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%).
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
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.
No information provided.