Prescription medication · Azole Antifungal

isavuconazonium

Name: isavuconazonium - FDA Drug Safety & Adverse Event Data
Creator: PlainMeds
License: https://creativecommons.org/publicdomain/zero/1.0/

Also sold as Cresemba. Cresemba treats invasive aspergillosis and invasive mucormycosis.

Compiled by PlainMeds Editorial, Drug Information Editorial Team

Data updated 2026-05-15

3,219
FDA reportsLightly reported: 9
InteractionsFew interactions: $107.94
Brand price (NADAC)

What the data shows

isavuconazonium (Cresemba) is a prescription Azole Antifungal, among the least-reported drugs the FDA tracks (3,219 FDA reports), with 9 documented drug interactions.

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

isavuconazonium (Cresemba) is a prescription Azole Antifungal. Cresemba treats invasive aspergillosis and invasive mucormycosis.

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

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Drug Pricing (NADAC)

Brand Price

$107.94/unit

Generic Available

ASTELLAS

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

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What it does

Cresemba treats invasive aspergillosis and invasive mucormycosis.

Common side effects

Nausea, Vomiting, Diarrhea

Key warnings

Cresemba can cause serious liver problems.

The sections below are summarized in plain English from isavuconazonium's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

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.

This is a plain-language summary of isavuconazonium's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.

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.

This is a plain-language summary of isavuconazonium's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.

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.

This is a plain-language summary of isavuconazonium's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.

Storage

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

Side Effects (from patient reports)

Based on 3,219 FDA adverse event reports.

Death

310
Feeling sick to your stomach

143
Fever with low white blood cell count

135
Fever

125
Lung infection

114
Condition getting worse

106
Feeling tired

101
Loose stools

91
Difficulty breathing

87
Medicine interacting with another medicine

84

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Reports over time

Adverse-event reports filed for isavuconazonium each year to the FDA Adverse Event Reporting System (FAERS).

Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.

Where isavuconazonium sits

isavuconazonium has more FDA adverse-event reports than 19% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.

fewest reports most reports

Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is isavuconazonium; the line is the median (50th percentile).

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

Reports Mentioning Death

674

20.9% of reports — not proof of cause

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
2	DEATH	310
3	NAUSEA	143
4	FEBRILE NEUTROPENIA	135
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
15	ACUTE KIDNEY INJURY	70
16	SEPSIS	63
17	PLATELET COUNT DECREASED	59
18	ASPERGILLUS INFECTION	56

Reactions in Death Reports

DEATH 310

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

DISEASE PROGRESSION 23

SEPSIS 23

Reactions in Hospitalization Reports

PNEUMONIA 90

FEBRILE NEUTROPENIA 89

PYREXIA 86

NAUSEA 62

DYSPNOEA 55

ACUTE KIDNEY INJURY 53

DIARRHOEA 50

DRUG INTERACTION 49

SEPSIS 45

VOMITING 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

major itraconazole

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.

moderate atorvastatin

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.

moderate cyclosporine

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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This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.

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 3,219 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.

Related Medications in Azole Antifungal

Other drugs grouped near isavuconazonium - same-class peers and common alternatives.

acyclovir

Zovirax

Acyclovir is an antiviral medicine.