"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"...
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Baclofen Side Effects Center
Baclofen is a muscle relaxant used for treating spasm of skeletal muscles, muscle clonus, rigidity, and pain caused by multiple sclerosis. It is also injected into the spinal cord to treat severe spasticity, spinal cord injuries, and other spinal cord diseases. A generic version is available. Baclofen side effects include drowsiness, weakness, dizziness, headache, seizures, nausea, vomiting, low blood pressure, constipation, confusion, respiratory depression, insomnia, and increased urinary frequency or urinary retention. Abrupt discontinuation of baclofen may cause seizures and hallucinations, high fever, rebound spasticity, muscle rigidity, and rhabdomyolysis. The recommended oral dose of baclofen is 15-80 mg daily. Combining baclofen and tricyclic antidepressants may cause muscle weakness. Use of baclofen and monoamine oxidase inhibitors (MAOIs) can result in greater depression of brain function as well as low blood pressure. The use of baclofen by pregnant women has not been evaluated. Baclofen can be detected in the breast milk when administered orally. Our Baclofen 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.
Baclofen FDA Prescribing Information: Side Effects
The most common is transient drowsiness (10-63%). In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen (baclofen (baclofen (baclofen tablets) tablets) 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.
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 (baclofen (baclofen (baclofen tablets) tablets) tablets) : increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.
Read the entire FDA prescribing information for Baclofen (Baclofen Tablets) »
Additional Baclofen 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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