{ "query": "cefadroxil", "ingredient": "cefadroxil", "slug": "cefadroxil", "rxcui": "2177", "brands": [], "names": [ "cefadroxil", "cefadroxil anhydrous", "cefadroxil hemihydrate", "cefadroxil hydrate", "cefadroxil monohydrate" ], "classes": [ { "id": "J01DB", "name": "First-generation cephalosporins" } ], "alternatives": [ "cefatrizine", "cefazolin", "cephalexin", "cephaloridine", "cephalothin", "cephapirin", "cephradine" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 36 }, "boxed_warning": "", "indications_and_usage": "INDICATIONS AND USAGE Cefadroxil tablets are indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections caused by E. coli , P. mirabilis , and Klebsiella species. Skin and skin structure infections caused by staphylococci and/or streptococci. Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci). Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefadroxil for the prophylaxis of subsequent rheumatic fever are not available. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefadroxil tablets and other antibacterial drugs, cefadroxil tablets should be used only to treat or prevent infections that are proven or strongly suspected to be ...", "contraindications": "CONTRAINDICATIONS Cefadroxil tablets are contraindicated in patients with known allergy to the cephalosporin group of antibiotics.", "warnings_and_cautions": "", "warnings": "WARNINGS BEFORE THERAPY WITH CEFADROXIL IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFADROXIL, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-SENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFADROXIL OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefadroxil, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypert...", "adverse_reactions": "ADVERSE REACTIONS Gastrointestinal Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS ). Dyspepsia, nausea and vomiting have been reported rarely. Diarrhea has also occurred. Hypersensitivity Allergies (in the form of rash, urticaria, angioedema, and pruritus) have been observed. These reactions usually subsided upon discontinuation of the drug. Anaphylaxis has also been reported. Other Other reactions have included hepatic dysfunction including cholestasis and elevations in serum transaminase, genital pruritus, genital moniliasis, vaginitis, moderate transient neutropenia, fever. Agranulocytosis, thrombocytopenia, idiosyncratic hepatic failure, erythema multiforme, Stevens-Johnson syndrome, serum sickness, and arthralgia have been rarely reported. In addition to the adverse reactions listed above which have been observed in patients treated with cefadroxil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: Toxic epidermal necrolysis, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, prolonged prot...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "", "information_for_patients": "Information for Patients Patients should be counseled that antibacterial drugs including cefadroxil tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefadroxil tablets are 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 cefadroxil tablets 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": "", "clinical_studies": "", "brand_name": "Cefadroxil", "manufacturer": "Teva Pharmaceuticals USA, Inc.", "application_number": "ANDA062774", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20241230", "set_id": "4674a05c-fdef-4737-a4b8-e3229bdada9d", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 2061, "serious": 1608, "death": 120, "hospitalization": 617, "primary_suspect": 2054, "top_reactions": [ [ "Pain", 394 ], [ "Drug Hypersensitivity", 377 ], [ "Pneumonia", 331 ], [ "Vomiting", 311 ], [ "Dyspnoea", 307 ], [ "Asthma", 305 ], [ "Cough", 293 ], [ "Malaise", 290 ], [ "Oedema", 290 ], [ "Chest Pain", 279 ], [ "Nasal Oedema", 244 ], [ "Respiratory Tract Infection", 242 ], [ "Wheezing", 241 ], [ "Chronic Kidney Disease", 140 ], [ "Diarrhoea", 119 ] ], "by_year": { "2019": 205, "2020": 171, "2021": 191, "2022": 178, "2023": 171, "2024": 173, "2025": 232, "2026": 139 }, "by_year_primary": { "2019": 205, "2020": 171, "2021": 191, "2022": 177, "2023": 171, "2024": 173, "2025": 232, "2026": 133 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [], "recall_total": 0, "drugsfda": { "applications": 0, "nda": 0, "anda": 0, "first_approval": "", "rems": false, "rems_last": "", "labeling_supplements": 0, "labeling_recent": 0, "sponsors": [], "unapproved": false, "first_approval_fmt": "" }, "trials": { "total": 20, "completed": 14, "terminated": 1, "with_results": 7, "industry": 7, "phase3": 2, "results_share": 0.5, "terminated_share": 0.05 }, "pubmed": { "rct": 60, "meta": 0, "recent_rct": 0, "cochrane": [] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "cefadroxil" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 537342, "beneficiaries": 411136, "spend": 7257153.06, "by_brand": [ { "brand": "Cefadroxil", "claims": 537342, "per_claim": 13.505650145, "is_generic": true } ], "per_claim": 13.505650144600645 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": null, "name": "cefadroxil", "matched": "cefadroxil", "stewardship": [ "AccessGroup" ] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 538, "fills": 537342, "per_million": 1001.2245460060817, "ratio": 0.36159000163708144, "median": 2768.949753790441 }, "scores": { "safety": { "score": 100, "letter": "A", "why": [ "1,001 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 (0.6x)" ], "weight": 0.35 }, "evidence": { "score": 37, "letter": "F", "why": [ "60 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)" ], "weight": 0.25 }, "regulatory": { "score": 100, "letter": "A", "why": [ "No recalls on record since 2016" ], "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": 70, "letter": "C", "why": [ "No generic version approved: brand-only pricing (-30)", "7 same-class alternatives exist" ], "weight": 0.1 } }, "total": 81, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are pain, drug hypersensitivity, pneumonia, vomiting. How would we recognize and handle those?", "Why this one over cefatrizine, cefazolin, cephalexin? What would make you pick one of those instead?", "There is no generic. Is there an older generic in the same class that works as well for my situation?", "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.)" ] }