Baclofen

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 5/22/2023

Drug Summary

What Is Baclofen

Baclofen is a muscle relaxant and antispastic used for treating spasm of skeletal muscles, muscle clonus, rigidity, and pain caused by multiple sclerosis. Baclofen is also injected into the spinal cord to treat severe spasticity, spinal cord injuries, and other spinal cord diseases. Baclofen is available in generic form.

What Are Side Effects of Baclofen

Baclofen may cause serious side effects including:

  • mood changes,
  • confusion,
  • depression, and
  • hallucinations

Get medical help right away, if you have any of the symptoms listed above.

Baclofen side effects include

  • drowsiness,
  • weakness,
  • dizziness,
  • tiredness,
  • headache,
  • seizures,
  • nausea,
  • vomiting,
  • low blood pressure,
  • constipation,
  • confusion,
  • respiratory depression,
  • trouble sleeping (insomnia), and
  • increased urinary frequency or urinary retention.

Abrupt discontinuation of baclofen may cause:

  • seizures and hallucinations,
  • high fever,
  • rebound spasticity,
  • muscle rigidity, and
  • rhabdomyolysis (muscle breakdown and wasting)

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Baclofen

The recommended oral dose of baclofen is 15-80 mg daily.

What Drugs, Substances, or Supplements Interact with Baclofen

Combining baclofen and tricyclic antidepressants may cause muscle weakness. Use of baclofen and monoamine oxidase inhibitors (MAOIs) can result in greater depression of brain function as well as low blood pressure.

Baclofen and Pregnancy

During pregnancy, baclofen should be used only when prescribed. Baclofen passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Baclofen Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

Description for Baclofen

Baclofen is a muscle relaxant and antispastic.

Its chemical name is 4-amino-3-(4-chlorophenyl) butanoic acid. The structural formula is:

BACLOFEN Structural Formula Illustration
C10H12ClNO2     M.W. 213.66

Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform.

Each tablet, for oral administration, contains 10 mg or 20 mg Baclofen. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, potato starch, povidone.

Uses for Baclofen

Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.

Dosage for Baclofen

The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40-80 mg daily).

The following dosage titration schedule is suggested:

5 mg t.i.d. for 3 days

10 mg t.i.d. for 3 days

15 mg t.i.d. for 3 days

20 mg t.i.d. for 3 days

Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.).

The lowest dose compatible with an optimal response is recommended. If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (See WARNINGS, Abrupt Drug Withdrawal).

HOW SUPPLIED

Baclofen Tablets, USP 5 mg are available as a White to off white, round flat-faced, beveled edge tablets debossed with “023” on one side and plain on other side, containing 5 mg baclofen USP packaged in bottles of 100 tablets.

NDC 72888-009-01 100s count

Baclofen Tablets, USP 10 mg are available as a White to off white, round flat-faced, beveled edge tablets debossed with “024” on one side and score on other side, containing 10 mg baclofen USP packaged in bottles of 100, 500 and 1000 tablets.

NDC 72888-010-01 100s count
NDC 72888-010-05 500s count
NDC 72888-010-00 1000s count

Baclofen Tablets, USP 20 mg are available as a White to off white, round flat-faced, beveled edge tablets debossed with “025” on one side and score on other side, containing 20 mg baclofen USP packaged in bottles of 100, 500 and 1000 tablets.

NDC 72888-011-01 100s count
NDC 72888-011-05 500s count
NDC 72888-011-00 1000s count

PHARMACIST: Dispense in a well closed container as defined in the USP, with a child-resistant closure (as required).

Store at 20° to 25°C (68°to 77°F) [See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Distributed by: Advagen Pharma Ltd, 666 Plainsboro Road, Plainsboro Suite 605, Plainsboro, NJ, 08536, USA. Manufactured by: Rubicon Research Private Limited, Ambernath, Dist: Thane, 421506. Revised: Aug 2019

Side Effects for Baclofen

The most common is transient drowsiness (10 to 63%). In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the placebo group. Other common adverse reactions are dizziness (5 to 15%), weakness (5 to 15%) and fatigue (2 to 4%).

Others Reported

Neuropsychiatric: Confusion (1 to 11%), headache (4 to 8%), insomnia (2 to 7%); and, rarely, euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure.

Cardiovascular: Hypotension (0 to 9%). Rare instances of dyspnea, palpitation, chest pain, syncope.

Gastrointestinal: Nausea (4 to 12%), constipation (2 to 6%); and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool.

Genitourinary: Urinary frequency (2 to 6%); and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria.

Other: Instances of rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion.

Some of the CNS and genitourinary symptoms may be related to the underlying disease rather than to drug therapy. The following laboratory tests have been found to be abnormal in a few patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.

Drug Interactions for Baclofen

No Information provided

Warnings for Baclofen

  1. Abrupt Drug Withdrawal: Hallucinations and seizures have occurred on abrupt withdrawal of baclofen. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued.
  2. Impaired Renal Function: Because baclofen is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage.
  3. Stroke: Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.
  4. Pregnancy: Baclofen has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times the maximum dose recommended for human use, at a dose which caused significant reductions in food intake and weight gain in dams. This abnormality was not seen in mice or rabbits.

There was also an increased incidence of incomplete sternebral ossification in fetuses of rats given approximately 13 times the maximum recommended human dose, and an increased incidence of unossified phalangeal nuclei of forelimbs and hindlimbs in fetuses of rabbits given approximately 7 times the maximum recommended human dose. In mice, no teratogenic effects were observed, although reductions in mean fetal weight with consequent delays in skeletal ossification were present when dams were given 17 and 34 times the human daily dose. There are no studies in pregnant women. Baclofen should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus.

Precautions for Baclofen

Because of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system effects of baclofen may be additive to those of alcohol and other CNS depressants.

Baclofen should be used with caution where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function.

In patients with epilepsy, the clinical state and electroencephalogram should be monitored at regular intervals, since deterioration in seizure control and EEG have been reported occasionally in patients taking baclofen.

It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

A dose-related increase in incidence of ovarian cysts and a less marked increase in enlarged and/or hemorrhagic adrenal glands was observed in female rats treated chronically with baclofen.

Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients that were treated with baclofen for up to one year. In most cases these cysts disappeared spontaneously while patients continued to receive the drug. Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Overdose Information for Baclofen

Signs and Symptoms: Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression and seizures.

Treatment: In the alert patient, empty the stomach promptly by induced emesis followed by lavage. In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis). Maintain adequate respiratory exchange, do not use respiratory stimulants.

Contraindications for Baclofen

Hypersensitivity to baclofen.

Clinical Pharmacology for Baclofen

The precise mechanism of action of baclofen is not fully known. Baclofen is capable of inhibiting both monosynaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Although baclofen is an analog of the putative inhibitory neurotransmitter gamma-aminobutyric acid (GABA), there is no conclusive evidence that actions on GABA systems are involved in the production of its clinical effects. In studies with animals baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression. Baclofen is rapidly and extensively absorbed and eliminated. Absorption may be dose-dependent, being reduced with increasing doses. Baclofen is excreted primarily by the kidney in unchanged form and there is relatively large intersubject variation in absorption and/or elimination.

Patient Information for Baclofen

No information provided. Please refer to the WARNINGS AND PRECAUTIONS section.

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