CARISOPRODOL

Details

Stereochemistry	RACEMIC
Molecular Formula	C12H24N2O4
Molecular Weight	260.33
Optical Activity	( + / - )
Defined Stereocenters	0 / 1
E/Z Centers	0
Charge	0

SHOW SMILES / InChI

Structure Search

SMILES

CCCC(C)(COC(N)=O)COC(=O)NC(C)C

InChI

InChIKey=OFZCIYFFPZCNJE-UHFFFAOYSA-N

InChI=1S/C12H24N2O4/c1-5-6-12(4,7-17-10(13)15)8-18-11(16)14-9(2)3/h9H,5-8H2,1-4H3,(H2,13,15)(H,14,16)

HIDE SMILES / InChI

Description
Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/011792s045lbl.pdf
Curator's Comment: description was created based on several sources, including: http://www.ncbi.nlm.nih.gov/pubmed/22318620, http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7c9184c0-7a2e-11df-8c8d-0002a5d5c51b

A centrally acting skeletal muscle relaxant whose mechanism of action is not completely understood but may be related to its sedative actions. Carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Most common adverse reactions (incidence > 2%) are drowsiness, dizziness, and headache. Carisoprodol might be mixtured with Aspirin and Codeine Phosphate. Studies indicating increased risk of abuse or addiction led to withdrawal of the drug from the market in Norway and other EU countries in 2008.

CNS Activity

Originator

Approval Year

Targets

Primary Target	Pharmacology	Condition	Potency
GABA-A receptor 3 Target ID: CHEMBL2364024 Sources: http://www.ncbi.nlm.nih.gov/pubmed/20419052	Positive Allosteric Modulator 179		142.0 µM [EC50]

Conditions

Condition	Modality	Targets	Highest Phase	Product
Painful musculoskeletal conditions 3 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/011792s045lbl.pdf	Palliative		Approved 8429	SOMA Approved Use SOMA is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. SOMA should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration Launch Date 1959

C_max

Value	Dose	Analyte	Population
1.2 μg/mL DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011792s048lbl.pdf	250 mg single, oral dose: 250 mg route of administration: Oral experiment type: SINGLE co-administered:	CARISOPRODOL plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
1.8 μg/mL DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011792s050lbl.pdf	350 mg single, oral dose: 350 mg route of administration: Oral experiment type: SINGLE co-administered:	CARISOPRODOL plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
13.3 μM EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7974621	700 mg single, oral dose: 700 mg route of administration: Oral experiment type: SINGLE co-administered:	CARISOPRODOL serum	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED

AUC

Value	Dose	Co-administered	Analyte	Population
4.5 μg × h/mL DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011792s048lbl.pdf	250 mg single, oral dose: 250 mg route of administration: Oral experiment type: SINGLE co-administered:		CARISOPRODOL plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
7 μg × h/mL DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011792s050lbl.pdf	350 mg single, oral dose: 350 mg route of administration: Oral experiment type: SINGLE co-administered:		CARISOPRODOL plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN

T_1/2

Value	Dose	Analyte	Population
1.7 h DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011792s048lbl.pdf	250 mg single, oral dose: 250 mg route of administration: Oral experiment type: SINGLE co-administered:	CARISOPRODOL plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
2 h DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011792s050lbl.pdf	350 mg single, oral dose: 350 mg route of administration: Oral experiment type: SINGLE co-administered:	CARISOPRODOL plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
99 min EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7974621	700 mg single, oral dose: 700 mg route of administration: Oral experiment type: SINGLE co-administered:	CARISOPRODOL serum	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED

F_unbound

Value	Dose	Co-administered	Analyte	Population
46% EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7974621	700 mg single, oral dose: 700 mg route of administration: Oral experiment type: SINGLE co-administered:		CARISOPRODOL serum	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED

Doses

Dose	Population	Adverse events
250 mg 3 times / day steady, oral Recommended Dose: 250 mg, 3 times / day Route: oral Route: steady Dose: 250 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 548 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 548 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	Disc. AE: Dizziness, Headache... AEs leading to discontinuation/dose reduction: Dizziness (0.5%) Headache (0.5%) Diarrhea (0.2%) Stomach discomfort (0.2%) Upper abdominal pain (0.2%) Intervertebral disc protrusion (0.2%) Pain in extremity (0.2%) Abdominal distension (0.2%) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
350 mg 3 times / day steady, oral Recommended Dose: 350 mg, 3 times / day Route: oral Route: steady Dose: 350 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 279 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 279 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	Disc. AE: Dizziness, Headache... AEs leading to discontinuation/dose reduction: Dizziness (0.7%) Headache (0.4%) Stomach discomfort (0.7%) Upper abdominal pain (0.7%) Somnolence (0.7%) Nausea (0.4%) Rash (0.4%) Nephrolithiasis (0.4%) Intervertebral disc protrusion (0.4%) Fatigue (0.4%) Disorientation (0.4%) Paraesthesia (0.4%) Skin papilloma (0.4%) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
2100 mg 1 times / day steady, oral Highest studied dose Dose: 2100 mg, 1 times / day Route: oral Route: steady Dose: 2100 mg, 1 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/1998178	unhealthy, adult n = 9 Health Status: unhealthy Age Group: adult Sex: M Population Size: 9 Sources: https://pubmed.ncbi.nlm.nih.gov/1998178	Sources: https://pubmed.ncbi.nlm.nih.gov/1998178

AEs

Overview

CYP3A4	CYP2C9	CYP2D6	hERG
inhibitor 1587 substrate 1737		inhibitor 1852 substrate 1217

OverviewOther

Other Inhibitor	Other Substrate	Other Inducer
CYP2C8 911	CYP2C19 991 CYP1A2 1054

Drug as perpetrator

Target	Modality	Activity
CYP2C8 965	inhibitor 3277 Sources: https://onlinelibrary.wiley.com/doi/full/10.1111/bcpt.12999 Page: 333.0	weak
CYP2D6 1891	inhibitor 3277 Sources: https://onlinelibrary.wiley.com/doi/full/10.1111/bcpt.12999 Page: 333.0	weak
CYP3A4 1925	inhibitor 3277 Sources: https://onlinelibrary.wiley.com/doi/full/10.1111/bcpt.12999 Page: 333.0	weak

Drug as victim

Target	Modality	Activity
CYP2C19 991	substrate 3367 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011792s050lbl.pdf Page: 4.0	major
CYP1A2 1054	substrate 3367 Sources: https://link.springer.com/article/10.1007/s40262-016-0373-8 Page: 1012.0	yes
CYP2D6 1217	substrate 3367 Sources: https://link.springer.com/article/10.1007/s40262-016-0373-8 Page: 1012.0	yes
CYP3A4 1737	substrate 3367 Sources: https://link.springer.com/article/10.1007/s40262-016-0373-8 Page: 1012.0	yes

Sourcing

Vendor/Aggregator	ID	URL
ChEBI	CHEBI:3419	https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:3419
ChemicalBook	CB0215440	https://www.chemicalbook.com/ChemicalProductProperty_EN_CB0215440
eMolecules	536553	https://www.emolecules.com/cgi-bin/more?vid=536553

PubMed

Title	Date	PubMed
National All Schedules Prescription Electronic Reporting Act (NASPER): balancing substance abuse and medical necessity.	2002 Jul	16902657
Simultaneous determination of carisoprodol and meprobamate in human hair using solid-phase extraction and gas chromatography/mass spectrometry of the trimethylsilyl derivatives.	2005	16200657
Carisoprodol intoxications and serotonergic features.	2005	15732445
The CYP2C19 genotype and the use of oral contraceptives influence the pharmacokinetics of carisoprodol in healthy human subjects.	2005 Aug	16021435
Treatment of carisoprodol dependence: a case report.	2005 Sep	16184075
Simple pharmacological test battery to assess efficacy and side effect profile of centrally acting muscle relaxant drugs.	2005 Sep-Oct	16125625
Biology and therapy of fibromyalgia. New therapies in fibromyalgia.	2006	16762044
A one-step and sensitive GC-MS assay for meprobamate determination in emergency situations.	2006 Jun	16839465
Carisoprodol abuse in Texas, 1998-2003.	2006 Mar	18072105
Carisoprodol withdrawal induced delirium: A case study.	2007	19300598
Carisoprodol abuse in Mississippi.	2007 Dec	19292137
[Somadril recalled in Norway].	2007 May 17	17519999
Upper limb impairments associated with spasticity in neurological disorders.	2007 Nov 29	18047660
Acute intoxications with carisoprodol.	2008 Apr	18363125
Reliability of Ashworth and Modified Ashworth scales in children with spastic cerebral palsy.	2008 Apr 10	18402701
[Somadril will be recalled June 1, 2008].	2008 Apr 2-8	18478757
Are there alternatives to the use of quinine to treat nocturnal leg cramps?	2008 Feb	18454580
Double-blind, placebo-controlled trial of carisoprodol 250-mg tablets in the treatment of acute lower-back spasm.	2008 Feb	18194591
Muscle and reflex changes with varying joint angle in hemiparetic stroke.	2008 Feb 27	18304313
Carisoprodol-induced amnestic state.	2008 Jan	19771317
Drug screening of hair by liquid chromatography-tandem mass spectrometry.	2008 Jun	18544222
High-dose carisoprodol during pregnancy and lactation.	2008 Jun	18460586
[The Somadril Association in Norway].	2008 Jun 26	18587468
[Somadril is accessible after May 1, 2008].	2008 May 1	18451900
Urine drug testing of chronic pain patients: licit and illicit drug patterns.	2008 Oct	19007501
Carisoprodol should be taken off the market.	2008 Oct	18791514
Effects of naltrexone on pain sensitivity and mood in fibromyalgia: no evidence for endogenous opioid pathophysiology.	2009	19365548
Reliability and validity of pendulum test measures of spasticity obtained with the Polhemus tracking system from patients with chronic stroke.	2009 Jul 30	19642989
A multi-drug intoxication fatality involving Xyrem (GHB).	2009 Mar	19187456
[Prescription shopping of addictive drugs in Norway].	2009 Mar 12	19282887
Prescription pattern of codeine for non-malignant pain: a pharmacoepidemiological study from the Norwegian Prescription Database.	2009 May	19419357
Carisoprodol-mediated modulation of GABAA receptors: in vitro and in vivo studies.	2009 May	19244096
A pilot study evaluating use of a computer-assisted neurorehabilitation platform for upper-extremity stroke assessment.	2009 May 28	19476637
The effect of scheduling and withdrawal of carisoprodol on prevalence of intoxications with the drug.	2009 Nov	19663822
Drugs associated with more suicidal ideations are also associated with more suicide attempts.	2009 Oct 2	19798416
Regulation of intermittent oscillatory activity of pyramidal cell neurons by GABA inhibitory interneurons is impaired in schizophrenia: rationale for pharmacotherapeutic GABAergic interventions.	2010	20686196
Inappropriate prescribing in the hospitalized elderly patient: defining the problem, evaluation tools, and possible solutions.	2010 Apr 7	20396637
Carisoprodol legal status and patterns of abuse.	2010 Dec	21062909
Rapid and sensitive LC-MS/MS method for determination of felbamate in mouse plasma and tissues and human plasma.	2010 Dec 15	21081288
Pharmacogenetics and forensic toxicology.	2010 Dec 15	20828952
Clinical perspective: monitoring sodium oxybate-treated narcolepsy patients for the development of sleep-disordered breathing.	2010 Feb	19626356
Carisoprodol withdrawal after internet purchase.	2010 Jul	20592570
The relation between neuromechanical parameters and Ashworth score in stroke patients.	2010 Jul 27	20663189
Adaptive robot training for the treatment of incoordination in Multiple Sclerosis.	2010 Jul 29	20670420
Observations of medication compliance by measurement of urinary drug concentrations in a pain management population.	2010 Jul-Aug	20862905
Pharmacologic management of chronic pain.	2010 Jun	20556211
Quantification of the effects of an alpha-2 adrenergic agonist on reflex properties in spinal cord injury using a system identification technique.	2010 Jun 23	20573252
Carisoprodol: abuse potential and withdrawal syndrome.	2010 Mar	20088817
Comparison of drug concentrations in blood and oral fluid collected with the Intercept sampling device.	2010 May	20465866
Screening and quantitative determination of twelve acidic and neutral pharmaceuticals in whole blood by liquid-liquid extraction and liquid chromatography-tandem mass spectrometry.	2010 Sep	20822673

Patents

Sample Use Guides

In Vivo Use Guide

250 mg to 350 mg three times a day and at bedtime

Route of Administration: Oral

In Vitro Use Guide

HEK293 cells were transiently transfected with human alpha1beta2 and alpha1beta2gamma2 receptors. Whole-cell patch clamp electrophysiology was used to assess carisoprodol-activated Cl- current. EC50 value for carisoprodol was 142 ± 13 uM.

Name

Type

Language

CARISOPRODOL

Official Name

English

(±)-2-METHYL-2-PROPYL-1,3-PROPANEDIOL CARBAMATE ISOPROPYLCARBAMATE

Systematic Name

English

CARISOPRODOL [HSDB]

Common Name

English

CARISOPRODOL COMPONENT OF CARISOPRODOL COMPOUND

Common Name

English

CARISOPRODOL [USP MONOGRAPH]

Common Name

English

NSC-172124

Code

English

CARISOPRODOL [MI]

Common Name

English

CARISOPRODOL [EP IMPURITY]

Common Name

English

CARISOPRODOL [JAN]

Common Name

English

carisoprodol [INN]

Common Name

English

SOMA

Brand Name

English

Carisoprodol [WHO-DD]

Common Name

English

RELA

Brand Name

English

CARISOPRODOL CIV

Common Name

English

CARISOPRODOL COMPONENT OF SOMA COMPOUND

Common Name

English

SOMA COMPOUND COMPONENT CARISOPRODOL

Common Name

English

CARISOPRODOL [VANDF]

Common Name

English

CARISOPRODOL [ORANGE BOOK]

Common Name

English

CARISOPRODOL CIV [USP-RS]

Common Name

English

CARISOPRODOL COMPOUND COMPONENT CARISOPRODOL

Common Name

English

CARISOPRODOL [MART.]

Common Name

English

Classification Tree Code System Code

NDF-RT

N0000175737

Created by admin on Fri Dec 15 15:04:38 GMT 2023 , Edited by admin on Fri Dec 15 15:04:38 GMT 2023

LIVERTOX

NBK548829

Created by admin on Fri Dec 15 15:04:38 GMT 2023 , Edited by admin on Fri Dec 15 15:04:38 GMT 2023

WHO-ATC

M03BA72

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WHO-VATC

QM03BA72

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WHO-VATC

QM03BA52

Created by admin on Fri Dec 15 15:04:38 GMT 2023 , Edited by admin on Fri Dec 15 15:04:38 GMT 2023

WHO-ATC

M03BA02

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NCI_THESAURUS

C29696

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WHO-VATC

QM03BA02

Created by admin on Fri Dec 15 15:04:38 GMT 2023 , Edited by admin on Fri Dec 15 15:04:38 GMT 2023

DEA NO.

8192

Created by admin on Fri Dec 15 15:04:37 GMT 2023 , Edited by admin on Fri Dec 15 15:04:37 GMT 2023

WHO-ATC

M03BA52

Created by admin on Fri Dec 15 15:04:37 GMT 2023 , Edited by admin on Fri Dec 15 15:04:37 GMT 2023

NDF-RT

N0000175730

Created by admin on Fri Dec 15 15:04:38 GMT 2023 , Edited by admin on Fri Dec 15 15:04:38 GMT 2023

Code System Code Type Description

NCI_THESAURUS

C28904

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PRIMARY

MESH

D002328

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SMS_ID

100000084595

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RS_ITEM_NUM

1096600

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WIKIPEDIA

CARISOPRODOL

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LACTMED

Carisoprodol

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FDA UNII

21925K482H

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DAILYMED

21925K482H

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PRIMARY

CHEBI

3419

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PRIMARY

IUPHAR

7610

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PRIMARY

HSDB

3021

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PRIMARY

DRUG BANK

DB00395

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PRIMARY

EPA CompTox

DTXSID8024733

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PRIMARY

PUBCHEM

2576

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NSC

172124

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PRIMARY

CAS

78-44-4

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PRIMARY

DRUG CENTRAL

509

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PRIMARY

EVMPD

SUB06631MIG

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ECHA (EC/EINECS)

201-118-7

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MERCK INDEX

m3112

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Merck Index

RXCUI

2101

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RxNorm

INN

902

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ChEMBL

CHEMBL1233

Created by admin on Fri Dec 15 15:04:37 GMT 2023 , Edited by admin on Fri Dec 15 15:04:37 GMT 2023

PRIMARY

ACTIVE MOIETY


					21925K482H

CARISOPRODOL

AE	Significance	Dose	Population
Abdominal distension	0.2% Disc. AE	250 mg 3 times / day steady, oral Recommended Dose: 250 mg, 3 times / day Route: oral Route: steady Dose: 250 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 548 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 548 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Diarrhea	0.2% Disc. AE	250 mg 3 times / day steady, oral Recommended Dose: 250 mg, 3 times / day Route: oral Route: steady Dose: 250 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 548 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 548 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Intervertebral disc protrusion	0.2% Disc. AE	250 mg 3 times / day steady, oral Recommended Dose: 250 mg, 3 times / day Route: oral Route: steady Dose: 250 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 548 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 548 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Pain in extremity	0.2% Disc. AE	250 mg 3 times / day steady, oral Recommended Dose: 250 mg, 3 times / day Route: oral Route: steady Dose: 250 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 548 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 548 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Stomach discomfort	0.2% Disc. AE	250 mg 3 times / day steady, oral Recommended Dose: 250 mg, 3 times / day Route: oral Route: steady Dose: 250 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 548 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 548 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Upper abdominal pain	0.2% Disc. AE	250 mg 3 times / day steady, oral Recommended Dose: 250 mg, 3 times / day Route: oral Route: steady Dose: 250 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 548 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 548 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Dizziness	0.5% Disc. AE	250 mg 3 times / day steady, oral Recommended Dose: 250 mg, 3 times / day Route: oral Route: steady Dose: 250 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 548 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 548 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Headache	0.5% Disc. AE	250 mg 3 times / day steady, oral Recommended Dose: 250 mg, 3 times / day Route: oral Route: steady Dose: 250 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 548 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 548 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Disorientation	0.4% Disc. AE	350 mg 3 times / day steady, oral Recommended Dose: 350 mg, 3 times / day Route: oral Route: steady Dose: 350 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 279 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 279 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Fatigue	0.4% Disc. AE	350 mg 3 times / day steady, oral Recommended Dose: 350 mg, 3 times / day Route: oral Route: steady Dose: 350 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 279 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 279 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Headache	0.4% Disc. AE	350 mg 3 times / day steady, oral Recommended Dose: 350 mg, 3 times / day Route: oral Route: steady Dose: 350 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 279 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 279 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Intervertebral disc protrusion	0.4% Disc. AE	350 mg 3 times / day steady, oral Recommended Dose: 350 mg, 3 times / day Route: oral Route: steady Dose: 350 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 279 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 279 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Nausea	0.4% Disc. AE	350 mg 3 times / day steady, oral Recommended Dose: 350 mg, 3 times / day Route: oral Route: steady Dose: 350 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 279 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 279 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Nephrolithiasis	0.4% Disc. AE	350 mg 3 times / day steady, oral Recommended Dose: 350 mg, 3 times / day Route: oral Route: steady Dose: 350 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 279 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 279 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Paraesthesia	0.4% Disc. AE	350 mg 3 times / day steady, oral Recommended Dose: 350 mg, 3 times / day Route: oral Route: steady Dose: 350 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 279 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 279 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Rash	0.4% Disc. AE	350 mg 3 times / day steady, oral Recommended Dose: 350 mg, 3 times / day Route: oral Route: steady Dose: 350 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 279 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 279 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Skin papilloma	0.4% Disc. AE	350 mg 3 times / day steady, oral Recommended Dose: 350 mg, 3 times / day Route: oral Route: steady Dose: 350 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 279 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 279 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Dizziness	0.7% Disc. AE	350 mg 3 times / day steady, oral Recommended Dose: 350 mg, 3 times / day Route: oral Route: steady Dose: 350 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 279 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 279 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Somnolence	0.7% Disc. AE	350 mg 3 times / day steady, oral Recommended Dose: 350 mg, 3 times / day Route: oral Route: steady Dose: 350 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 279 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 279 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Stomach discomfort	0.7% Disc. AE	350 mg 3 times / day steady, oral Recommended Dose: 350 mg, 3 times / day Route: oral Route: steady Dose: 350 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 279 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 279 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6
Upper abdominal pain	0.7% Disc. AE	350 mg 3 times / day steady, oral Recommended Dose: 350 mg, 3 times / day Route: oral Route: steady Dose: 350 mg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6	unhealthy, 41 years n = 279 Health Status: unhealthy Condition: acute, mechanical, lower back pain Age Group: 41 years Sex: M+F Population Size: 279 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf Page: 6

Details

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CNS Activity

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Approved Use

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AUC

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Funbound

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Overview

OverviewOther

Drug as perpetrator​

Drug as victim

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PubMed

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Drug as perpetrator