Fleqsuvy Side Effects
Generic name: baclofen
Medically reviewed by Drugs.com. Last updated on Feb 27, 2024.
Note: This document contains side effect information about baclofen. Some dosage forms listed on this page may not apply to the brand name Fleqsuvy.
Applies to baclofen: intrathecal solution. Other dosage forms:
Warning
Intrathecal route (Solution)
Do not discontinue abruptly. Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in a condition that includes high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, and in rare cases has led to rhabdomyolysis, multiple organ-system failure, and death. Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (eg, spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional post-implant clinician and patient information.
Serious side effects of Fleqsuvy
Along with its needed effects, baclofen (the active ingredient contained in Fleqsuvy) 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 as soon as possible if any of the following side effects occur while taking baclofen:
More common
- Convulsions (seizures)
Less common or rare
- Blurred vision or double vision
- fainting
- mental depression
- muscle weakness
- ringing or buzzing in ears
- seeing, hearing, or feeling things that are not there
- shortness of breath or troubled breathing
Symptoms of overdose
- Convulsions (seizures)
- dizziness, drowsiness, or lightheadedness
- increased watering of the mouth
- mental confusion
- muscle weakness
- nausea and/or vomiting
- shortness of breath or troubled breathing
Other side effects of Fleqsuvy
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
- Constipation
- difficult urination
- dizziness
- headache
- nausea and/or vomiting
- numbness or tingling in hands or feet
- sleepiness
Less common
- Clumsiness, unsteadiness, trembling, or other problems with muscle control
- diarrhea
- difficulty sleeping
- dizziness or lightheadedness, especially when getting up from a lying or sitting position
- dry mouth
- frequent urge to urinate
- irritation of the skin at the site where the pump is located
- itching of the skin
- sexual problems
- slurred speech or other speech problems
- swelling of ankles, feet, or lower legs
- trembling or shaking
After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, Check with your doctor immediately if you notice the following side effects:
- Convulsions (seizures)
- facial flushing, headache, increased sweating, or slow heartbeat
- increased muscle spasms
- seeing, hearing, or feeling things that are not there
For Healthcare Professionals
Applies to baclofen: compounding powder, intrathecal solution, oral granule, oral liquid, oral solution, oral suspension, oral tablet.
Cardiovascular
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
Common (1% to 10%): Pneumonia
Uncommon (0.1% to 1%): Septicemia[Ref]
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]
More about Fleqsuvy (baclofen)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Drug images
- Dosage information
- During pregnancy
- Generic availability
- FDA approval history
- Drug class: skeletal muscle relaxants
- Breastfeeding
- En español
Patient resources
Other brands
Lioresal, Ozobax, Gablofen, Lyvispah, Ozobax DS
Professional resources
Other brands
Lioresal, Ozobax, Gablofen, Lyvispah, ... +2 more
Related treatment guides
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
Further information
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.