ADVERSE REACTIONS
The most common is transient drowsiness (10 to 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 to 15%), weakness (5 to 15%) and fatigue (2 to 4%).
Others reported:
Neuropsychiatric:
Confusion (1 to 11%), headache (4 to 8%), insomnia (2 to 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 to 9%). Rare instances of dyspnea, palpitation, chest pain, syncope.
Gastrointestinal:
Nausea (4 to 12%), constipation (2 to 6%); and, rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool.
Genitourinary:
Urinary frequency (2 to 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 elevation of blood sugar.
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REPORTS OF SUSPECTED BACLOFEN SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Baclofen. The information is not vetted and should not be considered as verified clinical evidence.
Possible Baclofen side effects / adverse reactions in 77 year old male
Reported by a pharmacist from United States on 2011-10-04
Patient: 77 year old male weighing 83.2 kg (183.0 pounds)
Reactions: Back Pain, Confusional State, Documented Hypersensitivity TO Administered Drug, Sedation, Mental Status Changes, Staring, Sluggishness
Adverse event resulted in: hospitalization
Suspect drug(s):
Baclofen
Dosage: mg bid po
Administration route: Oral
Indication: Pain
Start date: 2009-10-29
End date: 2011-09-29
Temazepam
Dosage: 30 mg at bedtime po
Administration route: Oral
Indication: Insomnia
Start date: 2008-07-01
End date: 2011-09-29
Possible Baclofen side effects / adverse reactions in 53 year old male
Reported by a physician from Greece on 2011-10-05
Patient: 53 year old male
Reactions: Dysphagia, Drug Effect Decreased, Drug Tolerance, Aphonia
Suspect drug(s):
Carbamazepine
Dosage: 1200 mg, daily
Indication: Trigeminal Neuralgia
Pregabalin
Indication: Glossopharyngeal Neuralgia
Baclofen
Dosage: unk
Indication: Trigeminal Neuralgia
Carbamazepine
Indication: Glossopharyngeal Neuralgia
Topiramate
Dosage: unk
Pregabalin
Dosage: unk
Indication: Trigeminal Neuralgia
Baclofen
Indication: Glossopharyngeal Neuralgia
Possible Baclofen side effects / adverse reactions in 24 year old male
Reported by a physician from Japan on 2011-10-06
Patient: 24 year old male
Reactions: Muscle Spasticity, Calculus Urinary, Hyperhidrosis
Suspect drug(s):
Baclofen
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