{
 "query": "methimazole",
 "ingredient": "methimazole",
 "slug": "methimazole",
 "rxcui": "6835",
 "brands": [],
 "names": [
  "methimazole"
 ],
 "classes": [
  {
   "id": "H03BB",
   "name": "Sulfur-containing imidazole derivatives"
  }
 ],
 "alternatives": [
  "carbimazole"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 39
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Methimazole tablets are indicated: In patients with Graves\u2019 disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option. To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.",
  "contraindications": "CONTRAINDICATIONS Methimazole tablets are contraindicated in the presence of hypersensitivity to the drug or any of the other product components.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS First Trimester Use of Methimazole and Congenital Malformations Methimazole crosses the placental membranes and can cause fetal harm, when administered in the first trimester of pregnancy. Rare instances of congenital defects, including aplasia cutis, craniofacial malformations (facial dysmorphism; choanal atresia), gastrointestinal malformations (esophageal atresia with or without tracheoesophageal fistula), omphalocele and abnormalities of the omphalomesenteric duct have occurred in infants born to mothers who received methimazole tablets in the first trimester of pregnancy. If methimazole tablets are used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be warned of the potential hazard to the fetus. Because of the risk for congenital malformations associated with use of methimazole tablets in the first trimester of pregnancy, it may be appropriate to use other agents in pregnant women requiring treatment for hyperthyroidism. If methimazole tablets are used, the lowest possible dose to control the maternal disease should be given. Agranulocytosis Agranulocytosis is potentially a life-threatening adverse reaction of methimazo...",
  "adverse_reactions": "ADVERSE REACTIONS Major adverse reactions (which occur with much less frequency than the minor adverse reactions) include inhibition of myelopoiesis (agranulocytosis, granulocytopenia, thrombocytopenia, and aplastic anemia), drug fever, a lupus-like syndrome, insulin autoimmune syndrome (which can result in hypoglycemic coma), hepatitis (jaundice may persist for several weeks after discontinuation of the drug), periarteritis, and hypoprothrombinemia. Nephritis occurs very rarely. There have been postmarketing case reports of acute pancreatitis. There are reports of a vasculitis, often associated with the presence of anti-neutrophilic cytoplasmic antibodies (ANCA), resulting in severe complications [see WARNINGS ] . Minor adverse reactions include skin rash, urticaria, nausea, vomiting, epigastric distress, arthralgia, paresthesia, loss of taste, abnormal loss of hair, myalgia, headache, pruritus, drowsiness, neuritis, edema, vertigo, skin pigmentation, jaundice, sialadenopathy, and lymphadenopathy. To report SUSPECTED ADVERSE REACTIONS, contact AiPing Pharmaceutical, Inc. at 1-844-374-0016 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Patients should be advised that if they become pregnant or intend to become pregnant while taking an antithyroid drug, they should contact their physician immediately about their therapy. Inform patients that cases of vasculitis resulting in severe complications have occurred with methimazole tablets. Inform patients to promptly report symptoms that may be associated with vasculitis including new rash, hematuria or decreased urine output, dyspnea or hemoptysis [see WARNINGS and ADVERSE REACTIONS ] .",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Methimazole",
  "manufacturer": "AiPing Pharmaceutical, Inc.",
  "application_number": "ANDA040547",
  "pharm_class_epc": [
   "Thyroid Hormone Synthesis Inhibitor [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260820",
  "set_id": "06bb4bcc-5e47-48b6-a76c-648f846704e8",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 9181,
  "serious": 6908,
  "death": 768,
  "hospitalization": 3686,
  "primary_suspect": 9135,
  "top_reactions": [
   [
    "Drug Ineffective",
    696
   ],
   [
    "Off Label Use",
    603
   ],
   [
    "Fatigue",
    514
   ],
   [
    "Hyperthyroidism",
    480
   ],
   [
    "Nausea",
    439
   ],
   [
    "Diarrhoea",
    409
   ],
   [
    "Headache",
    378
   ],
   [
    "Dyspnoea",
    363
   ],
   [
    "Pain",
    349
   ],
   [
    "Dizziness",
    329
   ],
   [
    "Agranulocytosis",
    291
   ],
   [
    "Asthenia",
    291
   ],
   [
    "Weight Decreased",
    247
   ],
   [
    "Anxiety",
    245
   ],
   [
    "Condition Aggravated",
    236
   ]
  ],
  "by_year": {
   "2019": 747,
   "2020": 876,
   "2021": 732,
   "2022": 794,
   "2023": 797,
   "2024": 1077,
   "2025": 835,
   "2026": 385
  },
  "by_year_primary": {
   "2019": 747,
   "2020": 875,
   "2021": 731,
   "2022": 782,
   "2023": 792,
   "2024": 1070,
   "2025": 821,
   "2026": 379
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 12,
  "nda": 1,
  "anda": 11,
  "first_approval": "19500621",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 13,
  "labeling_recent": 0,
  "sponsors": [
   "AIPING PHARM INC",
   "BIONPHARMA",
   "CHARTWELL RX",
   "DISCOVERY THERAP",
   "HERITAGE PHARMA",
   "KING PHARMS",
   "KING PHARMS LLC",
   "MACLEODS PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/21/1950"
 },
 "trials": {
  "total": 40,
  "completed": 16,
  "terminated": 6,
  "with_results": 0,
  "industry": 3,
  "phase3": 4,
  "results_share": 0.0,
  "terminated_share": 0.15
 },
 "pubmed": {
  "rct": 56,
  "meta": 8,
  "recent_rct": 8,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "methimazole"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 943504,
  "beneficiaries": 220650,
  "spend": 10607522.02,
  "by_brand": [
   {
    "brand": "Methimazole",
    "claims": 943504,
    "per_claim": 11.242688976,
    "is_generic": true
   }
  ],
  "per_claim": 11.242688976411335
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "methimazole",
  "matched": "methimazole",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2270,
  "fills": 943504,
  "per_million": 2405.925147111194,
  "ratio": 0.8688944766215786,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "2,406 FDA reports naming it as the suspect drug per million Medicare fills, 0.9x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.9x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 30,
   "letter": "F",
   "why": [
    "56 randomized trials and 8 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 0% of completed registered trials posted results (-15)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "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": 90,
   "letter": "A",
   "why": [
    "Generic versions approved (11 applications)",
    "1 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, hyperthyroidism. 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?",
  "Why this one over carbimazole? 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.)"
 ]
}