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Keflex (cefalexin)
Keflex (cefalexin) is a cephalosporin antibiotic developed by Shionogi Inc. in 1971. It targets the solute carrier family 15 member 2 and is effective against a range of bacterial infections, including urinary tract infections, skin infections, and bone infections. Keflex is a small molecule modality with a bioavailability of 90% and a half-life of 0.57 hours. It is currently owned by Shionogi Inc. and is used to treat various bacterial infections. Key safety considerations include its potential to cause allergic reactions and gastrointestinal side effects.
At a glance
| Generic name | cefalexin |
|---|---|
| Sponsor | Shionogi |
| Drug class | Cephalosporin Antibacterial |
| Target | Solute carrier family 15 member 2 |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1971 |
Approved indications
- Acute otitis media
- Bacterial urinary infection
- Escherichia coli urinary tract infection
- Haemophilus Influenzae Acute Otitis Media
- Infection due to Staphylococcus aureus
- Infection of bone
- Infection of skin AND/OR subcutaneous tissue
- Infectious disorder of joint
- Infective otitis media
- Klebsiella Prostatitis
- Klebsiella cystitis
- Moraxella Catarrhalis Acute Otitis Media
- Osteomyelitis due to Staphylococcus aureus
- Pneumonia due to Streptococcus
- Prostatitis
- Proteus Prostatitis
- Proteus urinary tract infection
- Staphylococcus Acute Otitis Media
- Streptococcal tonsillitis
- Streptococcus Osteomyelitis
Common side effects
- Diarrhea
- Rash
- Nausea
- Vomiting
- Urticaria
- Dyspepsia
- Gastritis
- Abdominal pain
- Genital pruritus
- Anal pruritus
- Genital moniliasis
- Vaginitis
Serious adverse events
- Pseudomembranous colitis
- Anaphylaxis
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis
- Erythema multiforme
- Angioedema
- Transient hepatitis
- Cholestatic jaundice
- Reversible interstitial nephritis
- Aplastic anemia
Drug interactions
- metformin
- warfarin
Key clinical trials
- The Effect of Losartan on Cephalexin (PHASE1)
- Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery (PHASE4)
- Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing (PHASE2)
- Microbiome and Association With Implant Infections (PHASE2)
- Effects of Treatments on Atopic Dermatitis (PHASE2)
- Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial (NA)
- Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis (PHASE4)
- A Clinical Trial of Extended (High) Treatment Dose Antibiotics in Combination With Methenamine Hippurate Compared to the Standard of Care (Either Prophylactic (Low) Dose Antibiotic Treatment or Methenamine Hippurate) in Females With Chronic Urinary Tract Infection (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Keflex CI brief — competitive landscape report
- Keflex updates RSS · CI watch RSS
- Shionogi portfolio CI