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Drug Profile

The information on this site is intended to supplement and enhance, not replace, the advice of a physician who is familiar with your medical history. Decisions about your health should always be made ONLY after detailed conversation with your doctor.

Limited Use [what does this mean?]
Generic drug name: baclofen (BAK loe fen)
Brand name(s): FLEQSUVY, GABLOFEN, LIORESAL, LYVISPAH, OZOBAX
GENERIC: available FAMILY: Muscle Relaxants
Find the drug label by searching at DailyMed.

Pregnancy and Breast-feeding Warnings [top]

Pregnancy Warning

Baclofen caused harm in animal studies, including interference with bone formation and an increased incidence of abdominal hernias. In addition, withdrawal symptoms in newborns whose mothers were treated with oral baclofen throughout pregnancy have been reported starting hours to days after delivery. The symptoms of withdrawal in these infants have included increased muscle tone, tremor, jitteriness and seizures. Because of the potential for serious adverse events, women should talk to their doctor if they are taking or plan to take baclofen and are pregnant or plan to become pregnant. If possible, pregnant women treated with baclofen should gradually reduce the dosage and discontinue the drug before delivery.

Breast-Feeding Warning

Baclofen is excreted in human breast milk. Withdrawal symptoms can occur in breastfed infants when nursing mothers stop taking baclofen or when breastfeeding is stopped. Women taking baclofen should talk to their doctor about whether to discontinue the drug if they plan to nurse.

Safety Warnings For This Drug [top]

Important Safety Warnings

  • Abruptly stopping baclofen can cause serious adverse reactions, including hallucinations, seizures, high fever, mental status changes, and exaggerated rebound muscle spasms and rigidity that in rare cases has resulted in rhabdomyolysis (a life-threatening, muscle-destroying condition), multi-organ failure and death. Therefore, the dosage of the drug should be reduced slowly prior to discontinuation unless there is an urgent need to discontinue the drug rapidly.
  • Patients with stroke have been shown to tolerate baclofen poorly and not significantly benefit from the drug.
  • Because baclofen is removed from the body by the kidneys, increased, potentially dangerous concentrations of baclofen in the blood can occur in patients with impaired kidney function.
  • Drowsiness and sedation have been reported in up to 63% of patients taking baclofen. Patients using the drug should not drive a car, operate dangerous machinery or engage in other activities that would be hazardous with decreased alertness when starting this drug or increasing the dose until they know how the drug affects them. The risk of sedation is increased if baclofen is taken with alcohol or other drugs known to reduce alertness, such as benzodiazepines (for example, diazepam [VALIUM]).
  • Baclofen may exacerbate psychotic disorders, schizophrenia and confusion and should be used with caution in patients with any of these conditions.
  • Baclofen may increase the risk of falling in patients who rely on muscle spasms to maintain upright posture and balance while moving.
  • Baclofen may cause deterioration of seizure control in patients with epilepsy.
  • The effectiveness and safety of baclofen has not been established in children younger than 12 years.

Facts About This Drug [top]

Baclofen (FLEQSUVY, GABLOFEN, LIORESAL, LYVISPAH, OZOBAX) is a muscle relaxant approved for the treatment of reversible muscle spasms in patients with multiple sclerosis and for the treatment of patients with spinal-cord injuries or other spinal-cord diseases.[1] The Food and Drug Administration first approved the drug in 1977. How baclofen relaxes muscles is not fully understood.[1]

Multiple sclerosis is a potentially debilitating disease of the central nervous system (brain and spinal...

Baclofen (FLEQSUVY, GABLOFEN, LIORESAL, LYVISPAH, OZOBAX) is a muscle relaxant approved for the treatment of reversible muscle spasms in patients with multiple sclerosis and for the treatment of patients with spinal-cord injuries or other spinal-cord diseases.[1] The Food and Drug Administration first approved the drug in 1977. How baclofen relaxes muscles is not fully understood.[1]

Multiple sclerosis is a potentially debilitating disease of the central nervous system (brain and spinal cord) that is characterized by damage, which is often progressive, to the protective sheathes that surround nerve fibers.[2] This damage leads to disrupted communication between nerves in the brain and spinal cord.

Multiple sclerosis can cause an array of symptoms, including weakness, numbness, vision problems, difficulty walking or loss of control of various bodily functions (such as bladder and bowel control).[2] Another common symptom that can develop over time in multiple sclerosis patients is involuntary muscle spasms (also known as spasticity), which baclofen is approved to treat.[3]

In addition, spinal cord injuries and certain other conditions that damage the spinal cord often are eventually associated with muscle spasticity.[4]

A 2003 systematic review analyzed all randomized controlled trials (of at least seven days in duration) of baclofen in subjects with a diagnosis of multiple sclerosis.[5] The review found that, compared with placebo, baclofen significantly improved subjects’ spasticity on a range of measures: increased ability to flex their muscles, improved muscle tone, reduction in painful spasms and general improvement in perceived functioning. When combined with exercise, baclofen also significantly improved muscle tone, as measured by a standardized scale.

By contrast, there is no good evidence that baclofen is effective for treating spasticity due to spinal cord injuries. A systematic review initially conducted in 2000 and later updated in 2009 analyzed all randomized controlled trials of baclofen (and other drugs) in subjects with spinal-cord injury who reported severe spasticity.[6] The review found that, for oral baclofen and a number of other drugs, “the results did not provide evidence for clinically significant effectiveness.”

Adverse effects

Baclofen has numerous risks.[1] There is a risk of hallucinations and seizures when patients stop taking baclofen suddenly rather than gradually tapering down the dose. Because the concentration of baclofen in the blood may increase to dangerous levels in patients with impaired kidney function, the drug may need to be given at reduced doses in such patients. Baclofen also is poorly tolerated in, and does not seem to benefit, patients who have had a stroke.

Baclofen is a sedating drug that can cause temporary drowsiness. Therefore, the label warns patients not to drive a car, operate dangerous machinery or engage in other activities that would be hazardous with decreased alertness while starting the drug or increasing the dose until they know how the drug affects them. The risk of sedation is increased if baclofen is taken with alcohol or drugs known to reduce alertness, such as benzodiazepines (for example, diazepam [VALIUM]).

Patients with multiple sclerosis who rely on muscle spasms to maintain upright posture and balance while moving also should use baclofen with caution because the drug may increase the risk of falling in such cases. There have been occasional reports of an increased risk of seizures in patients with epilepsy while they were taking baclofen.

Other adverse reactions that commonly occur in patients taking baclofen include dizziness, weakness, fatigue, confusion, headache, insomnia, nausea, constipation and frequent urination. Overdoses of baclofen can cause vomiting, loss of muscle tone, loss of ability to breathe sufficiently, severe drowsiness, coma and seizures.

Because of possible fetal risks, baclofen’s label warns that the drug should be used during pregnancy only if the benefits clearly outweigh any potential risk to the fetus. In addition, because baclofen is excreted in human breast milk, women taking baclofen should talk to their doctor about whether to discontinue the drug if they plan to nurse.

The effectiveness and safety of baclofen has not been established in children younger than 12 years.

If your muscle stiffness is due to multiple sclerosis, physical therapy and exercise therapy may improve spasticity.[7] If your health care provider believes that you need drug therapy, then baclofen is a relatively safe and effective option. The label notes, however, that if benefits are not apparent after a reasonable trial period, baclofen should be slowly withdrawn.

If you have spinal cord injury and are suffering from long-term muscle stiffness, you should not use baclofen. Instead, you should consult with your doctor to discuss a comprehensive treatment plan that might include physical therapy, exercise or other drug treatments.

Before You Use This Drug [top]

Do not use this drug if you have or have had:

  • an allergic reaction to baclofen

Tell your doctor if you have or have had:

  • an allergic reaction to baclofen, to any other medications or to any of the ingredients in baclofen tablets and oral solution;
  • epilepsy;
  • stroke;
  • rheumatic disease;
  • cerebral palsy;
  • Parkinson’s disease;
  • a psychiatric condition such as schizophrenia or a confusional state;
  • diabetes (Micromedex, p.2);
  • ovarian cyst (Micromedex, p.2);
  • posture or balance problems (Micromedex, p.2);
  • a history of autonomic dysreflexia (Micromedex, p.2);
  • kidney disease;
  • mental illness (Micromedex, p.2);
  • are pregnant or plan to become pregnant; or
  • are breast-feeding.

Tell your doctor about any other drugs you take, including aspirin, dietary supplements, herbs, vitamins and other nonprescription products.

When You Use This Drug [top]

  • Take exactly as directed by your doctor.
  • Do not take more or less of it or take it more often than prescribed by your doctor.
  • If you are taking a liquid form of the drug, measure the medicine with a marked measuring spoon, oral syringe or medicine cup.
  • Continue to take baclofen even if you feel well. Do not stop taking this medication without talking to your doctor.
  • Baclofen may make you drowsy; do not drive a car or operate machinery until you know how this medication affects you.
  • Ask your doctor about the safe use of alcoholic beverages while you are taking this medication.
  • Take a missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule.
  • Do not take a double dose to make up for a missed one.
  • If you become pregnant while taking baclofen, call your doctor immediately.
  • Store the tablets at room temperature away from excess heat and moisture (not in the bathroom). Store the oral solution in the refrigerator.

Interactions with Other Drugs [top]

Baclofen can have clinically important interactions with the following drugs: benzodiazepines, opioids.

Adverse Effects [top]

Call your doctor immediately if you experience the following:

  • Seeing things or hearing voices that do not exist
  • Allergic reaction: itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Lightheadedness, dizziness, fainting
  • Seizures
  • Muscles weakness, trouble breathing, trouble seeing
  • Increase in how much or how often you urinate

Call your doctor for these symptoms if they are severe or do not go away:

  • Drowsiness, dizziness, weakness
  • Confusion, headache, trouble sleeping
  • Constipation, nausea
  • Tiredness

Signs of an overdose:

  • Vomiting
  • Weak muscle tone
  • Drowsiness
  • Vision problems
  • Coma
  • Difficulty breathing
  • Seizures

last reviewed July 31, 2022