Cefiderocol Injection
Cefiderocol Injection (Fetroja) is an intravenous cephalosporin antibiotic for adults with complicated urinary tract infections, including pyelonephritis (kidney infection), and hospital-acquired or ventilator-associated bacterial pneumonia caused by susceptible Gram-negative bacteria.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Fetroja (cefiderocol) is an IV cephalosporin antibiotic, on the market since about 2019, that slips into bacteria through their iron-uptake channels. Hospitals use it for adults with complicated urinary tract infections, including pyelonephritis (kidney infection), and hospital-acquired or ventilator-associated pneumonia, usually reserving it for germs that resist other antibiotics. It is generally well tolerated, with diarrhea, irritation at the IV site, nausea and rash the usual complaints. Report breathing trouble, swelling, seizures, muscle jerking or ongoing diarrhea right away, and speak up if you feel worse, because one trial in critically ill patients with resistant infections saw more deaths with Fetroja, which is why the team watches you closely.
Clinical pearls
- Your dose is set by kidney function and dialysis, and an unadjusted dose with weak kidneys raises the risk of seizures.
- It can make urine dipstick tests falsely show protein, ketones or blood, so a positive result should be confirmed another way.
- Diarrhea can signal C. difficile, a serious gut infection, even months after the last dose, so report it whenever it starts.
- If a penicillin or cephalosporin ever caused a reaction, describe it exactly, since a severe one to that family rules Fetroja out.
Patient information guide A plain-language walkthrough of Cefiderocol Injection, written from its FDA label.
What Cefiderocol Injection is used for
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Cefiderocol Injection is an antibiotic for adults with certain serious Gram-negative bacterial infections.
- Fetroja is used for complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible E. coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa and Enterobacter cloacae complex.
- Fetroja is used for hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible Acinetobacter baumannii complex, E. coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa and Serratia marcescens.
- Fetroja should be used only for infections proven or strongly suspected to be bacterial.
How Cefiderocol Injection works
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Cefiderocol is a cephalosporin antibacterial drug that fights Gram-negative bacteria. It works best when the free drug level in your blood stays above the level needed to stop the bacteria for more of the time between doses.
A 3-hour infusion keeps levels above that mark longer than a 1-hour infusion. Animal pneumonia studies showed greater antibacterial activity with the 3-hour infusion.
Cefiderocol Injection dosage
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Fetroja is given through a vein (IV) by a healthcare team. The usual schedule is every 8 hours, with each dose infused over 3 hours. Some people need a different dose or schedule based on kidney function, dialysis or continuous renal replacement therapy.
- Treatment generally lasts 7 to 14 days.
- If you are on intermittent hemodialysis, dosing starts right after dialysis.
- The powder is mixed with sodium chloride or dextrose solution and then diluted in an infusion bag.
Dosing details from the FDA-approved label
From the Cefiderocol Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults with CLcr 60 to 119 mL/min
- 2 grams every 8 hours by intravenous (IV) infusion over 3 hours
- Recommended duration of treatment is 7 to 14 days, guided by the patient's clinical status
- CLcr 30 to 59 mL/min
- 1.5 grams every 8 hours, infusion time 3 hours
- Estimated by Cockcroft-Gault equation; for fluctuating renal function, monitor CLcr and adjust dosage accordingly
- CLcr 15 to 29 mL/min
- 1 gram every 8 hours, infusion time 3 hours
- Estimated by Cockcroft-Gault equation; for fluctuating renal function, monitor CLcr and adjust dosage accordingly
- CLcr less than 15 mL/min, with or without intermittent HD
- 0.75 grams every 12 hours, infusion time 3 hours
- Cefiderocol is removed by HD; for intermittent HD, start dosing immediately after completion of HD
- CRRT with effluent flow rate 2 L/hr or less
- 1.5 grams every 12 hours
- Initial dosing; may need to be tailored based on residual renal function and clinical status
- CRRT with effluent flow rate 2.1 to 3 L/hr
- 2 grams every 12 hours
- Initial dosing; may need to be tailored based on residual renal function and clinical status
- CRRT with effluent flow rate 3.1 to 4 L/hr
- 1.5 grams every 8 hours
- Initial dosing; may need to be tailored based on residual renal function and clinical status
- CRRT with effluent flow rate 4.1 L/hr or greater
- 2 grams every 8 hours
- Initial dosing; may need to be tailored based on residual renal function and clinical status
- CLcr 120 mL/min or greater
- 2 grams every 6 hours by IV infusion over 3 hours
- Dosage adjustment for CLcr greater than or equal to 120 mL/min
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Administer 2 grams of FETROJA for injection every 8 hours by intravenous (IV) infusion over 3 hours in patients with creatinine clearance (CLcr) 60 to 119 mL/min. ( 2.1 ) Dose adjustments are required for patients with CLcr less than 60 mL/min, (including patients receiving intermittent hemodialysis (HD) or continuous renal replacement therapy (CRRT)), and for patients with CLcr 120 mL/min or greater. ( 2.2 ) See full prescribing information for instructions on preparation of FETROJA doses. ( 2.3 ) See full prescribing information for drug compatibilities. ( 2.4 ) 2.1 Recommended Dosage The recommended dosage of FETROJA is 2 grams administered every 8 hours by intravenous (IV) infusion over 3 hours in adults with a creatinine clearance (CLcr) of 60 to 119 mL/min. Dosage adjustment of FETROJA is recommended for patients with CLcr less than 60 mL/min, including patients receiving intermittent hemodialysis (HD) or continuous renal replacement therapy (CRRT), and for patients with CLcr 120 mL/min or greater [see Dosage and Administration (2.2) ]. The recommended duration of treatment with FETROJA is 7 to 14 days. The duration of therapy should be guided by the patient's clinical status. 2.2 Dosage Adjustments in Patients with CLcr Less Than 60 mL/min (Including Patients Undergoing Intermittent HD or CRRT), and CLcr 120 mL/min or Greater Dosage Adjustments in Patients with CLcr Less Than 60 mL/min Including Patients Receiving Intermittent HD Dosage adjustment of FETROJA is recommended in patients with CLcr less than 60 mL/min (Table 1). For patients undergoing intermittent HD, start the dosing of FETROJA immediately after the completion of HD. For patients with fluctuating renal function, monitor CLcr and adjust dosage accordingly. Table 1 Recommended Dosage of FETROJA for Patients with CLcr Less Than 60 mL/min Including Patients Receiving Intermittent HD Estimated Creatinine Clearance (CLcr) CLcr = creatinine clearance estimated by Cockcroft-Gault equation. Dose Frequency Infusion Time HD = hemodialysis. CLcr 30 to 59 mL/min 1.5 grams Every 8 hours 3 hours CLcr 15 to 29 mL/min 1 gram Every 8 hours 3 hours CLcr less than 15 mL/min, with or without intermittent HD Cefiderocol is removed by HD; administer FETROJA immediately after HD for patients receiving intermittent HD.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Cefiderocol Injection side effects
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Most side effects are mild to moderate and vary by the type of infection treated.
Common side effects
- Diarrhea
- Infusion site reactions (redness, pain, itching, inflammation)
- Constipation
- Rash
- Nausea and vomiting
- Headache
- Low potassium (hypokalemia)
- Elevated liver tests
- Candidiasis (yeast infection)
- Cough
- Low potassium or magnesium
- Atrial fibrillation (irregular heartbeat), seen in pneumonia patients
When to get medical help
- Call your doctor or get emergency help right away for signs of a serious allergic reaction, such as trouble breathing, swelling or a severe skin reaction.
- Tell your care team if you have diarrhea during or after treatment. It can be a sign of C. difficile infection, which can happen even more than 2 months later.
- Report seizures, focal tremors or muscle jerking (myoclonus) right away.
- Tell your team if you feel your infection is getting worse, since more deaths were seen with this drug in one trial of critically ill patients with carbapenem-resistant infections.
Cefiderocol Injection warnings and precautions
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- Higher all-cause mortality was seen in one trial of critically ill patients with carbapenem-resistant infections. Response to treatment should be closely monitored.
- Serious allergic reactions, sometimes fatal, can occur, especially with a history of beta-lactam or penicillin allergy. Treatment stops if an allergic reaction occurs.
- C. difficile-associated diarrhea can range from mild diarrhea to fatal colitis and can appear months after antibiotics.
- Seizures and nervous system effects are more likely with a history of epilepsy or when the dose is too high for kidney function.
- Drug-resistant bacteria can develop if antibiotics are used without a bacterial infection.
Cefiderocol Injection interactions
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The label lists few interaction concerns.
- Urine dipstick tests for protein, ketones or blood may be falsely positive, so results should be confirmed another way.
- No meaningful changes were seen with furosemide, metformin or rosuvastatin.
- Only sodium chloride and dextrose solutions are listed as compatible for the infusion.
Interactions listed in the FDA-approved label
From the Cefiderocol Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Dipstick tests (urine protein, ketones, or occult blood): Cefiderocol may result in false-positive results in dipstick tests (urine protein, ketones, or occult blood). Use alternate clinical laboratory methods of testing to confirm positive tests.
Read the label’s full interactions text
7 DRUG INTERACTIONS Use alternate testing methods to confirm positive results of dipstick tests (urine protein, ketones, or occult blood). ( 7.1 ) 7.1 Drug/Laboratory Test Interactions Cefiderocol may result in false-positive results in dipstick tests (urine protein, ketones, or occult blood). Use alternate clinical laboratory methods of testing to confirm positive tests.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Cefiderocol Injection
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- Do not use with a known severe allergy to cefiderocol, other beta-lactam antibiotics or any ingredient.
- Tell your team about prior reactions to penicillins or cephalosporins.
- Tell your team about seizure disorders.
- Kidney function determines the dose and should be checked regularly. Higher-than-normal kidney clearance also needs dose adjustment.
- Pregnancy: no human data. Animal studies showed no harm.
- Breastfeeding: it is not known if it passes into human milk. Discuss the benefits and risks with your doctor.
- Not established for people under 18.
- Older adults: dose by kidney function, not age.
- Liver problems: no dose change is needed.
Cefiderocol Injection overdose
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There is no information on the signs of a Fetroja overdose. If someone gets more than the recommended dose and has unexpected reactions, they should be watched closely and given supportive care. Stopping or pausing treatment may be considered. About 60% of cefiderocol is removed by a 3- to 4-hour hemodialysis session.
What Cefiderocol Injection does in the body
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Cefiderocol's antibacterial effect correlates with how long free drug levels stay above the minimum amount needed to stop the bacteria. In animal studies, a 3-hour infusion did this better than a 1-hour infusion. At 1 and 2 times the maximum recommended dose, it does not prolong the QT interval (a heart rhythm measure) to any clinically relevant degree.
How your body processes Cefiderocol Injection
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Cefiderocol levels rise in proportion to the dose. It is only 40% to 60% bound to proteins and its half-life is 2 to 3 hours. It is minimally metabolized and is cleared mainly by the kidneys, with about 90.6% leaving unchanged in urine.
Reduced kidney function raises drug levels, while very high kidney clearance lowers them. Hemodialysis removes about 60% of it.
How to store Cefiderocol Injection
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stored refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light. Store in the carton until time of use.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Cefiderocol Injection
27 supplements and herbal products have documented interactions with Cefiderocol Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 26
- Minor · 1
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Cefiderocol Injection has been associated with lower levels of 7 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 6
- Moderate · 1
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Cefiderocol Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Cefiderocol Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is Fetroja used for?
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How will I get it, and for how long?
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What side effects should I expect?
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When should I speak up right away?
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I'm allergic to penicillin. Can I still get it?
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Is it safe in pregnancy or while breastfeeding?
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Is Cefiderocol Injection available over the counter?
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When was Cefiderocol Injection first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Cefiderocol Injection on HelloPharmacist
Cefiderocol Injection forms and strengths (how it comes)
Cefiderocol Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Cefiderocol Injection inactive ingredients by manufacturer.
Injection
How this form is used
- Fetroja is used in adults for complicated urinary tract infections, including pyelonephritis.
- Fetroja is used in adults for hospital-acquired and ventilator-associated bacterial pneumonia.
- Fetroja is supplied as a sterile powder that is mixed and diluted before IV infusion.
- Fetroja is given as an infusion over 3 hours, with dose and timing adjusted for kidney function.
- Fetroja treatment generally lasts 7 to 14 days, guided by clinical status.
Cefiderocol Injection on the U.S. market: products, makers and brands
How Cefiderocol Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Cefiderocol Injection product record with the FDA, mostly as injection; the earliest marketing or approval year on record is 2019. Brand names on the directory include Fetroja; the rest are generics.
How widely Cefiderocol Injection is used (Medicaid data)
A general measure of how commonly Cefiderocol Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Cefiderocol Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Cefiderocol Injection prescribed? Of the 1,601 medications we measure, Cefiderocol Injection ranks #1,268 by Medicaid prescriptions — more than 21% of them.
Utilization by Cefiderocol Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
cefiderocol 1000 MG Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2265706
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Cefiderocol Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Cefiderocol Injection NDCs with Medicaid activity.
Compare Cefiderocol Injection products
A representative set of FDA-listed product records for Cefiderocol Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 1 g/10 mL | Intravenous | Shionogi Inc. | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Cefiderocol Injection NDCs →
Cefiderocol Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Cefiderocol Injection — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Cefiderocol Injection are death, drug resistance, treatment failure; about 90% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Cefiderocol Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Cefiderocol Injection FDA approval history
How Cefiderocol Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Cefiderocol Injection was first approved by the FDA in 2019 (Brand: FETROJA · Shionogi). It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Cefiderocol Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Cefiderocol recalls since July 2021.
✅No Cefiderocol recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2265702 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 2265705In current FDA listingsClinical drug / strength (SCD) 1000 MGRxCUI 2265706
Look up RxCUI 2265702 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Cefiderocol Injection supply and shortage status
Whether Cefiderocol Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Cefiderocol Injection brand names
Cefiderocol Injection is sold under one brand name in the FDA directory — Fetroja. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Cefiderocol Injection: manufacturers and labelers
One company lists Cefiderocol Injection products with the FDA. By number of product records, the largest are Shionogi Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Cefiderocol Injection drug class (RxNorm)
Cefiderocol Injection belongs to the Cephalosporin Antibacterial class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Cefiderocol Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Shionogi Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →