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metaxalone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
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 |
|---|---|---|---|---|---|---|
| Completed suicide | 380.57 | 18.02 | 190 | 6109 | 144868 | 90477280 |
| Toxicity to various agents | 297.15 | 18.02 | 206 | 6093 | 287640 | 90334508 |
| Accidental death | 278.98 | 18.02 | 56 | 6243 | 1992 | 90620156 |
| Drug hypersensitivity | 229.91 | 18.02 | 216 | 6083 | 463393 | 90158755 |
| Serotonin syndrome | 85.51 | 18.02 | 45 | 6254 | 37842 | 90584306 |
| Overdose | 54.87 | 18.02 | 61 | 6238 | 157648 | 90464500 |
| Clonus | 47.18 | 18.02 | 17 | 6282 | 5733 | 90616415 |
| Foot fracture | 42.00 | 18.02 | 25 | 6274 | 26581 | 90595567 |
| Drug abuse | 41.65 | 18.02 | 39 | 6260 | 82308 | 90539840 |
| Purpura senile | 39.20 | 18.02 | 9 | 6290 | 606 | 90621542 |
| Muscle rigidity | 38.07 | 18.02 | 19 | 6280 | 14290 | 90607858 |
| Respiratory arrest | 34.48 | 18.02 | 24 | 6275 | 33287 | 90588861 |
| Tarsal tunnel syndrome | 34.41 | 18.02 | 8 | 6291 | 569 | 90621579 |
| Concussion | 30.31 | 18.02 | 15 | 6284 | 11076 | 90611072 |
| Resorption bone increased | 28.47 | 18.02 | 8 | 6291 | 1211 | 90620937 |
| Autonomic nervous system imbalance | 27.55 | 18.02 | 10 | 6289 | 3440 | 90618708 |
| Vestibular disorder | 26.58 | 18.02 | 8 | 6291 | 1541 | 90620607 |
| Suicidal behaviour | 25.57 | 18.02 | 9 | 6290 | 2835 | 90619313 |
| Ankle fracture | 24.23 | 18.02 | 16 | 6283 | 20354 | 90601794 |
| Fall | 23.33 | 18.02 | 80 | 6219 | 481730 | 90140418 |
| Unresponsive to stimuli | 23.10 | 18.02 | 20 | 6279 | 38101 | 90584047 |
| Hyperreflexia | 21.20 | 18.02 | 10 | 6289 | 6647 | 90615501 |
| Mydriasis | 20.85 | 18.02 | 13 | 6286 | 14999 | 90607149 |
| Poisoning | 20.69 | 18.02 | 13 | 6286 | 15204 | 90606944 |
| Vertigo positional | 20.55 | 18.02 | 8 | 6291 | 3336 | 90618812 |
| Exposure via ingestion | 18.61 | 18.02 | 7 | 6292 | 2660 | 90619488 |
| Bronchitis | 18.60 | 18.02 | 36 | 6263 | 152891 | 90469257 |
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 |
|---|---|---|---|---|---|---|
| Toxicity to various agents | 170.49 | 27.08 | 96 | 1138 | 229040 | 42391061 |
| Completed suicide | 170.06 | 27.08 | 73 | 1161 | 96392 | 42523709 |
| Accidental death | 77.74 | 27.08 | 18 | 1216 | 3065 | 42617036 |
| Drug hypersensitivity | 63.45 | 27.08 | 38 | 1196 | 99351 | 42520750 |
| Cerebral vasoconstriction | 27.61 | 27.08 | 5 | 1229 | 250 | 42619851 |
FDA Adverse Event Reporting System (Geriatric)
| 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 | 589.23 | 19.70 | 278 | 5724 | 242103 | 110341194 |
| Toxicity to various agents | 462.74 | 19.70 | 299 | 5703 | 480256 | 110103041 |
| Accidental death | 341.61 | 19.70 | 74 | 5928 | 4935 | 110578362 |
| Drug hypersensitivity | 252.39 | 19.70 | 203 | 5799 | 453887 | 110129410 |
| Serotonin syndrome | 101.85 | 19.70 | 54 | 5948 | 59099 | 110524198 |
| Overdose | 97.54 | 19.70 | 89 | 5913 | 233705 | 110349592 |
| Clonus | 55.39 | 19.70 | 20 | 5982 | 8696 | 110574601 |
| Respiratory arrest | 45.28 | 19.70 | 32 | 5970 | 58267 | 110525030 |
| Drug abuse | 42.13 | 19.70 | 50 | 5952 | 177361 | 110405936 |
| Muscle rigidity | 41.50 | 19.70 | 22 | 5980 | 24009 | 110559288 |
| Hyperreflexia | 39.52 | 19.70 | 16 | 5986 | 9469 | 110573828 |
| Tarsal tunnel syndrome | 36.78 | 19.70 | 8 | 5994 | 541 | 110582756 |
| Cardio-respiratory arrest | 36.74 | 19.70 | 38 | 5964 | 115798 | 110467499 |
| Purpura senile | 35.87 | 19.70 | 8 | 5994 | 607 | 110582690 |
| Poisoning | 34.95 | 19.70 | 21 | 5981 | 29084 | 110554213 |
| Intentional overdose | 30.87 | 19.70 | 37 | 5965 | 132464 | 110450833 |
| Mydriasis | 29.25 | 19.70 | 17 | 5985 | 22140 | 110561157 |
| Resorption bone increased | 28.61 | 19.70 | 8 | 5994 | 1526 | 110581771 |
| Vestibular disorder | 28.44 | 19.70 | 9 | 5993 | 2623 | 110580674 |
| Suicidal behaviour | 25.93 | 19.70 | 9 | 5993 | 3488 | 110579809 |
| Vertigo positional | 21.18 | 19.70 | 8 | 5994 | 3940 | 110579357 |
| Unresponsive to stimuli | 20.34 | 19.70 | 21 | 5981 | 63769 | 110519528 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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|
| 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 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SKELAXIN | KING PHARMS | N013217 | Aug. 30, 2002 | DISCN | TABLET | ORAL | 7122566 | Feb. 6, 2026 | TREATMENT OF MUSCULOSKELETAL CONDITIONS |
| 640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | METAXALONE | PRIMUS PHARMS | N022503 | June 1, 2015 | RX | TABLET | ORAL | 12485111 | May 14, 2043 | METAXALONE IS INDICATED AS AN ADJUNCT TO REST, PHYSICAL THERAPY, AND OTHER MEASURES FOR THE RELIEF AND DISCOMFORT ASSOCIATED WITH ACUTE, PAINFUL 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 |
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Metaxalone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1745 | TABLET | 400 mg | ORAL | ANDA | 25 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 | 25 sections |
| Metaxalone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-2341 | TABLET | 800 mg | ORAL | ANDA | 24 sections |
| Metaxalone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-6831 | TABLET | 800 mg | ORAL | ANDA | 26 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 | 42291-985 | TABLET | 800 mg | ORAL | ANDA | 25 sections |
| Metaxalone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-985 | TABLET | 800 mg | ORAL | ANDA | 25 sections |
| METAXALONE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42549-650 | TABLET | 800 mg | ORAL | NDA | 20 sections |
| Metaxalone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 45865-161 | TABLET | 800 mg | ORAL | ANDA | 17 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 | 26 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 | 50228-323 | TABLET | 800 mg | ORAL | ANDA | 20 sections |
| Metaxalone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50228-474 | TABLET | 400 mg | ORAL | ANDA | 25 sections |
| Metaxalone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50268-530 | TABLET | 800 mg | ORAL | ANDA | 20 sections |
| Metaxalone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50436-0449 | TABLET | 800 mg | ORAL | ANDA | 19 sections |
| Metaxalone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51655-162 | TABLET | 800 mg | ORAL | ANDA | 5 sections |