Itraconazole: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Itraconazole. Educational only — not medical advice.

Reported adverse reactions

ReactionHighest frequency reported*
Gastrointestinal disorders4%
Rash3%
Rash/pruritus3%
Hypertriglyceridemia3%
Hypertension2%
Orthostatic hypotension1%
Headache1%
Malaise1%
Myalgia1%
Vasculitis1%
Vertigo1%

*Highest percentage across placebo-controlled trial tables summarized in current labeling.

Labeled uses

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…

Source: FDA labeling via NIH DailyMed (set 349ffcf4…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.