{
 "query": "cefuroxime",
 "ingredient": "cefuroxime",
 "slug": "cefuroxime",
 "rxcui": "2194",
 "brands": [],
 "names": [
  "cefuroxime",
  "cefuroxime axetil",
  "cefuroxime sodium"
 ],
 "classes": [
  {
   "id": "J01DC",
   "name": "Second-generation cephalosporins"
  },
  {
   "id": "S01AA",
   "name": "Antibiotics"
  }
 ],
 "alternatives": [
  "amikacin",
  "ampicillin",
  "azithromycin",
  "bacitracin",
  "cefaclor",
  "cefamandole",
  "cefmetazole",
  "cefonicid",
  "ceforanide",
  "cefotetan",
  "cefotiam",
  "cefoxitin",
  "cefprozil",
  "chloramphenicol",
  "chlortetracycline",
  "dibekacin",
  "dihydrostreptomycin",
  "erythromycin",
  "framycetin",
  "fusidic acid",
  "gentamicin",
  "kanamycin",
  "loracarbef",
  "micronomicin",
  "natamycin",
  "neomycin",
  "netilmicin",
  "oxytetracycline",
  "penicillin g",
  "polymyxin b",
  "rifamycin sv",
  "tetracycline",
  "tobramycin",
  "tyrothricin",
  "vancomycin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 31,
   "INTRAVENOUS": 6,
   "INTRAMUSCULAR": 3
  },
  "boxed_warning": "",
  "indications_and_usage": "Cefuroxime axetil tablet is a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: Pharyngitis/tonsillitis (adults and pediatric patients) ( 1.1 ) Acute bacterial otitis media (pediatric patients) ( 1.2 ) Acute bacterial maxillary sinusitis (adults and pediatric patients) ( 1.3 ) Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) ( 1.4 ) Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) ( 1.5 ) Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) ( 1.6 ) Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) ( 1.7 ) Early Lyme disease (adults and pediatric patients 13 years and older) ( 1.8 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil and other antibacterial drugs, cefuroxime axetil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.1 Pharyngitis/Tonsillitis Cefuroxime axetil tablets are indicated for the treatment of adult patients and...",
  "contraindications": "Cefuroxime axetil is contraindicated in patients with a known hypersensitivity (e.g., anaphylaxis) to cefuroxime axetil or to other \u03b2-lactam antibacterial drugs (e.g., penicillins and cephalosporins). Known hypersensitivity (e.g., anaphylaxis) to cefuroxime axetil or to other \u03b2-lactams (e.g., penicillins and cephalosporins).",
  "warnings_and_cautions": "Serious hypersensitivity (anaphylactic) reactions: In the event of a serious reaction, discontinue cefuroxime axetil and institute appropriate therapy. ( 5.1 ) Clostridium difficile -associated diarrhea (CDAD): If diarrhea occurs, evaluate patients for CDAD. ( 5.2 ) 5.1 Anaphylactic Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on \u03b2-lactam antibacterials. These reactions are more likely to occur in individuals with a history of \u03b2-lactam hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Cefuroxime axetil is contraindicated in patients with a known hypersensitivity to cefuroxime axetil or other \u03b2-lactam antibacterial drugs [see Contraindications ( 4 )] . Before initiating therapy with cefuroxime axetil, inquire about previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, discontinue cefuroxime axetil and institute appropriate therapy. 5.2 Clostridium difficile-associated Diarrh...",
  "warnings": "",
  "adverse_reactions": "The following serious and otherwise important adverse reaction is described in greater detail in the Warnings and Precautions section of the label: Anaphylactic Reactions [see Warnings and Precautions ( 5.1 )] The most common adverse reactions (\u22653%) for cefuroxime axetil tablets are diarrhea, nausea/vomiting, Jarisch-Herxheimer reaction and vaginitis (early Lyme disease). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) 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. Tablets Multiple-dose Dosing Regimens with 7 to 10 Days\u2019 Duration : In multiple-dose clinical trials, 912 subjects were treated with cefuroxime axetil (125 to 500 mg twice daily). It is noted that 125 mg twice daily is not an approved dosage. Twenty (2.2%) subjects discontinued medication due to adverse reactions. Seventeen (85%) of the 20 subjects who discontin...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage, Acute Bacterial 11/2016 Exacerbations of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis: Secondary Bacterial Infections of Acute Bronchitis (1.4)- Removed Dosage and Administration, Dosage for 11/2016 cefuroxime axetil tablets: Secondary Bacterial Infections of Acute Bronchitis (2.2)-Removed",
  "information_for_patients": "Allergic Reactions Inform patients that cefuroxime axetil is a cephalosporin that can cause allergic reactions in some individuals [see Warnings and Precautions ( 5.1 )] . Clostridium difficile -associated Diarrhea Inform patients that diarrhea is a common problem caused by antibacterials, and it usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibacterial. If this occurs, advise patients to contact their physician as soon as possible. Crushing Tablets Instruct patients to swallow the tablet whole, without crushing the tablet. Patients who cannot swallow the tablet whole should receive the oral suspension. Drug Resistance Inform patients that antibacterial drugs, including cefuroxime axetil, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefuroxime axetil is prescribed to treat a bacterial infection, inform patients that although it is common to feel better early in the course of therapy, the...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Acute Bacterial Maxillary Sinusitis One adequate and well-controlled trial was performed in subjects with acute bacterial maxillary sinusitis. In this trial, each subject had a maxillary sinus aspirate collected by sinus puncture before treatment was initiated for presumptive acute bacterial sinusitis. All subjects had radiographic and clinical evidence of acute maxillary sinusitis. In the trial, the clinical effectiveness of cefuroxime axetil in treating acute maxillary sinusitis was comparable to an oral antimicrobial agent containing a specific \u03b2-lactamase inhibitor. However, microbiology data demonstrated cefuroxime axetil to be effective in treating acute bacterial maxillary sinusitis due only to Streptococcus pneumoniae or non-\u03b2-lactamase\u2013producing Haemophilus influenzae. Insufficient numbers of \u03b2-lactamase\u2013producing Haemophilus influenzae and Moraxella catarrhalis isolates were obtained in this trial to adequately evaluate the effectiveness of cefuroxime axetil in treating acute bacterial maxillary sinusitis due to, these 2 organisms. This trial randomized 317 adult subjects, 132 subjects in the U.S and 185 subjects in South America. Table 12 shows the results of the in...",
  "brand_name": "Cefuroxime axetil",
  "manufacturer": "NuCare Pharmaceuticals,Inc.",
  "application_number": "ANDA065496",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240715",
  "set_id": "83476d51-be74-748b-e053-2a91aa0a3d36",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 16347,
  "serious": 13757,
  "death": 1533,
  "hospitalization": 6851,
  "primary_suspect": 16303,
  "top_reactions": [
   [
    "Dyspnoea",
    1065
   ],
   [
    "Diarrhoea",
    1006
   ],
   [
    "Drug Ineffective",
    998
   ],
   [
    "Off Label Use",
    992
   ],
   [
    "Pneumonia",
    882
   ],
   [
    "Fatigue",
    848
   ],
   [
    "Pyrexia",
    819
   ],
   [
    "Drug Hypersensitivity",
    790
   ],
   [
    "Headache",
    783
   ],
   [
    "Acute Kidney Injury",
    777
   ],
   [
    "Rash",
    774
   ],
   [
    "Chronic Kidney Disease",
    755
   ],
   [
    "Vomiting",
    751
   ],
   [
    "Nausea",
    720
   ],
   [
    "Dizziness",
    664
   ]
  ],
  "by_year": {
   "2019": 2113,
   "2020": 1782,
   "2021": 1385,
   "2022": 1267,
   "2023": 1027,
   "2024": 978,
   "2025": 952,
   "2026": 406
  },
  "by_year_primary": {
   "2019": 2110,
   "2020": 1780,
   "2021": 1384,
   "2022": 1265,
   "2023": 1019,
   "2024": 968,
   "2025": 943,
   "2026": 401
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 33,
  "nda": 5,
  "anda": 28,
  "first_approval": "19831019",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 90,
  "labeling_recent": 4,
  "sponsors": [
   "ACS DOBFAR",
   "ACS DOBFAR SPA",
   "ALKEM LABS LTD",
   "ANDA REPOSITORY",
   "ANI PHARMS",
   "APOTEX",
   "AUROBINDO PHARMA",
   "B BRAUN"
  ],
  "unapproved": false,
  "first_approval_fmt": "10/19/1983"
 },
 "trials": {
  "total": 114,
  "completed": 58,
  "terminated": 9,
  "with_results": 7,
  "industry": 13,
  "phase3": 9,
  "results_share": 0.1206896551724138,
  "terminated_share": 0.07894736842105263
 },
 "pubmed": {
  "rct": 287,
  "meta": 5,
  "recent_rct": 4,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "cefuroxime"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1149864,
  "beneficiaries": 920833,
  "spend": 17213463.130000003,
  "by_brand": [
   {
    "brand": "Cefuroxime",
    "claims": 1149804,
    "per_claim": 14.967964331,
    "is_generic": false
   },
   {
    "brand": "Cefuroxime Sodium",
    "claims": 60,
    "per_claim": 53.9645,
    "is_generic": true
   }
  ],
  "per_claim": 14.96999917381534
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "cefuroxime",
  "matched": "cefuroxime",
  "stewardship": [
   "KeyAccessGroup",
   "WatchGroup"
  ]
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2312,
  "fills": 1149864,
  "per_million": 2010.67256649482,
  "ratio": 0.7261498926596237,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "2,011 FDA reports naming it as the suspect drug per million Medicare fills, 0.7x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.0x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 45,
   "letter": "F",
   "why": [
    "287 randomized trials and 5 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 12% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 91,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "4 label changes approved since 2021 (-4)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "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 (28 applications)",
    "35 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 83,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, 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 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.)"
 ]
}