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, Drug Information Editorial Process

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.

Verify with FDA → · CMS NADAC pricing →

Drug Pricing (NADAC)

Brand Price

$107.94/unit

Generic Available

ASTELLAS

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

NADAC price trail: CRESEMBA 186 MG CAPSULE

Same CMS presentation as the headline brand unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: +0.8% vs prior release.

Effective	NADAC / unit	vs prior	NDCs
January 18, 2024	$107.12/EA	-	1
December 18, 2024	$107.94/EA	+0.8%	2

View Alternatives → Compare with Another Drug → Full Side Effects Report →

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.

Side Effects (from patient reports)

Based on 3,219 FDA adverse event reports.

Death

310
Nausea

143
Febrile Neutropenia

135
Pyrexia

125
Pneumonia

114
Condition Aggravated

106
Fatigue

101
Diarrhoea

91
Dyspnoea

87
Drug Interaction

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) 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.

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.

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.

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.

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.

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This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

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 registry lists Nausea, Vomiting, Diarrhea, Headache, Changes in liver tests among the most-reported FAERS reaction terms for isavuconazonium. The compiled record contains 3,219 FDA adverse-event reports. These counts are not an individual symptom assessment.

Does isavuconazonium interact with other medications?

The registry has 9 documented interaction rows for isavuconazonium. Notable source-record pairings include itraconazole, atorvastatin, bupropion. These rows are not a complete medication review.

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.

What pregnancy or breastfeeding source fields are listed for isavuconazonium?

The FDA label for isavuconazonium contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

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