Itraconazole: Side Effects, Uses & Monitoring
Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1.
- Data source
- FDA labeling via NIH DailyMed (label 349ffcf4…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Gastrointestinal disorders | 4% |
| Rash | 3% |
| Rash/pruritus | 3% |
| Hypertriglyceridemia | 3% |
| Hypertension | 2% |
| Orthostatic hypotension | 1% |
| Headache | 1% |
| Malaise | 1% |
| Myalgia | 1% |
| Vasculitis | 1% |
| Vertigo | 1% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1. Blastomycosis, pulmonary and extrapulmonary 2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and 3. Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly. Itraconazole capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised patients: 1. Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and 2. Onychomycosis of the fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens…
Conditions associated with Itraconazole in labeling
Aspergillosis
Aspergillosis is a medical condition that may be associated with various symptoms and signs....
Fungal Skin Infection
A skin infection caused by dermatophytes, causing itchy, scaly, ring-shaped rashes....
Ringworm
A fungal skin infection causing an itchy, ring-shaped rash, also known as tinea....
Frequently Asked Questions
What is Itraconazole used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Itraconazole?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Itraconazole. Individual risk varies.
Does Itraconazole require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Itraconazole.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.