Prescription medicine
Itraconazole Brand names: Tolsura, Sporanox
Itraconazole (Sporanox) is a prescription medicine with an FDA approval on record since 1992. FDA's NDC Directory lists it from 11 generic labelers, and pharmacies paid $0.910 per itraconazole 100 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the itraconazole FDA label on DailyMed (effective July 13, 2026, Janssen Pharmaceuticals, Inc.); the NDA 20083 record on Drugs@FDA; every itraconazole label on DailyMed.
Highlights of the record
FDA label of July 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Congestive Heart Failure, Cardiac Effects and Drug Interactions Congestive Heart Failure and Cardiac Effects SPORANOX ® (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 SPORANOX ® 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 SPORANOX ® . Some examples of drugs that are contraindicated for coadministration with SPORANOX ® 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. […]
Used for
From the label: indications and usageSPORANOX ® (itraconazole) Capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: Blastomycosis, pulmonary and extrapulmonary Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to
Forms and strengths
- 65 mg
- 100 mg
- 10 mg/ml
Capsule; solution; capsule (coated pellets); gelatin-coated capsule.
On the market
- Earliest approval on file
- September 11, 1992 Sporanox, Janssen Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 14 first May 28, 2004; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 14 of which 11 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- June 21, 2033 Tolsura capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.910 per capsule Itraconazole 100 mg capsule
- Shortage (FDA)
- None current 3 past records
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest April 1, 2021; 2 more by firms not listed as its makers
- FAERS reports
- 11,610 through July 30, 2026
What is itraconazole used for?
From the label: indications and usageSPORANOX ® (itraconazole) Capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: Blastomycosis, pulmonary and extrapulmonary Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and 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. […]
Conditions named in the indications of itraconazole's FDA labels, with every medicine labeled for each:
From other itraconazole labelsFungal infections: Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and Onychomycosis of the fingernail due to dermatophytes (tinea unguium).
FDA pharmacologic class: Azole Antifungal.
Source: FDA drug label (SPORANOX), Janssen Pharmaceuticals, Inc., effective July 13, 2026 (SPL set a4d555fa-787c-40fb-bb7d-b0d4f7318fd0), via openFDA; the full label on DailyMed
What does the patient leaflet for itraconazole say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SPORANOX?SPORANOX can cause serious side effects, including: 1. Heart failure. Do not take SPORANOX if you have had heart failure, including congestive heart failure. Stop taking SPORANOX and call your healthcare provider right away if you have any of these symptoms of congestive heart failure: shortness of breath swelling of your feet, ankles or legs sudden weight gain increased tiredness coughing up white or pink mucus (phlegm) fast heartbeat waking up at night more than normal for you 2. Heart problems and other serious medical problems. Serious medical problems that affect the heart and other parts of your body can happen if you take SPORANOX with certain other medicines. Do not take SPORANOX if you also take the following medicines: 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 venetoclax (see below) finerenone voclosporin Do not take SPORANOX with venetoclax for chronic lymphocytic leukemia/small lymphocytic lymphoma when you first start treatment with venetoclax or with increasing doses of venetoclax. This is not a complete list of medicines that can interact with SPORANOX. SPORANOX may affect the way other medicines work, and other medicines may affect how SPORANOX works. You can ask your pharmacist for a list of medicines that interact with SPORANOX. Before you start taking SPORANOX, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. […]
From the patient leaflet: What should I avoid while taking SPORANOX?SPORANOX can cause dizziness and vision problems. Do not drive or operate machinery until you know how SPORANOX affects you.
From the patient leaflet: How should I store SPORANOX?Store SPORANOX at room temperature between 59 °F to 77 °F (15 °C to 25 °C). Keep SPORANOX dry and away from light. Keep SPORANOX and all medicines out of the reach of children.
Source: FDA drug label (SPORANOX), Janssen Pharmaceuticals, Inc., effective July 13, 2026 (SPL set a4d555fa-787c-40fb-bb7d-b0d4f7318fd0), via openFDA; the full label on DailyMed
Is there a generic for itraconazole (Sporanox)?
The FDA approved the first generic itraconazole on May 28, 2004. 14 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists itraconazole from 11 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Sporanox capsules; a patent listed only for Tolsura capsules runs to June 21, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1992 earliest approval on file
- 2004 first generic approved
- 2033 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for itraconazole (Sporanox)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.910 per Itraconazole 100 mg capsule, down 4% from $0.943 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Itraconazole 100 mg capsule (generic)
- Sporanox 100 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Itraconazole 10 mg/mL solution | Generic | $1.14 per mL | n/a | +8% |
| Itraconazole 100 mg capsule | Generic | $0.910 per capsule | $27.31 | -4% |
| Sporanox 100 mg capsule | Brand | $28.36 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $850.70 | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is itraconazole in shortage?
No itraconazole presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 3 records are all marked to be discontinued, the latest updated February 27, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Sporanox, Capsule, 100 mg (NDC 10147-1700-3) | Janssen Pharmaceuticals | To Be Discontinued | February 27, 2026 |
| Sporanox, Capsule, 100 mg (NDC 50458-290-01) | Janssen Pharmaceuticals | To Be Discontinued | February 27, 2026 |
| Sporanox, Capsule, 100 mg (NDC 50458-290-04) | Janssen Pharmaceuticals | To Be Discontinued | February 27, 2026 |
Every itraconazole presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has itraconazole been recalled?
The FDA's Enforcement Report lists 3 recalls naming itraconazole since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of itraconazole and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 1, 2021 | Class II | Jubilant Cadista Pharmaceuticals, Inc. | Failed Dissolution Specifications |
| February 9, 2018 | Class II | American Pharmaceutical Ingredients LLC not a listed maker | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; ITRACONAZOLE, Capsule, 100 mg may be potentially mislabeled as FAMCICLOVIR, Tablet, 500 mg, NDC 00093811956, Pedigree: AD54549_4, EXP … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the itraconazole label say about other medicines?
The itraconazole label names 155 other medicines in its interaction, contraindication or warning sections. The labels of 37 other medicines name itraconazole. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Alfuzosin | drug interactions | Examples of Concomitant Drugs Within Class: Alfuzosin Silodosin Tamsulosin; Prevention or Management: Not recommended during and 2 weeks after SPORANOX ® treatment. |
| Aliskiren | drug interactions | Aliskiren Riociguat Sildenafil (for pulmonary hypertension) Tadalafil (for pulmonary hypertension) Not recommended during and 2 weeks after SPORANOX ® treatment. |
| Alitretinoin | drug interactions | Alitretinoin (oral) Cabergoline Cannabinoids Cinacalcet Galantamine Ivacaftor Monitor for adverse reactions. |
| Alprazolam | drug interactions | Antipsychotics, Anxiolytics and Hypnotics Alprazolam Aripiprazole Buspirone Cariprazine Diazepam Haloperidol Midazolam (IV) Quetiapine Ramelteon Risperidone Suvorexant Monitor for adverse reactions. |
| Apixaban | drug interactions | Apixaban Rivaroxaban Vorapaxar Not recommended during and 2 weeks after SPORANOX ® treatment. Cilostazol Dabigatran Warfarin Monitor for adverse reactions. |
| Aprepitant | drug interactions | Gastrointestinal Drugs Cisapride Naloxegol Contraindicated during and 2 weeks after SPORANOX ® treatment. Aprepitant Loperamide Monitor for adverse reactions. |
| Aripiprazole | drug interactions | Antipsychotics, Anxiolytics and Hypnotics Alprazolam Aripiprazole Buspirone Cariprazine Diazepam Haloperidol Midazolam (IV) Quetiapine Ramelteon Risperidone Suvorexant Monitor for adverse reactions. |
| Atorvastatin | drug interactions | Lipid-Lowering Drugs Lomitapide Lovastatin Simvastatin Contraindicated during and 2 weeks after SPORANOX ® treatment. Atorvastatin Monitor for drug adverse reactions. |
| Avanafil | boxed warning | … nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor, finerenone, voclosporin. |
| Axitinib | drug interactions | Examples of Concomitant Drugs Within Class: Axitinib Bosutinib Cabazitaxel Cabozantinib Ceritinib Cobimetinib Crizotinib Dabrafenib Dasatinib Docetaxel; Prevention or Management: Ibrutinib Lapatinib Nilotinib Olaparib Pazopanib Sunitinib Trabectedin Trastuzumab-emtansine Vinca alkaloids; … |
| Bedaquiline | drug interactions | Concomitant SPORANOX ® not recommended for more than 2 weeks at any time during bedaquiline treatment. |
| Bortezomib | drug interactions | Examples of Concomitant Drugs Within Class: Bortezomib Brentuximab-vedotin Busulfan Erlotinib Gefitinib Idelalisib Imatinib Ixabepilone; Prevention or Management: Nintedanib Panobinostat Ponatinib Ruxolitinib Sonidegib Tretinoin (oral) Vandetanib; Monitor for adverse reactions. … |
| Bosentan | drug interactions | For sildenafil and tadalafil, see also Urologic Drugs below. Bosentan Guanfacine Monitor for adverse reactions. |
| Bosutinib | drug interactions | Examples of Concomitant Drugs Within Class: Axitinib Bosutinib Cabazitaxel Cabozantinib Ceritinib Cobimetinib Crizotinib Dabrafenib Dasatinib Docetaxel; Prevention or Management: Ibrutinib Lapatinib Nilotinib Olaparib Pazopanib Sunitinib Trabectedin Trastuzumab-emtansine Vinca alkaloids; … |
Every other medicine the itraconazole label names
| Medicine named | Section | What the label says |
|---|---|---|
| Budesonide | drug interactions | Examples of Concomitant Drugs Within Class: Budesonide (inhalation) Budesonide (non-inhalation) Ciclesonide (inhalation) Cyclosporine (IV) Cyclosporine (non-IV) Dexamethasone; … |
| Buprenorphine | drug interactions | Alfentanil Buprenorphine (IV and sublingual) Oxycodone Based on clinical drug interaction information with itraconazole. Sufentanil Monitor for adverse reactions. |
| Buspirone | drug interactions | Antipsychotics, Anxiolytics and Hypnotics Alprazolam Aripiprazole Buspirone Cariprazine Diazepam Haloperidol Midazolam (IV) Quetiapine Ramelteon Risperidone Suvorexant Monitor for adverse reactions. |
| Busulfan | drug interactions | Examples of Concomitant Drugs Within Class: Bortezomib Brentuximab-vedotin Busulfan Erlotinib Gefitinib Idelalisib Imatinib Ixabepilone; … |
| Cabazitaxel | drug interactions | Examples of Concomitant Drugs Within Class: Axitinib Bosutinib Cabazitaxel Cabozantinib Ceritinib Cobimetinib Crizotinib Dabrafenib Dasatinib Docetaxel; … |
| Cabergoline | drug interactions | Alitretinoin (oral) Cabergoline Cannabinoids Cinacalcet Galantamine Ivacaftor Monitor for adverse reactions. |
| Cabozantinib | drug interactions | Examples of Concomitant Drugs Within Class: Axitinib Bosutinib Cabazitaxel Cabozantinib Ceritinib Cobimetinib Crizotinib Dabrafenib Dasatinib Docetaxel; … |
| Carbamazepine | drug interactions | Anticonvulsants Carbamazepine Not recommended 2 weeks before, during, and 2 weeks after SPORANOX ® treatment. |
| Cariprazine | drug interactions | Antipsychotics, Anxiolytics and Hypnotics Alprazolam Aripiprazole Buspirone Cariprazine Diazepam Haloperidol Midazolam (IV) Quetiapine Ramelteon Risperidone Suvorexant Monitor for adverse reactions. |
| Ceritinib | drug interactions | Examples of Concomitant Drugs Within Class: Axitinib Bosutinib Cabazitaxel Cabozantinib Ceritinib Cobimetinib Crizotinib Dabrafenib Dasatinib Docetaxel; … |
| Ciclesonide | drug interactions | Examples of Concomitant Drugs Within Class: Budesonide (inhalation) Budesonide (non-inhalation) Ciclesonide (inhalation) Cyclosporine (IV) Cyclosporine (non-IV) Dexamethasone; … |
| Cilostazol | drug interactions | Apixaban Rivaroxaban Vorapaxar Not recommended during and 2 weeks after SPORANOX ® treatment. Cilostazol Dabigatran Warfarin Monitor for adverse reactions. |
| Cinacalcet | drug interactions | Alitretinoin (oral) Cabergoline Cannabinoids Cinacalcet Galantamine Ivacaftor Monitor for adverse reactions. |
| Ciprofloxacin | drug interactions | Examples of Concomitant Drugs Within Class: Ciprofloxacin Based on clinical drug interaction information with itraconazole. Erythromycin Clarithromycin; … |
| Clarithromycin | drug interactions | See also Table 2 . Clarithromycin Monitor for adverse reactions. |
| Cobicistat | drug interactions | Cobicistat Elvitegravir (ritonavir-boosted) Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir Ritonavir Saquinavir (unboosted) Monitor for adverse reactions. |
| Cobimetinib | drug interactions | Examples of Concomitant Drugs Within Class: Axitinib Bosutinib Cabazitaxel Cabozantinib Ceritinib Cobimetinib Crizotinib Dabrafenib Dasatinib Docetaxel; … |
| Colchicine | boxed warning | Coadministration with colchicine, fesoterodine and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment. |
| Crizotinib | drug interactions | Examples of Concomitant Drugs Within Class: Axitinib Bosutinib Cabazitaxel Cabozantinib Ceritinib Cobimetinib Crizotinib Dabrafenib Dasatinib Docetaxel; … |
| Cyclosporine | drug interactions | Examples of Concomitant Drugs Within Class: Budesonide (inhalation) Budesonide (non-inhalation) Ciclesonide (inhalation) Cyclosporine (IV) Cyclosporine (non-IV) Dexamethasone; … |
| Dabigatran | drug interactions | Apixaban Rivaroxaban Vorapaxar Not recommended during and 2 weeks after SPORANOX ® treatment. Cilostazol Dabigatran Warfarin Monitor for adverse reactions. |
| Dabrafenib | drug interactions | Examples of Concomitant Drugs Within Class: Axitinib Bosutinib Cabazitaxel Cabozantinib Ceritinib Cobimetinib Crizotinib Dabrafenib Dasatinib Docetaxel; … |
| Darifenacin | drug interactions | Darifenacin Vardenafil Not recommended during and 2 weeks after SPORANOX ® treatment. |
| Darunavir | drug interactions | Examples of Concomitant Drugs Within Class: Cobicistat Darunavir (ritonavir-boosted) Elvitegravir (ritonavir-boosted) Fosamprenavir (ritonavir-boosted) Indinavir Ombitasvir/ Paritaprevir/ Ritonavir … |
| Dasatinib | drug interactions | Examples of Concomitant Drugs Within Class: Axitinib Bosutinib Cabazitaxel Cabozantinib Ceritinib Cobimetinib Crizotinib Dabrafenib Dasatinib Docetaxel; … |
| Dexamethasone | drug interactions | … (non-inhalation) Ciclesonide (inhalation) Cyclosporine (IV) Cyclosporine (non-IV) Dexamethasone; Prevention or Management: Fluticasone (inhalation) Fluticasone (nasal) Methylprednisolone Tacrolimus … |
| Diazepam | drug interactions | Antipsychotics, Anxiolytics and Hypnotics Alprazolam Aripiprazole Buspirone Cariprazine Diazepam Haloperidol Midazolam (IV) Quetiapine Ramelteon Risperidone Suvorexant Monitor for adverse reactions. |
| Digoxin | drug interactions | Antiarrhythmics Disopyramide Dofetilide Dronedarone Quinidine Contraindicated during and 2 weeks after SPORANOX ® treatment. Digoxin Monitor for adverse reactions. |
| Dihydroergotamine | boxed warning | … dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)), irinotecan, lurasidone … |
| Diltiazem | drug interactions | Diltiazem Other dihydropyridines Verapamil Monitor for adverse reactions. |
| Disopyramide | boxed warning | Some examples of drugs that are contraindicated for coadministration with SPORANOX ® Capsules are: methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as … |
| Docetaxel | drug interactions | Examples of Concomitant Drugs Within Class: Axitinib Bosutinib Cabazitaxel Cabozantinib Ceritinib Cobimetinib Crizotinib Dabrafenib Dasatinib Docetaxel; … |
| Dofetilide | boxed warning | Some examples of drugs that are contraindicated for coadministration with SPORANOX ® Capsules are: methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as … |
| Dronedarone | boxed warning | Some examples of drugs that are contraindicated for coadministration with SPORANOX ® Capsules are: methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as … |
| Dutasteride | drug interactions | Dutasteride Oxybutynin Sildenafil (for erectile dysfunction) Tadalafil (for erectile dysfunction and benign prostatic hyperplasia) Tolterodine Monitor for adverse reactions. |
| Efavirenz | drug interactions | Antivirals Efavirenz Nevirapine Not recommended 2 weeks before and during SPORANOX ® treatment. |
| Elbasvir and grazoprevir | drug interactions | Elbasvir/grazoprevir Not recommended during and 2 weeks after SPORANOX ® treatment. Glecaprevir/pibrentasvir Monitor for adverse reactions. … |
| Eletriptan | drug interactions | Antimigraine Drugs Ergot alkaloids (e.g., dihydroergotamine, ergotamine) Contraindicated during and 2 weeks after SPORANOX ® treatment. Eletriptan Monitor for adverse reactions. |
| Eliglustat | boxed warning | Coadministration with eliglustat is contraindicated in subjects that are poor or intermediate metabolizers of CYP2D6 and in subjects taking strong or moderate CYP2D6 inhibitors. |
| Entrectinib | drug interactions | Entrectinib Pemigatinib Talazoparib Refer to the entrectinib, pemigatinib and talazoparib prescribing information for dosing instructions if concomitant use cannot be avoided. |
| Eplerenone | boxed warning | … pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor, finerenone, voclosporin. |
| Ergotamine | boxed warning | … dronedarone, quinidine, isavuconazole, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam … |
| Erlotinib | drug interactions | Examples of Concomitant Drugs Within Class: Bortezomib Brentuximab-vedotin Busulfan Erlotinib Gefitinib Idelalisib Imatinib Ixabepilone; … |
| Erythromycin | drug interactions | Examples of Concomitant Drugs Within Class: Ciprofloxacin Based on clinical drug interaction information with itraconazole. Erythromycin Clarithromycin; … |
| Everolimus | drug interactions | Everolimus Sirolimus Temsirolimus (IV) Not recommended during and 2 weeks after SPORANOX ® treatment. |
| Felodipine | boxed warning | … (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin … |
| Fentanyl | drug interactions | Fentanyl Not recommended during and 2 weeks after SPORANOX ® treatment. |
| Fesoterodine | boxed warning | Coadministration with colchicine, fesoterodine and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment. |
| Finerenone | boxed warning | … naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor, finerenone, voclosporin. |
| Fluticasone | drug interactions | … (IV) Cyclosporine (non-IV) Dexamethasone; Prevention or Management: Fluticasone (inhalation) Fluticasone (nasal) Methylprednisolone Tacrolimus (IV) Tacrolimus (oral); Monitor for adverse reactions. … |
| Fosamprenavir | drug interactions | Examples of Concomitant Drugs Within Class: Cobicistat Darunavir (ritonavir-boosted) Elvitegravir (ritonavir-boosted) Fosamprenavir (ritonavir-boosted) Indinavir Ombitasvir/ Paritaprevir/ Ritonavir … |
| Galantamine | drug interactions | Alitretinoin (oral) Cabergoline Cannabinoids Cinacalcet Galantamine Ivacaftor Monitor for adverse reactions. |
| Gefitinib | drug interactions | Examples of Concomitant Drugs Within Class: Bortezomib Brentuximab-vedotin Busulfan Erlotinib Gefitinib Idelalisib Imatinib Ixabepilone; … |
| Glasdegib | drug interactions | Glasdegib Refer to the glasdegib prescribing information for safety monitoring if concomitant use cannot be avoided. |
| Glecaprevir and pibrentasvir | drug interactions | Elbasvir/grazoprevir Not recommended during and 2 weeks after SPORANOX ® treatment. Glecaprevir/pibrentasvir Monitor for adverse reactions. … |
| Guanfacine | drug interactions | For sildenafil and tadalafil, see also Urologic Drugs below. Bosentan Guanfacine Monitor for adverse reactions. |
| Haloperidol | drug interactions | Antipsychotics, Anxiolytics and Hypnotics Alprazolam Aripiprazole Buspirone Cariprazine Diazepam Haloperidol Midazolam (IV) Quetiapine Ramelteon Risperidone Suvorexant Monitor for adverse reactions. |
| Ibrutinib | drug interactions | … Crizotinib Dabrafenib Dasatinib Docetaxel; Prevention or Management: Ibrutinib Lapatinib Nilotinib Olaparib Pazopanib Sunitinib Trabectedin Trastuzumab-emtansine Vinca alkaloids; … |
| Idelalisib | drug interactions | Examples of Concomitant Drugs Within Class: Bortezomib Brentuximab-vedotin Busulfan Erlotinib Gefitinib Idelalisib Imatinib Ixabepilone; … |
| Imatinib | drug interactions | Examples of Concomitant Drugs Within Class: Bortezomib Brentuximab-vedotin Busulfan Erlotinib Gefitinib Idelalisib Imatinib Ixabepilone; … |
| Irinotecan | boxed warning | … ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone … |
| Isavuconazonium | drug interactions | Antihelminthics, Antifungals and Antiprotozoals Isavuconazonium Contraindicated during and 2 weeks after SPORANOX ® treatment. Praziquantel Monitor for adverse reactions. |
| Isoniazid | drug interactions | Examples of Concomitant Drugs Within Class: Isoniazid Rifampicin; Prevention or Management: Not recommended 2 weeks before and during SPORANOX ® treatment. |
| Ivabradine | boxed warning | … lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor … |
| Ivacaftor | drug interactions | Alitretinoin (oral) Cabergoline Cannabinoids Cinacalcet Galantamine Ivacaftor Monitor for adverse reactions. |
| Ivacaftor and lumacaftor | drug interactions | Lumacaftor/Ivacaftor Not recommended 2 weeks before, during, and 2 weeks after SPORANOX ® treatment. |
| Ixabepilone | drug interactions | Examples of Concomitant Drugs Within Class: Bortezomib Brentuximab-vedotin Busulfan Erlotinib Gefitinib Idelalisib Imatinib Ixabepilone; … |
| Ketoconazole | drug interactions | Although many of the clinical drug interactions in Table 1 are based on information with a similar azole antifungal, ketoconazole, these interactions are expected to occur with SPORANOX ® . |
| Lomitapide | boxed warning | … nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor, finerenone, voclosporin. |
| Loperamide | drug interactions | Gastrointestinal Drugs Cisapride Naloxegol Contraindicated during and 2 weeks after SPORANOX ® treatment. Aprepitant Loperamide Monitor for adverse reactions. |
| Lovastatin | boxed warning | … ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor, finerenone, voclosporin. |
| Lurasidone | boxed warning | … (ergonovine), ergotamine, methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride … |
| Maraviroc | drug interactions | Antivirals Daclatasvir Indinavir Maraviroc Monitor for adverse reactions. |
| Mavacamten | drug interactions | Cardiac Myosin Inhibitor Mavacamten Refer to the mavacamten prescribing information for detailed guidance including dosing and safety monitoring. |
| Meloxicam | drug interactions | Nonsteroidal Anti-Inflammatory Drugs Meloxicam Concomitant drug dose increase may be necessary. |
| Methadone | boxed warning | Some examples of drugs that are contraindicated for coadministration with SPORANOX ® Capsules are: methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as … |
| Methylergonovine | boxed warning | … dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine … |
| Methylprednisolone | drug interactions | … Prevention or Management: Fluticasone (inhalation) Fluticasone (nasal) Methylprednisolone Tacrolimus (IV) Tacrolimus (oral); Monitor for adverse reactions. … |
| Midazolam | boxed warning | … methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide … |
| Nadolol | drug interactions | … Tenofovir disoproxil fumarate Monitor for adverse reactions. Beta Blockers Nadolol Monitor for adverse reactions. |
| Naloxegol | boxed warning | … felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor, finerenone, voclosporin. |
| Nevirapine | drug interactions | Antivirals Efavirenz Nevirapine Not recommended 2 weeks before and during SPORANOX ® treatment. |
| Nilotinib | drug interactions | … Dasatinib Docetaxel; Prevention or Management: Ibrutinib Lapatinib Nilotinib Olaparib Pazopanib Sunitinib Trabectedin Trastuzumab-emtansine Vinca alkaloids; … |
| Nintedanib | drug interactions | … Gefitinib Idelalisib Imatinib Ixabepilone; Prevention or Management: Nintedanib Panobinostat Ponatinib Ruxolitinib Sonidegib Tretinoin (oral) Vandetanib; Monitor for adverse reactions. … |
| Nisoldipine | boxed warning | … irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil … |
| Olaparib | drug interactions | … Docetaxel; Prevention or Management: Ibrutinib Lapatinib Nilotinib Olaparib Pazopanib Sunitinib Trabectedin Trastuzumab-emtansine Vinca alkaloids; … |
| Omeprazole | drug interactions | … such as H 2 - receptor antagonists and proton pump inhibitors (e.g., omeprazole). |
| Oxybutynin | drug interactions | Dutasteride Oxybutynin Sildenafil (for erectile dysfunction) Tadalafil (for erectile dysfunction and benign prostatic hyperplasia) Tolterodine Monitor for adverse reactions. |
| Oxycodone | drug interactions | Alfentanil Buprenorphine (IV and sublingual) Oxycodone Based on clinical drug interaction information with itraconazole. Sufentanil Monitor for adverse reactions. |
| Pazopanib | drug interactions | … Docetaxel; Prevention or Management: Ibrutinib Lapatinib Nilotinib Olaparib Pazopanib Sunitinib Trabectedin Trastuzumab-emtansine Vinca alkaloids; … |
| Pemigatinib | drug interactions | Entrectinib Pemigatinib Talazoparib Refer to the entrectinib, pemigatinib and talazoparib prescribing information for dosing instructions if concomitant use cannot be avoided. |
| Phenobarbital | drug interactions | Anticonvulsants Phenobarbital Phenytoin Not recommended 2 weeks before and during SPORANOX ® treatment. |
| Phenytoin | drug interactions | Anticonvulsants Phenobarbital Phenytoin Not recommended 2 weeks before and during SPORANOX ® treatment. |
| Pimozide | boxed warning | … methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide … |
| Ponatinib | drug interactions | … Imatinib Ixabepilone; Prevention or Management: Nintedanib Panobinostat Ponatinib Ruxolitinib Sonidegib Tretinoin (oral) Vandetanib; Monitor for adverse reactions. … |
| Praziquantel | drug interactions | Antihelminthics, Antifungals and Antiprotozoals Isavuconazonium Contraindicated during and 2 weeks after SPORANOX ® treatment. Praziquantel Monitor for adverse reactions. |
| Quetiapine | drug interactions | Antipsychotics, Anxiolytics and Hypnotics Alprazolam Aripiprazole Buspirone Cariprazine Diazepam Haloperidol Midazolam (IV) Quetiapine Ramelteon Risperidone Suvorexant Monitor for adverse reactions. |
| Quinidine | boxed warning | Some examples of drugs that are contraindicated for coadministration with SPORANOX ® Capsules are: methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as … |
| Quinine | drug interactions | Concomitant drug dose reduction may be necessary. Artemether-lumefantrine Quinine Monitor for adverse reactions. |
| Ramelteon | drug interactions | Antipsychotics, Anxiolytics and Hypnotics Alprazolam Aripiprazole Buspirone Cariprazine Diazepam Haloperidol Midazolam (IV) Quetiapine Ramelteon Risperidone Suvorexant Monitor for adverse reactions. |
| Ranolazine | boxed warning | … midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor, finerenone, voclosporin. |
| Regorafenib | drug interactions | Examples of Concomitant Drugs Within Class: Regorafenib; Prevention or Management: Not recommended during and 2 weeks after SPORANOX ® treatment. |
| Repaglinide | drug interactions | Antidiabetic Drugs Repaglinide Saxagliptin Monitor for adverse reactions. |
| Rifabutin | drug interactions | Rifabutin Not recommended 2 weeks before, during, and 2 weeks after SPORANOX ® treatment. |
| Riociguat | drug interactions | Aliskiren Riociguat Sildenafil (for pulmonary hypertension) Tadalafil (for pulmonary hypertension) Not recommended during and 2 weeks after SPORANOX ® treatment. |
| Risperidone | drug interactions | Antipsychotics, Anxiolytics and Hypnotics Alprazolam Aripiprazole Buspirone Cariprazine Diazepam Haloperidol Midazolam (IV) Quetiapine Ramelteon Risperidone Suvorexant Monitor for adverse reactions. |
| Ritonavir | drug interactions | Cobicistat Elvitegravir (ritonavir-boosted) Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir Ritonavir Saquinavir (unboosted) Monitor for adverse reactions. |
| Rivaroxaban | drug interactions | Apixaban Rivaroxaban Vorapaxar Not recommended during and 2 weeks after SPORANOX ® treatment. Cilostazol Dabigatran Warfarin Monitor for adverse reactions. |
| Ruxolitinib | drug interactions | … Ixabepilone; Prevention or Management: Nintedanib Panobinostat Ponatinib Ruxolitinib Sonidegib Tretinoin (oral) Vandetanib; Monitor for adverse reactions. … |
| Salmeterol | drug interactions | Respiratory Drugs Salmeterol Not recommended during and 2 weeks after SPORANOX ® treatment. |
| Saxagliptin | drug interactions | Antidiabetic Drugs Repaglinide Saxagliptin Monitor for adverse reactions. |
| Sildenafil | drug interactions | Aliskiren Riociguat Sildenafil (for pulmonary hypertension) Tadalafil (for pulmonary hypertension) Not recommended during and 2 weeks after SPORANOX ® treatment. |
| Silodosin | drug interactions | Examples of Concomitant Drugs Within Class: Alfuzosin Silodosin Tamsulosin; Prevention or Management: Not recommended during and 2 weeks after SPORANOX ® treatment. |
| Simvastatin | boxed warning | … ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor, finerenone, voclosporin. |
| Sirolimus | drug interactions | Everolimus Sirolimus Temsirolimus (IV) Not recommended during and 2 weeks after SPORANOX ® treatment. |
| Solifenacin | boxed warning | Coadministration with colchicine, fesoterodine and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment. |
| Sonidegib | drug interactions | … Prevention or Management: Nintedanib Panobinostat Ponatinib Ruxolitinib Sonidegib Tretinoin (oral) Vandetanib; Monitor for adverse reactions. Concomitant drug dose reduction may be necessary. … |
| Sufentanil | drug interactions | Alfentanil Buprenorphine (IV and sublingual) Oxycodone Based on clinical drug interaction information with itraconazole. Sufentanil Monitor for adverse reactions. |
| Sunitinib | drug interactions | … Prevention or Management: Ibrutinib Lapatinib Nilotinib Olaparib Pazopanib Sunitinib Trabectedin Trastuzumab-emtansine Vinca alkaloids; Avoid use during and 2 weeks after SPORANOX ® treatment. |
| Suvorexant | drug interactions | Antipsychotics, Anxiolytics and Hypnotics Alprazolam Aripiprazole Buspirone Cariprazine Diazepam Haloperidol Midazolam (IV) Quetiapine Ramelteon Risperidone Suvorexant Monitor for adverse reactions. |
| Tacrolimus | drug interactions | … Management: Fluticasone (inhalation) Fluticasone (nasal) Methylprednisolone Tacrolimus (IV) Tacrolimus (oral); Monitor for adverse reactions. Concomitant drug dose reduction may be necessary. |
| Tadalafil | drug interactions | Aliskiren Riociguat Sildenafil (for pulmonary hypertension) Tadalafil (for pulmonary hypertension) Not recommended during and 2 weeks after SPORANOX ® treatment. |
| Talazoparib | drug interactions | Entrectinib Pemigatinib Talazoparib Refer to the entrectinib, pemigatinib and talazoparib prescribing information for dosing instructions if concomitant use cannot be avoided. |
| Tamsulosin | drug interactions | Examples of Concomitant Drugs Within Class: Alfuzosin Silodosin Tamsulosin; Prevention or Management: Not recommended during and 2 weeks after SPORANOX ® treatment. |
| Temsirolimus | drug interactions | Everolimus Sirolimus Temsirolimus (IV) Not recommended during and 2 weeks after SPORANOX ® treatment. |
| Tenofovir disoproxil | drug interactions | Elbasvir/grazoprevir Not recommended during and 2 weeks after SPORANOX ® treatment. Glecaprevir/pibrentasvir Monitor for adverse reactions. … |
| Ticagrelor | boxed warning | … cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor, finerenone, voclosporin. |
| Tolterodine | drug interactions | Dutasteride Oxybutynin Sildenafil (for erectile dysfunction) Tadalafil (for erectile dysfunction and benign prostatic hyperplasia) Tolterodine Monitor for adverse reactions. |
| Tolvaptan | drug interactions | Vasopressin Receptor Antagonists Conivaptan Tolvaptan Not recommended during and 2 weeks after SPORANOX ® treatment. |
| Trabectedin | drug interactions | … Management: Ibrutinib Lapatinib Nilotinib Olaparib Pazopanib Sunitinib Trabectedin Trastuzumab-emtansine Vinca alkaloids; Avoid use during and 2 weeks after SPORANOX ® treatment. |
| Tretinoin | drug interactions | … Management: Nintedanib Panobinostat Ponatinib Ruxolitinib Sonidegib Tretinoin (oral) Vandetanib; Monitor for adverse reactions. Concomitant drug dose reduction may be necessary. … |
| Triazolam | boxed warning | … (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin … |
| Ulipristal | drug interactions | Contraceptives CYP3A4 inhibitors (including itraconazole) may increase systemic contraceptive hormone concentrations. Dienogest Ulipristal Monitor for adverse reactions. |
| Valbenazine | drug interactions | Valbenazine Concomitant drug dose reduction is necessary. |
| Vandetanib | drug interactions | … Nintedanib Panobinostat Ponatinib Ruxolitinib Sonidegib Tretinoin (oral) Vandetanib; Monitor for adverse reactions. Concomitant drug dose reduction may be necessary. For idelalisib, see also. |
| Vardenafil | drug interactions | Darifenacin Vardenafil Not recommended during and 2 weeks after SPORANOX ® treatment. |
| Venetoclax | boxed warning | 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. |
| Venlafaxine | drug interactions | SSRIs, Tricyclics and Related Antidepressants Venlafaxine Monitor for adverse reactions. |
| Verapamil | drug interactions | Diltiazem Other dihydropyridines Verapamil Monitor for adverse reactions. |
| Voclosporin | boxed warning | … lomitapide, lovastatin, simvastatin, avanafil, ticagrelor, finerenone, voclosporin. |
| Warfarin | drug interactions | Apixaban Rivaroxaban Vorapaxar Not recommended during and 2 weeks after SPORANOX ® treatment. Cilostazol Dabigatran Warfarin Monitor for adverse reactions. |
Other labels that name itraconazole
- Acalabrutinib
- Afatinib
- Alosetron
- Amlodipine
- Aripiprazole lauroxil
- Atazanavir
- Atogepant
- Avacopan
- Bexarotene
- Calcifediol
- Dexlansoprazole
- Doxazosin
- Dronabinol
- Drospirenone and ethinyl estradiol
- Drospirenone and ethinyl estradiol and levomefolate
- Esomeprazole
- Estazolam
- Estradiol
- Estrogens conjugated
- Ethinyl estradiol and ferrous bisglycinate and levonorgestrel
- Ethinyl estradiol and ferrous fumarate and levonorgestrel
- Ethinyl estradiol and levonorgestrel
- Ethinyl estradiol and norelgestromin
- Ethinyl estradiol and norgestimate
- Ethinyl estradiol and segesterone
- Etonogestrel
- Etravirine
- Famotidine and ibuprofen
- Fluticasone and salmeterol
- Gemfibrozil
- Hydrocortisone
- Lansoprazole
- Lemborexant
- Leniolisib
- Levomilnacipran
- Micafungin
- Mifepristone
- Mometasone
- Naldemedine
- Nifedipine
- Nimodipine
- Norethindrone
- Oliceridine
- Osilodrostat
- Paclitaxel
- Palbociclib
- Pantoprazole
- Paricalcitol
- Rabeprazole
- Rilpivirine
- Thiotepa
- Toremifene
- Trastuzumab emtansine
- Trazodone
- Ubrogepant
- Umeclidinium and vilanterol
- Vamorolone
- Vilazodone
- Vincristine
- Vonoprazan
- Zolpidem
Source: FDA drug label (SPORANOX), Janssen Pharmaceuticals, Inc., effective July 13, 2026 (SPL set a4d555fa-787c-40fb-bb7d-b0d4f7318fd0), via openFDA; the full label on DailyMed
What do FAERS reports show for itraconazole?
The FDA Adverse Event Reporting System holds 11,610 reports that list itraconazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,259 are coded as a death and 4,411 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as itraconazole?
8 other medicines are given the same way (oral) and in the same FDA class as itraconazole or labeled mainly for the same use (fungal infections), the same class first. Fungal infections lists all 33 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Fluconazole | Fungal infections | 38 labelers | $0.380 per tablet 200 mg tablet | No current entry |
| Voriconazole | Fungal infections | 21 labelers | $1.88 per tablet 200 mg tablet | A presentation being discontinued |
| Posaconazole | Fungal infections | 21 labelers | $2.03 per tablet 100 mg tablet | A presentation being discontinued |
| Clotrimazole | Fungal infections | 3 labelers | $0.292 per troche 10 mg troche | No current entry |
| Terbinafine | Fungal infections | 22 labelers | $0.143 per tablet 250 mg tablet | No current entry |
| Nystatin | Fungal infections | 21 labelers | $0.0569 per mL 100,000 unit/mL suspension | No current entry |
| Griseofulvin | Fungal infections | 10 labelers | $3.74 per tablet 250 mg tablet | No current entry |
| Flucytosine | Fungal infections | 9 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as itraconazole
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does itraconazole compare with medicines for the same use?
6 side-by-side pages set itraconazole beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to itraconazole
- 8 medicines for the same use
- Other azole antifungals
- the pharmacologic class, with prices and generics
- Itraconazole side effects
- the label's list beside FAERS reports
- Itraconazole shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other