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Cefiderocol Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 7, 2020.

For the Consumer

Applies to cefiderocol: intravenous solution reconstituted

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Feeling confused.
  • Seizures.
  • Trouble controlling body movements.
  • Extra muscle action.
  • Shakiness.
  • Redness or white patches in mouth or throat.
  • Diarrhea is common with antibiotics. Rarely, a severe form called C diff–associated diarrhea (CDAD) may happen. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen during or a few months after taking antibiotics. Call your doctor right away if you have stomach pain, cramps, or very loose, watery, or bloody stools. Check with your doctor before treating diarrhea.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Diarrhea.
  • Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to cefiderocol: intravenous powder for injection

Hepatic

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]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Fetroja (cefiderocol)." Shionogi USA Inc, Florham Park, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.