Fetroja Side Effects
Generic name: cefiderocol
Medically reviewed by Drugs.com. Last updated on Aug 3, 2024.
Note: This document provides detailed information about Fetroja.
Applies to cefiderocol: intravenous powder for solution 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:
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
- 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]
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. (2019) "Product Information. Fetroja (cefiderocol)." Shionogi USA Inc
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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.