{
 "query": "ivermectin",
 "ingredient": "ivermectin",
 "slug": "ivermectin",
 "rxcui": "6069",
 "brands": [
  "Soolantra",
  "Stromectol",
  "Sklice"
 ],
 "names": [
  "ivermectin"
 ],
 "classes": [
  {
   "id": "P02CF",
   "name": "Avermectines"
  }
 ],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "TOPICAL": 23,
   "ORAL": 11
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE STROMECTOL is indicated for the treatment of the following infections: Strongyloidiasis of the intestinal tract . STROMECTOL is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis . This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies .) Onchocerciasis . STROMECTOL is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus . This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: STROMECTOL has no activity against adult Onchocerca volvulus parasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eli...",
  "contraindications": "CONTRAINDICATIONS STROMECTOL is contraindicated in patients who are hypersensitive to any component of this product.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory responses to the death of microfilariae. Patients treated with STROMECTOL for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself. (See ADVERSE REACTIONS, Onchocerciasis .) The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials. Oral hydration, recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat postural hypotension. Antihistamines and/or aspirin have been used for most mild to moderate cases. Neurotoxicity with the use of ivermectin, including alteration of consciousness of variable severity (e.g., somnolence/drowsiness, stupor, and coma), confusion, disorientation and death, has been reported in patients without onchocerciasis or in patients with onchocerciasis in the absence of ...",
  "adverse_reactions": "ADVERSE REACTIONS Strongyloidiasis In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of STROMECTOL, the following adverse reactions were reported as possibly, probably, or definitely related to STROMECTOL: Body as a Whole: asthenia/fatigue (0.9%), abdominal pain (0.9%) Gastrointestinal: anorexia (0.9%), constipation (0.9%), diarrhea (1.8%), nausea (1.8%), vomiting (0.9%) Nervous System/Psychiatric: dizziness (2.8%), somnolence (0.9%), vertigo (0.9%), tremor (0.9%) Skin: pruritus (2.8%), rash (0.9%), and urticaria (0.9%). In comparative trials, patients treated with STROMECTOL experienced more abdominal distention and chest discomfort than patients treated with albendazole. However, STROMECTOL was better tolerated than thiabendazole in comparative studies involving 37 patients treated with thiabendazole. The Mazzotti-type and ophthalmologic reactions associated with the treatment of onchocerciasis or the disease itself would not be expected to occur in strongyloidiasis patients treated with STROMECTOL. (See ADVERSE REACTIONS, Onchocerciasis .) Laboratory Test Findings In clinical trials involving 109 patients given either o...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients STROMECTOL should be taken on an empty stomach with water. (See CLINICAL PHARMACOLOGY, Pharmacokinetics .) Strongyloidiasis: The patient should be reminded of the need for repeated stool examinations to document clearance of infection with Strongyloides stercoralis . Onchocerciasis: The patient should be reminded that treatment with STROMECTOL does not kill the adult Onchocerca parasites, and therefore repeated follow-up and retreatment is usually required.",
  "spl_medguide": "",
  "clinical_studies": "Clinical Studies Strongyloidiasis Two controlled clinical studies using albendazole as the comparative agent were carried out in international sites where albendazole is approved for the treatment of strongyloidiasis of the gastrointestinal tract, and three controlled studies were carried out in the U.S. and internationally using thiabendazole as the comparative agent. Efficacy, as measured by cure rate, was defined as the absence of larvae in at least two follow-up stool examinations 3 to 4 weeks post-therapy. Based on this criterion, efficacy was significantly greater for STROMECTOL (a single dose of 170 to 200 mcg/kg) than for albendazole (200 mg b.i.d. for 3 days). STROMECTOL administered as a single dose of 200 mcg/kg for 1 day was as efficacious as thiabendazole administered at 25 mg/kg b.i.d. for 3 days. Summary of Cure Rates for Ivermectin Versus Comparative Agents in the Treatment of Strongyloidiasis Cure Rate Number and % of evaluable patients (%) Ivermectin 170-200 mcg/kg Comparative Agent Albendazole 200 mg b.i.d. for 3 days Comparative International Study WHO Study 24/26 (92) 126/152 (83) 12/22 (55) 67/149 (45) Thiabendazole 25 mg/kg b.i.d. for 3 days Comparative Inter...",
  "brand_name": "STROMECTOL",
  "manufacturer": "Merck Sharp & Dohme LLC",
  "application_number": "NDA050742",
  "pharm_class_epc": [
   "Antiparasitic [EPC]",
   "Pediculicide [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240920",
  "set_id": "681888c9-af79-4b7d-ae80-c3f4f6f1effd",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 5054,
  "serious": 2525,
  "death": 407,
  "hospitalization": 1202,
  "primary_suspect": 5030,
  "top_reactions": [
   [
    "Drug Ineffective",
    744
   ],
   [
    "Off Label Use",
    486
   ],
   [
    "Product Use In Unapproved Indication",
    475
   ],
   [
    "Pruritus",
    295
   ],
   [
    "Erythema",
    236
   ],
   [
    "Headache",
    199
   ],
   [
    "Rash",
    190
   ],
   [
    "Fatigue",
    171
   ],
   [
    "Rosacea",
    161
   ],
   [
    "Nausea",
    150
   ],
   [
    "Condition Aggravated",
    146
   ],
   [
    "Diarrhoea",
    144
   ],
   [
    "Skin Burning Sensation",
    123
   ],
   [
    "Pain",
    122
   ],
   [
    "Vomiting",
    119
   ]
  ],
  "by_year": {
   "2019": 439,
   "2020": 366,
   "2021": 621,
   "2022": 483,
   "2023": 401,
   "2024": 409,
   "2025": 626,
   "2026": 351
  },
  "by_year_primary": {
   "2019": 439,
   "2020": 366,
   "2021": 621,
   "2022": 482,
   "2023": 398,
   "2024": 408,
   "2025": 614,
   "2026": 345
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 15,
  "nda": 3,
  "anda": 12,
  "first_approval": "19961122",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 20,
  "labeling_recent": 3,
  "sponsors": [
   "AJANTA PHARMA LTD",
   "ARBOR PHARMS LLC",
   "E5 PHARMA",
   "EDENBRIDGE PHARMS",
   "EPIC PHARMA LLC",
   "GALDERMA LABS LP",
   "MERCK SHARP DOHME",
   "PADAGIS ISRAEL"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/22/1996"
 },
 "trials": {
  "total": 242,
  "completed": 153,
  "terminated": 18,
  "with_results": 52,
  "industry": 45,
  "phase3": 84,
  "results_share": 0.33986928104575165,
  "terminated_share": 0.0743801652892562
 },
 "pubmed": {
  "rct": 388,
  "meta": 52,
  "recent_rct": 91,
  "cochrane": [
   {
    "pmid": "35726131",
    "title": "Ivermectin for preventing and treating COVID-19",
    "year": "2022"
   },
   {
    "pmid": "34318930",
    "title": "Ivermectin for preventing and treating COVID-19",
    "year": "2021"
   },
   {
    "pmid": "34184757",
    "title": "Ivermectin treatment in humans for reducing malaria transmission",
    "year": "2021"
   },
   {
    "pmid": "29608022",
    "title": "Ivermectin and permethrin for treating scabies",
    "year": "2018"
   },
   {
    "pmid": "26778150",
    "title": "Ivermectin versus albendazole or thiabendazole for Strongyloides stercoralis infection",
    "year": "2016"
   },
   {
    "pmid": "26771164",
    "title": "Doxycycline plus ivermectin versus ivermectin alone for treatment of patients with onchocerciasis",
    "year": "2016"
   },
   {
    "pmid": "22895928",
    "title": "Ivermectin for onchocercal eye disease (river blindness)",
    "year": "2012"
   },
   {
    "pmid": "11279760",
    "title": "Ivermectin for onchocercal eye disease (river blindness)",
    "year": "2001"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "ivermectin",
   "Soolantra",
   "Stromectol",
   "Sklice"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 80931,
  "beneficiaries": 50916,
  "spend": 13225720.95,
  "by_brand": [
   {
    "brand": "IVermectin",
    "claims": 79001,
    "per_claim": 149.82076531,
    "is_generic": true
   },
   {
    "brand": "Soolantra",
    "claims": 1911,
    "per_claim": 726.70604396,
    "is_generic": false
   },
   {
    "brand": "Stromectol",
    "claims": 19,
    "per_claim": 52.390526316,
    "is_generic": false
   }
  ],
  "per_claim": 163.4197149423583
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "ivermectin",
  "matched": "ivermectin",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "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": 61,
   "letter": "D",
   "why": [
    "388 randomized trials and 52 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 34% 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": 96,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "3 label changes approved since 2021 (-4)"
   ],
   "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 (12 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 85,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are product use in unapproved indication, pruritus. 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.)"
 ]
}