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intrathecal baclofen

Generic Lioresal, Gablofen
Used for Multiple Sclerosis, Spasticity
Used for Multiple Sclerosis, Spasticity

Intrathecal baclofen (Lioresal) is a muscle relaxant. It's given to adults and children ages 4 years and older to treat severe spasticity caused by certain conditions, like spinal cord injuries, that can't be treated with oral baclofen. Intrathecal baclofen (Lioresal) is typically given as a continuous infusion through an implantable pump. But before you can undergo the procedure to receive the pump, your healthcare team will inject test doses of intrathecal baclofen (Lioresal) to see if it works for you. Some side effects of this medication include nausea, sleepiness, and dizziness.

Reviewed by:
reviewer
Robert Chad Hakim, PharmD, BCCCP
reviewer
Kristianne Hannemann, PharmD
Last reviewed on June 20, 2024
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageInteractionsAlternativesLatest newsImagesReferencesPricesMedicare
basics-icon

What is Intrathecal baclofen (Lioresal)?

What is Intrathecal baclofen (Lioresal) used for?

  • Severe spasticity in people who are either having too many side effects from oral baclofen or who aren't getting enough symptom relief from it

How Intrathecal baclofen (Lioresal) works

Baclofen is a muscle relaxant. The way it works isn't well-understood. It's thought to ease spasticity by relaxing the nerves that make your muscles tighten or cramp up.

Intrathecal baclofen (Lioresal) is given directly into the intrathecal space (space around the spinal cord), typically via a pump.

Are you looking for information on baclofen (oral tablets and solution) instead?

Drug Facts

Common BrandsGablofen, Lioresal
Drug ClassMuscle relaxant
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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What are the side effects of Intrathecal baclofen (Lioresal)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

  • Muscle weakness (up to 35%)
  • Sleepiness (up to 21%)
  • Headache (up to 11%)
  • Nausea and vomiting (up to 11%)
  • Convulsions (up to 10%)
  • Dizziness (8%)
  • "Pins and needles" feeling in arms and legs (up to 7%)
  • Stiff muscles (up to 6%)
  • Constipation (up to 5%)

Other Side Effects

  • Dry mouth
  • Confusion
  • Trouble urinating
  • Pain
  • Diarrhea
  • Slow breathing
  • Swelling in the arms and legs
  • Depression
  • More saliva than usual
  • Itching

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Overdose: sleepiness, dizziness, slowed breathing, seizures
  • Withdrawal: muscle spasms, itching, low blood pressure, "pins and needles" sensation, hallucinations, seizures
  • Extreme sleepiness

Source: DailyMed

More on Intrathecal baclofen (Lioresal) side effects

Health: Baclofen: side effects baclofen

8 Baclofen Side Effects You Should Know About

Written by Alex Evans, PharmD, MBA

The following side effects have also been reported

Along with its needed effects, a medicine 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:

Less common or rare

Bloody or dark urine

chest pain

fainting

mental depression or other mood changes

ringing or buzzing in the ears

seeing or hearing things that are not there

skin rash or itching

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blurred vision

convulsions

difficult or troubled breathing

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

sleepiness or unusual drowsiness

unusual weak feeling

unusually slow or troubled breathing

Some side effects 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

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

Abdominal or stomach pain or discomfort

clumsiness, unsteadiness, trembling, or other problems with muscle control

diarrhea

false sense of well-being

loss of appetite

muscle or joint pain

numbness or tingling in the hands or feet

pounding heartbeat

slurred speech or other speech problems

stuffy nose

swelling of the ankles

unexplained muscle stiffness

unusual excitement

weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

pros-and-cons

Pros and cons of Intrathecal baclofen (Lioresal)

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Pros

A possible option for those who can't take oral baclofen

Less side effects compared to oral baclofen

Infused through a pump, so don't need to remember to take medication by mouth daily

Might be an option for children as young as 4 years old

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Cons

The intrathecal pump must be placed by a surgeon while under anesthesia

Pump must be replaced after the battery runs out (5 to 7 years)

Refills must be given by a qualified healthcare professional

Some people might need the dose raised after long-term use because of tolerance.

pharmacist-tips

Pharmacist tips for Intrathecal baclofen (Lioresal)

pharmacist

  • Mark your appointments on your calendar to see your prescriber, including appointments to get any refills for the medication. This will make sure you're being properly monitored and you're not at risk for running out of intrathecal baclofen (Lioresal), which can cause withdrawal (e.g., sudden muscle spasms, itching, seizures).

    • Seek medical help right away if you notice signs of an overdose, such as changes in heart rate, sleepiness, delirium, and poor strength due to poor muscle tone.

      • Intrathecal baclofen (Lioresal) can make you feel very tired or dizzy. Let your care team know if you're taking other medications that make you tired. Avoid driving or performing any activity that requires a lot of attention until you know how this medication affects you.

        • Avoid drinking alcohol while receiving intrathecal baclofen (Lioresal). Alcohol can worsen certain side effects, such as sleepiness and dizziness. If avoiding alcohol is difficult for you, talk to your prescriber about safer medication options, or resources to help you quit drinking.

          • If you're pregnant or thinking of becoming pregnant, let your healthcare team know. intrathecal baclofen (Lioresal) hasn't been well-studied during human pregnancy, but animal studies suggest that it can cause birth defects in unborn babies. In addition, babies born to mothers who took intrathecal baclofen (Lioresal) throughout pregnancy also experienced withdrawal symptoms at birth.

            faqs

            Frequently asked questions about Intrathecal baclofen (Lioresal)

            What does intrathecal baclofen (Lioresal) treat?
            Intrathecal baclofen (Lioresal) is used to treat severe spasticity caused by certain brain and spinal cord conditions, including spinal cord injuries. It's not a first-choice option for these conditions. But your healthcare team might recommend intrathecal baclofen (Lioresal) for you if you're not able to tolerate the side effects from oral baclofen or if oral baclofen no longer works well for you. Because intrathecal baclofen (Lioresal) is delivered directly to the area around the spinal cord, your dose of intrathecal baclofen (Lioresal) is much lower compared to the dose of oral baclofen. This means that you're less likely to experience side effects, such as sleepiness and confusion.
            How is intrathecal baclofen (Lioresal) given?
            Intrathecal baclofen (Lioresal) is given as an intrathecal (IT) infusion. Your healthcare team will place an implantable pump under the skin in the belly area. This pump can continuously release baclofen into the IT space, which is the area around spine that contains spinal cord fluid. Please note that before you can receive the pump, your healthcare team will inject test doses of intrathecal baclofen (Lioresal) through a lumbar puncture to see if this medication works well for you.
            Where is intrathecal baclofen (Lioresal) pump placed?
            A healthcare professional will place the intrathecal baclofen (Lioresal) pump under the skin of your stomach while you're under anesthesia (sleep medicine). In order to do so, you'll need to undergo a minor surgery. Once the pump is in place, a small tube (also called a catheter) then deliver intrathecal baclofen (Lioresal) from the pump to your spine.
            Who can refill my intrathecal baclofen (Lioresal) pump?
            A qualified healthcare professional can refill your pump. Your prescriber will typically set up refill appointments with you to refill your intrathecal baclofen (Lioresal) pump before it runs out. Make sure to mark these appointments in your calendar to avoid the risk of running out of medication. Suddenly stopping intrathecal baclofen (Lioresal) can lead to withdrawal, which can be life-threatening.
            What happens if I forget to refill my pump?
            If you missed your appointment to refill your intrathecal baclofen (Lioresal) pump, contact your prescriber immediately. They can help set you up with a new refill appointment. Or, they might recommend going to the emergency room for further treatment if you're at risk for completely running out of medication. This is because suddenly stopping intrathecal baclofen (Lioresal) can cause serious and life-threatening withdrawal symptoms, including high fever, confusion, and seizures.
            What are some common side effects of intrathecal baclofen (Lioresal)?
            Muscle weakness is the most common side effect of intrathecal baclofen (Lioresal). This is because it treats muscle spasms by relaxing the nerves of your muscles. Let your healthcare team know if your muscles are too weak to the point where it's affecting your ability to go about your day. They'll consider lowering your dose. Sleepiness and dizziness are also common side effects of intrathecal baclofen (Lioresal). Being too sleepy or dizzy can affect your ability to think, react, and focus. So don't drive or do anything requiring your full attention, especially during the first few days following treatment or a change in your dose, until you know how this medication affects you. If you have any questions about a particular baclofen side effect, talk with your care team.
            Is intrathecal baclofen (Lioresal) a controlled substance?
            No, intrathecal baclofen (Lioresal) isn't a controlled substance because it's unlikely to lead to dependence or abuse.
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            What are the risks and warnings for Intrathecal baclofen (Lioresal)?

            Intrathecal baclofen (Lioresal) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

            risk-warning

            Withdrawal when stopping intrathecal baclofen (Lioresal) suddenly

            • Risk factors: Disconnection of the catheter that delivers the medication | Low volume of medication | Dead battery of the pump | Catheter blockage

              Everyone receiving intrathecal baclofen (Lioresal) is potentially at risk for severe and life-threatening withdrawal. Symptoms of early withdrawal include muscle spasms, fever, and itching. If not treated in time, symptoms can worsen to hallucinations (seeing or hearing things that aren't real), delirium, seizures, and rigid muscles. Seek medical help right away if you start to show any symptoms of withdrawal.

              Withdrawal can happen because of problems with the actual pump and catheter, such as a dead pump battery, catheter blockage, or disconnection of the catheter that delivers the medication from the pump and into your spine. Withdrawal can also happen if your pump runs out of medication. Your care team will schedule refill appointments with you. Make sure to mark these appointments on your calendar so your pump can be refilled.

              risk-warning

              Intrathecal baclofen overdose

              • Risk factors: Pump malfunction | Errors with refilling the pump

                Seek medical help right away if you notice signs of an overdose, such as changes in heart rate, sleepiness, delirium, trouble breathing, and poor strength due to poor muscle tone. You'll need to receive treatment, which includes emptying your pump. A healthcare professional will need to investigate the cause of the overdose, which can be due to too high of a dose or something wrong with the pump.

                risk-warning

                Worsening of other health conditions

                Make sure to tell your care team about all of your medical conditions before starting intrathecal baclofen (Lioresal) because it can worsen the symptoms of certain conditions. Examples include mental health problems (e.g., schizophrenia), high blood pressure due to spinal cord injury (autonomic dysreflexia), seizures, and people who need muscle tone for posture or balance.

                risk-warning

                Extreme sleepiness or dizziness

                • Risk factors: Taking with alcohol or illicit drugs | Taking other medications that cause drowsiness | People over 65

                  Receiving intrathecal baclofen (Lioresal) can make you feel sleepy and dizzy. These side effects can affect your ability to think, concentrate, and focus. Don't drink alcohol or take other medications that cause sleepiness or dizziness while receiving intrathecal baclofen (Lioresal) because it can make these side effects worse. Avoid activities that require you to be alert, like driving or operating machinery, until you know how the medication affects you.

                  risk-warning

                  Ovarian cysts

                  Though rare, some females who have multiple sclerosis developed ovarian cysts within a year after starting oral baclofen. It's unclear whether the cysts were caused by baclofen or other factors, but they typically went away on their own. If you notice any pelvic pain or changes to your menstrual cycles while using intrathecal baclofen (Lioresal), talk to your prescriber.

                  dosage

                  Intrathecal baclofen (Lioresal) dosage forms

                  Typical dosing for Intrathecal baclofen (Lioresal)

                  Intrathecal baclofen (Lioresal) is typically given as a continuous infusion via an implantable pump into the space around the spinal cord.

                  Before your healthcare team can implant the pump to deliver intrathecal baclofen (Lioresal), they'll inject test doses of baclofen through a lumbar puncture to make sure this medication is working well for you. If this medication helps with your spasticity, you'll undergo a minor surgery to have the intrathecal baclofen (Lioresal) pump implanted under the skin of the belly area.

                  Once you've received the intrathecal baclofen (Lioresal) pump, your healthcare team will determine and adjust your maintenance dose of intrathecal baclofen (Lioresal) based on different factors, such as your age and how well intrathecal baclofen (Lioresal) is working to treat your symptoms. The maintence dose can range from 22 mcg/day to 1400 mcg/day, but most of the time people rarely need doses higher than 1000 mcg/day.

                  interactions

                  Interactions between Intrathecal baclofen (Lioresal) and other drugs

                  Intrathecal baclofen (Lioresal) may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking. The list below does not include all possible drug interactions with Intrathecal baclofen (Lioresal). Please note that only the generic name of each medication is listed below.

                  More on Intrathecal baclofen (Lioresal) interactions

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                  6 Baclofen Interactions You Should Watch Out for

                  Written by Makaela Premont, PharmD

                  Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

                  alternatives

                  What are alternatives to Intrathecal baclofen (Lioresal)?

                  There are a number of medications that your doctor can prescribe in place of Intrathecal baclofen (Lioresal). Compare a few possible alternatives below.
                  Intrathecal baclofen (Lioresal)
                  Used for:

                  • Severe spasticity in people who are either having too many side effects from oral baclofen or who aren't getting enough symptom relief from it

                  View Prices
                  Tizanidine (Zanaflex)
                  Used for:

                  • Muscle stiffness and rigidity

                  $9.00 Lowest GoodRx priceView Prices
                  Baclofen
                  Used for:
                  $10.59 Lowest GoodRx priceView Prices
                  latest news

                  What is the latest news about Intrathecal baclofen (Lioresal)?

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                  References

                  Best studies we found

                  Allen, K. J., et al. (2023). Autonomia dysreflexia. StatPearls.

                  Billington, Z. J., et al. (2022). Spasticity management after spinal cord injury: The here and now. Journal of Personalized Medicine.

                  Ertzgaard, P., et al. (2017). Efficacy and safety of oral baclofen in the management of spasticity: A rationale for intrathecal baclofen. Journal of Rehabilitation Medicine.

                  View All References (5)

                  Medical Advisory Secretariat. (2005). Intrathecal baclofen pump for spasticity: An evidence-based analysis. Ontario Health Technology Assessment Series.

                  Nexus Pharmaceuticals Inc. (2024). Baclofen injection [package insert]. DailyMed

                  Romito, J. W., et al. (2021). Baclofen therapeutics, toxicity, and withdrawal: A narrative review. SAGE Open Medicine.

                  Shah, N., et al. (2024). Implantable intrathecal drug delivery system. StatPearls.

                  University of Rochester Medical Center. (n.d.). Baclofen pump.

                  GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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