Cefiderocol: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: December 18, 2025🚩 Report this page

Cefiderocol

Other Cephalosporins and Penems

Sold as Fetcroja

EU EMA

Drug class: Other Cephalosporins and Penems
Availability: See label
Markets covered: 1
Products on record: 1

Overview

Cefiderocol is an active pharmaceutical ingredient in the Other Cephalosporins and Penems group (J01DI). 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
EU European Union	EMA	1	December 18, 2025

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised December 18, 2025[1]

1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

How to take

Drug interactions

Known interactions involving Cefiderocol. 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]European Medicines Agency · EMEA/H/C/004829 · revised December 18, 2025

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.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised December 18, 2025[1]

3%) and cough (2%). Tabulated list of adverse reactions The following adverse reactions have been reported with cefiderocol during clinical studies (Table 3). Adverse reactions are classified according to frequency and System Organ Class (SOC).
Frequency categories are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each System Organ Class, undesirable effects are presented in order of decreasing seriousness.
Table 3 Tabulated list of adverse reactions System organ class Common Uncommon Not known (≥1/100 to <1/10) (≥1/1,000 to <1/100) Infections and infestations Candidiasis including oral candidiasis, vulvovaginal candidiasis, candiduria and candida infection, Clostridioides difficile coli tis including pseudomembranous colitis and Clostridioides difficile infection Blood and lymphatic system disorders Neutropenia Immune System Disorders Hypersensitivity including skin reactions and Pruritus Respiratory, thoracic and Cough 7 mediastinal disorders Gastrointestinal disorders Diarrhoea, Nausea, Vomiting Skin and subcutaneous tissue disorders Rash including rash macular, rash maculo- papular, rash erythematous and drug eruption Renal and urinary disorders: Chromaturia General disorders and administration site conditions Infusion site reaction including infusion site pain, injection site pain, infusion site erythema and injection site phlebitis Investigations Alanine aminotransferase increased, Gamma- glutamyltransferase increased, Aspartate aminotransferase increased, Hepatic function abnormal including liver function test increased, hepatic enzyme increased, transaminases increased and liver function test abnormal, Blood creatinine increased Blood urea increased Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised December 18, 2025[1]

8). Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibacterial medicinal products may also be hypersensitive to cefiderocol. 3). If a severe allergic reaction occurs, treatment with Fetcroja must be discontinued immediately and adequate emergency measures must be initiated.
8). The condition can range in severity from mild diarrhoea to fatal colitis and should be considered in patients who present with diarrhoea during or subsequent to the administration of cefiderocol. Discontinuation of therapy with cefiderocol and the use of supportive measures together with the administration of specific treatment for Clostridioides difficile should be considered.
Medicinal products that inhibit peristalsis should not be given. Seizure Cephalosporins have been implicated in triggering seizures. Patients with known seizure disorders should continue anticonvulsant therapy. Patients who develop focal tremors, myoclonus, or seizures should be evaluated neurologically and placed on anticonvulsant therapy if not already instituted.
2). Alternatively, cefiderocol should be discontinued. Limitations of the clinical data In clinical trials, cefiderocol has only been used to treat patients with the following types of infection: complicated urinary tract infections (cUTI); hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), healthcare-associated pneumonia (HCAP); sepsis and patients with bacteraemia (some with no identified primary focus of infection).
The use of cefiderocol to treat patients with infections due to Gram-negative aerobic pathogens who have limited treatment options is based on pharmacokinetic-pharmacodynamic analyses for cefiderocol and on limited clinical data from a randomized clinical trial in which 80 patients were treated with cefiderocol and 38 patients were treated with best available therapy for infections caused by carbapenem-resistant organisms.
All-cause mortality in patients with infections due to carbapenem-resistant Gram-negative bacteria A higher all-cause mortality rate was observed in patients treated with cefiderocol as compared to best available therapy (BAT) in a randomised, open-label trial in critically-ill patients with infections known or suspected to be due to carbapenem-resistant Gram-negative bacteria.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

EUEuropean Union· EMA

Drug interactions

Drugs in the same class

Sources & citations