{
 "query": "nystatin",
 "ingredient": "nystatin",
 "slug": "nystatin",
 "rxcui": "7597",
 "brands": [
  "Nystop",
  "Nyamyc",
  "Bio-Statin"
 ],
 "names": [
  "nystatin"
 ],
 "classes": [
  {
   "id": "A07AA",
   "name": "Antibiotics"
  },
  {
   "id": "D01AA",
   "name": "Antibiotics"
  },
  {
   "id": "G01AA",
   "name": "Antibiotics"
  }
 ],
 "alternatives": [
  "amphotericin b",
  "chloramphenicol",
  "clindamycin",
  "colistin",
  "fidaxomicin",
  "griseofulvin",
  "kanamycin",
  "natamycin",
  "neomycin",
  "oxytetracycline",
  "paromomycin",
  "polymyxin b",
  "rifamycin sv",
  "rifaximin",
  "streptomycin",
  "vancomycin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "TOPICAL": 98,
   "ORAL": 27
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.",
  "contraindications": "CONTRAINDICATIONS The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.",
  "warnings_and_cautions": "",
  "warnings": "",
  "adverse_reactions": "ADVERSE REACTIONS Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported (See PRECAUTIONS: General ). Gastrointestinal: Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances. Dermatologic : Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely. Other: Tachycardia, bronchospasm, facial swelling, and non-specific myalgia have also been reported.",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "NYSTATIN",
  "manufacturer": "Genus Lifesciences Inc.",
  "application_number": "ANDA065148",
  "pharm_class_epc": [
   "Polyene Antifungal [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260507",
  "set_id": "b25cbae5-eaf5-4501-b013-02c778ca4a4e",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 25766,
  "serious": 19749,
  "death": 3232,
  "hospitalization": 11285,
  "primary_suspect": 25724,
  "top_reactions": [
   [
    "Nausea",
    1855
   ],
   [
    "Fatigue",
    1745
   ],
   [
    "Diarrhoea",
    1728
   ],
   [
    "Off Label Use",
    1612
   ],
   [
    "Pneumonia",
    1516
   ],
   [
    "Dyspnoea",
    1375
   ],
   [
    "Vomiting",
    1251
   ],
   [
    "Drug Ineffective",
    1231
   ],
   [
    "Death",
    1156
   ],
   [
    "Acute Kidney Injury",
    1089
   ],
   [
    "Pain",
    1062
   ],
   [
    "Pyrexia",
    1014
   ],
   [
    "Headache",
    1001
   ],
   [
    "Chronic Kidney Disease",
    942
   ],
   [
    "Cough",
    912
   ]
  ],
  "by_year": {
   "2019": 2863,
   "2020": 2823,
   "2021": 2177,
   "2022": 1890,
   "2023": 1909,
   "2024": 1824,
   "2025": 1803,
   "2026": 890
  },
  "by_year_primary": {
   "2019": 2861,
   "2020": 2823,
   "2021": 2170,
   "2022": 1880,
   "2023": 1903,
   "2024": 1820,
   "2025": 1794,
   "2026": 887
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260623",
   "reason": "Subpotent Drug: Low out of specification assay results performed during long-term stability testing.",
   "firm": "Padagis US LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20210729",
   "reason": "Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.",
   "firm": "PAI Holdings, LLC. dba Pharmaceutical Associates Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200804",
   "reason": "Subpotent drug: Out of specification for assay at the 15-month test interval.",
   "firm": "PAI Holdings, LLC. dba Pharmaceutical Associates Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200319",
   "reason": "SubPotent Drug: Low out-of-specification results for assay testing.",
   "firm": "PAI Holdings, LLC. dba Pharmaceutical Associates Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200114",
   "reason": "Subpotent: Out of specification for assay at the 12-month time point.",
   "firm": "Pharmaceutical Associates Inc",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20180529",
   "reason": "Resuspension problems: Out of specification for appearance and resuspendability.",
   "firm": "Pharmaceutical Associates Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 6,
 "drugsfda": {
  "applications": 81,
  "nda": 5,
  "anda": 59,
  "first_approval": "19640708",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 4,
  "labeling_recent": 0,
  "sponsors": [
   "ACTAVIS MID ATLANTIC",
   "ADAPTIS",
   "ALPHARMA US PHARMS",
   "AUROBINDO PHARMA",
   "BARLAN",
   "BAYER PHARMS",
   "CHARTWELL MOLECULES",
   "CHARTWELL RX"
  ],
  "unapproved": false,
  "first_approval_fmt": "07/08/1964"
 },
 "trials": {
  "total": 68,
  "completed": 42,
  "terminated": 7,
  "with_results": 7,
  "industry": 19,
  "phase3": 17,
  "results_share": 0.16666666666666666,
  "terminated_share": 0.10294117647058823
 },
 "pubmed": {
  "rct": 70,
  "meta": 6,
  "recent_rct": 1,
  "cochrane": [
   {
    "pmid": "25188770",
    "title": "Nystatin prophylaxis and treatment in severely immunodepressed patients",
    "year": "2014"
   },
   {
    "pmid": "12519566",
    "title": "Nystatin prophylaxis and treatment in severely immunodepressed patients",
    "year": "2002"
   },
   {
    "pmid": "12076436",
    "title": "Nystatin prophylaxis and treatment in severely immunodepressed patients",
    "year": "2002"
   },
   {
    "pmid": "10796846",
    "title": "Nystatin prophylaxis and treatment in severely immunodepressed patients",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "nystatin",
   "Nystop",
   "Nyamyc",
   "Bio-Statin"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3917980,
  "beneficiaries": 2114824,
  "spend": 76508881.33,
  "by_brand": [
   {
    "brand": "Nystatin",
    "claims": 2998339,
    "per_claim": 17.664293057,
    "is_generic": true
   },
   {
    "brand": "Nystop",
    "claims": 440088,
    "per_claim": 24.861907414,
    "is_generic": false
   },
   {
    "brand": "Nyamyc",
    "claims": 349852,
    "per_claim": 27.269383025,
    "is_generic": false
   },
   {
    "brand": "Klayesta",
    "claims": 129701,
    "per_claim": 23.620999453,
    "is_generic": false
   }
  ],
  "per_claim": 19.527634477460325
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "nystatin",
  "matched": "nystatin",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4501,
  "fills": 3917980,
  "per_million": 1148.8062726200747,
  "ratio": 0.4148888115602182,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "1,149 FDA reports naming it as the suspect drug per million Medicare fills, 0.4x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.4x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 40,
   "letter": "F",
   "why": [
    "70 randomized trials and 6 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "4 independent Cochrane review(s) exist",
    "Only 17% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 94,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 5 Class II, 1 Class III across 59 generic makers (-6)"
   ],
   "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 (59 applications)",
    "16 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 82,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are nausea, fatigue, diarrhoea. 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 amphotericin b, chloramphenicol, clindamycin? 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.)"
 ]
}