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:: Precautions :: Side Effects Search results last updated: 5/11/2009

Generic & Brand Name : Source: (RXList)

Brand Name : Baclofen
Generic Name : Baclofen Tablets

Precautions (Source: RXList)
Abrupt Drug Withdrawal : Hallucinations and seizures have occurred on abrupt withdrawal of baclofen. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued. Impaired Renal Function : Because baclofen is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage. Stroke : Baclofen has not significantly benefitted patients with stroke. These patients have also shown poor tolerability to the drug. Pregnancy : Baclofen has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times the maximum dose recommended for human use, at a dose which caused significant reductions in food intake and weight gain in dams. This abnormality was not seen in mice or rabbits. There was also an increased incidence of incomplete sternebral ossification in fetuses of rats given approximately 13 times the maximum recommended human dose, and an increased incidence of unossified phalangeal nuclei of forelimbs and hindlimbs in fetuses of rabbits given approximately 7 times the maximum recommended human dose. In mice, no teratogenic effects were observed, although reductions in mean fetal weight with consequent delays in skeletal ossification were present when dams were given 17 or 34 times the human daily dose. There are no studies in pregnant women. Baclofen should be used during pregnancy only if the benefit clearly jus ...
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Side Effects (Source: RXList)
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 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 . Cardiovascular : Hypotension (0-9%). Rare instances of dyspnea , palpitation, chest pain , syncope . Gastrointestinal : Nausea (4-12%), constipation (2-6%); and, rarely, dry mouth , anorexia , taste disorder, abdominal pain , vomiting, diarrhea , and positive test for occult blood in stool . Genitourinary : Urinary frequency (2-6%); and, rarely, enuresis , urinary retention, dysuria , impotence , inability to ejaculate , nocturia , hematuria . 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 e ...
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