Verifying…
Home / Medicines A–Z / Baclofen

Baclofen

Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relie.

Prescription medicine Oral Safety alerts on record

How to use Baclofen

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Who it is for

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. …

How to take it and how often
  • 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  • If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (See WARNINGS, Abrupt Drug Withdrawal)
Talk to a doctor first if

Hypersensitivity to baclofen.

Warnings

A. 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. b. 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. c. Stroke: Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug. d. …

Possible side effects

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. …

If you take too much

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.

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2025-01-28.

Brands around the world

Products with Baclofen as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

BaclofenBACLOFEN 5 mg/1 · Tablet · American Health Packaging
NDC 60687-804Label
Lioresal (baclofen)BACLOFEN .05 mg/mL · Injection · Amneal Pharmaceuticals LLC
NDC 70121-2496Label
BaclofenBACLOFEN 20 mg/1 · Tablet · Aphena Pharma Solutions - Tennessee, LLC
NDC 71610-444Label
BaclofenBACLOFEN 20 mg/1 · Tablet · Aphena Pharma Solutions - Tennessee, LLC
NDC 71610-446Label
Lioresal (baclofen)Kit · Amneal Pharmaceuticals LLC
NDC 70121-2501Label

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10U.S. FDA Class II
26 Nov 2025 · Golden State Medical Supply Inc. · OngoingPresence of Foreign Tablets/Capsules
BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605U.S. FDA Class I
5 Oct 2020 · Med Shop Total Care Inc. · TerminatedNon-Sterility
HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/ML, b) 10MG-5MG-10MCG/ML, c) 2MG-1MG-10MCG/ML, d) 10MG-5MG-1U.S. FDA Class I
5 Oct 2020 · Med Shop Total Care Inc. · TerminatedNon-Sterility
SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605U.S. FDA Class I
5 Oct 2020 · Med Shop Total Care Inc. · TerminatedNon-Sterility

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Baclofen

Or take photos of the pack
3 free checks left today Official sources: U.S. FDA · EMA (EU) · NAFDAC · WHO alerts

Questions about Baclofen

What is Baclofen used for?

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 a (From the official U.S. FDA label.)

How do I take Baclofen?

Follow your prescription or the leaflet in your pack. The official label says: 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 neces…

Do I need a prescription for Baclofen?

Usually yes. Baclofen is a prescription medicine in most countries. Rules differ by country.

What brands contain Baclofen?

Baclofen is sold under names such as Gablofen, Lioresal, Ozobax, Lyvispah, Fleqsuvy, Baclofen. Brand names differ between countries.

How can I check that my Baclofen is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.