metaxalone Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 1722 | 1665-48-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
muscle spasm relaxant; structure
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 13, 1962 | FDA | KING PHARMS |
FDA Adverse Event Reporting System (Female)
| 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 |
|---|---|---|---|---|---|---|
| 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 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 |
|---|---|---|---|---|---|---|
| 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:
| Source | Code | Description |
|---|---|---|
| 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)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 13.45 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |