Prescription medication · Azole Antifungal
itraconazole
Also sold as Sporanox. Itraconazole treats fungal infections like blastomycosis, histoplasmosis, and aspergillosis.
Data updated 2026-05-15
- 11,311
- FDA reportsModerately reported
- 116
- InteractionsMany interactions
- In shortage
- FDA status
What the data shows
itraconazole (Sporanox) is a prescription Azole Antifungal, reported less often than most tracked drugs (11,311 FDA reports), with 116 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.
itraconazole (Sporanox) is a prescription Azole Antifungal. Itraconazole treats fungal infections like blastomycosis, histoplasmosis, and aspergillosis.
Itraconazole capsules are an antifungal medicine. They treat fungal infections in your body.
Verify with FDA → · CMS NADAC pricing →
Drug Shortage Alert
itraconazole is currently listed as to be discontinued by the FDA. Affected manufacturer: Janssen Pharmaceuticals.
View all drug shortages →Drug Pricing (NADAC)
Generic Price
$0.96/unit
Generic Available
Yes (7 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Itraconazole treats fungal infections like blastomycosis, histoplasmosis, and aspergillosis.
Common side effects
Nausea, Rash, Headache
Key warnings
Itraconazole can cause congestive heart failure.
The sections below are summarized in plain English from itraconazole's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Itraconazole stops fungi from growing. It does this by interfering with the production of a substance fungi need to build their cell membranes. This eventually kills the fungus and clears the infection.
How to Take It
Take itraconazole capsules with a full meal to help your body absorb the medicine. Swallow the capsules whole. Do not crush or chew them. The usual dose is 2 capsules (200 mg) once a day, but your doctor may adjust this depending on your infection.
This is a plain-language summary of itraconazole's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
You should not take itraconazole if you are pregnant or plan to become pregnant. It can harm your unborn baby. Talk to your doctor about safe alternatives.
This is a plain-language summary of itraconazole'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 itraconazole's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store itraconazole capsules at room temperature, away from light and moisture. Keep out of reach of children.
Side Effects (from patient reports)
Based on 11,311 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for itraconazole, by number of reports
- Interaction with another medicine
Interaction with another medicine
1,118 reports
- Fever
Fever
570 reports
- Difficulty breathing
Difficulty breathing
472 reports
- Lung infection
Lung infection
462 reports
- Feeling sick to your stomach 446
Feeling sick to your stomach
446 reports
- Loose stools 396
Loose stools
396 reports
- Condition got worse 387
Condition got worse
387 reports
- Fever with low white blood cell count 362
Fever with low white blood cell count
362 reports
- Feeling tired 327
Feeling tired
327 reports
- Skin breakout 300
Skin breakout
300 reports
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 itraconazole 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 itraconazole sits
itraconazole has more FDA adverse-event reports than 42% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is itraconazole; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 11,311 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
11,311
Reports Mentioning Death
2,227
19.7% of reports — not proof of cause
Hospitalization Reports
4,304
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INTERACTION | 1,118 |
| 4 | PYREXIA | 568 |
| 5 | DYSPNOEA | 474 |
| 6 | PNEUMONIA | 461 |
| 7 | NAUSEA | 445 |
| 8 | DIARRHOEA | 396 |
| 9 | CONDITION AGGRAVATED | 387 |
| 10 | FEBRILE NEUTROPENIA | 362 |
| 11 | FATIGUE | 327 |
| 12 | RASH | 300 |
| 13 | ANAEMIA | 296 |
| 14 | NEUTROPENIA | 284 |
| 15 | SEPSIS | 282 |
| 16 | COUGH | 279 |
| 17 | VOMITING | 276 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Itraconazole can cause congestive heart failure. You should not take this medicine if you have heart problems. Itraconazole can also interact with many other medicines. Some of these interactions can be dangerous or even fatal. Check with your doctor about all the medicines you take.
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.
Lurasidone Midazolam (oral) a Pimozide Triazolam a Contraindicated during and 2 weeks after itraconazole treatment.
Mechanism: Itraconazole stops the enzymes that process lurasidone, leading to a buildup of the medication in your blood.
What to do: Avoid taking these two drugs together and for at least two weeks after your itraconazole treatment ends.
Apixaban Rivaroxaban Vorapaxar Not recommended during and 2 weeks after itraconazole treatment. Lurasidone Midazolam (oral) a Pimozide Triazolam a Contraindicated during and 2 weeks after itraconazole treatment.
Mechanism: Itraconazole slows down the removal of pimozide from your body, which can increase the risk of serious heart side effects.
What to do: This combination is not allowed during treatment or for two weeks after you finish taking itraconazole.
Analgesics Methadone Contraindicated during and 2 weeks after itraconazole treatment.
Mechanism: Itraconazole prevents your body from clearing methadone, which can lead to a dangerous buildup and breathing issues.
What to do: Do not use these medications together, and wait two weeks after your last dose of itraconazole before taking methadone.
Antipsychotics, Anxiolytics and Hypnotics Alprazolam a Midazolam (IV) a Aripiprazole a Quetiapine Buspirone a Cariprazine Ramelteon Diazepam a Risperidone a Haloperidol a Suvorexant Monitor for adverse reactions. Lurasidone Midazolam (oral) a Pimozide Triazolam a Contraindicated during and 2 weeks after itraconazole treatment.
Mechanism: Itraconazole blocks the breakdown of midazolam, making its calming effects much stronger and potentially dangerous.
What to do: Avoid the oral version of this drug with itraconazole, and ensure a doctor monitors you closely if the IV version is used.
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
Can I take itraconazole with food?
What should I do if I experience side effects?
Can I drink alcohol while taking itraconazole?
How long will I need to take itraconazole?
What if I have kidney problems?
Can itraconazole interact with other medications?
What if I have liver problems?
Is there a generic version of itraconazole?
What does itraconazole look like?
How do I dispose of unused itraconazole?
What are the common side effects of itraconazole?
Does itraconazole interact with other medications?
What drug class is itraconazole?
Is itraconazole safe during pregnancy?
Is itraconazole currently in shortage?
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Medication Guides
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Common Drug Interactions
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What the FDA Data Shows for itraconazole
The FDA label for itraconazole (sold under brand names such as Sporanox) classifies it as a prescription-only medication in the Azole Antifungal class. Itraconazole treats fungal infections like blastomycosis, histoplasmosis, and aspergillosis. Official labeling lists 3 commonly reported side effects, including Nausea, Rash, Headache.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 11,311 voluntary reports. The database also lists 116 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.96.
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). Shortage status: FDA Drug Shortages Database.
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: March 10, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages