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isavuconazonium

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Brand names: Cresemba

Azole Antifungal Rx

Cresemba is an antifungal medicine. It is used to treat serious fungal infections in adults and children.

Drug Pricing (NADAC)

Brand Price

$107.94/unit

Generic Available

No

ASTELLAS

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Cresemba treats invasive aspergillosis and invasive mucormycosis.

Common side effects

Nausea, Vomiting, Diarrhea

Key warnings

Cresemba can cause serious liver problems.

How It Works

Cresemba belongs to a class of drugs called azole antifungals. It works by stopping the growth of the fungi. This helps your body fight off the infection.

How to Take It

Cresemba can be given as an injection or capsules. The injection is given into your vein over at least 1 hour. Capsules can be taken with or without food. Follow your doctor's instructions on how much and how often to take Cresemba.

Pregnancy & Breastfeeding

Cresemba can harm your unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Do not breastfeed while taking Cresemba.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store Cresemba capsules at room temperature, away from moisture. Store Cresemba for injection in the refrigerator.

Side Effects (from patient reports)

Based on 2,176 FDA adverse event reports.

Using the medicine for a condition it is not approved for
926
Death
310
Feeling sick to your stomach
143
Fever with low white blood cell count
135
Medicine not working
125
Fever
125
Lung infection
114
Condition getting worse
106
Feeling tired
101
Loose stools
91

FDA Adverse Event Report Analysis

Detailed analysis of 3,219 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2015–2025.

Total Reports

3,219

Death-Related Reports

674

Hospitalization Reports

1,032

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 1,166 (41%)
Male 1,709 (59%)

Age Distribution

0–17 130
18–44 330
45–64 634
65–74 522
75+ 244

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 OFF LABEL USE 926
2 DEATH 310
3 NAUSEA 143
4 FEBRILE NEUTROPENIA 135
5 DRUG INEFFECTIVE 125
6 PYREXIA 125
7 PNEUMONIA 114
8 CONDITION AGGRAVATED 106
9 FATIGUE 101
10 DIARRHOEA 91
11 DYSPNOEA 87
12 DRUG INTERACTION 84
13 VOMITING 81
14 PRODUCT USE IN UNAPPROVED INDICATION 72
15 ACUTE KIDNEY INJURY 70

Reactions in Death Reports

DEATH 310
OFF LABEL USE 126
DRUG INEFFECTIVE 51
ACUTE MYELOID LEUKAEMIA 33
SEPTIC SHOCK 33
CONDITION AGGRAVATED 32
ACUTE KIDNEY INJURY 31
MULTIPLE ORGAN DYSFUNCTION SYNDROME 31
ASPERGILLUS INFECTION 25
RESPIRATORY FAILURE 25

Reactions in Hospitalization Reports

OFF LABEL USE 155
PNEUMONIA 90
FEBRILE NEUTROPENIA 89
PYREXIA 86
NAUSEA 62
DYSPNOEA 55
ACUTE KIDNEY INJURY 53
DIARRHOEA 50
DRUG INTERACTION 49
SEPSIS 45

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Cresemba can cause serious liver problems. Your doctor will check your liver function before and during treatment. Cresemba can also cause allergic reactions. Tell your doctor right away if you have any signs of a reaction, like trouble breathing or skin rash. Cresemba can harm an unborn baby. Use birth control while taking this medicine.

Known Drug Interactions

Antihelminthics, Antifungals and Antiprotozoals Isavuconazonium Contraindicated during and 2 weeks after itraconazole treatment.

Mechanism: Itraconazole blocks the body's ability to break down isavuconazonium, which can cause the drug to reach unsafe levels.

What to do: Do not take these medicines together, and wait two weeks after stopping itraconazole before starting the new drug.

Atorvastatin Use with Caution Caution should be used when atorvastatin is used with CRESEMBA due to a potential increase in atorvastatin exposure. Monitor patients for adverse reactions that are typical of atorvastatin [see Clinical Pharmacology ( 12.3 )] .

Mechanism: Isavuconazonium can increase the amount of atorvastatin in your blood by slowing down how your body processes it. This can make you more likely to experience side effects from the cholesterol medicine.

What to do: Use this combination with caution and tell your doctor if you notice any new side effects like muscle pain.

moderate bupropion

Bupropion Use with Caution Concomitant administration of CRESEMBA and bupropion results in decrease in bupropion exposure. Dose increase of bupropion may be necessary when coadministered with CRESEMBA, but should not exceed the maximum recommended dose [see Clinical Pharmacology ( 12.3 )] .

Mechanism: Taking isavuconazonium can lower the amount of bupropion in your system, making the medication less effective. This happens because the body clears the drug faster than normal.

What to do: Your doctor may need to increase your dose of bupropion to ensure it still works correctly.

Cyclosporine Use with Caution Concomitant administration of CRESEMBA and cyclosporine results in increase in cyclosporine exposure. Monitor drug concentrations of cyclosporine and adjust dose as needed [see Clinical Pharmacology ( 12.3 )] . ( 7 ) • Appropriate therapeutic drug monitoring and dose adjustment of immunosuppressants (i.e., tacrolimus, sirolimus, and cyclosporine) may be necessary when coadministered with CRESEMBA.

Mechanism: Isavuconazonium causes cyclosporine to build up in your body by slowing its removal. This can lead to higher levels of the drug, which may cause harm.

What to do: Your doctor should monitor your cyclosporine blood levels and adjust your dose as needed.

moderate midazolam

Midazolam Use with Caution Concomitant administration of CRESEMBA and midazolam results in increase in midazolam exposure. Consider dose reduction of midazolam when isavuconazole is coadministered [see Clinical Pharmacology ( 12.3 )] .

Mechanism: Isavuconazonium slows down the breakdown of midazolam, which leads to higher levels of the sedative in your blood. This can make the drug's effects much stronger or last longer than intended.

What to do: Your doctor may need to reduce your dose of midazolam while you are taking these medications together.

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Common Questions

What should I tell my doctor before taking Cresemba?
Tell your doctor about all your medical conditions, including liver problems, heart problems, allergies, and if you are pregnant or breastfeeding.
Can I take other medicines with Cresemba?
Some medicines can interact with Cresemba. Tell your doctor about all the medicines you take, including prescription and over-the-counter drugs, vitamins, and herbal supplements.
How long will I need to take Cresemba?
Your doctor will decide how long you need to take Cresemba. It depends on the type and severity of your infection.
What if I have infusion-related reactions?
Infusion-related reactions, like low blood pressure or trouble breathing, can happen during the injection. Your doctor may stop the infusion if this happens.
What if I have abnormal liver tests?
Your doctor will monitor your liver tests. If they become too high, your doctor may need to stop Cresemba.
What is the dose for adults?
Adults usually take two 186 mg capsules every 8 hours for 6 doses, then two 186 mg capsules once a day.
What is the dose for children?
The dose for children depends on their age and weight. Your doctor will determine the right dose.
Can Cresemba cause any serious side effects?
Yes, Cresemba can cause serious side effects, including liver problems, allergic reactions, and harm to an unborn baby.
What should I do if I think I have a side effect?
Tell your doctor right away if you have any side effects while taking Cresemba.
How should I store Cresemba?
Store Cresemba capsules at room temperature in the original packaging. Store Cresemba for injection in the refrigerator.
What are the common side effects of isavuconazonium?
The most commonly reported side effects of isavuconazonium include Nausea, Vomiting, Diarrhea, Headache, Changes in liver tests. Based on 2,176 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does isavuconazonium interact with other medications?
Yes, isavuconazonium has 9 known drug interactions. Notable interactions include itraconazole, atorvastatin, bupropion. Always inform your doctor about all medications you are taking.
What drug class is isavuconazonium?
isavuconazonium belongs to the Azole Antifungal drug class. It requires a prescription (Rx). Cresemba treats invasive aspergillosis and invasive mucormycosis.
Is isavuconazonium safe during pregnancy?
Cresemba can harm your unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for isavuconazonium

The FDA label for isavuconazonium (sold under brand names such as Cresemba) classifies it as a prescription-only medication in the Azole Antifungal class. Cresemba treats invasive aspergillosis and invasive mucormycosis. Official labeling lists 11 commonly reported side effects, including Nausea, Vomiting, Diarrhea.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 2,176 voluntary reports. The database also lists 9 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: April 25, 2025

All federal data sources used on this page