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fidaxomicin

Dificlir · ATC code A07AA12

Key facts
Active substance
fidaxomicin
Drug class
Antidiarrhoeal
ATC code
A07AA12
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
DIFICLIR 200 mg film-coated tablets · DIFICLIR 40 mg/ml granules for oral suspension
Marketing authorisation holder
Tillotts Pharma GmbH
Information as of
2026-10-27

Key facts

Fidaxomicin is a macrocyclic antibacterial used to treat Clostridioides difficile infections in adults and children.

What it is used for

  • Film-coated tablets: C. difficile infections in adults and paediatric patients weighing at least 12.5 kg
  • Granules for oral suspension: adults and paediatric patients from birth to < 18 years
  • Official guidelines on appropriate use of antibacterial agents should be considered

Dosing

  • Adults, standard: 200 mg twice daily (every 12 hours) for 10 days
  • Adults, extended-pulsed: 200 mg twice daily on days 1-5, then once daily on alternate days for days 7-25
  • Children at least 12.5 kg: 200 mg twice daily for 10 days; below that, weight-based oral suspension doses
  • No dose adjustment for elderly, renal or hepatic impairment
  • Granules may also be used by adults with difficulty swallowing tablets

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Hypersensitivity reactions including severe angioedema; caution with known macrolide allergy
  • Caution in severe renal impairment and moderate to severe hepatic impairment
  • Limited data in pseudomembranous colitis and fulminant or life-threatening CDI
  • Potent P-glycoprotein inhibitors are not recommended
  • Caution in patients below 6 months of age

Side effects

  • Most common: vomiting, nausea and constipation
  • Hypersensitivity reactions including angioedema have been reported

Interactions

  • Potent P-gp inhibitors (e.g. cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone, amiodarone) increase exposure; not recommended
  • Fidaxomicin may be a mild to moderate inhibitor of intestinal P-gp

Pregnancy and breastfeeding

  • No data in pregnant women; as a precaution, use is preferably avoided
  • Breast-feeding: decision weighing breast-feeding against therapy

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • DificlirTillotts Pharma GmbH · EMEA/H/C/002087

Source: European Medicines Agency (EMA), product information

Turkey

  • DificlirEİP ECZACIBAŞI İLAÇ PAZARLAMA A.Ş · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 8 more European countries
France
Fidaxomicine Sun
Iceland
Dificlir
Liechtenstein
Dificlir
Norway
Dificlir
Poland
Fidaxomicin Ranbaxy
Romania
Fidaxomicin Terapia
Spain
Fidaxomicina Sun
Sweden
Fidaxomicin Sun

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

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Sources

  1. European Medicines Agency. Dificlir – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/dificlir-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC A07AA.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.