{
 "query": "gentamicin",
 "ingredient": "gentamicin",
 "slug": "gentamicin",
 "rxcui": "1596450",
 "brands": [
  "Gentak"
 ],
 "names": [
  "gentamicin",
  "gentamicin sulfate"
 ],
 "classes": [
  {
   "id": "S01AA",
   "name": "Antibiotics"
  },
  {
   "id": "S02AA",
   "name": "Antiinfectives"
  },
  {
   "id": "S03AA",
   "name": "Antiinfectives"
  }
 ],
 "alternatives": [
  "acetic acid",
  "aluminum acetotartrate",
  "amikacin",
  "ampicillin",
  "azithromycin",
  "bacitracin",
  "boric acid",
  "cefuroxime",
  "chloramphenicol",
  "chlorhexidine",
  "chlortetracycline",
  "ciprofloxacin",
  "clioquinol",
  "dibekacin",
  "dihydrostreptomycin",
  "erythromycin",
  "fosfomycin",
  "framycetin",
  "fusidic acid",
  "hexamidine",
  "hydrogen peroxide",
  "kanamycin",
  "miconazole",
  "micronomicin",
  "natamycin",
  "neomycin",
  "netilmicin",
  "nitrofurazone",
  "ofloxacin",
  "oxytetracycline",
  "penicillin g",
  "polymyxin b",
  "rifamycin sv",
  "tetracycline",
  "tobramycin",
  "tyrothricin",
  "vancomycin"
 ],
 "label": {
  "route_mode": "INTRAMUSCULAR",
  "route_counts": {
   "INTRAMUSCULAR": 18,
   "INTRAVENOUS": 18,
   "OPHTHALMIC": 16,
   "TOPICAL": 5
  },
  "boxed_warning": "WARNINGS Patients treated with aminoglycosides should be under close clinical observation because of the potential toxicity associated with their use. As with other aminoglycosides, Gentamicin Sulfate Injection, USP is potentially nephrotoxic. The risk of nephrotoxicity is greater in patients with impaired renal function and in those who receive high dosage or prolonged therapy. Neurotoxicity manifested by ototoxicity, both vestibular and auditory, can occur in patients treated with Gentamicin Sulfate Injection, USP, primarily in those with pre-existing renal damage and in patients with normal renal function treated with higher doses and/or for longer periods than recommended. Aminoglycoside-induced ototoxicity is usually irreversible. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions. Renal and eighth cranial nerve function should be closely monitored, especially in patients with known or suspected reduced renal function at onset of therapy and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy. Urine should be examined for decreased specific gravity, increased e...",
  "indications_and_usage": "INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of gentamicin and other antibacterial drugs, gentamicin 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. Gentamicin Sulfate Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa , Proteus species (indole-positive and indole-negative), Escherichia coli , Klebsiella-Enterobacter-Serratia species, Citrobacter species, and Staphylococcus species(coagulase-positive and coagulase-negative). Clinical studies have shown Gentamicin Sulfate Injection, USP to be effective in bacterial neonatal sepsis; bacterial septicemia; and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (in...",
  "contraindications": "CONTRAINDICATIONS Hypersensitivity to gentamicin is a contraindication to its use. A history of hypersensitivity or serious toxic reactions to other aminoglycosides may contraindicate use of gentamicin because of the known cross-sensitivity of patients to drugs in this class.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS (see WARNINGS box ). Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycoside antibiotics cross the placenta, and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Animal reproduction studies conducted on rats and rabbits did not reveal evidence of impaired fertility or harm to the fetus due to gentamicin sulfate. It is also not known whether gentamicin sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Serious side effects to mother, fetus, or newborn have not been reported in treatment of pregnant women with other aminoglycosides. If gentamicin is used during pregnancy or if the patient becomes pregnant while taking gentamicin, she should be apprised of the potential hazard to the fetus. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfit...",
  "adverse_reactions": "ADVERSE REACTIONS Nephrotoxicity: Adverse renal effects, as demonstrated by the presence of casts, cells or protein in the urine or by rising BUN, NPN, serum creatinine or oliguria, have been reported. They occur more frequently in patients with a history of renal impairment and in patients treated for longer periods or with larger dosages than recommended. Neurotoxicity: Serious adverse effects on both vestibular and auditory branches of the eighth nerve have been reported, primarily in patients with renal impairment (especially if dialysis is required) and in patients on high doses and/or prolonged therapy. Symptoms include dizziness, vertigo, tinnitus, roaring in the ears and also hearing loss, which, as with the other aminoglycosides, may be irreversible. Hearing loss is usually manifested initially by diminution of high-tone acuity. Other factors which may increase the risk of toxicity include excessive dosage, dehydration and previous exposure to other ototoxic drugs. Peripheral neuropathy or encephalopathy, including numbness, skin tingling, muscle twitching, convulsions, and a myasthenia gravis-like syndrome, have been reported. NOTE: The risk of toxic reactions is low in p...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Patients should be counseled that antibacterial drugs including gentamicin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When gentamicin 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 gentamicin or other antibacterial drugs in the future.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Gentamicin Sulfate",
  "manufacturer": "Medical Purchasing Solutions, LLC",
  "application_number": "ANDA062420",
  "pharm_class_epc": [],
  "route": [
   "INTRAMUSCULAR",
   "INTRAVENOUS"
  ],
  "effective_time": "20250515",
  "set_id": "3532bb39-a1a6-9d67-e063-6294a90abc0c",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 14022,
  "serious": 12753,
  "death": 2297,
  "hospitalization": 6667,
  "primary_suspect": 13973,
  "top_reactions": [
   [
    "Acute Kidney Injury",
    1687
   ],
   [
    "Drug Ineffective",
    1254
   ],
   [
    "Off Label Use",
    915
   ],
   [
    "Pyrexia",
    731
   ],
   [
    "Renal Failure",
    557
   ],
   [
    "Diarrhoea",
    522
   ],
   [
    "Chronic Kidney Disease",
    504
   ],
   [
    "Condition Aggravated",
    475
   ],
   [
    "Product Use In Unapproved Indication",
    451
   ],
   [
    "Rash",
    416
   ],
   [
    "Foetal Exposure During Pregnancy",
    410
   ],
   [
    "Pneumonia",
    407
   ],
   [
    "Maternal Exposure During Pregnancy",
    403
   ],
   [
    "Sepsis",
    389
   ],
   [
    "Fatigue",
    385
   ]
  ],
  "by_year": {
   "2019": 1565,
   "2020": 1636,
   "2021": 1306,
   "2022": 1258,
   "2023": 1157,
   "2024": 896,
   "2025": 755,
   "2026": 394
  },
  "by_year_primary": {
   "2019": 1563,
   "2020": 1630,
   "2021": 1304,
   "2022": 1244,
   "2023": 1154,
   "2024": 892,
   "2025": 749,
   "2026": 385
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250529",
   "reason": "Failed Stability Specifications:  Out of specification results for the Color Absorbance test during 12 Month sample analysis.",
   "firm": "Eugia US LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20141112",
   "reason": "Defective Container: Vials may be missing stoppers.",
   "firm": "Fresenius Kabi USA, LLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20130502",
   "reason": "Presence of Particulate Matter: visible particles were identified floating in the primary container.",
   "firm": "Hospira Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 60,
  "nda": 3,
  "anda": 42,
  "first_approval": "19660315",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 11,
  "labeling_recent": 0,
  "sponsors": [
   "ABBOTT",
   "ALCON PHARMS LTD",
   "ALLERGAN",
   "ALPHARMA US PHARMS",
   "B BRAUN",
   "BAUSCH AND LOMB INC",
   "BAXTER HLTHCARE",
   "BRISTOL"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/15/1966"
 },
 "trials": {
  "total": 294,
  "completed": 156,
  "terminated": 40,
  "with_results": 54,
  "industry": 39,
  "phase3": 63,
  "results_share": 0.34615384615384615,
  "terminated_share": 0.1360544217687075
 },
 "pubmed": {
  "rct": 490,
  "meta": 50,
  "recent_rct": 17,
  "cochrane": [
   {
    "pmid": "36847592",
    "title": "Intratympanic gentamicin for M\u00e9ni\u00e8re's disease",
    "year": "2023"
   },
   {
    "pmid": "27921299",
    "title": "One dose per day compared to multiple doses per day of gentamicin for treatment of suspected or proven sepsis in neonates",
    "year": "2016"
   },
   {
    "pmid": "22071818",
    "title": "One dose per day compared to multiple doses per day of gentamicin for treatment of suspected or proven sepsis in neonates",
    "year": "2011"
   },
   {
    "pmid": "21412917",
    "title": "Intratympanic gentamicin for M\u00e9ni\u00e8re's disease or syndrome",
    "year": "2011"
   },
   {
    "pmid": "16437518",
    "title": "One dose per day compared to multiple doses per day of gentamicin for treatment of suspected or proven sepsis in neonates",
    "year": "2006"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "gentamicin",
   "Gentak"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 403508,
  "beneficiaries": 259462,
  "spend": 12573190.33,
  "by_brand": [
   {
    "brand": "Gentamicin Sulfate",
    "claims": 403490,
    "per_claim": 31.159721877,
    "is_generic": true
   },
   {
    "brand": "Gentak",
    "claims": 18,
    "per_claim": 30.786111111,
    "is_generic": false
   }
  ],
  "per_claim": 31.15970521030562
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "gentamicin",
  "matched": "gentamicin",
  "stewardship": [
   "KeyAccessGroup",
   "AccessGroup"
  ]
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2026,
  "fills": 403508,
  "per_million": 5020.966127065634,
  "ratio": 1.8133106677693906,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 56,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "5,021 FDA reports naming it as the suspect drug per million Medicare fills, 1.8x the median drug on this site (-5)",
    "Death appears in 1.8x the share of reports seen across all of FAERS (-4)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 67,
   "letter": "C",
   "why": [
    "490 randomized trials and 50 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 35% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 99,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 42 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": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (42 applications)",
    "37 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "grade": "B",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are acute kidney injury, pyrexia. 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 acetic acid, aluminum acetotartrate, amikacin? 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.)"
 ]
}