Cephalexin
First-Generation Cephalosporins
Sold as KEFLEX · APO-CEPHALEX
- Drug class
- First-Generation Cephalosporins
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 78
- FDA reports (12 mo)
- 1,360
Overview
Plain-language summary, compiled from the cited regulatory records
Cephalexin is an antibacterial drug belonging to the first-generation cephalosporin class [1]. It is approved for treating infections caused by specific bacteria that are susceptible to its action [1]. These approved uses include respiratory tract infections, otitis media (middle ear infections), skin and skin structure infections, bone infections, and genitourinary tract infections [1].
Cephalexin is available under various brand names [1]. In the last 12 months, there have been 1360 adverse event reports associated with cephalexin [2]. The most frequently reported adverse events include headache, hypersensitivity reactions, and diarrhea, alongside reports of the drug being ineffective or used off-label [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 36 | May 29, 2026 |
| CA Canada | Health Canada | 27 | February 24, 2026 |
| US United States | FDA | 15 | April 3, 2026 |
GBUnited Kingdom· MHRA
36 products
Uses
Cefalexin is indicated in the treatment of the following infections:
Respiratory tract infections; bone and joint infections; genito urinary infections, including acute prostatitis and dental infections.
Cefalexin is active against the following organisms:
Beta-haemolytic streptococci; staphylococci, including coagulase-positive, coagulase-negative and penicillinase- producing strains; streptococcus pneumoniae; escherichia coli; proteus mirabilis; klebsiella species, haemophilus influenzae; branhamella catarrhalis.
Most strains of enterococci (streptococcus faecalis) and a few strains of staphylococci are resistant to cefalexin. Cefalexin is not active against most strains of enterobacter species, morganella morganii, pseudomonas or herellea species.
When tested by in vitro methods, staphylococci exhibit cross-resistance between cefalexin and methicillin-type antibiotics.
CACanada· Health Canada
27 products
Side effects & warnings
Of 12,917 patients treated with cephalexin in formal clinical trials, 771(6%) reported adverse events, of which 385 (3%) were judged to be drug related(8) . 6% reacted. The incidence of reported side effects is shown in Table 1. I. 2 Other adverse reactions experienced less frequently include: glossitis/stomatitis, oral moniliasis, pruritus ani, gastroenteritis, fever, pruritus, a positive direct Coombs', allergy/anaphylaxis, intertrigo, angioedema, dizziness, paresthesia, somnolence, visual hallucination/diplopia, insomnia, tremor, leucorrhea, dysuria, malaise/fatigue, super infection, myalgia/back pain, nuchal swelling, dyspnea, cardiac arrhythmia and vasodilatation.
3%) had abnormal laboratory values. There was no consistent pattern of abnormality and only 2 patients were withdrawn from studies as a result of these findings. 4 Biochemical Elev. Alk Phosphatase. 2 Elev. 3 Elev. 2 Renal Elev. 1 Other abnormal values reported less frequently included: elevated creatinine, bilirubin and cholesterol; decreased platelets, hemoglobin and/or hematocrit.
USUnited States· FDA
15 products
Uses
5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
1 Respiratory Tract Infections Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes . 2 Otitis Media Cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis.
3 Skin and Skin Structure Infections Cephalexin is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes.
4 Bone Infections Cephalexin is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis. 5 Genitourinary Tract Infections Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae.
Drug interactions
Known interactions involving Cephalexin. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 370. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL082150172 · revised May 29, 2026
- [2]Health Canada (DPD) · 00342084 · revised March 22, 2025
- [3]FDA DailyMed · 06c2fb2e-0539-4f… · revised April 3, 2026 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.