cefiderocol
Fetcroja · ATC code J01D
- Key facts
- Active substance
- cefiderocol
- ATC code
- J01D
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Fetcroja 1 g powder for concentrate for solution for infusion
- Marketing authorisation holder
- Shionogi B.V.
- Information as of
- 2026-10-27
Key facts
Cefiderocol (Fetcroja) is a cephalosporin antibiotic given by intravenous infusion. It is used in adults with infections due to aerobic Gram-negative organisms who have limited treatment options.
What it is used for
- Infections due to aerobic Gram-negative organisms in adults with limited treatment options
- Official guidance on appropriate antibacterial use should be considered
Dosing
- Normal renal function: 2 g every 8 hours
- Augmented renal clearance (CrCL ≥ 120 mL/min): 2 g every 6 hours
- Mild renal impairment: 2 g every 8 hours; further adjusted doses for more severe impairment are in the full text
- Duration by infection site, e.g. 5 to 10 days for complicated urinary tract and intra-abdominal infections, 7 to 14 days for hospital-acquired pneumonia; up to 21 days may be required
- Combine with agents active against anaerobes and/or Gram-positive pathogens when these are involved
- Use only after consultation with a physician experienced in infectious diseases
Contraindications
- Hypersensitivity to the active substance, any excipient or any cephalosporin
- Severe hypersensitivity (e.g. anaphylaxis, severe skin reaction) to other beta-lactams such as penicillins, monobactams or carbapenems
Important warnings
- Hypersensitivity reactions; ask about prior beta-lactam reactions before starting, and stop immediately if a severe reaction occurs
- Clostridioides difficile-associated diarrhoea, ranging up to fatal colitis
- Seizures have been reported
Side effects
- Most common: diarrhoea (8.2%), vomiting (3.6%), nausea (3.3%), cough (2%)
- Candidiasis, Clostridioides difficile colitis
- Hypersensitivity including skin reactions and pruritus
Interactions
- No significant interactions anticipated with CYP substrates, inhibitors or inducers or with transporters
Pregnancy and breastfeeding
- Limited data; as a precaution, avoid use during pregnancy
- Unknown whether excreted in human milk; weigh 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.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
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)
- FetcrojaShionogi B.V. · EMEA/H/C/004829
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Fetcroja
- Liechtenstein
- Fetcroja
- Norway
- Fetcroja
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.
Related calculators
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Fetcroja – 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/fetcroja-epar-product-information_en.pdf
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.