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Cresemba Side Effects

Generic Name: isavuconazonium

Note: This document contains side effect information about isavuconazonium. Some of the dosage forms listed on this page may not apply to the brand name Cresemba.

In Summary

Common side effects of Cresemba include: dyspnea, increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase, and increased serum bilirubin. Other side effects include: hypotension. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to isavuconazonium: oral capsule

Other dosage forms:

Along with its needed effects, isavuconazonium (the active ingredient contained in Cresemba) 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 immediately if any of the following side effects occur while taking isavuconazonium:

More Common

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody urine
  • blurred vision
  • chest pain
  • confusion
  • convulsions
  • decreased frequency or amount of urine
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast or irregular heartbeat
  • loss of appetite
  • lower back or side pain
  • muscle pain or cramps
  • muscle spasms (tetany) or twitching
  • numbness or tingling in the hands, feet, or lips
  • seizures
  • severe nausea or vomiting
  • sweating
  • tightness in the chest
  • tingling of the hands or feet
  • trembling
  • trouble breathing
  • unusual tiredness or weakness

Less common or rare

  • Cough or hoarseness
  • dark urine
  • fever with or without chills
  • hives, itching, or rash
  • irritation
  • joint pain, stiffness, or swelling
  • light-colored stools
  • red, swollen skin
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain
  • unusual bleeding or bruising
  • upper right abdominal or stomach pain
  • yellow eyes and skin

Incidence Not Known

  • Blistering, peeling, or loosening of the skin
  • chills
  • diarrhea
  • red skin lesions, often with a purple center
  • red, irritated eyes

Some side effects of isavuconazonium 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:

More Common

  • Acid or sour stomach
  • anxiety
  • back pain
  • headache
  • heartburn or indigestion
  • seeing, hearing, or feeling things that are not there
  • stomach discomfort or upset
  • trouble sleeping
  • unusual excitement, nervousness, or restlessness

Less common or rare

  • Continuing ringing or buzzing or other unexplained noise in the ears
  • decreased vision
  • eye pain
  • feeling of constant movement of self or surroundings
  • hair loss or thinning of the hair
  • hearing loss
  • sensation of spinning

For Healthcare Professionals

Applies to isavuconazonium: intravenous powder for injection, oral capsule

General

The most common side effects were nausea, vomiting, diarrhea, headache, elevated liver chemistry tests, hypokalemia, constipation, dyspnea, cough, peripheral edema, and back pain. Serious side effects were reported in 55% of patients. Therapy was permanently discontinued due to side effects in 14% of patients; confusional state, acute renal failure, increased blood bilirubin, convulsion, dyspnea, epilepsy, respiratory failure, and vomiting led to permanent discontinuation most often.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 27.6%), vomiting (up to 25%), diarrhea (up to 23.7%), abdominal pain (16.7%), constipation (up to 14%)

Common (1% to 10%): Dyspepsia

Frequency not reported: Abdominal distension, gastritis, gingivitis, stomatitis

Metabolic

Very common (10% or more): Hypokalemia (up to 19.1%)

Common (1% to 10%): Decreased appetite, hypomagnesemia

Frequency not reported: Hypoalbuminemia, hypoglycemia, hyponatremia[Ref]

Hepatic

Elevated liver transaminases (ALT or AST) greater than 3 times the upper limit of normal (3 x ULN) and greater than 10 x ULN were reported in 4.4% and 1.2% of patients, respectively.[Ref]

Very common (10% or more): Elevated liver chemistry/laboratory tests (includes increased ALT, AST, blood alkaline phosphatase, blood bilirubin, GGT; up to 17.1%)

Common (1% to 10%): Elevated liver transaminases (ALT or AST)

Frequency not reported: Cholecystitis, cholelithiasis, hepatitis, hepatomegaly, hepatic failure, cholestasis[Ref]

Respiratory

Very common (10% or more): Dyspnea (up to 17.1%), cough (12%)

Common (1% to 10%): Acute respiratory failure

Frequency not reported: Bronchospasm, tachypnea[Ref]

Nervous system

Very common (10% or more): Headache (up to 17%)

Frequency not reported: Convulsion, epilepsy, dysgeusia, encephalopathy, hypoesthesia, migraine, peripheral neuropathy, paresthesia, somnolence, stupor, syncope, tremor, tinnitus, vertigo[Ref]

Other

Very common (10% or more): Peripheral edema (up to 15.2%), fatigue (10.5%)

Common (1% to 10%): Chest pain

Frequency not reported: Infusion-related reactions (including hypotension, dyspnea, chills, dizziness, paresthesia, hypoesthesia), catheter thrombosis, malaise, chills, fall[Ref]

Psychiatric

Very common (10% or more): Insomnia (10.5%)

Common (1% to 10%): Delirium (includes agitation, confusional state, delirium, disorientation, mental status changes), anxiety

Frequency not reported: Confusion, hallucination, depression[Ref]

Renal

Very common (10% or more): Renal failure (10.1%)

Frequency not reported: Acute renal failure[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 10.1%)

Frequency not reported: Myositis, bone pain, neck pain[Ref]

Cardiovascular

Common (1% to 10%): Hypotension

Frequency not reported: Atrial fibrillation, atrial flutter, bradycardia, reduced QT interval on ECG, palpitations, supraventricular extrasystoles, supraventricular tachycardia, ventricular extrasystoles, cardiac arrest, thrombophlebitis[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus

Frequency not reported: Alopecia, dermatitis, exfoliative dermatitis, erythema, petechiae, urticaria[Ref]

Local

Common (1% to 10%): Injection site reaction[Ref]

Hematologic

Frequency not reported: Agranulocytosis, leukopenia, pancytopenia[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity[Ref]

Genitourinary

Frequency not reported: Hematuria, proteinuria[Ref]

Ocular

Frequency not reported: Optic neuropathy[Ref]

References

1. "Product Information. Cresemba (isavuconazonium)." Astellas Pharma US, Inc, Deerfield, IL.

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.

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