Isavuconazonium Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 10, 2024.

Applies to isavuconazonium: oral capsule.

Other dosage forms:

• intravenous powder for solution

Precautions

It is important that your doctor check your progress after treatment. This is to make sure that the infection is cleared up completely, and to allow your doctor to check for any unwanted effects. Blood tests may be needed to check for unwanted effects.

If your symptoms do not improve, or if they become worse, check with your doctor. You may need to take this medicine for several weeks or months before your infection gets better.

Do not use this medicine together with carbamazepine (Tegretol®), ketoconazole (Nizoral®), phenobarbital (Luminal®), rifampin (Rifadin®, Rimactane®), ritonavir (Norvir®), or St. John's wort. Using these medicines together may cause unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 28 days after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious allergic reactions, including anaphylaxis, which 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.

Serious skin reactions (eg, Stevens-Johnson syndrome) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of isavuconazonium

Along with its needed effects, isavuconazonium 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:

Other side effects of isavuconazonium

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:

For healthcare professionals

Applies to isavuconazonium: intravenous powder for injection, oral capsule.

General adverse events

The most common side effects were nausea, vomiting, diarrhea, headache, elevated liver chemistry tests, hypokalemia, constipation, dyspnea, cough, peripheral edema, back pain, abdominal pain, injection site reaction, and rash. 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
• Uncommon (0.1% to 1%): Abdominal distension
• Frequency not reported: Gastritis, gingivitis, stomatitis^[Ref]

Metabolic

• Very common (10% or more): Hypokalemia (up to 19.1%)
• Common (1% to 10%): Decreased appetite, hypomagnesemia
• Uncommon (0.1% to 1%): Hypoalbuminemia, hypoglycemia, malnutrition
• Frequency not reported: Hyponatremia^[Ref]

Hepatic

• Very common (10% or more): Elevated liver chemistry/laboratory tests (includes increased ALT, increased AST, increased blood alkaline phosphatase, increased blood bilirubin, increased blood lactate dehydrogenase, increased GGT, increased hepatic enzyme, abnormal hepatic function, hyperbilirubinemia, abnormal liver function test, increased transaminases; up to 17.1%)
• Common (1% to 10%): Elevated liver transaminases (ALT or AST)
• Uncommon (0.1% to 1%): Hepatitis, hepatomegaly
• Frequency not reported: Cholecystitis, cholelithiasis, hepatic failure, cholestasis^[Ref]

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]

Respiratory

• Very common (10% or more): Dyspnea (up to 17.1%), cough (12%)
• Common (1% to 10%): Acute respiratory failure
• Uncommon (0.1% to 1%): Bronchospasm, tachypnea, hemoptysis, epistaxis^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 17%)
• Common (1% to 10%): Somnolence
• Uncommon (0.1% to 1%): Convulsion, syncope, dizziness, paresthesia, encephalopathy, presyncope, peripheral neuropathy, dysgeusia, vertigo
• Frequency not reported: Epilepsy, hypoesthesia, migraine, stupor, tremor, tinnitus^[Ref]

Other

• Very common (10% or more): Peripheral edema (up to 15.2%), fatigue (10.5%)
• Common (1% to 10%): Chest pain
• Uncommon (0.1% to 1%): Malaise, asthenia
• Frequency not reported: Infusion-related reactions (including hypotension, dyspnea, chills, dizziness, paresthesia, hypoesthesia), catheter thrombosis, 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
• Uncommon (0.1% to 1%): Depression
• Frequency not reported: Confusion, hallucination^[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, thrombophlebitis
• Uncommon (0.1% to 1%): Atrial fibrillation, atrial flutter, bradycardia, reduced QT interval on ECG/shortened ECG QT, palpitations, supraventricular extrasystoles, supraventricular tachycardia, tachycardia, ventricular extrasystoles, circulatory collapse
• Frequency not reported: Cardiac arrest^[Ref]

Dermatologic

• Common (1% to 10%): Rash, pruritus
• Uncommon (0.1% to 1%): Alopecia, dermatitis, petechiae, drug eruption
• Frequency not reported: Exfoliative dermatitis, erythema, urticaria^[Ref]

Local

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

Hematologic

• Uncommon (0.1% to 1%): Neutropenia, thrombocytopenia, leukopenia, pancytopenia, anemia
• Frequency not reported: Agranulocytosis^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity^[Ref]

Genitourinary

• Frequency not reported: Hematuria, proteinuria^[Ref]

Ocular

• Frequency not reported: Optic neuropathy^[Ref]

See also:

Further information

Isavuconazonium 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.

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