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
Cephalexin is an active pharmaceutical ingredient in the First-Generation Cephalosporins group (J01DB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
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 a semisynthetic cephalosporin antibiotic for oral administration. Cefalexin is indicated in the treatment of the following infections due to susceptible micro organisms: Respiratory tract infections Otitis media Skin and soft tissue infections Bone and joint infections Genito urinary tract infections, including acute prostatitis Dental infections
How to take
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 There was no consistent pattern of abnormality and only 2 patients were withdrawn from studies as a result of these findings. 4 Biochemical Elev.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 capsules and other antibacterial drugs, cephalexin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
1 Respiratory Tract Infections Cephalexin capsules are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. 2 Otitis Media Cephalexin capsules are 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 capsules are 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 .
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) · PL136210022 · revised April 10, 2026
- [2]Health Canada (DPD) · 00342084 · revised March 22, 2025
- [3]FDA DailyMed · 02b5cd6f-3df8-43… · revised February 11, 2025 [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.