{
 "query": "simethicone\r",
 "ingredient": "simethicone",
 "slug": "simethicone",
 "rxcui": "9796",
 "brands": [
  "Bicarsim",
  "Gas Aide",
  "Gas-X",
  "Little Tummys",
  "Mi-Acid Gas Relief",
  "Mylicon",
  "Phazyme"
 ],
 "names": [
  "simethicone"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": null,
  "route_counts": {},
  "boxed_warning": "",
  "indications_and_usage": "Uses for the relief of \u2022 acid indigestion \u2022 heartburn \u2022 sour stomach \u2022 upset stomach associated with these symptoms \u2022 pressure and bloating commonly referred to as gas",
  "contraindications": "",
  "warnings_and_cautions": "",
  "warnings": "Warnings Ask a doctor before use if you have \u2022 kidney disease \u2022 a magnesium-restricted diet Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not take more than 80 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician Keep out of reach of children.",
  "adverse_reactions": "",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "",
  "manufacturer": "",
  "application_number": "",
  "pharm_class_epc": [],
  "route": [],
  "effective_time": "20221129",
  "set_id": "00f70847-095e-4bfa-ae9e-b4776f4c37bb",
  "has_boxed_warning": false,
  "boxed_labels": "0 of 24",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 0,
  "serious": 0,
  "death": 0,
  "hospitalization": 0,
  "primary_suspect": 0,
  "top_reactions": [],
  "by_year": {},
  "by_year_primary": {}
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 0,
  "nda": 0,
  "anda": 0,
  "first_approval": "",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [],
  "unapproved": false,
  "first_approval_fmt": ""
 },
 "trials": {
  "total": 114,
  "completed": 72,
  "terminated": 8,
  "with_results": 17,
  "industry": 33,
  "phase3": 22,
  "results_share": 0.2361111111111111,
  "terminated_share": 0.07017543859649122
 },
 "pubmed": {
  "rct": 77,
  "meta": 10,
  "recent_rct": 18,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "simethicone",
   "Bicarsim",
   "Gas Aide",
   "Gas-X",
   "Little Tummys",
   "Mi-Acid Gas Relief",
   "Mylicon",
   "Phazyme"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [],
   "weight": 0.35
  },
  "evidence": {
   "score": 39,
   "letter": "F",
   "why": [
    "77 randomized trials and 10 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 24% of completed registered trials posted results (-15)"
   ],
   "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": 70,
   "letter": "C",
   "why": [
    "Sold over the counter under an FDA monograph: no application to approve, many makers",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 82,
 "grade": "B",
 "questions": [
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "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.)"
 ],
 "grade_history": [
  {
   "date": "2026-10-28",
   "grade": "B",
   "total": 82,
   "reason": ""
  }
 ]
}