"Medscape Medical News
March 19, 2013 -- People with low back pain may benefit from a hands-on treatment known as osteopathic manual therapy (OMT) more than they do from ultrasound therapy.
A new study suggests that OMT leads t"...
Soma Side Effects Center
Pharmacy Editor: Omudhome Ogbru, PharmD
Soma (carisoprodol) is a muscle relaxant used for short-term relief of discomfort associated with painful muscle conditions. A generic formulation is available. Common side effects of Soma include drowsiness, dizziness, agitation, nervousness, tremor, irritability, inability to sleep, and depression. Soma may cause dependence and is associated with withdrawal symptoms.
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.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Soma in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using carisoprodol and call your doctor at once if you have any of these serious side effects:
- paralysis (loss of feeling);
- extreme weakness or lack of coordination;
- feeling light-headed, fainting;
- fast heartbeat;
- seizure (convulsions);
- vision loss; or
- agitation, confusion.
Less serious side effects may include:
- drowsiness, dizziness, tremor;
- depression, feeling irritable;
- blurred vision;
- sleep problems (insomnia); or
- nausea, vomiting, hiccups, upset stomach.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Soma (Carisoprodol) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Soma Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Soma (Carisoprodol)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Soma FDA Prescribing 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
|SOMA 250 mg
|SOMA 350 mg
|Drowsiness||31 (6)||73 (13)||47 (17)|
|Dizziness||11 (2)||43 (8)||19 (7)|
|Headache||11 (2)||26 (5)||9 (3)|
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.
Gastrointestinal: Nausea, vomiting, and epigastric discomfort.
Read the entire FDA prescribing information for Soma (Carisoprodol) »
Additional Soma Information
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Soma User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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