Itraconazole
Itraconazole is a broad-spectrum triazole antifungal medication used to treat a variety of systemic and superficial fungal infections. It works by inhibiting the synthesis of ergosterol, a critical component of fungal cell membranes, thereby disrupting fungal growth and replication. This medication is typically prescribed for conditions such as aspergillosis, blastomycosis, histoplasmosis, and certain nail or skin fungal infections in patients with compromised immune systems or specific fungal exposures.
Itraconazole is an oral antifungal medication used to treat serious systemic and superficial fungal infections by disrupting fungal cell membrane formation.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- J02AC02
- RxNorm
- 28031
- Generic
- Itraconazole
- Class
- atc-j02
- Brands
- Sporanox, Tolsura
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- solution, capsule, tablet
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 200mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 5mg/kg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 200mg once daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
9 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks - teratogenic in animal studies
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use close to delivery - may prolong QT interval in neonates
fetal monitoring and neonatal cardiac monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdiscontinue breastfeeding or avoid drug
itraconazole is excreted in breast milk - avoid breastfeeding during treatment
monitor infant for adverse effects
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
under 12 yearsuse with caution - limited data
not recommended for children under 12 years due to limited safety and efficacy data
monitor growth, liver function, and for adverse effects
Use with caution and monitor for adverse effects.
geriatric
elderly 65 years and olderno specific dose adjustment required
use with caution due to potential comorbidities and drug interactions - monitor for adverse effects
monitor liver function, cardiac function, and for drug interactions
Use with caution and monitor for adverse effects.
renal_impairment
moderate to severeno dose adjustment needed but use with caution
itraconazole is metabolized hepatically - renal impairment has minimal effect but use caution in severe impairment
monitor for signs of toxicity and drug accumulation
Use with caution and monitor for adverse effects.
hepatic_impairment
mildconsider dose reduction in mild impairment
use with caution - extensively metabolized in liver
monitor liver function tests regularly
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate to severeavoid if possible
use with extreme caution or avoid - significantly metabolized by liver
frequent liver function monitoring required
Use of this medication in this population requires careful consideration of risks and benefits.
Statistics and clinical data
FDA approval year
General prescribing information
Drug class
Drug class information
Common uses
Common therapeutic uses
Mechanism of action
Mode of action description
Treats systemic fungal infections including aspergillosis, blastomycosis, histoplasmosis, and paracoccidioidomycosis, as well as superficial infections like onychomycosis and cutaneous dermatophyte infections, particularly in immunocompromised patients or those with documented fungal exposure.
Inhibits the fungal cytochrome P450 enzyme lanosterol 14-alpha-demethylase, blocking ergosterol synthesis and compromising the integrity of the fungal cell membrane, leading to inhibition of fungal growth and replication.
Contraindicated in patients with heart failure or those taking certain cardiac medications; significant CYP3A4 drug interactions requiring careful review of concomitant medications; hepatotoxicity monitoring recommended; capsules should be taken with food while oral solution should be taken on empty stomach; avoid use during pregnancy unless benefits outweigh risks.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed August 24, 2026. · Read our editorial policy