Last reviewed · How we verify
Ceftaroline Fosamil (CEFTAROLINE)
Ceftaroline works by inhibiting bacterial cell wall synthesis through binding to penicillin-binding proteins.
Ceftaroline Fosamil, also known as ceftaroline, is a small molecule antibiotic developed by Abbvie. It is approved for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. Ceftaroline is a patented medication, with a single generic manufacturer. The safety considerations for ceftaroline include potential allergic reactions and increased risk of Clostridioides difficile infection. Ceftaroline was first approved by the FDA in 2012.
At a glance
| Generic name | CEFTAROLINE |
|---|---|
| Sponsor | Abbvie |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2012 |
Mechanism of action
Ceftaroline is a cephalosporin antibacterial drug [see Microbiology ( 12.4 )] .
Approved indications
- Acute bacterial skin and skin structure infections
- Community-acquired bacterial pneumonia
Common side effects
- Diarrhea
- Nausea
- Constipation
- Vomiting
- Increased transaminases
- Hypokalemia
- Rash
- Phlebitis
- Anemia
- Eosinophilia
- Neutropenia
- Thrombocytopenia
Key clinical trials
- Combination Antibiotic Therapy for Staphylococcus Aureus Bacteremia (PHASE4)
- Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT) (PHASE3)
- Pathogenicity Factors of Staphylococcus Pettenkoferi in Foot Wounds and Osteitis in Diabetic Patients
- Does Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes? (PHASE4)
- Pharmacokinetic and Pharmacodynamic Analysis of Ceftaroline in Children and Adolescents With Cystic Fibrosis (PHASE4)
- Comparing Oral Versus Parenteral Antimicrobial Therapy (PHASE4)
- Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (PHASE3)
- Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ceftaroline Fosamil CI brief — competitive landscape report
- Ceftaroline Fosamil updates RSS · CI watch RSS
- Abbvie portfolio CI