Cefadroxil
/api/v1/drug/cefadroxilMechanism of action
Sourced from openFDAMechanism-of-action class: Enzyme Inhibitors.
Indications
Sourced from openFDA- Cefadroxil is 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.ICD-10: N39.0
Contraindications
Sourced from openFDA- Cefadroxil is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.contraindicated
Dosage & administration
Sourced from openFDACefadroxil is acid-stable and may be administered orally without regard to meals. Administration with food may be helpful in diminishing potential gastrointestinal complaints occasionally associated with oral cephalosporin therapy. Adults Urinary Tract Infections: For uncomplicated lower urinary tract infections (i.e., cystitis) the usual dosage is 1 or 2 g per day in a single (q.d.) or divided doses (b.i.d.). For all other urinary tract infections the usual dosage is 2 g per day in divided doses (b.i.d.). Skin and Skin Structure Infections: For skin and skin structure infections the usual dosage is 1 g per day in single (q.d.) or divided doses (b.i.d.). Pharyngitis and Tonsillitis: Treatment of group A beta-hemolytic streptococcal pharyngitis and tonsillitis—1 g per day in single (q.d.) or divided doses (b.i.d.) for 10 days. Children For urinary tract infections, the recommended daily dosage for children is 30 mg/kg/day in divided doses every 12 hours. For pharyngitis, tonsillitis, and impetigo, the recommended daily dosage for children is 30 mg/kg/day in a single dose or in equally divided doses every 12 hours. For other skin and skin structure infections, the recommended daily dosage is 30 mg/kg/day in equally divided doses every 12 hours. In the treatment of beta-hemolytic streptococcal infections, a therapeutic dosage of cefadroxil should be administered for at least 10 days. Renal Impairment In patients with renal impairment, the dosage of cefadroxil should be adjusted according to creatinine clearance rates to prevent drug accumulation.
Warnings & precautions
Sourced from openFDABEFORE 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. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
Adverse reactions
Sourced from openFDAGastrointestinal 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 prothrombin time, positive Coombs’ test, increased BUN, increased creatinine, elevated alkaline phosphatase, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated bilirubin, elevated LDH, eosinophilia, pancytopenia, neutropenia.
Overdosage
Sourced from openFDAA study of children under six years of age suggested that ingestion of less than 250 mg/kg of cephalosporins is not associated with significant outcomes. No action is required other than general support and observation. For amounts greater than 250 mg/kg, induce gastric emptying. In five anuric patients, it was demonstrated that an average of 63% of a 1 g oral dose is extracted from the body during a 6 to 8 hour hemodialysis session.
Approval history
Sourced from openFDA- Apr 8, 1987ANDAANDA062774Teva Pharms
- Jan 20, 2006ANDAANDA065282Teva Pharms
- Jan 25, 2007ANDAANDA065352Aurobindo Pharma
- May 29, 2007ANDAANDA065392Lupin
- Feb 21, 2008ANDAANDA065396Lupin
- Apr 25, 2013ANDAANDA065349Aurobindo
FAERS reports
- 1Pain33618%
- 2Pneumonia26114%
- 3Drug Hypersensitivity26014%
- 4Dyspnoea25013%
- 5Vomiting24813%
- 6Asthma23412%
- 7Cough22112%
- 8Malaise22011%
- 9Chest Pain21811%
- 10Oedema1899.8%
- 11Nasal Oedema1799.3%
- 12Respiratory Tract Infection1749.1%
- 13Wheezing1708.9%
- 14Chronic Kidney Disease1296.7%
- 15Fatigue1226.4%
Literature
Recent PubMed references pinned to Cefadroxil as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Amoxicillin-induced Erythema Scarlatiniforme Desquamativum Recidivans with cross-reactivity to cefadroxil in a child: A case report and review of literature.British journal of clinical pharmacology · 2026 · Bouraoui H, Mansour K, Jemmeli N, et al.PMID 41689210DOI 10.1002/bcp.70495
- Chitosan coated yeast microcapsules for efficient delivery of cefadroxil for the treatment of inflammatory bowel disease.International journal of biological macromolecules · 2026 · Mohammed AISG, Hmingthansanga V, Das P, et al.PMID 41308768DOI 10.1016/j.ijbiomac.2025.149162
- Identification, synthesis, isolation, and characterization of formulation related degradation impurity of Cefadroxil Oral suspension.Journal of chromatography. B, Analytical technologies in the biomedical and life sciences · 2025 · Murkute SR, Vasantharaju SG, Singh GP, et al.PMID 40081217DOI 10.1016/j.jchromb.2025.124537
- Cefadroxil photodegradation processes sensitized by natural pigments: mechanistic aspects and impact on the antimicrobial function.Photochemical & photobiological sciences : Official journal of the European Photochemistry Association and the European Society for Photobiology · 2024 · Urquiza AS, Reynoso A, Biondi MA, et al.PMID 39331320DOI 10.1007/s43630-024-00633-3
- In Vitro In Vivo Extrapolation and Bioequivalence Prediction for Immediate-Release Capsules of Cefadroxil Based on a Physiologically-Based Pharmacokinetic ACAT Model.AAPS PharmSciTech · 2024 · Rahim N, Naqvi SBSPMID 38714602DOI 10.1208/s12249-024-02811-z
- Cefadroxil and cephalexin pharmacokinetics and pharmacodynamics in children with musculoskeletal infections.Antimicrobial agents and chemotherapy · 2024 · Haynes AS, Wei Z, Anderson P, et al.PMID 38597672DOI 10.1128/aac.00182-24
- Cefadroxil Use for Musculoskeletal Infections in an Academic Pediatric Hospital.Journal of the Pediatric Infectious Diseases Society · 2022 · Weslander E, Thomas H, Jeune R, et al.PMID 36112393DOI 10.1093/jpids/piac104
- A mechanism for matrikine regulation in acute inflammatory lung injury.JCI insight · 2021 · Robison SW, Li J, Viera L, et al.PMID 33830084DOI 10.1172/jci.insight.140750
Clinical trials
The 10 most recently updated of 20 ClinicalTrials.gov registrations naming Cefadroxil as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Optimizing the Diagnostic Approach to Cephalosporin Allergy TestingRecruiting · Phase 2 · Interventional · 300 enrolled · Massachusetts General HospitalNCT06406114updated 2026-05-26
- Extended Oral Antibiotic Prophylaxis in Diabetic Fracture PatientsRecruiting · Phase 4 · Interventional · 40 enrolled · Texas Tech University Health Sciences Center, El PasoNCT07561541updated 2026-05-08
- A Platform Trial for Gram Negative Bloodstream InfectionsRecruiting · Interventional · 2,500 enrolled · Sunnybrook Health Sciences CentreNCT06537609updated 2026-02-10
- Comparing Oral Versus Parenteral Antimicrobial TherapyTerminated · Phase 4 · Interventional · 94 enrolled · West Virginia UniversityNCT05977868updated 2025-08-26
- Antibiotic Prophylaxis in High-Risk Arthroplasty PatientsEnrolling by invitation · Phase 4 · Interventional · 4,618 enrolled · Mayo ClinicNCT04297592updated 2025-07-03
- BALANCE+ Vanguard PhaseCompleted · Interventional · 174 enrolled · Sunnybrook Health Sciences CentreNCT05893147updated 2024-10-01
- Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSACompleted · Phase 3 · Interventional · 199 enrolled · AbbVieNCT02814916updated 2024-09-19
- Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.Completed · Phase 1 · Interventional · 26 enrolled · Teva Pharmaceuticals USANCT00835081updated 2024-08-19
- Cefadroxil 500 mg Capsules Under Fasting ConditionsCompleted · Phase 1 · Interventional · 26 enrolled · Teva Pharmaceuticals USANCT00834275updated 2024-08-19
- Surgical Site Infection and Antibiotic Use StudyCompleted · Interventional · 235 enrolled · The Plastic Surgery FoundationNCT04631185updated 2024-05-29
Frequently asked questions
- How does Cefadroxil work?
- Mechanism-of-action class: Enzyme Inhibitors.
- What is Cefadroxil used for?
- According to FDA labeling, Cefadroxil carries indications including: Cefadroxil is 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Cefadroxil?
- Cefadroxil is classified as First-generation cephalosporins, Enzyme Inhibitors, Decreased Cell Wall Synthesis & Repair.
- What are the contraindications for Cefadroxil?
- Cefadroxil labeling lists contraindications including: Cefadroxil is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.. Always consult the full prescribing information and a clinician.
cefadroxil is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.