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Baclofen (Baclofen) - Side Effects and Adverse Reactions

 
 



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 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



See index of all Baclofen side effect reports >>

Drug label data at the top of this Page last updated: 2008-09-26

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