Fetroja Side Effects

Generic name: cefiderocol

Medically reviewed by Drugs.com. Last updated on Oct 16, 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.

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:

Less common side effects

• decreased urine
• dizziness
• drowsiness
• dry mouth
• fainting
• fast or irregular heartbeat
• increased thirst
• loss of appetite
• mood or mental changes
• muscle pain, cramps, or spasms
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• seizures
• trembling
• trouble breathing
• unusual tiredness or weakness

Incidence not known

• black, tarry stools
• bleeding gums
• blood in urine or stools
• change in taste
• cough
• diarrhea
• difficulty swallowing
• fever
• gaseous stomach pain
• hives, itching, or skin rash
• indigestion
• loss of taste
• nervousness
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• severe stomach cramps and pain
• stomach fullness or tenderness
• swelling or inflammation of the mouth
• tightness in the chest
• unusual bleeding or bruising
• watery and severe diarrhea, which may also be bloody
• weakness or heaviness of legs

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:

Less common side effects

• difficulty having a bowel movement (stool)
• headache
• redness, itching, swelling, or pain at the injection site
• white patches in the mouth or throat or on the tongue
• white patches with diaper rash

For healthcare professionals

Applies to cefiderocol: intravenous powder for injection.

Hepatic adverse events

• Very common (10% or more): Elevated liver tests (including increased ALT, increased AST, increased GGT, increased blood alkaline phosphatase, increased hepatic enzyme, increased liver function test, abnormal liver function test, increased transaminases, hypertransaminasemia; up to 16%)
• Common (1% to 10%): Increased ALT, increased GGT, increased AST, abnormal hepatic function (including increased liver function test, increased hepatic enzyme, increased transaminases, abnormal liver function test)
• Frequency not reported: Cholelithiasis, cholecystitis, gallbladder pain, cholestasis^[Ref]

Metabolic

• Very common (10% or more): Hypokalemia (including decreased blood potassium; up to 11%)
• Common (1% to 10%): Hypomagnesemia
• Frequency not reported: Decreased appetite, hypocalcemia, fluid overload, hyperkalemia^[Ref]

Gastrointestinal

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

Cardiovascular

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

Local

• Common (1% to 10%): Infusion site reactions (including infusion site erythema, inflammation, pain, pruritus, injection site pain, phlebitis, infusion site pain, injection site phlebitis)^[Ref]

Dermatologic

• Common (1% to 10%): Rash (including macular rash, maculopapular rash, erythema, skin irritation, erythematous rash, drug eruption)
• Frequency not reported: Pruritus

Beta-lactam antibacterial drugs:

• Frequency not reported: Serious skin reactions^[Ref]

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^[Ref]

Other

• Common (1% to 10%): Candidiasis (including oral candidiasis, vulvovaginal candidiasis, candiduria, candida infection)
• Frequency not reported: Pyrexia, peripheral edema, C difficile infection, increase in all-cause mortality, death^[Ref]

Respiratory

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

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity (including skin reactions, pruritus)
• Frequency not reported: Drug hypersensitivity

Beta-lactam antibacterial drugs:

• Frequency not reported: Serious and sometimes fatal hypersensitivity (anaphylactic) reactions^[Ref]

Hematologic

• Frequency not reported: Thrombocytosis, thrombocytopenia, prolonged prothrombin time (PT), prolonged PT-INR, prolonged activated partial thromboplastin time^[Ref]

Renal

• Frequency not reported: Acute interstitial nephritis

Psychiatric

• Frequency not reported: Insomnia, restlessness^[Ref]

Musculoskeletal

• Frequency not reported: Increased creatine phosphokinase^[Ref]

Genitourinary

• Frequency not reported: RBC urine positive^[Ref]

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