pharmacopeia
GET
/api/v1/drug/baclofen
2D structure
4-amino-3-(4-chlorophenyl)butanoic acid
SMILES C1=CC(=CC=C1C(CC(=O)O)CN)Cl
InChIKey KPYSYYIEGFHWSV-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: GABA A Agonists; GABA B Agonists.

GABA AGABA B

Indications

Sourced from openFDA
  • 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.ICD-10: G35

Contraindications

Sourced from openFDA
  • Hypersensitivity to baclofen.contraindicated

Dosage & administration

Sourced from openFDA

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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (See WARNINGS , Abrupt Drug Withdrawal ).

Warnings & precautions

Sourced from openFDA

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, gradua ly 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.

Adverse reactions

Sourced from openFDA

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.

Overdosage

Sourced from openFDA

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.

Approval history

Sourced from openFDA
  • Jul 21, 1988ANDAANDA072234Ivax Sub Teva Pharms
  • Jul 21, 1988ANDAANDA072235Ivax Sub Teva Pharms
  • Jun 17, 1992NDANDA020075Amneal
  • Aug 19, 1996ANDAANDA074584Yiling
  • Nov 19, 2010NDANDA022462Piramal Critical
  • Sep 18, 2019NDANDA208193Metacel Pharms Llc
  • Nov 22, 2021NDANDA215422Strides Pharma Intl
  • Feb 4, 2022NDANDA215602Azurity

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
87,256 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Fatigue6,2307.1%
  2. 2Pain5,7896.6%
  3. 3Drug Ineffective5,7886.6%
  4. 4Fall5,5216.3%
  5. 5Nausea4,6935.4%
  6. 6Headache4,4565.1%
  7. 7Gait Disturbance4,1584.8%
  8. 8Off Label Use3,7714.3%
  9. 9Dizziness3,6054.1%
  10. 10Urinary Tract Infection3,5644.1%
  11. 11Muscle Spasms3,4534.0%
  12. 12Asthenia3,4514.0%
  13. 13Multiple Sclerosis Relapse3,4073.9%
  14. 14Diarrhoea3,0873.5%
  15. 15Muscle Spasticity2,9723.4%

Literature

View JSON

Recent PubMed references pinned to Baclofen as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 145 ClinicalTrials.gov registrations naming Baclofen as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Baclofen work?
Mechanism-of-action classes: GABA A Agonists; GABA B Agonists.
What is Baclofen used for?
According to FDA labeling, Baclofen carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Baclofen?
Baclofen is classified as Other centrally acting agents, gamma-Aminobutyric Acid-ergic Agonist, GABA A Agonists, GABA B Agonists, Central Nervous System Depression, Decreased Organized Electrical Activity, Decreased Striated Muscle Contraction, Increased Spinal Cord GABA Activity.
What are the brand names for Baclofen?
Baclofen is marketed under brand names including Fleqsuvy, Gablofen, Lioresal, Lyvispah, Ozobax.
What are the contraindications for Baclofen?
Baclofen labeling lists contraindications including: Hypersensitivity to baclofen.. Always consult the full prescribing information and a clinician.
Note. Data for baclofen is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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