{
 "query": "baclofen",
 "ingredient": "baclofen",
 "slug": "baclofen",
 "rxcui": "1292",
 "brands": [
  "Lyvispah",
  "Fleqsuvy",
  "Gablofen",
  "Lioresal",
  "Ozobax"
 ],
 "names": [
  "baclofen"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 158,
   "INTRATHECAL": 10
  },
  "boxed_warning": "",
  "indications_and_usage": "Baclofen is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. Baclofen is a gamma-aminobutyric acid (GABA-ergic) agonist indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. ( 1 ) Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases. ( 1 ) Limitations of Use Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. ( 1 )",
  "contraindications": "Baclofen oral suspension is contraindicated in patients with hypersensitivity to baclofen. Hypersensitivity to baclofen ( 4 )",
  "warnings_and_cautions": "Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, reduce the dosage slowly when baclofen is discontinued. ( 5.1 ) Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue baclofen before delivery. ( 5.2 ) Baclofen can cause drowsiness and sedation. Patients should avoid the operation of automobiles or other dangerous machinery until they know how the drug affects them. Advise patients that the central nervous system effects of baclofen may be additive to those of alcohol and other CNS depressants. ( 5.3 ) Baclofen can cause exacerbation of the following: psychotic disorders, schizophrenia, or confusional states; autonomic dysreflexia; epilepsy. Use with caution in patients with these conditions. ( 5.5 , 5.6 , 5.7 ) 5.1 Adverse Reactions from Abrupt Withdrawal of Baclofen Abrupt discontinuation of baclofen, regardless of the cause, has resulted in adverse reactions that include hallucinations, seizures, high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death. Therefore, reduce the...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Adverse Reactions from Abrupt Withdrawal of Baclofen [see Warnings and Precautions ( 5.1 )] Neonatal Withdrawal Symptoms [see Warnings and Precautions ( 5.2 )] Drowsiness and Sedation [see Warnings and Precautions ( 5.3 )] Poor Tolerability in Stroke Patients [see Warnings and Precautions ( 5.4 )] Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States [see Warnings and Precautions ( 5.5 )] Exacerbation of Autonomic Dysreflexia [see Warnings and Precautions ( 5.6 )] Exacerbation of Epilepsy [see Warnings and Precautions ( 5.7 )] Posture and Balance Effects [see Warnings and Precautions ( 5.8 )] Ovarian Cysts [see Warnings and Precautions ( 5.9 )] The most common (up to 15% or more) adverse reactions in patients were drowsiness, dizziness, and weakness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Wilshire Pharmaceuticals at 1-877-495-6856 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot b...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration ( 2.3 ) 4/2024",
  "information_for_patients": "Administration Instructions Inform patients that baclofen is a concentrated formulation. Instruct patients or caregivers to use an oral dosing syringe and not to use a household teaspoon to correctly measure the prescribed amount of medication. Inform patients that oral dosing syringes may be obtained from their pharmacy. Instruct patients to shake before using [see Dosage and Administration ( 2.1 , 2.3 )] . Risks Related to Sudden Withdrawal of Baclofen Advise patients and caregivers not to discontinue use of baclofen without consulting with their healthcare provider because sudden withdrawal of baclofen can result in serious complications that include hallucinations, seizures, high fever, confusion, muscle stiffness, multiple organ-system failure, and death [see Warnings and Precautions ( 5.1 )] . Inform patients that early symptoms of baclofen withdrawal may include increased spasticity, itching, and tingling of extremities. Neonatal Withdrawal Symptoms Advise patients to notify their healthcare provider if they are pregnant, plan to become pregnant, or plan to breastfeed [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.2 )] . Increased Risk of Drowsines...",
  "spl_medguide": "",
  "clinical_studies": "The efficacy of baclofen is based upon a bioavailability study in healthy adults comparing baclofen oral tablets to baclofen [see Clinical Pharmacology ( 12.3 )] .",
  "brand_name": "Baclofen",
  "manufacturer": "Wilshire Pharmaceuticals, Inc.",
  "application_number": "NDA215602",
  "pharm_class_epc": [
   "gamma-Aminobutyric Acid-ergic Agonist [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251216",
  "set_id": "4585aafe-0af8-4786-a419-6a7e76671ca2",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 80915,
  "serious": 53303,
  "death": 5817,
  "hospitalization": 25384,
  "primary_suspect": 80706,
  "top_reactions": [
   [
    "Fatigue",
    5569
   ],
   [
    "Pain",
    5490
   ],
   [
    "Drug Ineffective",
    5224
   ],
   [
    "Fall",
    5000
   ],
   [
    "Nausea",
    4109
   ],
   [
    "Off Label Use",
    4103
   ],
   [
    "Headache",
    3940
   ],
   [
    "Gait Disturbance",
    3782
   ],
   [
    "Muscle Spasticity",
    3478
   ],
   [
    "Muscle Spasms",
    3180
   ],
   [
    "Urinary Tract Infection",
    3170
   ],
   [
    "Dizziness",
    3135
   ],
   [
    "Asthenia",
    2961
   ],
   [
    "Multiple Sclerosis Relapse",
    2776
   ],
   [
    "Diarrhoea",
    2724
   ]
  ],
  "by_year": {
   "2019": 7477,
   "2020": 6652,
   "2021": 6152,
   "2022": 5678,
   "2023": 5966,
   "2024": 4457,
   "2025": 4299,
   "2026": 2062
  },
  "by_year_primary": {
   "2019": 7471,
   "2020": 6650,
   "2021": 6142,
   "2022": 5634,
   "2023": 5921,
   "2024": 4420,
   "2025": 4262,
   "2026": 2036
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20251126",
   "reason": "Presence of Foreign Tablets/Capsules",
   "firm": "Golden State Medical Supply Inc.",
   "status": "Ongoing"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 49,
  "nda": 7,
  "anda": 40,
  "first_approval": "19771122",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 19,
  "labeling_recent": 2,
  "sponsors": [
   "ADAPTIS",
   "AMNEAL",
   "ANDAS 5 HOLDING",
   "ANI PHARMS",
   "AUROBINDO PHARMA LTD",
   "AZURITY",
   "HERITAGE",
   "IMPAX"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/22/1977"
 },
 "trials": {
  "total": 148,
  "completed": 88,
  "terminated": 25,
  "with_results": 26,
  "industry": 33,
  "phase3": 32,
  "results_share": 0.29545454545454547,
  "terminated_share": 0.16891891891891891
 },
 "pubmed": {
  "rct": 167,
  "meta": 46,
  "recent_rct": 22,
  "cochrane": [
   {
    "pmid": "36637087",
    "title": "Baclofen for alcohol use disorder",
    "year": "2023"
   },
   {
    "pmid": "31689723",
    "title": "Baclofen for alcohol withdrawal",
    "year": "2019"
   },
   {
    "pmid": "30484285",
    "title": "Baclofen for alcohol use disorder",
    "year": "2018"
   },
   {
    "pmid": "28822350",
    "title": "Baclofen for alcohol withdrawal",
    "year": "2017"
   },
   {
    "pmid": "26563961",
    "title": "Intrathecal baclofen for treating spasticity in children with cerebral palsy",
    "year": "2015"
   },
   {
    "pmid": "25836263",
    "title": "Baclofen for alcohol withdrawal",
    "year": "2015"
   },
   {
    "pmid": "23450582",
    "title": "Baclofen for alcohol withdrawal",
    "year": "2013"
   },
   {
    "pmid": "21249712",
    "title": "Baclofen for alcohol withdrawal",
    "year": "2011"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 113289.83000000002,
  "records": 533,
  "by_name": [
   [
    "Gablofen",
    111536.41
   ],
   [
    "Ozobax",
    1738.82
   ],
   [
    "Lyvispah",
    14.6
   ]
  ],
  "names_checked": [
   "baclofen",
   "Lyvispah",
   "Fleqsuvy",
   "Gablofen",
   "Lioresal",
   "Ozobax"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 5181892,
  "beneficiaries": 1358598,
  "spend": 89490617.22999999,
  "by_brand": [
   {
    "brand": "Baclofen",
    "claims": 5180407,
    "per_claim": 17.059512272,
    "is_generic": true
   },
   {
    "brand": "Lyvispah",
    "claims": 846,
    "per_claim": 192.72004728,
    "is_generic": false
   },
   {
    "brand": "Lioresal Intrathecal",
    "claims": 331,
    "per_claim": 1222.8135952,
    "is_generic": false
   },
   {
    "brand": "Fleqsuvy",
    "claims": 176,
    "per_claim": 2184.7517614,
    "is_generic": false
   },
   {
    "brand": "Gablofen",
    "claims": 108,
    "per_claim": 1214.5482407,
    "is_generic": false
   },
   {
    "brand": "Ozobax Ds",
    "claims": 24,
    "per_claim": 1330.0191667,
    "is_generic": false
   }
  ],
  "per_claim": 17.269873094614862
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "baclofen",
  "matched": "baclofen",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 10718,
  "fills": 5181892,
  "per_million": 2068.356499903896,
  "ratio": 0.7469823159746772,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "2,068 FDA reports naming it as the suspect drug per million Medicare fills, 0.7x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.8x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 58,
   "letter": "D",
   "why": [
    "167 randomized trials and 46 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "8 independent Cochrane review(s) exist",
    "Only 30% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 90,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 40 generic makers (-1)",
    "2 label changes approved since 2021 (-4)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $113,290 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (40 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 83,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, pain, fall. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}