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Soma

Last reviewed on RxList: 5/3/2019
Soma Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 5/3/2019

Soma (carisoprodol) is a muscle relaxant used for short-term relief of discomfort associated with painful muscle conditions. Soma is available in generic form. Common side effects of Soma include:

  • Drowsiness
  • Dizziness
  • Agitation
  • Nervousness
  • Tremor
  • Headache
  • Irritability
  • Inability to sleep (insomnia)
  • Blurred vision
  • Depression
  • Nausea
  • Vomiting
  • Upset stomach
  • Hiccups

The recommended dose of Soma is 250-350 mg three times a day and at bedtime. Soma interacts with other agents that slow the brain's processes, such as alcohol, barbiturates, benzodiazepines (for example, lorazepam [Ativan]), and narcotics. There are no adequate studies of Soma in pregnant women. Soma accumulates in breast milk in concentrations 2-4 times the concentration in the mother's blood. The effects of Soma on the infants of lactating mothers are unknown. Consult your doctor before breastfeeding. Soma may cause dependence and is associated with withdrawal symptoms.

Our Soma Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Nearly everyone has low back pain at some time during their life. See Answer
Soma Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using carisoprodol and call your doctor at once if you have:

  • a seizure (convulsions); or
  • high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Common side effects may include:

  • drowsiness;
  • dizziness; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Soma (Carisoprodol)

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Soma Professional Information

SIDE EFFECTS

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]. In these studies, patients were treated with 250 mg of SOMA, 350 mg of SOMA, 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 SOMA, and 350 mg of SOMA, respectively, discontinued due to adverse events; and 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of SOMA, and 350 mg of SOMA, 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 SOMA in the two trials described above.

Table 1: Patients with Adverse Reactions in Controlled Studies

Adverse Reaction Placebo
(n=560)
n (%)
SOMA 250 mg
(n=548)
n (%)
SOMA 350 mg
(n=279)
n (%)
Drowsiness 31 (6) 73 (13) 47 (17)
Dizziness 11 (2) 43 (8) 19 (7)
Headache 11 (2) 26 (5) 9 (3)

Post-marketing Experience

The following events have been reported during postapproval use of SOMA. 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].

Central Nervous System

Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia, and seizures [see OVERDOSAGE].

Gastrointestinal

Nausea, vomiting, and epigastric discomfort.

Hematologic

Leukopenia, pancytopenia

Read the entire FDA prescribing information for Soma (Carisoprodol)

Related Resources for Soma

Read the Soma User Reviews »

© Soma Patient Information is supplied by Cerner Multum, Inc. and Soma Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

Nearly everyone has low back pain at some time during their life. See Answer

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