metaxalone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	1722	1665-48-1

Description:

Molecule	Description
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

Molecule

Description

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:

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	238.57	13.85	59	11086	1685	50592294
Completed suicide	210.44	13.85	197	10948	131692	50462287
Drug hypersensitivity	184.26	13.85	250	10895	250760	50343219
Toxicity to various agents	160.91	13.85	215	10930	212284	50381695
Serotonin syndrome	59.85	13.85	47	11098	24666	50569313
Deep vein thrombosis	40.40	13.85	64	11081	73240	50520739
Anxiety	40.00	13.85	107	11038	177499	50416480
Depression	35.58	13.85	98	11047	165325	50428654
Overdose	35.56	13.85	72	11073	99655	50494324
Purpura senile	34.65	13.85	10	11135	519	50593460
Clonus	33.52	13.85	17	11128	4158	50589821
Injury	31.60	13.85	46	11099	48879	50545100
Fibromyalgia	30.08	13.85	43	11102	44935	50549044
Tarsal tunnel syndrome	30.08	13.85	9	11136	530	50593449
Resorption bone increased	24.52	13.85	9	11136	1002	50592977
Foot fracture	24.49	13.85	26	11119	20065	50573914
Muscle rigidity	24.45	13.85	19	11126	9810	50584169
Intervertebral disc protrusion	24.17	13.85	26	11119	20367	50573612
Ankle fracture	24.03	13.85	23	11122	15699	50578280
Drug ineffective	23.55	13.85	97	11048	819236	49774743
Autonomic nervous system imbalance	22.99	13.85	11	11134	2374	50591605
Vestibular disorder	22.53	13.85	9	11136	1260	50592719
Infusion related reaction	22.34	13.85	5	11140	169552	50424427
Neck pain	21.28	13.85	42	11103	57025	50536954
Off label use	20.90	13.85	46	11099	474380	50119599
Migraine	20.73	13.85	49	11096	75231	50518748
Suicidal behaviour	20.20	13.85	10	11135	2324	50591655
Vertigo positional	19.51	13.85	10	11135	2501	50591478
Neutropenia	18.25	13.85	5	11140	147960	50446019
Muscle spasms	17.42	13.85	64	11081	125489	50468490
Concussion	17.37	13.85	14	11131	7614	50586365
Systemic lupus erythematosus	16.88	13.85	5	11140	140617	50453362
Drug withdrawal syndrome	16.80	13.85	24	11121	25057	50568922
Lower limb fracture	16.59	13.85	18	11127	14228	50579751
Drug abuse	16.52	13.85	39	11106	59807	50534172
Temporomandibular joint syndrome	16.30	13.85	10	11135	3529	50590450
Joint swelling	16.30	13.85	18	11127	245268	50348711
Respiratory arrest	16.24	13.85	26	11119	29983	50563996
Spinal stenosis	15.57	13.85	17	11128	13533	50580446
Mydriasis	15.21	13.85	15	11130	10612	50583367
Treatment failure	14.62	13.85	6	11139	137631	50456348
Thrombocytopenia	14.51	13.85	5	11140	127668	50466311
Road traffic accident	14.43	13.85	22	11123	24330	50569649

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	86.47	20.52	75	3217	90171	29481064
Toxicity to various agents	86.36	20.52	101	3191	173560	29397675
Accidental death	64.69	20.52	19	3273	2099	29569136
Drug hypersensitivity	46.40	20.52	47	3245	68359	29502876
Coronary artery disease	36.78	20.52	34	3258	44156	29527079
Overdose	24.79	20.52	37	3255	79782	29491453
Back pain	24.35	20.52	42	3250	102242	29468993
Drug withdrawal syndrome	23.57	20.52	18	3274	17966	29553269
Body height decreased	22.99	20.52	10	3282	3440	29567795
Depression	22.99	20.52	37	3255	85110	29486125
Back injury	22.90	20.52	10	3282	3474	29567761
Cerebral vasoconstriction	21.71	20.52	5	3287	211	29571024
Emotional distress	20.65	20.52	15	3277	13880	29557355

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	340.99	15.31	292	10776	224122	64263542
Accidental death	292.84	15.31	77	10991	3648	64484016
Toxicity to various agents	248.98	15.31	308	10760	363205	64124459
Drug hypersensitivity	226.05	15.31	239	10829	237576	64250088
Serotonin syndrome	73.69	15.31	58	11010	39224	64448440
Overdose	69.27	15.31	109	10959	159457	64328207
Anxiety	55.22	15.31	113	10955	202536	64285128
Depression	43.89	15.31	97	10971	183194	64304470
Coronary artery disease	42.29	15.31	52	11016	60381	64427283
Injury	40.51	15.31	49	11019	55943	64431721
Clonus	40.17	15.31	20	11048	6047	64481617
Deep vein thrombosis	37.73	15.31	66	11002	105116	64382548
Tarsal tunnel syndrome	32.88	15.31	9	11059	496	64487168
Purpura senile	32.77	15.31	9	11059	502	64487162
Drug withdrawal syndrome	28.75	15.31	31	11037	31260	64456404
Neutropenia	27.86	15.31	4	11064	239620	64248044
Myocardial infarction	27.22	15.31	76	10992	165745	64321919
Hyperlipidaemia	27.01	15.31	26	11042	22950	64464714
Muscle rigidity	26.88	15.31	23	11045	17450	64470214
Emotional distress	26.81	15.31	32	11036	36006	64451658
Hyperreflexia	26.33	15.31	16	11052	7132	64480532
Off label use	25.95	15.31	43	11025	632763	63854901
Intervertebral disc protrusion	25.93	15.31	24	11044	20167	64467497
Resorption bone increased	25.45	15.31	9	11059	1159	64486505
Vertigo positional	23.52	15.31	11	11057	2900	64484764
Vestibular disorder	22.75	15.31	10	11058	2283	64485381
Back injury	22.67	15.31	15	11053	7742	64479922
Respiratory arrest	21.30	15.31	35	11033	52950	64434714
Mydriasis	21.23	15.31	19	11049	15293	64472371
Gastrooesophageal reflux disease	21.00	15.31	45	11023	83098	64404566
Fibromyalgia	20.68	15.31	28	11040	35703	64451961
Poisoning	20.67	15.31	22	11046	21857	64465807
Muscle spasms	19.66	15.31	61	11007	140962	64346702
Thrombocytopenia	19.53	15.31	7	11061	223794	64263870
Migraine	19.50	15.31	37	11031	62640	64425024
Road traffic accident	19.19	15.31	25	11043	30720	64456944
Spinal stenosis	18.75	15.31	17	11051	13914	64473750
Infusion related reaction	18.53	15.31	3	11065	164464	64323200
Body height decreased	18.27	15.31	13	11055	7541	64480123
Cardio-respiratory arrest	18.04	15.31	47	11021	98346	64389318
Febrile neutropenia	17.92	15.31	5	11063	187652	64300012
Chest pain	17.87	15.31	84	10984	235896	64251768
Drug dependence	17.62	15.31	25	11043	33287	64454377
Suicidal behaviour	17.60	15.31	9	11059	2878	64484786
Neck pain	17.53	15.31	35	11033	61498	64426166
Bronchitis	17.01	15.31	49	11019	108694	64378970
Drug abuser	16.42	15.31	11	11057	5797	64481867
Diarrhoea	15.91	15.31	67	11001	722637	63765027
Pain	15.56	15.31	154	10914	553357	63934307
Back pain	15.39	15.31	84	10984	250087	64237577

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

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	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	0115-1745	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	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	50436-0449	TABLET	800 mg	ORAL	ANDA	19 sections