pharmacopeia
GET
/api/v1/drug/carisoprodol
2D structure
[2-(carbamoyloxymethyl)-2-methylpentyl] N-propan-2-ylcarbamate
SMILES CCCC(C)(COC(=O)N)COC(=O)NC(C)C
InChIKey OFZCIYFFPZCNJE-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

The mechanism of action of carisoprodol in relieving discomfort associated with acute painful musculoskeletal conditions has not been clearly identified. In animal studies, muscle relaxation induced by carisoprodol is associated with altered interneuronal activity in the spinal cord and in the descending reticular formation of the brain.

Indications

Sourced from openFDA
  • Carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use Carisoprodol 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.

Contraindications

Sourced from openFDA
  • Carisoprodol is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate.contraindicated

Dosage & administration

Sourced from openFDA

The recommended dose of carisoprodol is 350 mg three times a day and at bedtime. The recommended maximum duration of carisoprodol use is up to two or three weeks. Recommended dose is 350 mg three times a day and at bedtime. (2)

Warnings & precautions

Sourced from openFDA

Due to sedative properties, may impair ability to perform hazardous tasks such as driving or operating machinery (5.1) Additive sedative effects when used with other CNS depressants including alcohol (5.1) Cases of abuse, dependence and withdrawal ( 5.2 , 9.2 , 9.3 ) Seizures (5.3) 5.1 Sedation Carisoprodol has sedative properties (in the low back pain trials, 13% to 17% of patients who received carisoprodol experienced sedation compared to 6% of patients who received placebo) [ see ADVERSE REACTIONS (6.1) ] and may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or operating machinery. There have been post-marketing reports of motor vehicle accidents associated with the use of carisoprodol. Since the sedative effects of carisoprodol and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive, appropriate caution should be exercised with patients who take more than one of these CNS depressants simultaneously. 5.2 Abuse, Dependence, and Withdrawal Carisoprodol, the active ingredient, has been subject to abuse, dependence, and withdrawal, misuse and criminal diversion. [ see Drug Abuse and Dependence (9.1 , 9.2 , 9.3) ]. Abuse of carisoprodol poses a risk of overdosage which may lead to death, CNS and respiratory depression, hypotension, seizures and other disorders [ see Overdosage (10) ]. Post-marketing experience cases of carisoprodol abuse and dependence have been reported in patients with prolonged use and a history of drug abuse.

Adverse reactions

Sourced from openFDA

Most common adverse reactions (incidence > 2%) are drowsiness, dizziness, and headache (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Oxford Pharmaceuticals LLC at 1-844 508 1455 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice. The data described below are based on 1387 patients pooled from two double blind, randomized, multicenter, placebo controlled, one-week trials in adult patients with acute, mechanical, lower back pain [ see Clinical Studies (14) ]. In these studies, patients were treated with 250 mg of carisoprodol, 350 mg of carisoprodol, or placebo three times a day and at bedtime for seven days. The mean age was about 41 years old with 54% females and 46% males and 74 % Caucasian, 16 % Black, 9% Asian, and 2% other. There were no deaths and there were no serious adverse reactions in these two trials. In these two studies, 2.7%, 2%, and 5.4%, of patients treated with placebo, 250 mg of carisoprodol, and 350 mg of carisoprodol, respectively, discontinued due to adverse events; and 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of carisoprodol, and 350 mg of carisoprodol, respectively, discontinued due to central nervous system adverse reactions.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary Data over many decades of carisoprodol use in pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Data on meprobamate, the primary metabolite of carisoprodol, also do not show a consistent association between maternal use of meprobamate and an increased risk of major birth defects (see Data ). In a published animal reproduction study, pregnant mice administered carisoprodol orally at 2.6­ and 4.1-times the maximum recommended human dose ([MRHD] of 1400 mg per day [350 mg QID] based on body surface area [BSA] comparison) from gestation through weaning resulted in reduced fetal weights, postnatal weight gain, and postnatal survival (see Data ). . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Retrospective case-control and cohort studies of meprobamate use during the first trimester of pregnancy have not consistently identified an increased risk or pattern of major birth defects.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption The pharmacokinetics of carisoprodol and its metabolite meprobamate were studied in a crossover study of 24 healthy subjects (12 male and 12 female) who received single doses of 250 mg and 350 mg carisoprodol (see Table 2 ). The exposure of carisoprodol and meprobamate was dose proportional between the 250 mg and 350 mg doses.

Overdosage

Sourced from openFDA

Clinical Presentation Overdosage of carisoprodol commonly produces CNS depression. Death, coma, respiratory depression, hypotension, seizures, delirium, hallucinations, dystonic reactions, nystagmus, blurred vision, mydriasis, euphoria, muscular incoordination, rigidity, and/or headache have been reported with carisoprodol overdosage. Serotonin syndrome has been reported with carisoprodol intoxication. Many of the carisoprodol overdoses have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol). The effects of an overdose of carisoprodol and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) can be additive even when one of the drugs has been taken in the recommended dosage. Fatal accidental and non-accidental overdoses of carisoprodol have been reported alone or in combination with CNS depressants. Treatment of Overdosage Basic life support measures should be instituted as dictated by the clinical presentation of the carisoprodol overdose. Vomiting should not be induced because of the risk of CNS and respiratory depression, and subsequent aspiration.

Approval history

Sourced from openFDA
  • Apr 9, 1959NDANDA011792Mylan Speciality Lp
  • Mar 7, 1997ANDAANDA040188Oxford Pharms
  • Sep 8, 1997ANDAANDA040245Chartwell Rx
  • Oct 22, 2008ANDAANDA040823Ingenus Pharms Llc
  • Aug 6, 2009ANDAANDA040792Aurobindo Pharma
  • Jan 27, 2014ANDAANDA203374Sciegen Pharms
  • Jul 8, 2015ANDAANDA205126Heritage
  • May 11, 2017ANDAANDA207237Mpp Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
18,904 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Pain1,6188.6%
  2. 2Completed Suicide1,4587.7%
  3. 3Drug Ineffective1,3207.0%
  4. 4Nausea1,2866.8%
  5. 5Headache1,0945.8%
  6. 6Anxiety9915.2%
  7. 7Depression9885.2%
  8. 8Fatigue9785.2%
  9. 9Toxicity To Various Agents9074.8%
  10. 10Insomnia8304.4%
  11. 11Vomiting8114.3%
  12. 12Drug Dependence7964.2%
  13. 13Fall7894.2%
  14. 14Dyspnoea7383.9%
  15. 15Overdose7363.9%

Literature

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Recent PubMed references pinned to Carisoprodol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 5 most recently updated of 5 ClinicalTrials.gov registrations naming Carisoprodol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Carisoprodol. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • CYP2C19CPIC B/C (provisional)ClinPGx 4FDA label: Actionable PGx

Frequently asked questions

How does Carisoprodol work?
The mechanism of action of carisoprodol in relieving discomfort associated with acute painful musculoskeletal conditions has not been clearly identified. In animal studies, muscle relaxation induced by carisoprodol is associated with altered interneuronal activity in the spinal cord and in the descending reticular formation of the brain.
What is Carisoprodol used for?
According to FDA labeling, Carisoprodol carries indications including: Carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use Carisoprodol 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Carisoprodol?
Carisoprodol is classified as Carbamic acid esters, Muscle Relaxant, Unknown Cellular or Molecular Interaction, Centrally-mediated Muscle Relaxation, Decreased Central Nervous System Organized Electrical Activity, Decreased Striated Muscle Contraction.
What are the brand names for Carisoprodol?
Carisoprodol is marketed under brand names including Soma, Vanadom.
What are the contraindications for Carisoprodol?
Carisoprodol labeling lists contraindications including: Carisoprodol is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate.. Always consult the full prescribing information and a clinician.
Note. Data for carisoprodol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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