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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
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:
Tell your doctor if you have or have had:
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]
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:
Call your doctor for these symptoms if they are severe or do not go away:
Signs of an overdose:
last reviewed July 31, 2022
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