{
 "query": "erythromycin",
 "ingredient": "erythromycin",
 "slug": "erythromycin",
 "rxcui": "4053",
 "brands": [
  "E.E.S.",
  "Emcin Clear",
  "Emgel",
  "Ery",
  "Ery-Tab",
  "Erygel",
  "EryPed",
  "Erythrocin",
  "Erythrocin Stearate",
  "Eyemycin",
  "Theramycin"
 ],
 "names": [
  "erythromycin",
  "erythromycin estolate",
  "erythromycin ethylsuccinate",
  "erythromycin gluceptate",
  "erythromycin lactobionate",
  "erythromycin phosphate",
  "erythromycin stearate",
  "erythromycin stinoprate"
 ],
 "classes": [
  {
   "id": "D10AF",
   "name": "Antiinfectives for treatment of acne"
  },
  {
   "id": "J01FA",
   "name": "Macrolides"
  },
  {
   "id": "S01AA",
   "name": "Antibiotics"
  }
 ],
 "alternatives": [
  "amikacin",
  "ampicillin",
  "azithromycin",
  "bacitracin",
  "cefuroxime",
  "chloramphenicol",
  "chlortetracycline",
  "clarithromycin",
  "clindamycin",
  "dibekacin",
  "dihydrostreptomycin",
  "dirithromycin",
  "framycetin",
  "fusidic acid",
  "gentamicin",
  "josamycin",
  "kanamycin",
  "meclocycline",
  "micronomicin",
  "midecamycin",
  "minocycline",
  "miocamycin",
  "natamycin",
  "neomycin",
  "netilmicin",
  "oleandomycin",
  "oxytetracycline",
  "penicillin g",
  "polymyxin b",
  "rifamycin sv",
  "roxithromycin",
  "spiramycin",
  "sulfacetamide",
  "telithromycin",
  "tetracycline",
  "tobramycin",
  "troleandomycin",
  "tyrothricin",
  "vancomycin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 37,
   "OPHTHALMIC": 21,
   "TOPICAL": 12,
   "INTRAVENOUS": 4
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin Ethylsuccinate and other antibacterial drugs, Erythromycin Ethylsuccinate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin Ethylsuccinate is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below: Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes , Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenza e are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.) Lower-respiratory tract infections of mild to moderate severi...",
  "contraindications": "CONTRAINDICATIONS Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic. Erythromycin is contraindicated in patients taking terfenadine, astemizole, pimozide, or cisapride (see PRECAUTIONS - Drug Interactions ). Do not use erythromycin concomitantly with HMG CoA reductase inhibitors (statins) that are extensively metabolized by CYP 3A4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Hepatotoxicity There have been reports of hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, occurring in patients receiving oral erythromycin products. QT Prolongation Erythromycin has been associated with prolongation of the QT interval and infrequent cases of arrhythmia. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving erythromycin. Fatalities have been reported. Erythromycin should be avoided in patients with known prolongation of the QT interval, patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval. Syphilis in Pregnancy There have been reports suggesting that erythromycin does not reach the fetus in adequate concentration to prevent congenital syphilis. Infants born to women treated during pregnancy with oral erythromycin for e...",
  "adverse_reactions": "ADVERSE REACTIONS The most frequent side effects of oral erythromycin preparations are gastrointestinal and are dose-related. They include nausea, vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur (see WARNINGS section). Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS section). Erythromycin has been associated with QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes (see WARNINGS ). Allergic reactions ranging from urticaria to anaphylaxis have occurred. Skin reactions ranging from mild eruptions to erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely. There have been reports of interstitial nephritis coincident with erythromycin use. There have been rare reports of pancreatitis and convulsions. There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal insufficiency and in patients receiving high doses of erythromycin.",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Patients should be counseled that antibacterial drugs including Erythromycin Ethylsuccinate should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Erythromycin Ethylsuccinate is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Erythromycin Ethylsuccinate or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.",
  "spl_medguide": "Revised: January 2019 Wilshire Pharmaceuticals, Inc. Atlanta, GA 30328 EES-AGPI-03 (No. 6369)",
  "clinical_studies": "",
  "brand_name": "Erythromycin Ethylsuccinate",
  "manufacturer": "Wilshire Pharmaceuticals Inc.",
  "application_number": "NDA050207",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20190129",
  "set_id": "f4a3fffd-ce02-450f-bbcc-d425374e3e32",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 16359,
  "serious": 9541,
  "death": 1394,
  "hospitalization": 3990,
  "primary_suspect": 16260,
  "top_reactions": [
   [
    "Drug Hypersensitivity",
    4066
   ],
   [
    "Nausea",
    1147
   ],
   [
    "Off Label Use",
    1055
   ],
   [
    "Drug Ineffective",
    1034
   ],
   [
    "Diarrhoea",
    992
   ],
   [
    "Vomiting",
    980
   ],
   [
    "Fatigue",
    969
   ],
   [
    "Rash",
    889
   ],
   [
    "Dyspnoea",
    861
   ],
   [
    "Headache",
    751
   ],
   [
    "Chronic Kidney Disease",
    683
   ],
   [
    "Dizziness",
    664
   ],
   [
    "Hypersensitivity",
    646
   ],
   [
    "Pain",
    643
   ],
   [
    "Pneumonia",
    621
   ]
  ],
  "by_year": {
   "2019": 2063,
   "2020": 1521,
   "2021": 1454,
   "2022": 1195,
   "2023": 1339,
   "2024": 1368,
   "2025": 1189,
   "2026": 390
  },
  "by_year_primary": {
   "2019": 2063,
   "2020": 1519,
   "2021": 1441,
   "2022": 1167,
   "2023": 1323,
   "2024": 1340,
   "2025": 1185,
   "2026": 384
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260429",
   "reason": "CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit",
   "firm": "Zydus Pharmaceuticals (USA) Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260429",
   "reason": "CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit",
   "firm": "Zydus Pharmaceuticals (USA) Inc",
   "status": "Ongoing"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 137,
  "nda": 16,
  "anda": 90,
  "first_approval": "19640624",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 152,
  "labeling_recent": 1,
  "sponsors": [
   "ABBOTT",
   "ABON PHARMS LLC",
   "ABRAXIS PHARM",
   "ALEMBIC",
   "ALKEM LABS LTD",
   "ALPHARMA US PHARMS",
   "ALTANA",
   "AMNEAL PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/24/1964"
 },
 "trials": {
  "total": 1010,
  "completed": 627,
  "terminated": 126,
  "with_results": 196,
  "industry": 307,
  "phase3": 223,
  "results_share": 0.31259968102073366,
  "terminated_share": 0.12475247524752475
 },
 "pubmed": {
  "rct": 495,
  "meta": 23,
  "recent_rct": 8,
  "cochrane": [
   {
    "pmid": "36723439",
    "title": "Erythromycin prior to endoscopy for acute upper gastrointestinal haemorrhage",
    "year": "2023"
   },
   {
    "pmid": "18646077",
    "title": "Erythromycin for the prevention and treatment of feeding intolerance in preterm infants",
    "year": "2008"
   },
   {
    "pmid": "14583992",
    "title": "Erythromycin for the prevention of chronic lung disease in intubated preterm infants at risk for, or colonized or infected with Ureaplasma urealyticum",
    "year": "2003"
   },
   {
    "pmid": "11406010",
    "title": "Erythromycin for feeding intolerance in preterm infants",
    "year": "2001"
   },
   {
    "pmid": "10796273",
    "title": "Erythromycin for feeding intolerance in preterm infants",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "erythromycin",
   "E.E.S.",
   "Emcin Clear",
   "Emgel",
   "Ery",
   "Ery-Tab",
   "Erygel",
   "EryPed",
   "Erythrocin",
   "Erythrocin Stearate",
   "Eyemycin",
   "Theramycin"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 7362,
  "beneficiaries": 1883,
  "spend": 3767643.14,
  "by_brand": [
   {
    "brand": "Erythromycin Ethylsuccinate",
    "claims": 7161,
    "per_claim": 502.38889122,
    "is_generic": true
   },
   {
    "brand": "E.E.S. 400",
    "claims": 67,
    "per_claim": 224.71029851,
    "is_generic": false
   },
   {
    "brand": "Eryped 400",
    "claims": 53,
    "per_claim": 1562.0898113,
    "is_generic": false
   },
   {
    "brand": "E.E.S. 200",
    "claims": 44,
    "per_claim": 449.21636364,
    "is_generic": false
   },
   {
    "brand": "Erythrocin Lactobionate",
    "claims": 37,
    "per_claim": 1416.8762162,
    "is_generic": false
   }
  ],
  "per_claim": 511.7689676718283
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "erythromycin",
  "matched": "erythromycin",
  "stewardship": [
   "KeyAccessGroup",
   "WatchGroup"
  ]
 },
 "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": 63,
   "letter": "C",
   "why": [
    "495 randomized trials and 23 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "5 independent Cochrane review(s) exist",
    "Only 31% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 97,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 90 generic makers (-3)"
   ],
   "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 (90 applications)",
    "39 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 89,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are drug hypersensitivity, 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?",
  "Why this one over amikacin, ampicillin, azithromycin? 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.)"
 ]
}