
Intervertebral disc protrusion 26.64 15.06 24 11281 23597 79709486
Resorption bone increased 25.07 15.06 9 11296 1466 79731617
Respiratory arrest 24.16 15.06 35 11270 57515 79675568
Vertigo positional 24.11 15.06 11 11294 3319 79729764
Vestibular disorder 23.93 15.06 10 11295 2445 79730638
Back injury 23.46 15.06 16 11289 10507 79722576
Cardio-respiratory arrest 22.05 15.06 48 11257 108462 79624621
Mydriasis 22.04 15.06 19 11286 17624 79715459
Poisoning 21.53 15.06 22 11283 25250 79707833
Gastrooesophageal reflux disease 21.05 15.06 46 11259 104200 79628883
Muscle spasms 20.64 15.06 63 11242 174667 79558416
Migraine 20.46 15.06 41 11264 87452 79645631
Infusion related reaction 20.28 15.06 4 11301 230233 79502850
Spinal stenosis 19.71 15.06 17 11288 15774 79717309
Bronchitis 19.23 15.06 51 11254 130593 79602490
Body height decreased 19.02 15.06 13 11292 8567 79724516
Thrombocytopenia 18.88 15.06 7 11298 265252 79467831
Neck pain 18.43 15.06 36 11269 75381 79657702
Chest pain 18.39 15.06 84 11221 282220 79450863
Febrile neutropenia 18.39 15.06 5 11300 230994 79502089
Suicidal behaviour 18.22 15.06 9 11296 3238 79729845
Drug abuser 17.99 15.06 11 11294 6002 79727081
Cerebrovascular accident 17.42 15.06 55 11250 155237 79577846
Drug dependence 17.41 15.06 25 11280 40744 79692339
Back pain 16.57 15.06 86 11219 304094 79428989
Road traffic accident 16.10 15.06 25 11280 43639 79689444
Angina unstable 15.20 15.06 15 11290 16512 79716571

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
MeSH PA D009465 Neuromuscular Agents
MeSH PA D018373 Peripheral Nervous System Agents
FDA PE N0000175730 Centrally-mediated Muscle Relaxation
FDA EPC N0000175737 Muscle Relaxant

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Spasticity indication 221360009
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Hemolytic anemia contraindication 61261009 DOID:583
Acute hepatic failure contraindication 197270009
Chronic Hepatic Disease contraindication




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 13.45 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
800MG SKELAXIN KING PHARMS N013217 Aug. 30, 2002 DISCN TABLET ORAL 7122566 Feb. 6, 2026 TREATMENT OF MUSCULOSKELETAL CONDITIONS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
4018807 VUID
N0000147110 NUI
D00773 KEGG_DRUG
4018807 VANDF
C0163055 UMLSCUI
CHEBI:6797 CHEBI
CHEMBL1079604 ChEMBL_ID
DB00660 DRUGBANK_ID
15459 PUBCHEM_CID
C011301 MESH_SUPPLEMENTAL_RECORD_UI
7609 IUPHAR_LIGAND_ID
1027 INN_ID
1NMA9J598Y UNII
204315 RXNORM
1680 MMSL
172287 MMSL
5062 MMSL
d00964 MMSL
001673 NDDF
404863006 SNOMEDCT_US
87599003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 0115-1745 TABLET 400 mg ORAL ANDA 20 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 0115-1745 TABLET 400 mg ORAL ANDA 20 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 0115-1745 TABLET 400 mg ORAL ANDA 20 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 0115-1748 TABLET 800 mg ORAL NDA 20 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 0185-0448 TABLET 800 mg ORAL ANDA 17 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 0185-0448 TABLET 800 mg ORAL ANDA 17 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 0276-0508 TABLET 400 mg ORAL ANDA 20 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 0527-1435 TABLET 800 mg ORAL ANDA 19 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 0527-1435 TABLET 800 mg ORAL ANDA 19 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 0591-2341 TABLET 800 mg ORAL ANDA 19 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 0904-6831 TABLET 800 mg ORAL ANDA 20 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 0904-6831 TABLET 800 mg ORAL ANDA 20 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 10544-002 TABLET 800 mg ORAL NDA 20 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 10544-144 TABLET 800 mg ORAL ANDA 20 sections
SKELAXIN HUMAN PRESCRIPTION DRUG LABEL 1 10544-524 TABLET 800 mg ORAL NDA 20 sections
SKELAXIN HUMAN PRESCRIPTION DRUG LABEL 1 16590-207 TABLET 800 mg ORAL NDA 20 sections
METAXALONE HUMAN PRESCRIPTION DRUG LABEL 1 16590-346 TABLET 800 mg ORAL NDA 20 sections
Skelaxin HUMAN PRESCRIPTION DRUG LABEL 1 21695-123 TABLET 800 mg ORAL NDA 21 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 21695-585 TABLET 800 mg ORAL ANDA 19 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 33261-724 TABLET 800 mg ORAL ANDA 20 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 42254-040 TABLET 800 mg ORAL NDA 20 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 42291-587 TABLET 800 mg ORAL ANDA 20 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 42494-449 TABLET 400 mg ORAL ANDA 21 sections
METAXALONE HUMAN PRESCRIPTION DRUG LABEL 1 42549-650 TABLET 800 mg ORAL NDA 20 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 45865-942 TABLET 800 mg ORAL ANDA 19 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 45865-985 TABLET 800 mg ORAL ANDA 20 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 50090-3174 TABLET 800 mg ORAL ANDA 20 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 50090-3650 TABLET 800 mg ORAL ANDA 20 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 50090-3650 TABLET 800 mg ORAL ANDA 20 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 50090-3670 TABLET 800 mg ORAL ANDA 19 sections