{
 "query": "methocarbamol",
 "ingredient": "methocarbamol",
 "slug": "methocarbamol",
 "rxcui": "6845",
 "brands": [
  "Tanlor",
  "Atmeksi",
  "Robaxin"
 ],
 "names": [
  "methocarbamol"
 ],
 "classes": [
  {
   "id": "M03BA",
   "name": "Carbamic acid esters"
  }
 ],
 "alternatives": [
  "carisoprodol",
  "febarbamate",
  "styramate"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 155,
   "INTRAVENOUS": 13,
   "INTRAMUSCULAR": 12
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Methocarbamol tablets, USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
  "contraindications": "CONTRAINDICATIONS Methocarbamol tablets, USP are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Since methocarbamol may possess a general CNS depressant effect, patients receiving Methocarbamol tablets, USP should be cautioned about combined effects with alcohol and other CNS depressants. Safe use of Methocarbamol tablets, USP has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, Methocarbamol tablets, USP should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see Precautions, Pregnancy ). Use In Activities Requiring Mental Alertness Methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities.",
  "adverse_reactions": "ADVERSE REACTIONS Adverse reactions reported coincident with the administration of methocarbamol include: Body as a whole: Anaphylactic reaction, angioneurotic edema, fever, headache Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting Hemic and lymphatic system: Leukopenia Immune system: Hypersensitivity reactions Nervous system: Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo Skin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for patients Patients should be cautioned that methocarbamol may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery. Because methocarbamol may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Methocarbamol",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "ANDA086988",
  "pharm_class_epc": [
   "Muscle Relaxant [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20211110",
  "set_id": "27c39343-44e0-4ca6-a67f-1e6d11dd6799",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 19785,
  "serious": 12134,
  "death": 1433,
  "hospitalization": 5896,
  "primary_suspect": 19745,
  "top_reactions": [
   [
    "Fatigue",
    1474
   ],
   [
    "Nausea",
    1426
   ],
   [
    "Pain",
    1423
   ],
   [
    "Drug Ineffective",
    1310
   ],
   [
    "Headache",
    1116
   ],
   [
    "Diarrhoea",
    1027
   ],
   [
    "Off Label Use",
    947
   ],
   [
    "Fall",
    935
   ],
   [
    "Arthralgia",
    863
   ],
   [
    "Dyspnoea",
    845
   ],
   [
    "Dizziness",
    796
   ],
   [
    "Chronic Kidney Disease",
    783
   ],
   [
    "Back Pain",
    728
   ],
   [
    "Vomiting",
    706
   ],
   [
    "Anxiety",
    681
   ]
  ],
  "by_year": {
   "2019": 1874,
   "2020": 1991,
   "2021": 1514,
   "2022": 1484,
   "2023": 1496,
   "2024": 1702,
   "2025": 2242,
   "2026": 1231
  },
  "by_year_primary": {
   "2019": 1872,
   "2020": 1990,
   "2021": 1514,
   "2022": 1480,
   "2023": 1493,
   "2024": 1686,
   "2025": 2236,
   "2026": 1224
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250321",
   "reason": "Lack of Assurance of Sterility: Media fill with bacterial contamination",
   "firm": "Somerset Therapeutics Private Limited",
   "status": "Ongoing"
  },
  {
   "class": "Class I",
   "date": "20240215",
   "reason": "Presence of Particulate Matter",
   "firm": "Eugia US LLC",
   "status": "Ongoing"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 75,
  "nda": 3,
  "anda": 50,
  "first_approval": "19570716",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 14,
  "labeling_recent": 0,
  "sponsors": [
   "ABLE",
   "AIPING PHARM INC",
   "AM REGENT",
   "AM THERAP",
   "ANI PHARMS",
   "ASCOT",
   "AUROBINDO PHARMA LTD",
   "BAXTER HLTHCARE CORP"
  ],
  "unapproved": false,
  "first_approval_fmt": "07/16/1957"
 },
 "trials": {
  "total": 45,
  "completed": 22,
  "terminated": 8,
  "with_results": 9,
  "industry": 17,
  "phase3": 8,
  "results_share": 0.4090909090909091,
  "terminated_share": 0.17777777777777778
 },
 "pubmed": {
  "rct": 11,
  "meta": 0,
  "recent_rct": 1,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "methocarbamol",
   "Tanlor",
   "Atmeksi",
   "Robaxin"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3191039,
  "beneficiaries": 1343692,
  "spend": 36171807.03,
  "by_brand": [
   {
    "brand": "Methocarbamol",
    "claims": 3190991,
    "per_claim": 11.309362126,
    "is_generic": true
   },
   {
    "brand": "Tanlor",
    "claims": 48,
    "per_claim": 1744.4639583,
    "is_generic": false
   }
  ],
  "per_claim": 11.335432450057803
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": {
  "section": "Haematology",
  "names": [
   "methocarbamol"
  ],
  "reason": "Methocarbamol has many adverse effects, in particular gastrointestinal and cutaneous disorders (including angioedema) (Rev Prescrire n\u00b0 282, 338, 468, 480).",
  "edition": "2026",
  "qualifier": null,
  "qualified": false,
  "matched": "methocarbamol"
 },
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 5146,
  "fills": 3191039,
  "per_million": 1612.6408984659854,
  "ratio": 0.5824016475049525,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 80,
   "letter": "B",
   "why": [
    "Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)",
    "1,613 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.8x)",
    "1 Class I recall(s): reasonable probability of serious harm (-10)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 6,
   "letter": "F",
   "why": [
    "11 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed",
    "Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)",
    "No Cochrane review found (-5)",
    "Only 41% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 82,
   "letter": "B",
   "why": [
    "Recalls since 2016: 1 Class I, 1 Class II, 0 Class III across 50 generic makers (-18)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (50 applications)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 67,
 "grade": "C",
 "questions": [
  "An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?",
  "The most-reported problems in FDA's adverse event data are fatigue, nausea, pain. How would we recognize and handle those?",
  "Why this one over carisoprodol, febarbamate, styramate? What would make you pick one of those instead?",
  "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.)"
 ]
}