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.
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
- Drug Interaction
Drug Interaction
1,118 reports
- Pyrexia
Pyrexia
568 reports
- Dyspnoea
Dyspnoea
474 reports
- Pneumonia
Pneumonia
461 reports
- Nausea 445
Nausea
445 reports
- Diarrhoea 396
Diarrhoea
396 reports
- Condition Aggravated 387
Condition Aggravated
387 reports
- Febrile Neutropenia 362
Febrile Neutropenia
362 reports
- Fatigue 327
Fatigue
327 reports
- Rash 300
Rash
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) 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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for itraconazole?
Is itraconazole currently in shortage?
Related Medications in Azole Antifungal
Other drugs grouped near itraconazole - same-class peers and common alternatives.
acyclovir
Zovirax
Acyclovir is an antiviral medicine.
Compare with itraconazole →
albendazole
Albenza
Albendazole is a medicine that fights parasites.
Compare with itraconazole →
amphotericin B
Ambisome, Fungizone
Amphotericin B liposome is an antifungal medicine.
Compare with itraconazole →
anidulafungin
Eraxis
Eraxis is an antifungal medicine.
Compare with itraconazole →
atovaquone/proguanil
Malarone
Malarone is a drug used to prevent and treat malaria.
Compare with itraconazole →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for itraconazole: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 11,311.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 19.69%.
- enzalutamide Δ 0.08 pts · 57,614 reports · Androgen Receptor Inhibitor 19.61%death share
- vancomycin Δ 0.17 pts · 55,549 reports · Glycopeptide Antibiotic 19.85%death share
- metolazone Δ 0.22 pts · 10,872 reports · Thiazide-Like Diuretic 19.91%death share
- heparin Δ 0.26 pts · 12,966 reports · Unfractionated Heparin 19.43%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on itraconazole
Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.
Disclosure: This link may earn us a commission at no extra cost to you. See our terms.
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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: March 10, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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