{
 "query": "mupirocin",
 "ingredient": "mupirocin",
 "slug": "mupirocin",
 "rxcui": "42372",
 "brands": [
  "Bactroban",
  "Centany",
  "Pirnuo"
 ],
 "names": [
  "mupirocin",
  "mupirocin calcium"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "TOPICAL",
  "route_counts": {
   "TOPICAL": 42
  },
  "boxed_warning": "",
  "indications_and_usage": "Mupirocin Cream USP, 2% is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2 in area) due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes) . Mupirocin cream is an RNA synthetase inhibitor antibacterial indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes . ( 1 )",
  "contraindications": "Mupirocin cream is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin cream. Known hypersensitivity to mupirocin or any of the excipients of mupirocin cream. ( 4 )",
  "warnings_and_cautions": "Severe Allergic Reactions: Anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients treated with formulations of mupirocin, including mupirocin cream. ( 5.1 ) Eye Irritation: Avoid contact with eyes. ( 5.2 ) Local Irritation: Discontinue in the event of sensitization or severe local irritation. ( 5.3 ) Clostridium difficile- Associated Diarrhea (CDAD): If diarrhea occurs, evaluate patients for CDAD. ( 5.4 ) Potential for Microbial Overgrowth: Prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi. ( 5.5 ) Risk Associated with Mucosal Use: Mupirocin cream is not formulated for use on mucosal surfaces. A separate formulation, mupirocin nasal ointment, is available for intranasal use. ( 5.6 ) 5.1 Severe Allergic Reactions Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash, have been reported in patients treated with formulations of mupirocin, including mupirocin cream [see Adverse Reactions (6.2) ] . 5.2 Eye Irritation Avoid contact with the eyes. In case of accidental contact, rinse well with water. 5.3 Local Irritation In the event of a sensitization or severe local irritati...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in more detail in other sections of the labeling: Severe Allergic Reactions [see Warnings and Precautions (5.1) ] Eye Irritation [see Warnings and Precautions (5.2) ] Local Irritation [see Warnings and Precautions (5.3) ] Clostridium difficile -Associated Diarrhea [see Warnings and Precautions (5.4) ] The most frequent adverse reactions (at least 1%) were headache, rash, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. In 2 randomized, double-blind, double-dummy trials, 339 subjects were treated with topical mupirocin cream plus oral placebo. Adverse reactions occurred in 28 (8.3%) subjects. The following adverse reactions were reported by at least 1% of subjects in connection with the use of mupirocin cream in clinical tria...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Advise the patient to administer mupirocin cream as follows: Use mupirocin cream only as directed by the healthcare provider. It is for external use only. Avoid contact of mupirocin cream with the eyes. If mupirocin cream gets in the eyes, rinse thoroughly with water. Do not use mupirocin cream in the nose. Wash your hands before and after applying mupirocin cream. Use a gauze pad or cotton swab to apply a small amount of mupirocin cream to the affected area. The treated area may be covered by gauze dressing if desired. Report to the healthcare provider any signs of local adverse reactions. Mupirocin cream should be stopped and the healthcare provider contacted if irritation, severe itching, or rash occurs. Report to the healthcare provider or go to the nearest emergency room if severe allergic reactions, such as swelling of the lips, face, or tongue, or wheezing occur [see Warnings and Precautions (5.1) ] . If no improvement is seen in 3 to 5 days, contact the healthcare provider.",
  "spl_medguide": "",
  "clinical_studies": "The efficacy of topical mupirocin cream for the treatment of secondarily infected traumatic skin lesions (e.g., lacerations, sutured wounds, and abrasions not more than 10 cm in length or 100 cm 2 in total area) was compared with that of oral cephalexin in 2 randomized, double-blind, double-dummy clinical trials. Clinical efficacy rates at follow-up in the per-protocol populations (adults and pediatric subjects included) were 96.1% for mupirocin cream (n = 231) and 93.1% for oral cephalexin (n = 219). Pathogen eradication rates at follow-up in the per-protocol populations were 100% for both mupirocin cream and oral cephalexin. Pediatrics There were 93 pediatric subjects aged 2 weeks to 16 years enrolled per protocol in the secondarily infected skin lesion trials, although only 3 were younger than 2 years of age in the population treated with mupirocin cream. Subjects were randomized to either 10 days of topical mupirocin cream 3 times daily or 10 days of oral cephalexin (250 mg 4 times daily for subjects greater than 40 kg or 25 mg per kg per day oral suspension in 4 divided doses for subjects less than or equal to 40 kg). Clinical efficacy at follow-up (7 to 12 days post-therapy) ...",
  "brand_name": "Mupirocin",
  "manufacturer": "Sun Pharmaceutical Industries, Inc.",
  "application_number": "ANDA207116",
  "pharm_class_epc": [],
  "route": [
   "TOPICAL"
  ],
  "effective_time": "20260410",
  "set_id": "6719ffba-3430-4fa9-b65b-c5c195ee1b35",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 14026,
  "serious": 7634,
  "death": 883,
  "hospitalization": 3464,
  "primary_suspect": 14008,
  "top_reactions": [
   [
    "Drug Ineffective",
    1579
   ],
   [
    "Off Label Use",
    1074
   ],
   [
    "Product Use In Unapproved Indication",
    1070
   ],
   [
    "Nausea",
    929
   ],
   [
    "Pain",
    914
   ],
   [
    "Fatigue",
    826
   ],
   [
    "Macular Degeneration",
    823
   ],
   [
    "Headache",
    778
   ],
   [
    "Diarrhoea",
    714
   ],
   [
    "Rash",
    630
   ],
   [
    "Pruritus",
    614
   ],
   [
    "Weight Decreased",
    595
   ],
   [
    "Chronic Kidney Disease",
    594
   ],
   [
    "Pyrexia",
    536
   ],
   [
    "Dyspnoea",
    529
   ]
  ],
  "by_year": {
   "2019": 1446,
   "2020": 1516,
   "2021": 1457,
   "2022": 1241,
   "2023": 1381,
   "2024": 1380,
   "2025": 1491,
   "2026": 646
  },
  "by_year_primary": {
   "2019": 1446,
   "2020": 1515,
   "2021": 1456,
   "2022": 1240,
   "2023": 1380,
   "2024": 1379,
   "2025": 1487,
   "2026": 637
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20240830",
   "reason": "Subpotent Drug",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 17,
  "nda": 4,
  "anda": 13,
  "first_approval": "19871231",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 21,
  "labeling_recent": 1,
  "sponsors": [
   "ALEMBIC",
   "AMNEAL",
   "ENCUBE",
   "FOUGERA PHARMS",
   "GLAXOSMITHKLINE",
   "GLENMARK PHARMS",
   "PADAGIS ISRAEL",
   "PADAGIS US"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/31/1987"
 },
 "trials": {
  "total": 108,
  "completed": 71,
  "terminated": 16,
  "with_results": 35,
  "industry": 21,
  "phase3": 16,
  "results_share": 0.49295774647887325,
  "terminated_share": 0.14814814814814814
 },
 "pubmed": {
  "rct": 100,
  "meta": 14,
  "recent_rct": 11,
  "cochrane": [
   {
    "pmid": "18843708",
    "title": "Mupirocin ointment for preventing Staphylococcus aureus infections in nasal carriers",
    "year": "2008"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "mupirocin",
   "Bactroban",
   "Centany",
   "Pirnuo"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3983304,
  "beneficiaries": 2824648,
  "spend": 39297626.89,
  "by_brand": [
   {
    "brand": "Mupirocin",
    "claims": 3920145,
    "per_claim": 8.0367119073,
    "is_generic": true
   },
   {
    "brand": "Mupirocin",
    "claims": 63159,
    "per_claim": 123.37989661,
    "is_generic": false
   }
  ],
  "per_claim": 9.865585677116284
 },
 "mdl": [],
 "dsc": [],
 "settlements": [
  {
   "year": 2010,
   "company": "GlaxoSmithKline",
   "amount_usd": 750000000.0,
   "amount_text": "$750 million",
   "violations": "Poor manufacturing practices",
   "products": "Kytril, Bactroban, Paxil CR, Avandamet",
   "laws": "False Claims Act, FDCA",
   "urls": [
    "https://www.justice.gov/opa/pr/2010/October/10-civ-1205.html"
   ],
   "matched": "bactroban"
  }
 ],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "mupirocin",
  "matched": "mupirocin",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3503,
  "fills": 3983304,
  "per_million": 879.4207020101906,
  "ratio": 0.31760081626845826,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "879 FDA reports naming it as the suspect drug per million Medicare fills, 0.3x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.7x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 50,
   "letter": "D",
   "why": [
    "100 randomized trials and 14 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "1 independent Cochrane review(s) exist",
    "Only 49% of completed registered trials posted results (-8)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 97,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 13 generic makers (-3)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Maker paid $750 million in 2010 to settle federal allegations naming this drug (Poor manufacturing practices) (-15)",
    "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 (13 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "grade": "B",
 "questions": [
  "The maker paid $750 million in 2010 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?",
  "The most-reported problems in FDA's adverse event data are product use in unapproved indication, nausea. 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.)"
 ]
}