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Cephalexin

Cephalobene, Keflex, Ospexin · ATC code J01DB01

Also known as: Cefalexin, Sefaleksin · Brand names: Cephalobene, Keflex, Ospexin, Cefalexin Reiwa Healthcare, Cephalex-Ct, Cephalexin Ratiopharm, Bilfasin, Maksipor, Sef

Key facts
Active substance
Cephalexin
Drug class
Cephalosporin antibiotic
ATC code
J01DB01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Key facts

Cephalexin is an oral cephalosporin antibacterial used for respiratory, ear, skin, bone and genitourinary tract infections caused by susceptible bacteria.

What it is used for

  • Respiratory tract infections caused by susceptible Streptococcus pneumoniae and Streptococcus pyogenes
  • Otitis media
  • Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes
  • Bone infections
  • Genitourinary tract infections including acute prostatitis

Dosing

  • Adults and patients at least 15 years: usually 250 mg every 6 hours or 500 mg every 12 hours for 7 to 14 days
  • More severe infections: up to 4 grams daily in two to four divided doses
  • Children over 1 year: 25 to 50 mg/kg per day in divided doses; severe infections 50 to 100 mg/kg
  • Otitis media (children): 75 to 100 mg/kg per day in divided doses; β-hemolytic streptococcal infections at least 10 days
  • Renal impairment: creatinine clearance 30 to 59 mL/min max 1 g daily; lower clearance needs longer intervals (see full text)

Contraindications

  • Known hypersensitivity to cephalexin or other cephalosporins

Important warnings

  • Hypersensitivity reactions including anaphylaxis, Stevens-Johnson syndrome and toxic epidermal necrolysis; cross-hypersensitivity in penicillin allergy may occur
  • Clostridium difficile-associated diarrhea, even over two months after treatment
  • Seizure potential, particularly in renal impairment
  • Direct Coombs' test seroconversion, effect on prothrombin activity, drug-resistant bacteria

Side effects

  • Most frequent: diarrhea
  • Nausea, vomiting, dyspepsia, gastritis, abdominal pain
  • Transient hepatitis and cholestatic jaundice have been reported

Interactions

  • Metformin: increased metformin concentrations; monitoring and metformin dose adjustment recommended
  • Probenecid inhibits renal excretion; co-administration not recommended
  • False-positive urine glucose tests with Benedict's or Fehling's solution

Pregnancy and breastfeeding

  • Epidemiologic data on cephalosporins including cephalexin have not established drug-associated risks of major birth defects, miscarriage or adverse outcomes

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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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

  • CephalobeneTeva B.V · 1 register entry
  • KeflexArcana Arzneimittel Gmbh · 1 register entry
  • OspexinSandoz Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Cefalexin Reiwa HealthcareReiwa Healthcare S.L · 2 register entries
  • Cephalex-CtAbz-Pharma Gmbh · 1 register entry
  • Cephalexin RatiopharmRatiopharm Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • BilfasinBİLİM İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
  • MaksiporORBİS PHARMA İLAÇ VE KİMYA KOZMETİK MEDİKAL SAN. TİC. LTD. ŞTİ. · 5 register entries
  • SefEİP ECZACIBAŞI İLAÇ PAZARLAMA A.Ş · 7 register entries

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

Brand names in 18 more European countries
Belgium
Keforal
Bulgaria
Оспексин
Croatia
Cefaleksin Belupo, Cefalexin Alkaloid
Cyprus
Felexin, Keflex, Medolexin, Syntolexin
Denmark
Keflex
Finland
Kefalex, Kefexin
France
Keforal, Kéforal
Hungary
Cefalexin Reiwa Healthcare, Pyassan
Ireland
Keflex
Italy
Ceporex, Keforal
Luxembourg
Keforal
Malta
Keflex
Netherlands
Keforal
Norway
Keflex
Poland
Cefaleksyna Tzf
Romania
Cefalexina Atb, Cefalexină Arena, Keflex, Ospexin
Slovakia
Ospexin
Spain
Cefalexina Normon, Cefalexina Reiwa Healthcare, Kefloridina Forte

EMA – Article 57 product data (EU/EEA), 2026-10-28

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. Cephalexin (Ascend Laboratories, LLC) – Prescribing Information, 2026-06-17. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4fec8daf-6e09-4153-926f-64709dbdd26c
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. 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), 2026-10-28. 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 2026-10-27 · 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.