Soma Side Effects Center

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Medical Editor: John P. Cunha, DO, FACOEP

What Is Soma?

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

What Are Side Effects of Soma?

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

Soma may cause serious side effects including:

seizure (convulsions),
agitation,
hallucinations,
fever,
sweating,
shivering,
fast heart rate,
muscle stiffness,
twitching,
loss of coordination,
nausea,
vomiting, and
diarrhea

Get medical help right away, if you have any of the symptoms listed above.

Seek medical care or call 911 at once if you have the following serious side effects:

Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Soma

The recommended dose of Soma is 250-350 mg three times a day and at bedtime.

What Drugs, Substances, or Supplements Interact with Soma?

Soma interacts with other agents that slow the brain's processes, such as alcohol, barbiturates, benzodiazepines (for example, lorazepam [Ativan]), and narcotics.

Soma During Pregnancy and Breastfeeding

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.

Additional Information

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.

SLIDESHOW

Back Pain: 16 Back Pain Truths and Myths See Slideshow

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)