Lyvispah, Ozobax, Baclofen, Lioresal Intrathecal, Gablofen, Fleqsuvy

Written by Sarah Lewis, PharmD
Medically reviewed by Melissa Badowski, PharmD, MPH, FCCP
Updated on June 23, 2023

The Food and Drug Administration (FDA) has approved baclofen to treat muscle spasticity in adults and some children due to the following:

• multiple sclerosis
• spinal cord injuries or disorders
• brain injuries or disorders

These approved uses differ based on the form of baclofen your doctor prescribes.

This article describes baclofen’s uses, side effects, and more. You’ll also find some coupon options to help save on the cost of baclofen.

Boxed warning: Risk of serious harm with baclofen intrathecal infusion if the drug is abruptly stopped

Baclofen intrathecal infusion (injection into the spine given over time) has a boxed warning about the risk of serious harm if the drug is abruptly stopped. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).

For details, see the “Interactions and warnings for baclofen” section.

The Food and Drug Administration (FDA) approves prescription drugs such as baclofen for certain conditions. Approved uses for baclofen are described below. These uses differ based on the form of baclofen prescribed.

Use for relaxing muscles

Doctors may prescribe baclofen oral tablet, oral solution, or oral suspension for treating muscle spasticity (stiffness and tightness) due to multiple sclerosis (MS) or spinal cord injuries or disorders. It’s used for this purpose in adults and children 12 years and older. It can be prescribed as a short-term or long-term treatment.

Doctors may prescribe baclofen intrathecal infusion (injection into the spine given over time) for treating severe spasticity due to MS or injuries or disorders of the spinal cord or brain. It’s used for this purpose in adults and children ages 4 years and older when oral baclofen doesn’t work or causes too many side effects. It’s usually prescribed as a long-term treatment. This form of baclofen is delivered through a pump implanted under the skin of the abdomen.

With spasticity, there’s an atypical increase in muscle tone or stiffness. This makes muscles tight and can cause odd postures, limb positions, or movements. Spasticity is common in MS, cerebral palsy, and other conditions or injuries of the brain or spinal cord.

Doctors may not prescribe baclofen oral tablet, oral solution, oral suspension, or intrathecal infusion for muscle spasticity resulting from certain conditions. Examples include Parkinson’s disease, stroke, and rheumatic disorders, such as rheumatoid arthritis.

Below you’ll find answers to a few commonly asked questions about baclofen.

Can baclofen be used for hiccups, back pain, anxiety, or nerve pain?

Possibly. Baclofen isn’t approved by the Food and Drug Administration to treat hiccups, back pain, anxiety, or nerve pain. But doctors may choose to prescribe it for these purposes. Prescribing a drug for uses other than what the FDA approves is called off-label use. Off-label uses typically have some limited research to support them.

To learn more about off-label uses of baclofen, talk with your doctor.

Do I need to take my dose of baclofen at bedtime?

Possibly, depending on the form of baclofen you’re prescribed.

Baclofen oral tablet, oral solution, and oral suspension are usually taken three times per day. It’s best to space the doses as evenly as possible throughout the day. This could mean taking a dose at bedtime.

Baclofen intrathecal infusion (injection into the spine given over time) is given through a pump implanted under the skin of your abdomen. The pump continuously delivers your dose, so you don’t have to worry about when to take it.

If you have questions about when to take your baclofen doses, talk with your doctor or pharmacist.

How does baclofen work? And how long does it take to start working?

Baclofen works to relax skeletal muscles. The way it does this isn’t completely clear. Most likely, baclofen blocks signals from the nervous system that tells muscles to tighten or stiffen.

Baclofen oral tablets, oral solution, and oral suspension will start working within a few days. Doctors usually start with a low dose and wait 3 days for a response. If muscles don’t respond enough, they increase the dose and wait another 3 days. So it can take a couple of weeks to find the lowest effective dose.

Baclofen intrathecal infusion is given through a pump implanted under the skin of the abdomen. This form of the drug will start working within 6–8 hours of starting the pump. It can take a day or two to feel the full effect and for your symptoms to ease. After that, doctors may need to adjust the rate of the infusion.

If you’d like to know more about how baclofen works, talk with your doctor or pharmacist.

Is withdrawal possible with baclofen?

Yes, baclofen can cause withdrawal symptoms. Such symptoms can occur when you stop taking a drug your body is dependent on. (Drug dependence means the body needs the drug to function like usual.)

Baclofen intrathecal infusion has a boxed warning about the risk of serious harm if the drug is abruptly stopped. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA). For details, see the “Interactions and warnings for baclofen” section.

Baclofen oral tablet, oral solution, and oral suspension don’t have this boxed warning. But serious withdrawal symptoms are also possible with these oral forms of baclofen. This includes seizures and hallucinations (seeing or hearing things that aren’t real).

Due to the risk of withdrawal symptoms, your doctor will slowly reduce the dosage of baclofen if you need to stop treatment.

If you have more questions about withdrawal from baclofen, talk with your doctor.

Baclofen may cause mild or serious side effects. More common mild side effects of baclofen and its serious side effects are listed below. This article doesn’t include all possible side effects of the drug. Side effects can vary based on your age, overall health, and any other medications you take.

To learn more about the side effects of baclofen oral tablets, see this article. Your doctor or pharmacist can also give you information about the side effects of the tablet as well as the other forms of baclofen. Additionally, you can refer to the prescribing information for baclofen listed in the “Article resources” section.

Mild side effects

More common mild side effects reported with some forms of baclofen are listed below. These side effects may differ based on the form of baclofen your doctor prescribes.

This article doesn’t include all possible mild side effects of the drug. To learn more about baclofen’s side effects based on the form, refer to the prescribing information for baclofen listed in the “Article resources” section.

With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects are bothersome, tell your doctor or pharmacist. They may be able to suggest ways to manage them.

Mild side effects of baclofen oral tablet, oral solution, and oral suspension include:

• dizziness
• drowsiness
• nausea
• weakness
• mild allergic reaction*

Mild side effects of baclofen intrathecal infusion (injection into the spine given over time) include:

• dizziness
• drowsiness
• headache
• nausea or vomiting
• mild allergic reaction*

* For details about this side effect, see the “Interactions and warnings for baclofen” section.

Serious side effects

Serious side effects of baclofen are listed below. These side effects may differ based on the form of baclofen your doctor prescribes.

This article doesn’t include all possible serious side effects of the drug. To learn more about baclofen’s side effects based on the form, refer to the prescribing information for baclofen listed in the “Article resources” section.

With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number.

In general, baclofen’s serious side effects include:

• agitation, confusion, and other mental health changes or atypical thinking
• extreme drowsiness that can affect the ability to operate vehicles and machinery
• increased white blood cell counts
• low blood pressure
• low muscle tone
• paresthesia (burning, prickling, or other odd sensations in the hands or other body parts)
• sexual side effects, such as erectile dysfunction and inability to ejaculate
• slow or shallow breathing
• urinary retention (being unable to completely empty your bladder)
• boxed warning: risk of serious harm if the drug is abruptly stopped*
• severe allergic reaction*

* For details about this side effect, see the “Interactions and warnings for baclofen” section.

Below, you’ll find information about baclofen’s possible interactions and warnings.

Interactions of baclofen

Certain things may affect how a drug works. These include getting vaccines, consuming alcohol or certain foods, or taking the drug with other medications. This effect is called a drug interaction.

Before you take baclofen, ask your doctor to check for possible interactions. Be sure to tell them about any of the following you take or use:

• prescription or over-the-counter drugs
• vitamins, herbs, or supplements

To learn about drug-condition interactions, see the “Warnings for baclofen” section just below.

Warnings for baclofen

Some people should not take baclofen, and others should take it cautiously.

Boxed warning: Risk of serious harm with baclofen intrathecal infusion if the drug is abruptly stopped

Baclofen intrathecal infusion (injection into the spine given over time) has a boxed warning about the risk of serious harm if the drug is abruptly stopped. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).

Abruptly stopping baclofen intrathecal infusion can result in serious side effects, which may be life threatening. These include:

• high fever
• a change in mental function, which may result in symptoms such as confusion or hallucinations (seeing or hearing things that aren’t real)
• exaggerated rebound spasticity (increased severity of spasticity)
• muscle stiffness
• rhabdomyolysis (muscle damage and breakdown that can be life threatening)
• organ failure

These side effects can start within hours to days of suddenly stopping treatment.

Baclofen intrathecal infusion is given through a pump that’s implanted under the skin of the abdomen. Problems with the pump may cause an abrupt halt to baclofen treatment. Examples of such problems include:

• a disconnected catheter (the tiny tube that delivers the drug into the space around the spinal cord)
• low amount of drug in the pump’s reservoir
• a drained battery in the pump

If you experience any of the symptoms listed above or have problems with the pump, seek immediate medical care.

Due to the serious risks of abruptly stopping baclofen treatment, try to keep all scheduled pump refill appointments.

Baclofen oral tablet, oral solution, and oral suspension don’t have a boxed warning. However, serious withdrawal symptoms* are possible if you suddenly stop taking these forms of baclofen. Do not stop taking any oral form of baclofen without first talking with your doctor.

* Withdrawal symptoms can occur when you stop taking a drug your body is dependent on. (Drug dependence means the body needs the drug to function like usual.)

Other warnings

Baclofen could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether baclofen is a safe option for you. These warnings may differ based on the form of baclofen your doctor prescribes.

Ask your doctor about specific warnings for baclofen, and be sure to tell your doctor about your:

• current health, including any allergies to medications
• past health conditions or surgeries

Allergic reaction

Baclofen can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.

If you’ve had an allergic reaction to baclofen or any of its ingredients, your doctor will likely not prescribe baclofen. They can tell you about medications that are safer options for you.

A mild allergic reaction may cause the following symptoms:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A severe allergic reaction may cause the following symptoms:

• swelling under your skin, usually in your hands, feet, eyelids, or lips
• swelling of your mouth, throat, or tongue, which can cause breathing problems

If you have an allergic reaction to baclofen, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.

Overdose of baclofen

If you take baclofen by mouth, you should not take more baclofen than your doctor prescribes. For some drugs, doing so may lead to harmful effects or overdose.

Overdose is also possible with baclofen intrathecal infusion. Caregivers of people using this form of baclofen need to know about overdose symptoms and the procedures to follow if an overdose may have happened.

If you think you’ve taken too much baclofen, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have concerning symptoms, call 911 or a local emergency number immediately. You can also go to the closest emergency room.

Pregnancy or breastfeeding and baclofen

Information about baclofen and pregnancy and breastfeeding is described below.

Baclofen and pregnancy

It’s not known whether baclofen intrathecal infusion should be used during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before using this medication.

There are risks to taking baclofen oral tablet, oral solution, or oral suspension during pregnancy. But there are also risks with having untreated muscle spasticity (stiffness and tightness) while pregnant. (Keep in mind that baclofen is used for treating muscle spasticity.)

If you’re planning a pregnancy or can become pregnant, talk with your doctor about your treatment options during pregnancy. Together, you can discuss the risks and benefits of your treatment options and decide whether you should take baclofen during pregnancy.

Baclofen and breastfeeding

It’s not known whether baclofen intrathecal infusion should be used while breastfeeding. If you’re breastfeeding or planning to do so, talk with your doctor before using this medication.

Baclofen oral tablet, oral solution, and oral suspension should not be taken while breastfeeding. If you’re breastfeeding or planning to do so, talk with your doctor before taking this medication. Your doctor may recommend other ways to feed your child during treatment with baclofen.

This article describes baclofen’s uses and side effects, ways to save on cost, and more. Let your doctor know if you have questions about baclofen or would like more details about it.

Here’s a list of some possible questions you may want to ask your doctor:

• Am I at higher risk of side effects from baclofen?
• Are there any alternative medications you can prescribe for my condition?
• Am I a candidate for the baclofen spinal infusion pump?

• Baclofen — baclofen injection. (2022). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/e05080ef-53d9-4060-aaa4-86a6935467de/spl-doc
• Baclofen oral solution. (2022). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/6cc2773b-cb64-48e9-a69b-e457b82cb2d4/spl-doc
• Baclofen oral suspension. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/4585aafe-0af8-4786-a419-6a7e76671ca2/spl-doc
• Baclofen tablets, USP. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/80a4c6f7-4f02-493c-9263-62e1c90404ba/spl-doc
• Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm

Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.