Baclofen is used to help relax certain muscles in your body. It relieves the spasms, cramping, and tightness of muscles caused by medical problems such as multiple sclerosis or certain injuries to the spine. Baclofen does not cure these problems, but it may allow other treatment, such as physical therapy, to be more helpful in improving your condition.

Baclofen acts on the central nervous system (CNS) to produce its muscle relaxant effects. Its actions on the CNS may also cause some of the medicine's side effects. Baclofen may also be used to relieve other conditions as determined by your doctor.

This medicine is available only with your doctor's prescription.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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 as soon as possible if any of the following side effects occur:

Less common or rare

Bloody or dark urine

chest pain

fainting

hallucinations (seeing or hearing things that are not there)

mental depression or other mood changes

ringing or buzzing in the ears

skin rash or itching

Symptoms of overdose

Blurred or double vision

convulsions (seizures)

muscle weakness (severe)

shortness of breath or unusually slow or troubled breathing

vomiting

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

dizziness or lightheadedness

drowsiness

nausea

unusual weakness, especially muscle weakness

Less common or rare

Abdominal or stomach pain or discomfort

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

constipation

diarrhea

difficult or painful urination or decrease in amount of urine

false sense of well-being

frequent urge to urinate or uncontrolled urination

headache

loss of appetite

low blood pressure

muscle or joint pain

numbness or tingling in hands or feet

pounding heartbeat

sexual problems in males

slurred speech or other speech problems

stuffy nose

swelling of ankles

trouble in sleeping

unexplained muscle stiffness

unusual excitement

unusual tiredness

weight gain

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Convulsions (seizures)

hallucinations (seeing or hearing things that are not there)

increase in muscle spasm, cramping, or tightness

mood or mental changes

unusual nervousness or restlessness

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.

Do not suddenly stop taking this medicine. Unwanted effects may occur if the medicine is stopped suddenly. Check with your doctor for the best way to reduce gradually the amount you are taking before stopping completely.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; other muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using baclofen.

This medicine may cause drowsiness, dizziness, vision problems, or clumsiness or unsteadiness in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, and able to see well.

For diabetic patients:

This medicine may cause your blood sugar levels to rise. If you notice a change in the results of your blood or urine sugar test or if you have any questions about this, check with your doctor.