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Cefadroxil

Biodroxil · ATC code J01DB05

Also known as: Sefadroksil

Key facts
Active substance
Cefadroxil
Drug class
Cephalosporin antibiotic
ATC code
J01DB05
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Cefadroxil is an oral first-generation cephalosporin antibiotic. Per the US prescribing information, it is used for urinary tract, skin and skin structure infections and streptococcal pharyngitis/tonsillitis caused by susceptible bacteria.

What it is used for

  • 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); efficacy for prophylaxis of rheumatic fever has not been established

Dosing

  • May be taken without regard to meals; food may reduce gastrointestinal complaints
  • Adults, uncomplicated lower urinary tract infection (cystitis): 1 or 2 g per day as a single dose or in two divided doses; other urinary tract infections: 2 g per day in two divided doses
  • Adults, skin and skin structure infections: 1 g per day; streptococcal pharyngitis/tonsillitis: 1 g per day for 10 days
  • Children: 30 mg/kg/day, given once daily or divided every 12 hours depending on the infection – see the full text for the weight table
  • Renal impairment (creatinine clearance up to 50 mL/min): initial dose 1000 mg, then 500 mg at intervals of 12 to 36 hours depending on creatinine clearance – see the full text

Contraindications

  • Known allergy to cephalosporin antibiotics

Important warnings

  • Hypersensitivity reactions, including anaphylaxis; ask about previous reactions to cephalosporins, penicillins or other drugs; cross-sensitivity may occur in up to 10% of patients with penicillin allergy
  • Clostridium difficile-associated diarrhea, ranging from mild diarrhea to fatal colitis
  • Use only for infections proven or strongly suspected to be caused by susceptible bacteria, to limit resistance

Side effects

  • Diarrhea; dyspepsia, nausea and vomiting have been reported rarely
  • Allergic reactions (rash, urticaria, angioedema, pruritus); anaphylaxis
  • Genital pruritus, genital moniliasis, vaginitis, transient neutropenia, fever, elevated transaminases
  • Rare: agranulocytosis, thrombocytopenia, hepatic failure, erythema multiforme, Stevens-Johnson syndrome, serum sickness

Pregnancy and breastfeeding

  • Animal studies showed no harm to the fetus, but there are no adequate and well-controlled studies in pregnant women; use only if clearly needed
  • Caution when given to a nursing mother

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • BiodroxilSandoz Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Cefadroxil1 A Pharma Gmbh · 2 register entries
  • GrüncefInfectopharm Arzneimittel Und Consilium Gmbh, De, Heppenheim · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • CefradurAVİXA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 13 more European countries
Belgium
Cefadroxil Sandoz
Bulgaria
Валдиоцеф, Дурацеф
Czechia
Biodroxil, Duracef
Estonia
Cefadroxil Auxilia, Duracef
France
Cefadroxil Biogaran, Cefadroxil Viatris Generiques
Latvia
Biodroxil, Duracef
Lithuania
Biodroxil, Duracef
Poland
Duracef, Valdocef
Romania
Ceforan
Slovakia
Cedrox
Slovenia
Valdiocef
Spain
Cefadroxilo Desgen, Duracef
Sweden
Cefadroxil Sandoz, Cefadroxil Viatris, Cefamox

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Cefadroxil (NorthStar Rx LLC) – Prescribing Information, 2024-02-09. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=30bb3686-87b4-4676-9ff5-e20deb8bff9d
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC J01DB.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.