Cephalexin is a cephalosporin antibacterial indicated for the treatment of infections when caused by susceptible strains of the designated microorganisms. It is available as capsules, powder for oral suspension and tablets. MedsAcross supplies Cephalexin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Cephalexin tablets are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes Otitis media due to susceptible isolates of Streptococcu. pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella Catarrhalis.
Source: US FDA prescribing information
Cephalexin tablets are administered orally. Adults and Pediatric Patients at Least 15 Years of Age The usual dose is 250 mg every 6 hours but a dose of 500 mg every 12 hours may be administered. Treatment is administered for 7 to 14 days. For more severe infections larger doses of oral cephalexin may be needed, up to 4 grams in two to four equally divided doses. Pediatric Patients (over 1 year of age) The recommended total daily dose of oral cephalexin for pediatric patients is 25 to 50 mg/kg in equally divided doses for 7 to 14 days. In the treatment of β-hemolytic streptococcal infections, duration of at least 10 days is recommended. In severe infections, a total daily dose of 50 to 100 mg/kg may be administered in equally divided doses. In the treatment of otitis media, the recommended daily dose is 75 to 100 mg/kg/day in equally divided doses.
Source: US FDA prescribing information
CONTRAINDICATION Cephalexin tablets are contraindicated in patients with known allergy to cephalexin or other members of the cephalosporin class of antibacterial drugs.
Source: US FDA prescribing information
Hypersensitivity Reactions Allergic reactions in the form of rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been reported with the use of cephalexin tablets. Before therapy with cephalexin tablets are instituted, inquire whether the patient has a history of hypersensitivity reactions to cephalexin, cephalosporins, penicillins, or other drugs. Cross-hypersensitivity among beta-lactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to cephalexin tablets occurs, discontinue the drug and institute appropriate treatment.
Source: US FDA prescribing information
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequent adverse reaction was diarrhea. Nausea and vomiting, dyspepsia, gastritis, and abdominal pain have also occurred. As with penicillins and other cephalosporins, transient hepatitis and cholestatic jaundice have been reported. Other reactions have included hypersensitivity reactions, genital and anal pruritus, genital candidiasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder. Reversible interstitial nephritis has been reported.
Source: US FDA prescribing information
Metformin: Administration of cephalexin tablets with metformin results in increased plasma metformin concentrations and decreased renal clearance of metformin. Careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking cephalexin tablets and metformin. Probenecid: The renal excretion of cephalexin tablets is inhibited by probenecid. Co-administration of probenecid with cephalexin tablets is not recommended. Drug/laboratory Test Interactions: A false-positive reaction may occur when testing for the presence of glucose in the urine using Benedict's solution or Fehling's solutions.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
8 presentations of Cephalexin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Cephalexin 500 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Cephalexin 250 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Cephalexin 250 mg/5 mL powder for oral suspensionOralGeneric name | — | US FDA | Available on request |
| Cephalexin 125 mg/5 mL powder for oral suspensionOralGeneric name | — | US FDA | Available on request |
| Cephalexin 750 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Cephalexin 333 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Cephalexin 250 mg tabletOralGeneric name | — | US FDA | Available on request |
| Cephalexin 500 mg tabletOralGeneric name | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 4 January 1971 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Cephalexin in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 8 presentations of Cephalexin and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Cephalexin on 4 January 1971, according to Drugs@FDA.
No listed presentation of Cephalexin is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Cephalexin is classified under ATC code J01DB01 (Cephalexin).
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