Fidaxomicin
Antibiotics
Sold as Dificlir · DIFICID
- Drug class
- Antibiotics
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 4
Overview
Fidaxomicin is an active pharmaceutical ingredient in the Antibiotics group (A07AA). 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 | 2 | March 13, 2026 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
| EU European Union | EMA | 1 | September 30, 2024 |
GBUnited Kingdom· MHRA
2 products
Uses
FIDAXOMICIN granules for oral suspension is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. 1). Consideration should be given to official guidelines on the appropriate use of antibacterial agents.
How to take
CACanada· Health Canada
1 product
Uses
DIFICID® (fidaxomicin) is indicated in adults (≥18 years of age) for the treatment of Clostridium difficile infection (CDI). To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID® and other antibacterial drugs, DIFICID® should be used only to treat infections that are proven or strongly suspected to be caused by Clostridium difficile.
1 Pediatrics Pediatrics <18 years of age: The safety and efficacy of DIFICID® in patients below 18 years of age have not been established. No data are available. 2 Geriatrics Geriatrics ≥65 years of age: Greater systemic drug exposures were seen in elderly patients compared to those <65 years of age, but the magnitudes of increase were not considered to be clinically significant (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Geriatrics).
No dose adjustment is recommended for elderly patients.
EUEuropean Union· EMA
1 product
Uses
DIFICLIR film-coated tablets is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. 1). Consideration should be given to official guidelines on the appropriate use of antibacterial agents.
How to take
Drug interactions
Known interactions involving Fidaxomicin. Select one for details. This list is informational and not a complete interaction checker.
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) · PLGB366330016 · revised October 10, 2025
- [2]Health Canada (DPD) · 02387174 · revised March 22, 2025
- [3]European Medicines Agency · EMEA/H/C/002087 · revised September 30, 2024
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.