{
 "query": "benzonatate",
 "ingredient": "benzonatate",
 "slug": "benzonatate",
 "rxcui": "18993",
 "brands": [
  "Tessalon Perles"
 ],
 "names": [
  "benzonatate"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 105
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Benzonatate Capsule is indicated for the symptomatic relief of cough.",
  "contraindications": "CONTRAINDICATIONS Hypersensitivity to benzonatate or related compounds.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Hypersensitivity Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures. Psychiatric Effects Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking Benzonatate Capsule in combination with other prescribed drugs. Accidental Ingestion and Death in Children Keep Benzonatate Capsules out of reach of children. Accidental ingestion of Benzonatate Capsules resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE ).",
  "adverse_reactions": "ADVERSE REACTIONS Potential Adverse Reactions to Benzonatate Capsules may include: Hypersensitivity reactions including bronchospasm, laryngospasm,cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule. CNS: sedation; headache; dizziness; mental confusion; visual hallucinations. GI: constipation; nausea; GI upset. Dermatologic: pruritus; skin eruptions. Other: nasal congestion; sensation of burning in the eyes; vague \"chilly\" sensation; numbness of the chest; hypersensitivity. Deliberate or accidental overdose has resulted in death, particularly in children.",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Swallow Benzonatate Capsules whole. Do not break, chew, dissolve, cut, or crush Benzonatate Capsules. Release of Benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention. Keep Benzonatate Capsules out of reach of children. Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15 - 20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately. Overdosage resulting in death may occur in adults. Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg. If you miss a dose of Benzonatate Capsules, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of Benzonatate Capsules at one time.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Benzonatate",
  "manufacturer": "Rising Pharma Holdings, Inc.",
  "application_number": "ANDA202765",
  "pharm_class_epc": [
   "Non-narcotic Antitussive [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240607",
  "set_id": "0ca22f92-9750-4eb4-8cdb-ebd3b12691cc",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 18979,
  "serious": 12079,
  "death": 2132,
  "hospitalization": 6385,
  "primary_suspect": 18948,
  "top_reactions": [
   [
    "Fatigue",
    1498
   ],
   [
    "Cough",
    1458
   ],
   [
    "Chronic Kidney Disease",
    1344
   ],
   [
    "Dyspnoea",
    1335
   ],
   [
    "Pneumonia",
    1288
   ],
   [
    "Diarrhoea",
    1287
   ],
   [
    "Nausea",
    1284
   ],
   [
    "Death",
    989
   ],
   [
    "Pain",
    987
   ],
   [
    "Headache",
    983
   ],
   [
    "Renal Failure",
    951
   ],
   [
    "Acute Kidney Injury",
    928
   ],
   [
    "Off Label Use",
    825
   ],
   [
    "Dizziness",
    735
   ],
   [
    "Drug Ineffective",
    689
   ]
  ],
  "by_year": {
   "2019": 2156,
   "2020": 2088,
   "2021": 1443,
   "2022": 1397,
   "2023": 1422,
   "2024": 1498,
   "2025": 1946,
   "2026": 884
  },
  "by_year_primary": {
   "2019": 2155,
   "2020": 2087,
   "2021": 1441,
   "2022": 1391,
   "2023": 1413,
   "2024": 1494,
   "2025": 1939,
   "2026": 883
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20231226",
   "reason": "Superpotent drug: Assay results were slightly above specification at the time zero point.",
   "firm": "Amerisource Health Services LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20170509",
   "reason": "Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.",
   "firm": "Strides Pharma INC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20150106",
   "reason": "Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules",
   "firm": "American Health Packaging",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20141223",
   "reason": "Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.",
   "firm": "Zydus Pharmaceuticals USA Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 4,
 "drugsfda": {
  "applications": 17,
  "nda": 1,
  "anda": 16,
  "first_approval": "19580210",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 7,
  "labeling_recent": 0,
  "sponsors": [
   "ACELLA",
   "ASCENT PHARMS INC",
   "BIONPHARMA",
   "CHARTWELL RX",
   "CSPC-NBP PHARM",
   "HERITAGE PHARMS LABS",
   "MIKART",
   "NESHER PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "02/10/1958"
 },
 "trials": {
  "total": 5,
  "completed": 2,
  "terminated": 0,
  "with_results": 0,
  "industry": 4,
  "phase3": 1,
  "results_share": 0.0,
  "terminated_share": 0.0
 },
 "pubmed": {
  "rct": 1,
  "meta": 2,
  "recent_rct": 0,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "benzonatate",
   "Tessalon Perles"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 169630,
  "beneficiaries": 120880,
  "spend": 1928702.62,
  "by_brand": [
   {
    "brand": "Benzonatate",
    "claims": 169630,
    "per_claim": 11.370056122,
    "is_generic": true
   }
  ],
  "per_claim": 11.370056122148206
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20101214",
   "title": "Death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of age",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm236651.htm",
   "kind": "drug",
   "matched": "benzonatate"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4316,
  "fills": 169630,
  "per_million": 25443.61256853151,
  "ratio": 9.188903675013067,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 77,
   "letter": "B",
   "why": [
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2010 (-8)",
    "25,444 FDA reports naming it as the suspect drug per million Medicare fills, 9.2x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (1.2x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 17,
   "letter": "F",
   "why": [
    "1 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 99,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 0 Class II, 2 Class III across 16 generic makers (-1)"
   ],
   "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": [
    "Generic versions approved (16 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 68,
 "grade": "C",
 "questions": [
  "In 2010 the FDA issued a safety communication about this drug (Death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years ). Does that risk apply to me?",
  "The most-reported problems in FDA's adverse event data are fatigue, cough, chronic kidney disease, dyspnoea. How would we recognize and handle those?",
  "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.)"
 ]
}