Fetroja Side Effects

Generic name: cefiderocol

Medically reviewed by Drugs.com. Last updated on Nov 29, 2024.

Note: This document provides detailed information about Fetroja Side Effects associated with cefiderocol. Some dosage forms listed on this page may not apply specifically to the brand name Fetroja.

Applies to cefiderocol: intravenous powder for solution.

Precautions

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis or certain skin reactions. These reactions can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Serious side effects of Fetroja

Along with its needed effects, cefiderocol (the active ingredient contained in Fetroja) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking cefiderocol:

Other side effects of Fetroja

Some side effects of cefiderocol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

See also:

For healthcare professionals

Applies to cefiderocol: intravenous powder for injection.

Cardiovascular adverse events

• Common (1% to 10%): Atrial fibrillation
• Frequency not reported: Congestive heart failure, bradycardia, myocardial infarction, atrial flutter^[Ref]

Dermatologic

• Common (1% to 10%): Rash
• Frequency not reported: Pruritus

Beta-lactam antibacterial drugs:

• Frequency not reported: Serious skin reactions

Rash included macular rash, maculopapular rash, erythema, skin irritation, erythematous rash, and drug eruption.

Gastrointestinal

• Common (1% to 10%): Diarrhea, vomiting, nausea, constipation, Clostridioides difficile colitis
• Frequency not reported: Abdominal pain, dry mouth, stomatitis, C difficile-associated diarrhea, oral candidiasis

C difficile colitis included pseudomembranous colitis and C difficile infection.

Genitourinary

• Frequency not reported: RBC urine positive
• Postmarketing reports: Chromaturia

Hematologic

• Frequency not reported: Thrombocytosis, thrombocytopenia, prolonged prothrombin time (PT), prolonged PT-INR, prolonged activated partial thromboplastin time
• Postmarketing reports: Neutropenia

Hepatic

• Very common (10% or more): Elevated liver tests (up to 16%)
• Common (1% to 10%): Increased ALT, increased GGT, increased AST, abnormal hepatic function
• Frequency not reported: Cholelithiasis, cholecystitis, gallbladder pain, cholestasis

Elevated liver tests included increased ALT, increased AST, increased GGT, increased blood alkaline phosphatase, increased hepatic enzyme, increased liver function test, abnormal liver function test, increased transaminases, and hypertransaminasemia.

Abnormal hepatic function included increased liver function test, increased hepatic enzyme, increased transaminases, and abnormal liver function test.

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity
• Frequency not reported: Drug hypersensitivity

Beta-lactam antibacterial drugs:

• Frequency not reported: Hypersensitivity reactions

Hypersensitivity included skin reactions and pruritus.

Serious and sometimes fatal hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterials.

Local

• Common (1% to 10%): Infusion site reactions

Infusion site reactions included infusion site erythema, inflammation, pain, pruritus, injection site pain, phlebitis, infusion site pain, and injection site phlebitis.

Metabolic

• Very common (10% or more): Hypokalemia (up to 11%)
• Common (1% to 10%): Hypomagnesemia
• Frequency not reported: Decreased appetite, hypocalcemia, fluid overload, hyperkalemia

Hypokalemia included decreased blood potassium.

Musculoskeletal

• Frequency not reported: Increased creatine phosphokinase

Nervous system

• Common (1% to 10%): Headache
• Frequency not reported: Dysgeusia, seizure

Cephalosporins:

• Frequency not reported: Seizures triggered, nonconvulsive status epilepticus, encephalopathy, coma, asterixis, neuromuscular excitability, myoclonia

Other

• Common (1% to 10%): Candidiasis
• Frequency not reported: Pyrexia, peripheral edema, C difficile infection, increase in all-cause mortality, death

Candidiasis included oral candidiasis, vulvovaginal candidiasis, candiduria, and candida infection.

Psychiatric

• Frequency not reported: Insomnia, restlessness

Renal

• Common (1% to 10%): Increased blood creatinine
• Uncommon (0.1% to 1%): Increased blood urea
• Frequency not reported: Acute interstitial nephritis

Respiratory

• Common (1% to 10%): Cough
• Frequency not reported: Dyspnea, pleural effusion

Further information

Fetroja side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer