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Itraconazole

Itraconazole is an azole antifungal used to treat serious fungal infections such as blastomycosis, histoplasmosis and aspergillosis, nail fungus (certain capsules), and thrush in the mouth and throat or esophagus (oral solution).

Brand names OnmelSporanoxTolsura
Drug class Azole Antifungal
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 15 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

How we combine label and product data →
Itraconazole at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Itraconazole is an azole antifungal, around since the early 1990s and available as a generic, that blocks fungi from making ergosterol, a building block of their cell membranes; it is a standard choice for blastomycosis and histoplasmosis and treats aspergillosis, nail fungus (capsules) and thrush (oral solution). Most people tolerate it reasonably well, and nausea, diarrhea or headache are what they usually notice. Its boxed warning covers heart failure and dangerous drug interactions, and it can injure the liver, so report breathing trouble, leg or ankle swelling, or yellow skin quickly. Give every prescriber your full medicine list, since it raises levels of many other drugs.

Clinical pearls

  • Take the capsules with a full meal, but the oral solution works best on an empty stomach, swished then swallowed.
  • Capsules, oral solution and Tolsura are not interchangeable, so check that each refill matches what was prescribed.
  • Simvastatin and lovastatin are off-limits, and interactions can linger about two weeks after your last dose.
  • Capsules should not be used for nail fungus if you have heart failure, are pregnant or are planning pregnancy.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Itraconazole can cause or worsen heart failure, and it can interact dangerously with many other medicines. This boxed warning appears on the Tolsura label.

Watch for shortness of breath, leg or ankle swelling, and unusual tiredness. Tell your doctor right away if these appear or get worse, because your doctor may need to reconsider treatment.

Some medicines are not safe with itraconazole because it raises their blood levels. This can cause serious, potentially fatal heart rhythm problems (QT prolongation and torsades de pointes). Always share your full medicine list with your doctor and pharmacist.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asCapsule, Oral solution
Earliest FDA record1992
Companies listing it with the FDA45
FDA label last updatedJan 28, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide — a plain-language walkthrough of Itraconazole, written from its FDA label.

What Itraconazole is used for

▾

Itraconazole treats several fungal infections, depending on the product.

  • Blastomycosis, histoplasmosis and aspergillosis: itraconazole capsules, including Sporanox and Tolsura. Aspergillosis use is for people who cannot tolerate or have not responded to amphotericin B.
  • Toenail and fingernail fungus (onychomycosis) in people with normal immune systems: Sporanox and itraconazole capsules only, not Tolsura.
  • Oropharyngeal and esophageal candidiasis (thrush): itraconazole oral solution only.

How Itraconazole works

▾

Itraconazole is an azole antifungal. It blocks a fungal enzyme-driven step that makes ergosterol, a vital part of fungal cell membranes. Without enough ergosterol, the fungus cannot maintain healthy membranes.

Itraconazole dosage

▾

Itraconazole is taken by mouth as capsules or an oral solution. They are different preparations and should not be swapped.

  • Sporanox and itraconazole capsules: take with a full meal and swallow whole.
  • Tolsura: take with food, swallow whole, and do not chew, crush or break. It is not interchangeable with other itraconazole products.
  • Oral solution: swish in the mouth for several seconds, then swallow. Take without food if possible.

Serious infections usually need at least three months of treatment, and stopping too soon can allow the infection to return. Follow your prescriber and the label for dose and duration.

Dosing details from the FDA-approved label

From the Itraconazole prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Treatment of Blastomycosis and Histoplasmosis
    • 200 mg once daily (2 capsules)
    • If no obvious improvement or evidence of progressive fungal disease, increase in 100-mg increments
    • Doses above 200 mg/day should be given in two divided doses. (Tolsura: 130 mg (2 × 65 mg capsules) once daily, increased in 65 mg increments)
    • Maximum: 400 mg daily (Tolsura: 260 mg/day)
    • Capsules taken with a full meal (Tolsura with food); swallow whole
  • Treatment of Aspergillosis
    • A daily dose of 200 to 400 mg (Tolsura: 130 mg (2 × 65 mg capsules) once daily, or 260 mg/day as 130 mg twice daily)
    • Capsules taken with a full meal; swallow whole
  • Treatment in Life-Threatening Situations
    • Loading dose of 200 mg (2 capsules) three times daily (600 mg/day) for the first 3 days (Tolsura: 130 mg (2 × 65 mg capsules) three times daily (390 mg/day) for the first 3 days, then the dose for the indication)
    • Continue treatment for a minimum of three months and until clinical parameters and laboratory tests indicate the active fungal infection has subsi
    • Loading dose based on pharmacokinetic data, not clinical studies
  • Onychomycosis of the toenails with or without fingernail involvement
    • 200 mg (2 capsules) once daily for 12 consecutive weeks
    • Take with a full meal
  • Onychomycosis of the fingernails only
    • 2 treatment pulses, each consisting of 200 mg (2 capsules) b.i.d. (400 mg/day) for 1 week
    • Pulses separated by a 3-week period without itraconazole
    • Take with a full meal
  • Oropharyngeal candidiasis (oral solution)
    • 200 mg (20 mL) daily for 1 to 2 weeks
    • Swish vigorously in the mouth (10 mL at a time) for several seconds and swallow
    • If unresponsive/refractory to fluconazole tablets: 100 mg (10 mL) b.i.d
    • Take oral solution without food, if possible
  • Esophageal candidiasis (oral solution)
    • 100 mg (10 mL) daily for a minimum treatment of three weeks
    • Continue for 2 weeks following resolution of symptoms
    • Maximum: Doses up to 200 mg (20 mL) per day may be used based on medical judgment
    • Take oral solution without food, if possible
  • Patients with renal impairment
    • Limited data are available on the use of oral itraconazole in patients with renal impairment
    • Caution should be exercised
  • Patients with hepatic impairment
    • Limited data are available on the use of oral itraconazole in patients with hepatic impairment
    • Caution should be exercised
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION Itraconazole Capsules should be taken with a full meal to ensure maximal absorption. Itraconazole Capsules must be swallowed whole. Itraconazole Capsules are a different preparation than SPORANOX ® (itraconazole) Oral Solution and should not be used interchangeably. Treatment of Blastomycosis and Histoplasmosis The recommended dose is 200 mg once daily (2 capsules). If there is no obvious improvement, or there is evidence of progressive fungal disease, the dose should be increased in 100-mg increments to a maximum of 400 mg daily. Doses above 200 mg/day should be given in two divided doses. Treatment of Aspergillosis A daily dose of 200 to 400 mg is recommended. Treatment in Life-Threatening Situations In life-threatening situations, a loading dose should be used. Although clinical studies did not provide for a loading dose, it is recommended, based on pharmacokinetic data, that a loading dose of 200 mg (2 capsules) three times daily (600 mg/day) be given for the first 3 days of treatment. Treatment should be continued for a minimum of three months and until clinical parameters and laboratory tests indicate that the active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Itraconazole Capsules and SPORANOX ® (itraconazole) Oral Solution should not be used interchangeably. Only the Oral Solution has been demonstrated effective for oral and/or esophageal candidiasis. Treatment of Onychomycosis Toenails with or without fingernail involvement The recommended dose is 200 mg (2 capsules) once daily for 12 consecutive weeks. Treatment of Onychomycosis Fingernails only The recommended dosing regimen is 2 treatment pulses, each consisting of 200 mg (2 capsules) b.i.d. (400 mg/day) for 1 week. The pulses are separated by a 3-week period without itraconazole. Use in Patients with Renal Impairment Limited data are available on the use of oral itraconazole in patients with renal impairment. Caution should be exercised when this drug is administered in this patient population. (See CLINICAL PHARMACOLOGY: Special Populations and PRECAUTIONS .) Use in Patients with Hepatic Impairment Limited data are available on the use of oral itraconazole in patients with hepatic impairment. Caution should be exercised when this drug is administered in this patient population.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Itraconazole side effects

▾

Common side effects

  • Nausea
  • Diarrhea
  • Vomiting
  • Abdominal pain
  • Fever
  • Rash
  • Headache
  • Cough

When to get medical help

  • Call your doctor right away if you have new or worsening shortness of breath, swelling in your legs or feet, or unusual tiredness. These can be signs of heart failure.
  • Get help if you notice signs of liver problems, such as yellow skin or eyes. Itraconazole has caused serious liver injury, including liver failure and death.
  • Seek urgent care for a racing, pounding or irregular heartbeat or fainting. Some drug combinations can cause dangerous heart rhythm problems.
  • Tell your doctor about new or worsening high blood pressure or low potassium (pseudoaldosteronism).
  • Report numbness, tingling or other nerve symptoms, especially with long-term use.
  • Tell your doctor about any hearing loss. It can be reversible or permanent.
  • Stop the drug and get help for allergic reactions such as hives, swelling or trouble breathing, or for severe skin reactions.

In trials of the oral solution, the most common side effects were:

  • Nausea and vomiting
  • Diarrhea
  • Abdominal pain
  • Fever
  • Rash
  • Headache
  • Cough

Seek help for signs of heart failure, liver problems, severe allergic or skin reactions, nerve symptoms or hearing loss.

Itraconazole warnings and precautions

▾
  • Heart failure: itraconazole can cause or worsen it. Watch for shortness of breath, swelling and unusual tiredness.
  • Liver injury: serious cases, including liver failure and death, have occurred, sometimes in the first week.
  • Heart rhythm problems: life-threatening rhythm problems and sudden death have occurred with certain drug combinations.
  • Pseudoaldosteronism: high blood pressure with low potassium. Blood pressure and potassium should be monitored.
  • Nerve damage and hearing loss: reported, with nerve problems seen during long-term use.
  • Allergic reactions: including anaphylaxis and severe skin reactions have been reported.

Itraconazole interactions

▾

Itraconazole strongly blocks CYP3A4 and affects drug transporters, so it can raise levels of many drugs.

  • Methadone, quinidine, dofetilide, dronedarone, disopyramide, pimozide: contraindicated because of dangerous heart rhythm risk.
  • Simvastatin and lovastatin: contraindicated.
  • Felodipine and nisoldipine: contraindicated, and other calcium channel blockers can add to heart failure risk.
  • Oral midazolam, triazolam, lurasidone: contraindicated.
  • Ergot migraine drugs, irinotecan, ticagrelor, eplerenone, finerenone, ranolazine, ivabradine: contraindicated.
  • Colchicine, fesoterodine, solifenacin: contraindicated with kidney or liver impairment. Eliglustat: contraindicated in certain CYP2D6 situations.
  • Venetoclax: contraindicated during starting and ramp-up in CLL/SLL.
  • Many others (for example blood thinners, some cancer drugs, rifabutin, carbamazepine) need monitoring, dose changes or avoidance. Effects can last about 2 weeks after stopping.

Interactions listed in the FDA-approved label

From the Itraconazole prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Methadone, disopyramide, dofetilide, dronedarone, quinidine (CYP3A4 substrates): Plasma concentrations of these drugs increase, which can lead to QT prolongation and ventricular tachyarrhythmias including torsade de pointes. Contraindicated during and 2 weeks after itraconazole treatment.
  • Ergot alkaloids (dihydroergotamine, ergotamine, etc.): Itraconazole increases concomitant drug concentrations and may increase risk of adverse reactions. Contraindicated during and 2 weeks after itraconazole treatment.
  • Lovastatin, simvastatin, triazolam, oral midazolam, pimozide, lurasidone: Plasma concentrations increase, which may increase or prolong pharmacologic effects and adverse reactions. Contraindicated with itraconazole (lurasidone, oral midazolam, pimozide, triazolam: during and 2 weeks after treatment).
  • Venetoclax: Potential for an increased risk of tumor lysis syndrome in CLL/SLL patients during dose initiation and ramp-up. Contraindicated during the dose initiation and ramp-up phase in patients with CLL/SLL; refer to venetoclax prescribing information.
  • Colchicine, fesoterodine, solifenacin: Concentrations increase in subjects with varying degrees of renal or hepatic impairment. Contraindicated in subjects with renal or hepatic impairment.
  • Eliglustat: Concentrations increase in CYP2D6 poor or intermediate metabolizers and with strong or moderate CYP2D6 inhibitors. Contraindicated in those subjects.
  • Felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, finerenone, ticagrelor: Itraconazole increases concomitant drug concentrations and may increase risk of adverse reactions. Contraindicated during and 2 weeks after itraconazole treatment.
  • Alpha blockers (alfuzosin, silodosin, tamsulosin): Itraconazole increases concomitant drug concentrations and may increase risk of adverse reactions. Not recommended during and 2 weeks after itraconazole treatment.
  • Rifabutin, carbamazepine: Interaction affecting concomitant drug concentrations (see Table 2 in label). Not recommended 2 weeks before, during, and 2 weeks after itraconazole treatment.
  • Digoxin, warfarin, dabigatran, cilostazol: Itraconazole increases concomitant drug concentrations and may increase risk of adverse reactions. Monitor for adverse reactions. Concomitant drug dose reduction may be necessary.
Read the label’s full interactions text

Drug Interactions: Co-administration of a number of CYP3A4 substrates are contraindicated with itraconazole. Some examples of drugs for which plasma concentrations increase 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. In addition, co-administration with colchicine, fesoterodine, and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment, and co-administration with eliglustat is contraindicated in subjects that are poor or intermediate metabolizers of CYP2D6 and in subjects taking strong or moderate CYP2D6 inhibitors (see PRECAUTIONS: Drug Interactions Section for specific examples). This increase in drug concentrations caused by co-administration with itraconazole 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. Some specific examples are listed in PRECAUTIONS: Drug Interactions . Co-administration with venetoclax is contraindicated in patients with CLL/SLL during the dose initiation and ramp-up phase of venetoclax due to the potential for an increased risk of tumor lysis syndrome. Itraconazole oral solution is contraindicated for patients who have shown hypersensitivity to itraconazole. There is limited information regarding cross-hypersensitivity between itraconazole and other azole antifungal agents.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿182 supplements and herbs with documented Itraconazole interactions, ranked by severity Check Itraconazole against a supplement or herb →

Before taking Itraconazole

▾
  • Do not use if you are allergic to itraconazole. Tell your doctor about allergies to other azoles.
  • Heart failure or a history of it: itraconazole capsules should not be used for nail fungus. For other uses, risks and benefits must be weighed carefully.
  • Pregnancy: capsules should not be used for nail fungus in pregnant women or those planning pregnancy. Animal studies showed harm to the fetus at high doses.
  • Breastfeeding: itraconazole passes into breast milk.
  • Liver disease or past liver toxicity: treatment is strongly discouraged unless the benefit clearly outweighs the risk.
  • Kidney impairment: limited data, so careful monitoring is advised.
  • Children: safety and effectiveness have not been established for Tolsura.
  • Older adults: more likely to have reduced liver, kidney or heart function. Hearing loss has been reported.

Itraconazole overdose

▾

Itraconazole cannot be removed by dialysis. Overdose effects are generally the same as the known side effects. Supportive care is used, and you should call poison control at 1-800-222-1222.

How your body processes Itraconazole

▾

Itraconazole is mostly bound to proteins in the blood and spreads widely into tissues, including skin and nails. It is heavily processed by the liver, mainly through CYP3A4, into an active metabolite (hydroxy-itraconazole). With Tolsura, steady levels build up over about 15 days and the half-life is roughly 34 to 42 hours. Most of the drug leaves as inactive metabolites in urine and feces. In nails, itraconazole can persist for at least six months after a 3-month course.

How to store Itraconazole

▾

Store at 25°C (77°F); excursions permitted 15°C to 30°C (59°F to 86°F) . Dispense in a tight, light resistant container.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

182

Supplements & herbs that interact with Itraconazole

182 supplements and herbal products have documented interactions with Itraconazole in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 6
  • Moderate · 136
  • Minor · 40
ACTIVATED CHARCOAL Major BEER Major GRAPEFRUIT Major SIBERIAN COCKLEBUR Major ST. JOHN'S WORT Major WINE Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate +174 more
Every supplement checked against Itraconazole — ranked by severity The full interaction hub: 6 major · 136 moderate · 40 minor · every one linked to its full report. Check Itraconazole against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Itraconazole: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Itraconazole — the kind of thing our pharmacy team would talk through with you at the counter.

What is itraconazole used for?

▾
It treats fungal infections. The capsules treat blastomycosis, histoplasmosis and aspergillosis, and some capsules also treat nail fungus. The oral solution treats thrush in the mouth, throat and esophagus. Which one you get depends on your infection.

How should I take it?

▾
Capsules go down whole with a full meal, since food helps you absorb them. Tolsura also needs food. The oral solution is swished in your mouth and swallowed, ideally without food. Don’t switch between forms on your own.

What side effects should I expect?

▾
Nausea, diarrhea, vomiting, stomach pain, rash and headache are the more common ones. Call your doctor if you have trouble breathing, swelling in your legs, yellow skin or eyes, or numbness and tingling. Those can be serious.

Can I take my other medicines with it?

▾
Not always. Itraconazole raises levels of many drugs, and some, like simvastatin, methadone and quinidine, must never be combined with it. Give me your full list, including over-the-counter products, so we can check.

Is it safe in pregnancy or if I have heart problems?

▾
The capsules should not be used for nail fungus in pregnancy, and animal studies showed fetal harm at high doses. If you have heart failure or a history of it, tell your doctor, since itraconazole can worsen it. Your doctor will weigh the benefits and risks for you.

Is Itraconazole available over the counter?

▾
No. Itraconazole is a prescription medicine: every Itraconazole product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Itraconazole first available?

▾
The earliest FDA record we hold for Itraconazole is from 1992: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Itraconazole was first used.

Who makes Itraconazole?

▾
45 companies list Itraconazole products in the FDA's NDC Directory, including Amneal Pharmaceuticals LLC, Janssen Pharmaceuticals, Inc., Alembic Pharmaceuticals Inc.. That count includes repackagers and distributors as well as manufacturers, so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Itraconazole on HelloPharmacist

📊Itraconazole supplement interactions182 checked — ranked by severity 🌿Drug & Supplement CheckerItraconazole vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Itraconazole NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Itraconazole Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Itraconazole forms and strengths (how it comes)

Itraconazole is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
Brands Sporanox Tolsura
How this form is used
What it may be used for
  • Sporanox and itraconazole capsules treat blastomycosis, histoplasmosis and aspergillosis (after amphotericin B intolerance or failure).
  • Sporanox and itraconazole capsules also treat toenail and fingernail fungus in people with normal immune systems.
  • Tolsura treats blastomycosis, histoplasmosis and aspergillosis in adults, and is not for nail fungus.
Important instructions
  • Sporanox and itraconazole capsules should be taken with a full meal and swallowed whole.
  • Tolsura must be taken with food, and swallowed whole without chewing, crushing or breaking.
  • Tolsura is not interchangeable with other itraconazole products.
  • Sporanox and itraconazole capsules should not be used in place of the oral solution.
Available strengths 2 strengths
65 mg 100 mg
48 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Sporanox
How this form is used
What it may be used for
  • Itraconazole oral solution treats thrush of the mouth and throat (oropharyngeal candidiasis) and of the esophagus (esophageal candidiasis).
Important instructions
  • Itraconazole oral solution is swished vigorously in the mouth for several seconds, then swallowed.
  • Itraconazole oral solution is taken without food if possible.
  • Itraconazole oral solution and capsules should not be used interchangeably.
Available strengths 1 strength
10 mg/mL
13 FDA-listed product records ⓘ

Itraconazole on the U.S. market: products, makers and brands

How Itraconazole appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

45 companies list 81 Itraconazole product records with the FDA, mostly as capsule, oral solution; the earliest marketing or approval year on record is 1992. Brand names on the directory include Onmel, Sporanox, Tolsura; the rest are generics.

2
Dose forms ⓘ
45
Labelers (makers, repackagers, distributors)
4
Brand names
81
FDA-listed product records ⓘ
1992
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (19) · Pellet (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Amneal Pharmaceuticals LLC11%
Janssen Pharmaceuticals, Inc.8%
Alembic Pharmaceuticals Inc.5%
Torrent Pharmaceuticals Limited5%
Ascend Laboratories, LLC4%
AvPAK4%
Other makers63%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Itraconazole is used (Medicaid data)

A general measure of how commonly Itraconazole is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Itraconazole is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

17,092
Medicaid prescriptions filled (Q1–Q4 2025)
$2.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Itraconazole prescribed? Of the 1,601 medications we measure, Itraconazole ranks #828 by Medicaid prescriptions — more than 48% of them.

Where Itraconazole ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #828 of 1,601
#823 Fenfluramine 17,553 Rx #824 Fam-trastuzumab deruxt... 17,489 Rx #825 Oxymetazoline Nasal Sp... 17,358 Rx #826 Arformoterol Oral Inha... 17,345 Rx #827 Colesevelam 17,250 Rx #828 Itraconazole 17,092 Rx #829 Potassium Acetate 16,989 Rx #830 Theophylline 16,886 Rx #831 Raltegravir 16,834 Rx #832 Glyburide and Metformi... 16,761 Rx #833 Travoprost Ophthalmic 16,632 Rx

Utilization by Itraconazole product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 100 mg oral capsule is the most-dispensed Itraconazole product — about 93% of these Medicaid prescriptions.

itraconazole 100 MG Oral Capsule Most dispensed

15,846 Medicaid prescriptions (Q1–Q4 2025) 93% of Itraconazole prescriptions shown $1.8M gross reimbursement (before rebates) ≈ $112 per prescription (gross)

Summed across the 9 of 59 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311204

itraconazole 10 MG/ML Oral Solution

1,216 Medicaid prescriptions (Q1–Q4 2025) 7% of Itraconazole prescriptions shown $518,033 gross reimbursement (before rebates) ≈ $426 per prescription (gross)

Summed across the 2 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 348506

itraconazole 65 MG Oral Capsule

30 Medicaid prescriptions (Q1–Q4 2025) <1% of Itraconazole prescriptions shown $72,325 gross reimbursement (before rebates) ≈ $2,411 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2106642

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Itraconazole, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 12 of 71 listed Itraconazole NDCs with Medicaid activity.

Compare Itraconazole products

A representative set of FDA-listed product records for Itraconazole — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 81 of 81 products — FDA National Drug Code Directory. See every product, package size and price: browse all 81 Itraconazole NDCs →

Itraconazole recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Itraconazole recalls since July 2021.

✅No Itraconazole recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Itraconazole RxCUI 28031 4 dose forms · 5 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 377223 No current FDA listing
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 311205
  2. Dose form (SCDF) Oral Capsule RxCUI 370725 In current FDA listings
    Clinical drug / strength (SCD) 65 MG RxCUI 2106642 100 MG RxCUI 311204
  3. Dose form (SCDF) Oral Solution RxCUI 378651 In current FDA listings
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 348506
  4. Dose form (SCDF) Oral Tablet RxCUI 440925 No current FDA listing
    Clinical drug / strength (SCD) 200 MG RxCUI 992413

Look up RxCUI 28031 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Itraconazole brand names

Itraconazole is sold under 3 brand names in the FDA directory — Onmel, Sporanox, Tolsura. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Onmel Sporanox Tolsura

Who makes Itraconazole: manufacturers and labelers

45 companies list Itraconazole products with the FDA. By number of product records, the largest are Amneal Pharmaceuticals LLC, Janssen Pharmaceuticals, Inc., Alembic Pharmaceuticals Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Amneal Pharmaceuticals LLC 8 Janssen Pharmaceuticals, Inc. 6 Alembic Pharmaceuticals Inc. 4 Torrent Pharmaceuticals Limited 4 Ascend Laboratories, LLC 3 AvPAK 3 Remedyrepack Inc. 3 Camber Pharmaceuticals, Inc. 3 Patriot Pharmaceuticals 3 Mayne Pharma Commercial LLC 2 Accord Healthcare Inc. 2 Rising Pharma Holdings, Inc. 2 Patriot Pharmaceuticals, LLC 2 Par Pharmaceutical, Inc. 2 NorthStar RxLLC 2 American Health Packaging 2 Alembic Pharmaceuticals Limited 2 Derivados Quimicos SAU 1 Alivus Life Sciences Limited 1 Zydus Pharmaceuticals USA Inc. 1 SMS Pharmaceuticals Limited 1 Smilax Laboratories Limited 1 Aurore Pharmaceuticals Private Limited 1 Bryant Ranch Prepack 1

…and 21 more on the FDA NDC directory.

Itraconazole drug class (RxNorm)

Itraconazole belongs to the Azole Antifungal class.

Pharmacologic class Azole Antifungal
Drug family (ATC) Triazole and tetrazole derivatives
How it works Cytochrome P450 3A4 Inhibitors, P-Glycoprotein Inhibitors, Breast Cancer Resistance Protein Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Itraconazole page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 28, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Itraconazole.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Itraconazole after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
15
Finished products in the current FDA directory
81
Companies listing them (makers, repackagers, distributors)
45
Linked representative label ⓘ
Patriot Pharmaceuticals
Linked label effective
Jan 28, 2025
Composite sections available
24
Linked SPL Set ID
6242b7ad-eaa0-a524-b6e0-ec33e63407db
Linked SPL Document ID
2cca3625-96e8-34cf-e063-6294a90ac975
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Patriot Pharmaceuticals is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →