Gablofen Side Effects
Generic name: baclofen
Medically reviewed by Drugs.com. Last updated on Dec 7, 2023.
Note: This document provides detailed information about Gablofen Side Effects associated with baclofen. Some dosage forms listed on this page may not apply specifically to the brand name Gablofen.
Applies to baclofen: oral packet, oral solution, oral suspension, oral tablet.
Other dosage forms:
Common side effects of Gablofen
Some side effects of baclofen may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- confusion
- constipation
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- headache
- increased need to urinate
- nausea
- passing urine more often
- sweating
- trouble sleeping
- unusual tiredness or weakness
Less common or rare side effects
- diarrhea
- loss of appetite
- muscle or joint pain
- numbness or tingling in the hands or feet
- stomach pain or discomfort
- stuffy nose
- weight gain
Serious side effects of Gablofen
Along with its needed effects, baclofen (the active ingredient contained in Gablofen) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking baclofen:
Less common or rare side effects
- bloody or dark urine
- chest pain
- clumsiness, unsteadiness, trembling, or other problems with muscle control
- fainting
- false sense of well-being
- mental depression or other mood changes
- pounding heartbeat
- ringing or buzzing in the ears
- seeing or hearing things that are not there
- skin rash or itching
- slurred speech or other speech problems
- swelling of the ankles
- unexplained muscle stiffness
- unusual excitement
Get emergency help immediately if any of the following symptoms of overdose occur while taking baclofen:
Symptoms of overdose
- blurred vision
- dizziness
- drowsiness
- irregular, fast or slow, or shallow breathing
- lightheadedness
- loss of strength or energy
- muscle pain or weakness
- pale or blue lips, fingernails, or skin
- seizures
- sleepiness or unusual drowsiness
- trouble breathing
- unusual weak feeling
For healthcare professionals
Applies to baclofen: compounding powder, intrathecal solution, oral granule, oral liquid, oral solution, oral suspension, oral tablet.
Cardiovascular adverse events
- Common (1% to 10%): Cardiac output decreased, hypotension, hypertension, diminished cardiovascular functions, peripheral edema
- Rare (less than 0.1%): Arrhythmias, palpitations, chest pain
- Frequency not reported: Bradycardia, orthostatic hypotension[Ref]
Dermatologic
- Common (1% to 10%): Rash, hyperhidrosis, urticaria/pruritus, facial edema
- Uncommon (0.1% to 1%): Alopecia, diaphoresis
- Frequency not reported: Rash, sweating, contact dermatitis, skin ulcer[Ref]
Endocrine
- Common (1% to 10%): Ovarian cysts are palpable in 4% of women treated with for up to one year[Ref]
Gastrointestinal
- Very common (10% or more): Nausea (especially at start of therapy) (up to 11%)
- Common (1% to 10%): Dry mouth, GI disorder/disturbance, constipation, diarrhea, retching, vomiting, increased salivation
- Uncommon (0.1% to 1%): Dysphagia, dehydration, ileus, decreased taste sensation
- Rare (less than 0.1%): Colicky abdominal pain, anorexia
- Frequency not reported: GI hemorrhage[Ref]
Genitourinary
- Very common (10% or more): Urinary retention (up to 12%)
- Common (1% to 10%): Urinary incontinence, urination impaired, sexual dysfunction, urinary frequency, enuresis, dysuria
- Rare (less than 0.1%): Erectile dysfunction
- Frequency not reported: Dysuria, abnormal ejaculation, oliguria, vaginitis[Ref]
Hematologic
- Frequency not reported: Leukocytosis, petechial rash[Ref]
Hepatic
- Rare (less than 0.1%): Disorders of hepatic function (e.g., increased AST)[Ref]
Immunologic
Metabolic
- Common (1% to 10%): Decreased appetite
- Frequency not reported: Blood glucose increased[Ref]
Musculoskeletal
- Very common (10% or more): Hypotonia (up to 52%), lower extremity weakness (up to 15%), disturbances of gait and balance
- Common (1% to 10%): Muscular weakness, myalgia, upper extremity weakness, back pain, muscular hypertonia[Ref]
Nervous system
- Very common (10% or more): Somnolence (up to 28%), drowsiness (up to 18%), headache (up to 16%), seizures (especially on discontinuation of therapy) (up to 15%), sedation, dizziness (up to 12%)
- Common (1% to 10%): Fatigue, ataxia, tremor, lightheadedness, lassitude, exhaustion, numbness/itching/tingling, slurred speech, lethargy, hypertonia, paresthesia
- Rare (less than 0.1%): Dysarthria, dysgeusia, syncope, dyskinesia, coma, potentially life-threatening withdrawal symptoms (as a result of sudden interruption of drug delivery)[Ref]
Other
- Common (1% to 10%): Tinnitus, pain, asthenia
- Uncommon (0.1% to 1%): Accidental injury, weight loss
- Very rare (less than 0.01%): Hypothermia
- Frequency not reported: Drug withdrawal syndrome
- Uncommon (0.1% to 1%): Subdural hemorrhage, accidental injury, weight loss[Ref]
Ocular
- Common (1% to 10%): Nystagmus, visual impairment, accommodation disorder, blurred vision, double vision, amblyopia[Ref]
Psychiatric
- Common (1% to 10%): Confusional state, hallucination, depression, insomnia, euphoric mood, nightmare, personality changes
- Uncommon (0.1% to 1%): Memory loss/impairment, suicidal ideation, attempted suicide
- Rare (less than 0.1%): Excitement[Ref]
Renal
- Very rare (less than 0.01%): Kidney calculus[Ref]
Respiratory
- Common (1% to 10%): Respiratory depression, hypoventilation, dyspnea, bradypnea, feeling of pressure in the chest[Ref]
References
1. (2001) "Product Information. Lioresal (baclofen)." Medtronic Neurological
2. (2001) "Product Information. Lioresal Intrathecal (baclofen)." Medtronic Neurological
3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
4. Pharmaceutical Society of Australia (2006) APPGuide online. Australian prescription products guide online. http://www.appco.com.au/appguide/default.asp
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Further information
Gablofen side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.