metaxalone 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: 2.14
  • 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 ┬ÁM/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 241.60 14.29 59 10973 1705 53336329
Completed suicide 224.96 14.29 203 10829 137998 53200036
Drug hypersensitivity 187.35 14.29 251 10781 264991 53073043
Toxicity to various agents 166.03 14.29 215 10817 219383 53118651
Serotonin syndrome 59.71 14.29 47 10985 26359 53311675
Deep vein thrombosis 38.87 14.29 65 10967 82848 53255186
Purpura senile 38.07 14.29 11 11021 611 53337423
Anxiety 37.37 14.29 107 10925 196597 53141437
Overdose 37.23 14.29 74 10958 107662 53230372
Clonus 34.10 14.29 17 11015 4274 53333760
Tarsal tunnel syndrome 33.31 14.29 10 11022 635 53337399
Depression 33.24 14.29 98 10934 182954 53155080
Fibromyalgia 32.88 14.29 43 10989 44032 53294002
Injury 29.47 14.29 44 10988 50927 53287107
Resorption bone increased 27.70 14.29 10 11022 1132 53336902
Vestibular disorder 25.64 14.29 10 11022 1401 53336633
Ankle fracture 24.30 14.29 23 11009 16492 53321542
Neck pain 24.14 14.29 44 10988 59972 53278062
Muscle rigidity 23.86 14.29 19 11013 10822 53327212
Muscle spasms 23.34 14.29 71 10961 134724 53203310
Foot fracture 23.08 14.29 25 11007 21014 53317020
Autonomic nervous system imbalance 22.61 14.29 11 11021 2623 53335411
Intervertebral disc protrusion 22.22 14.29 25 11007 21920 53316114
Vertigo positional 21.91 14.29 11 11021 2805 53335229
Suicidal behaviour 19.93 14.29 10 11022 2548 53335486
Migraine 19.56 14.29 48 10984 80369 53257665
Drug ineffective 18.95 14.29 96 10936 817149 52520885
Neutropenia 18.53 14.29 5 11027 159180 53178854
Thrombophlebitis superficial 18.38 14.29 12 11020 5023 53333011
Infusion related reaction 17.96 14.29 5 11027 155952 53182082
Concussion 17.87 14.29 14 11018 7790 53330244
Lower limb fracture 17.58 14.29 18 11014 14187 53323847
Off label use 17.14 14.29 46 10986 472166 52865868
Drug withdrawal syndrome 15.92 14.29 24 11008 27998 53310036
Drug abuse 15.81 14.29 39 10993 65487 53272547
Mydriasis 15.20 14.29 15 11017 11311 53326723
Thrombocytopenia 14.98 14.29 5 11027 138722 53199312
Road traffic accident 14.63 14.29 22 11010 25609 53312425
Systemic lupus erythematosus 14.48 14.29 4 11028 125410 53212624
Rheumatoid arthritis 14.37 14.29 27 11005 314504 53023530

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 96.67 21.41 78 3249 92439 32417760
Toxicity to various agents 89.51 21.41 100 3227 177941 32332258
Accidental death 65.75 21.41 19 3308 2158 32508041
Drug hypersensitivity 46.94 21.41 47 3280 73353 32436846
Coronary artery disease 35.81 21.41 34 3293 49672 32460527
Drug withdrawal syndrome 25.23 21.41 19 3308 20212 32489987
Overdose 24.71 21.41 37 3290 87040 32423159
Back pain 23.11 21.41 41 3286 111012 32399187
Depression 23.04 21.41 38 3289 97022 32413177
Back injury 22.86 21.41 10 3317 3796 32506403
Body height decreased 22.84 21.41 10 3317 3805 32506394

Pharmacologic Action:

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

Drug Use (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

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 RX 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
1027 INN_ID
C011301 MESH_SUPPLEMENTAL_RECORD_UI
7609 IUPHAR_LIGAND_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 0115-1748 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 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 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 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 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 50090-3670 TABLET 800 mg ORAL ANDA 19 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 50090-4448 TABLET 800 mg ORAL ANDA 21 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 50228-323 TABLET 800 mg ORAL ANDA 20 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 50228-474 TABLET 400 mg ORAL ANDA 20 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 50268-530 TABLET 800 mg ORAL ANDA 20 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 51655-162 TABLET 800 mg ORAL ANDA 5 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 51655-163 TABLET 800 mg ORAL NDA 1 sections
Metaxalone HUMAN PRESCRIPTION DRUG LABEL 1 51655-167 TABLET 800 mg ORAL ANDA 11 sections