Carisoprodol Side Effects

Brand Names: Soma, Somatuline Depot, Somavert

Please note - some side effects for Carisoprodol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Carisoprodol - for the Consumer

Carisoprodol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Carisoprodol:

Dizziness; drowsiness; headache.

Seek medical attention right away if any of these SEVERE side effects occur when using Carisoprodol:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; hoarseness); fainting; fast heartbeat; fever, chills, or persistent sore throat; loss of coordination; mood or mental changes (eg, agitation, depression, irritability); seizures; severe or persistent dizziness; severe or persistent trouble sleeping; tremors.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Carisoprodol Side Effects - for the Professional

Carisoprodol

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 the study, patients were treated with 350 mg of Carisoprodol Tablets, 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 the trial.  In the study, 2.7%, 2%, and 5.4 %, of patients treated with placebo and 350 mg of Carisoprodol Tablets, respectively, discontinued due to adverse events; and 0.5%, 0.5%, and 1.8% of patients treated with placebo and 350 mg of Carisoprodol Tablets, respectively, discontinued due to central nervous system adverse reactions.

Table 1 displays adverse reactions reported with frequencies greater than 2% and more frequently than placebo in patients treated with Carisoprodol Tablets in the trial described above.

Table 1 – Patients with Adverse Reactions in Controlled Studies

Adverse Reaction		Placebo (n=560) n(%)			Carisoprodol 350 mg (n=279) n(%)
Drowsiness		31(6)			47(17)
Dizziness		11(2)			19(7)
Headache		11(2)			9(3)

Postmarketing Experience

The following events have been reported during postapproval use of Carisoprodol Tablets.  Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular: Tachycardia, postural hypotension, and facial flushing [see OVERDOSAGE (10) ].

Central Nervous System:  Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia, and seizures [see OVERDOSAGE (10) ].

Gastrointestinal:  Nausea, vomiting, and epigastric discomfort.

Hematologic:  Leukopenia, pancytopenia.

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Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects are common and include drowsiness and sedation most often. There have been postmarketing reports of motor vehicle accidents associated with the use of carisoprodol. Dizziness, headache, tremor, agitation, insomnia, syncope and ataxia have also been reported.

Central respiratory depression may occur, particularly at high doses.

Other

Psychologic dependence and abuse of carisoprodol (often in combination with alcohol and other CNS depressants) have been reported.

Withdrawal symptoms after abrupt cessation of carisoprodol have been reported and may be due to dependency on the meprobamate metabolite. Such symptoms include abdominal pain, agitation, tremor, restlessness, anxiety, depression, insomnia, nausea, and sweating. Seizures have been reported rarely.

Hypersensitivity

Hypersensitivity effects include rash, pruritus and erythema multiforme. Asthma, fever, hypotension and anaphylaxis have been reported rarely.

Gastrointestinal

Gastrointestinal symptoms include nausea, vomiting, hiccups and epigastric distress.

Cardiovascular

Cardiovascular effects include tachycardia, hypotension, postural hypotension, and facial flushing.

Oncologic

Oncologic side effects have included mutagenicity and clastogenicity reported from in vitro animal cell assays.

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