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.
|
REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO BACLOFEN
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 cosidered as verified clinical evidence.
Possible Baclofen side effects / adverse reactions in 41 year old female
Reported by a pharmacist from United States on 2007-01-05
Patient: 41 year old female
Reactions: Drug Effect Decreased, Poor Quality Drug Administered, Pharmaceutical Product Complaint
Suspect drug(s):
Baclofen
Possible Baclofen side effects / adverse reactions in 18 year old female
Reported by a health professional (non-physician/pharmacist) from Romania on 2007-01-10
Patient: 18 year old female
Reactions: Intentional Overdose, Tachycardia, Intubation, Hyperglycaemia, Supraventricular Tachycardia, Coma, Loss of Consciousness, Miosis, Hypotonia, Respiratory Arrest, Hyporeflexia, Hypertension, Leukocytosis
Adverse event resulted in: hospitalization
Suspect drug(s):
Baclofen
Possible Baclofen side effects / adverse reactions in 63 year old male
Reported by a individual with unspecified qualification on 2007-01-12
Patient: 63 year old male
Reactions: Poisoning, Hypertension
Adverse event resulted in: hospitalization
Suspect drug(s):
Paracetamol/codeine
Administration route: Oral
Baclofen
Administration route: Oral
Temazepam
Administration route: Oral
Diazepam
Administration route: Oral
|
