Baclofen is a muscle relaxer and an antispasmodic agent.
Baclofen is given intrathecally (directly into the spinal cord) or orally (by mouth).
Do not use baclofen at a time when you need muscle tone for safe balance and movement during certain activities. Do not drive or operate heavy machinery until you know how this medicine affects you.
Do not stop using baclofen suddenly, or you could have unpleasant withdrawal symptoms.
Before taking this medicine
You should not use baclofen if you are allergic to it.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
mental illness or psychosis;
a nervous system disorder;
epilepsy or other seizure disorder;
a stroke or blood clot; or
Using baclofen may increase your risk of developing an ovarian cyst. Talk with your doctor about your specific risk.
Tell your doctor if you are pregnant or breastfeeding.
If you take baclofen during pregnancy, your newborn baby may have withdrawal symptoms such as tremors, rigid muscles, or a seizure. Follow your doctor's instructions about tapering your dose as your due date approaches.
If you take baclofen while breastfeeding,withdrawal symptoms may occur in the nursing baby. Ask your doctor if it is safe for you to breastfeed while taking this medicine.
Baclofen is not approved for use by anyone younger than 12 years old.
How should I take baclofen?
Take baclofen exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
Call your doctor if your muscle symptoms do not improve, or if they get worse.
You should not stop using baclofen suddenly or you could have serious or fatal withdrawal symptoms. Follow your doctor's instructions about tapering your dose.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include muscle weakness, vomiting, severe ditziness or drowsiness, dilated or pinpoint pupils, shallow breathing, seizure, or loss of consciousness.
What to avoid
Do not use baclofen at a time when you need muscle tone for safe balance and movement during certain activities. In some situations, it may be dangerous for you to have reduced muscle tone.
Drinking alcohol with baclofen can cause side effects.
Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.
Baclofen side effects
Get emergency medical help if you have signs of an allergic reaction to baclofen: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
severe drowsiness, weak or shallow breathing;
itching, tingling, or twitching in your hands, arms, feet, or legs;
Common baclofen side effects may include:
drowsiness, dizziness, weakness, tiredness;
sleep problems (insomnia);
nausea, constipation; or
urinating more often than usual.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect baclofen?
Using baclofen with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death.
Tell your physician if you are taking any of the following medications:
- Opioid medications
- Sleeping pills
- Muscle relaxers
- Medication for depression, anxiety, or bipolar disorder
- Seizure medication
- Blood pressure medication
Other drugs may interact with baclofen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.