Oropharyngeal candidiasis
Second line
Treats oropharyngeal candidiasis including fluconazole-resistant infections. AEMPS keeps fluconazole as first-line and reserves itraconazole for resistance or intolerance.
Antifungal, triazole
ATC code: J02AC02 (Itraconazole)
Brand names
Sporanox, Tolsura
Itraconazole inhibits fungal CYP51 (lanosterol 14-alpha-demethylase) and blocks ergosterol synthesis, the main component of fungal membranes. Its spectrum covers dermatophytes, Candida, Aspergillus, and endemic dimorphic fungi. In humans, itraconazole is one of the most potent inhibitors of CYP3A4 and P-glycoprotein: concentrations of dozens of substrates (statins, immunosuppressants, calcium channel blockers, ergotamine) rise several-fold. carries a boxed warning on heart failure because of a negative inotropic effect.
Second line
Treats oropharyngeal candidiasis including fluconazole-resistant infections. AEMPS keeps fluconazole as first-line and reserves itraconazole for resistance or intolerance.
Second line
Triazole for long-term maintenance therapy of invasive aspergillosis after successful induction with voriconazole or isavuconazole. SEIMC and ESCMID position itraconazole as second-line.
Third line
Treats recurrent vulvovaginal candidiasis and fluconazole-resistant cases. SEGO keeps fluconazole as first-line.
Opens the checker prefilled with this drug. Pick the second one from your regimen.
Direct links to regulator labels. Open in a new tab.
FDA Category C. Systemic azoles in the first trimester carry malformation risk (especially at doses >400 mg/day – a syndrome similar to chronic high-dose fluconazole exposure). AEMPS contraindicates systemic itraconazole in pregnancy except for life-threatening invasive mycoses. Topical and nail-lacquer forms are safer.
Compatible with caution. Hale L3. Transfers into milk (RID about 0.2%) with minimal infant exposure, but has a long half-life. AEMPS advises interrupting breastfeeding for courses >14 days; short vaginal or onychomycosis courses are compatible.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Itraconazole is evaluated for the following indications with varying evidence strength: Oropharyngeal candidiasis (evidence tier A), Vulvovaginal candidiasis (evidence tier B), Invasive aspergillosis (evidence tier B). See the full indication matrix with dosing and citations above on this page.
Common side effects of Itraconazole (≥ 1 in 100): Nausea, vomiting, diarrhoea, Elevated transaminases, Headache, Rash. See the Safety section for uncommon and serious reactions.
FDA category C. FDA Category C. Systemic azoles in the first trimester carry malformation risk (especially at doses >400 mg/day – a syndrome similar to chronic high-dose fluconazole exposure). AEMPS contraindicates systemic itraconazole in pregnancy except for life-threatening invasive mycoses. Topical and nail-lacquer forms are safer.
Compatible with caution. Hale L3. Transfers into milk (RID about 0.2%) with minimal infant exposure, but has a long half-life. AEMPS advises interrupting breastfeeding for courses >14 days; short vaginal or onychomycosis courses are compatible.
Itraconazole is contraindicated in: Hypersensitivity to itraconazole; Heart failure and left ventricular dysfunction; Pregnancy (systemic use); Co-administration with CYP3A4 substrates prolonging QT (quinidine, dofetilide, cisapride, pimozide, lovastatin, simvastatin, ergotamine). Full list in the Safety section.