"By Kathleen Doheny
WebMD Health News
Reviewed by Michael W. Smith, MD
Dec. 30, 2013 -- The FDA has rejected the new multiple sclerosis drug Lemtrada, saying the drugmaker didn't show the drug's benefits outweigh some s"...
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, tiredness, headache, seizures, nausea, vomiting, low blood pressure, constipation, confusion, respiratory depression, trouble sleeping (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 Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Baclofen 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.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as confusion, depression, hallucinations).
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 Baclofen (Baclofen Tablets)
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
Baclofen - User Reviews
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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