Last reviewed 2026-04-20 · How we verify

Sporanox (itraconazole)

Sporanox (itraconazole) is a small molecule azole antifungal medication originally developed by Janssen Pharmaceutica and currently owned by Sebela Ireland Ltd. It targets the C-X-C chemokine receptor type 1 and is FDA-approved for various fungal infections, including aspergillosis, blastomycosis, and candidiasis. Sporanox has a half-life of 25 hours and bioavailability of 55%, with 13 generic manufacturers available. The commercial status of Sporanox is off-patent, and it is used to treat a range of fungal infections. Key safety considerations include monitoring liver function and potential interactions with other medications.

At a glance

Approved indications

• Aspergillosis
• Blastomycosis
• Candidemia
• Candidiasis of the esophagus
• Disseminated candidiasis
• Fungal Infection due to Fusarium Solani
• Fungal Infection due to Scedosporium Apiospermum
• Fusarium infection
• Histoplasmosis
• Invasive pulmonary aspergillosis
• Onychomycosis of fingernails
• Onychomycosis of toenails
• Oropharyngeal Candidiasis

Boxed warnings

• BOXED WARNING Congestive Heart Failure, Cardiac Effects and Drug Interactions Congestive Heart Failure and Cardiac Effects: • Itraconazole capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF. If signs or symptoms of congestive heart failure occur during administration of itraconazole capsules, discontinue administration. • When itraconazole was administered intravenously to dogs and healthy human volunteers, negative inotropic effects were seen. (See CONTRAINDICATIONS, WARNINGS, PRECAUTIONS: Drug Interactions, ADVERSE REACTIONS: Postmarketing Experience, and CLINICAL PHARMACOLOGY: Special Populations for more information.) Drug Interactions: • Coadministration of a number of CYP3A4 substrates are contraindicated with itraconazole capsules. Some examples of drugs that are contraindicated for coadministration with itraconazole capsules are: methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor, finerenone, voclosporin. • Coadministration with colchicine, fesoterodine and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment. • Coadministration with eliglustat is contraindicated in subjects that are poor or intermediate metabolizers of CYP2D6 and in subjects taking strong or moderate CYP2D6 inhibitors. • Coadministration with venetoclax is contraindicated in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) during the dose initiation and ramp-up phase of venetoclax. See PRECAUTIONS: Drug Interactions Section for specific examples. • Coadministration with itraconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both the pharmacologic effects and/or adverse reactions to these drugs. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and ventricular tachyarrhythmias including occurrences of torsade de pointes, a potentially fatal arrhythmia. See CONTRAINDICATIONS and WARNINGS Sections, and PRECAUTIONS: Drug Interactions Section for specific examples.

Common side effects

• Drug interaction
• Aspergillus infection
• Bronchopulmonary aspergillosis
• Febrile neutropenia
• Drug resistance
• Acute graft versus host disease
• Hepatic function abnormal
• Neutrophil count decreased
• Symmetrical drug-related intertriginous and flexural exanthema
• Pathogen resistance
• Platelet count decreased
• Drug level increased

Drug interactions

• CYP3A4 Substrates
• P-glycoprotein Substrates
• alfentanil
• cobicistat
• dronedarone
• efavirenz
• etravirine
• ixabepilone
• lansoprazole
• lovastatin
• magnesium hydroxide
• magnesium oxide

Key clinical trials

• Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis (PHASE1)
• A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazolam Levels (MK-2828-007) (PHASE1)
• A Study to Evaluate the Effect of Food on the Single-Dose Pharmacokinetics and a Drug-Drug Interaction Evaluation of Itraconazole and Carbamazepine on INCB123667 When Administered Orally to Healthy Adult Participants (PHASE1)
• Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole (PHASE1)
• Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's Esophagus (PHASE2)
• A Study to Learn if Itraconazole Changes How the Body Processes PF-07248144 (Study Medicine) (PHASE1)
• A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 764198 in the Blood (PHASE1)
• A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma (PHASE1)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Sporanox CI brief — competitive landscape report
• Sporanox updates RSS · CI watch RSS
• Sebela Ireland Ltd portfolio CI