"The U.S. Food and Drug Administration today approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS).
MS is a chronic, inflammatory, autoimmune disease of the central nervous system"...
- Clinician Information:
Kemstro Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Kemstro (baclofen orally disintegrating tablets) is a muscle relaxant and antispastic used to alleviate signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include drowsiness, dizziness, weakness, and fatigue.
Start therapy with Kemstro at a low dosage and increase gradually until optimum effect is achieved (usually between 40-80 mg daily). Kemstro may interact with alcohol and other CNS depressants. Tell your doctor all medications and supplements you use. During pregnancy, Kemstro should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking this medication.
Our Kemstro (baclofen orally disintegrating tablets) 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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Kemstro FDA Prescribing Information: Side Effects
The most common adverse reaction during treatment with baclofen is transient drowsiness (10-63%). In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen tablets compared to 36% of those in the placebo group. Other common adverse reactions are dizziness (5-15%), weakness (5-15%) and fatigue (2-4%). Others reported:
Neuropsychiatric: Confusion (1-11%), headache (4-8%), insomnia (2-7%); and, rarely, euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure.
Other: Instances of rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion. Some of the CNS and genitourinary symptoms may be related to the underlying disease rather than to drug therapy. The following laboratory tests have been found to be abnormal in a few patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.
The adverse experience profile seen with KEMSTRO™ was similar to that seen with baclofen tablets.
Read the entire FDA prescribing information for Kemstro (Baclofen) »
Additional Kemstro Information
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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