Mediclarum
Medicine guide

Baclofen

5 mg · Tablet

  • Prescription only
  • gamma-Aminobutyric Acid-ergic Agonist
Active substance
Baclofen
Made by
Lannett Company, Inc.

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2021-02-24

What it is

gamma-Aminobutyric Acid-ergic Agonist

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.
The label’s usual adult dose

Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40 to 80 mg daily).

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.).

Full directions ↓
Warning

Neonatal Withdrawal Symptoms :

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
137other products contain Baclofen — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What 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.
  • 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.

From the official label · 2021-02-24 · DailyMed

How it works

From this product’s own US prescribing label.

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.

How it leaves the body

Baclofen is excreted primarily by the kidney in unchanged form and there is relatively large intersubject variation in absorption and/or elimination.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2021-02-24

Do not take it if

Hypersensitivity to baclofen.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • 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 to 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 ).

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • a.
  • Neonatal Withdrawal Symptoms :
  • Withdrawal symptoms have been reported starting hours to days after delivery in neonates whose mothers were treated with oral baclofen throughout pregnancy.
  • The symptoms of withdrawal in these infants have included increased muscle tone, tremor, jitteriness, and seizure.
  • If the potential benefit justifies the potential risk to the fetus and oral baclofen is continued during pregnancy, gradually reduce the dose and discontinue baclofen before delivery.
  • If slow withdrawal is not feasible, advise the parents or caregivers of the potential for neonatal withdrawal. b.
  • 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. c.
  • 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. d.
  • Stroke : Baclofen has not significantly benefited patients with stroke.
  • These patients have also shown poor tolerability to the drug. e.
  • 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.
  • 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.

Quoted from the official label, section “Warnings”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • 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.

Quoted from the official label, section “Overdosage”.

Use in children

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

Quoted from the official label, section “Pediatric Use”.

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.
  • 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.

Quoted from the official label, section “Adverse Reactions”.

What it looks like and how it is packed

  • Baclofen Tablets USP, 5 mg are available as a white round convex tablet debossed with “LCI” on one side and “1333” on the other side.
  • Available in bottles of 100 (NDC 0527-1333-01).
  • Baclofen Tablets USP, 10 mg are available as a white round flat-faced beveled edge bisected tablet debossed with "LCI" over "1330" on one side and plain on the other side, containing 10 mg Baclofen USP.
  • Available in bottles of 100 (NDC 0527-1330-01), 500 (NDC 0527-1330-05) and 1000 (NDC 0527-1330-10).
  • Baclofen Tablets USP, 20 mg are available as a white round flat-faced beveled edge bisected tablet debossed with "LCI" over "1337" on one side and plain on the other side, containing 20 mg Baclofen USP.
  • Available in bottles of 100 (NDC 0527-1337-01), 500 (NDC 0527-1337-05) and 1000 (NDC 0527-1337-10).
  • 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].
  • Distributed by: Lannett Company, Inc.
  • Philadelphia, PA 19136 CIB70280E Rev. 02/21

Quoted from the official label, section “How Supplied”.

What is in it

  • Baclofen, USP is a muscle relaxant and antispastic.
  • Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid.
  • The structural formula is:
  • 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 5 mg, 10 mg or 20 mg baclofen.
  • In addition, each tablet contains the following inactive ingredients:
  • microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate.
  • Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (24)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Hide versions whose label lists:

Showing 24 of 24

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

CanadaNo exact match for this strength and form

Every strength and form (28)

Netherlands1 matching products

Every strength and form (18)

Details

Made byLannett Company, Inc.
Active substanceBaclofen
Used inPain, sleep, mood, epilepsy and the brain
Strength5 mg
FormTablet
RouteOral
Packs100 TABLET in 1 BOTTLE, PLASTIC
NDC0527-1333

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

129 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Show all forms · 5 forms

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Baclofen10 mgPrescription onlyTablet Teva Pharmaceuticals USA, Inc. · BaclofenBaclofen20 mgPrescription onlyTablet Teva Pharmaceuticals USA, Inc. · BaclofenBaclofen10 mgPrescription onlyTablet Lannett Company, Inc. · BaclofenBaclofen20 mgPrescription onlyTablet Lannett Company, Inc. · BaclofenBaclofen10 mgPrescription onlyTablet Par Health USA, LLC · BaclofenBaclofen20 mgPrescription onlyTablet Par Health USA, LLC · Baclofen

See every product with Baclofen