Posaconazole
Posaconazole is an azole antifungal used to treat invasive aspergillosis, to help prevent serious Aspergillus and Candida infections in people with severely weakened immune systems, and (as an oral suspension) to treat thrush in the mouth and throat.
🧬 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 26 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 →
Posaconazole is a powerful azole antifungal, a specialist medicine on the market since about 2006 and available generically, that blocks fungi from making ergosterol, a key cell membrane component, and is used to treat invasive aspergillosis, prevent serious Aspergillus and Candida infections in people with severely weakened immune systems, and (as the oral suspension) treat thrush. Most people tolerate it reasonably well, and nausea, diarrhea and headache are the common complaints. Its two real risks are drug interactions, because it strongly blocks CYP3A4 (a liver enzyme that clears many medicines), and heart rhythm changes, so share your full medicine list and report a racing heartbeat or fainting.
Clinical pearls
- Take the oral suspension with a full meal, and never swap it for the delayed-release tablets, which are dosed differently.
- Atorvastatin, simvastatin and lovastatin must not be taken with it, so tell whoever prescribes your cholesterol medicine.
- Severe vomiting or diarrhea can stop it from being absorbed and let fungal infections break through, so report it promptly.
- Your team will check liver tests, potassium, magnesium and blood pressure, and adjust tacrolimus or cyclosporine if you take them.
Patient information guide A plain-language walkthrough of Posaconazole, written from its FDA label.
What Posaconazole is used for
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Posaconazole is used for serious fungal infections, with uses that vary by product.
- Invasive aspergillosis (treatment): Noxafil and posaconazole injection, and delayed-release tablets in some products.
- Prevention of invasive Aspergillus and Candida infections in severely immunocompromised people, such as stem cell transplant recipients with graft-versus-host disease or people with blood cancers and prolonged neutropenia: injection, delayed-release tablets and oral suspension.
- Oropharyngeal candidiasis, including thrush that has not responded to itraconazole or fluconazole: oral suspension only (adults and children 13 and older).
How Posaconazole works
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Posaconazole is an azole antifungal. It blocks a fungal enzyme (lanosterol 14α-demethylase) needed to make ergosterol, a key part of the fungal cell membrane. Ergosterol drops and abnormal precursors build up, which weakens the membrane.
Posaconazole dosage
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Posaconazole is taken by mouth or given by intravenous infusion, depending on the product.
- Delayed-release tablets: with or without food.
- Oral suspension: with a full meal.
- Injection: a nurse or clinician gives it over about 90 minutes through a central line.
- Treatment often starts with a loading phase on day 1, then once daily. Forms are not interchangeable.
Follow your prescriber's directions and ask your pharmacist what to do about a missed dose.
Dosing details from the FDA-approved label
From the Posaconazole 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 Invasive Aspergillosis (adults)
- Noxafil Injection: Loading dose 300 mg intravenously twice a day on the first day
- Maintenance dose 300 mg intravenously once a day starting on the second day
- Noxafil Delayed-Release Tablets: Loading dose 300 mg (three 100 mg delayed-release tablets) twice a day on the first day
- Maintenance dose 300 mg (three 100 mg delayed-release tablets) once a day star
- Loading dose: 1 day. Recommended total duration of therapy is 6 to 12 weeks. Switching between injection and delayed-release tablets is acceptable; no loading dose required when switching.
- Prophylaxis of Invasive Aspergillus and Candida Infections (adults) - Injection and Delayed-Release Tablets
- Noxafil Injection: Loading dose 300 mg intravenously twice a day on the first day
- Maintenance dose 300 mg intravenously once a day thereafter
- Noxafil Delayed-Release Tablets: Loading dose 300 mg (three 100 mg tablets) twice a day on the first day
- Maintenance dose 300 mg (three 100 mg tablets) once a day starting on the second day
- Duration of therapy is based on recovery from neutropenia or immunosuppression
- Prophylaxis of Invasive Aspergillus and Candida Infections (adults) - Oral Suspension
- 200 mg (5 mL) three times a day
- Administer with a full meal; duration based on recovery from neutropenia or immunosuppression
- Oropharyngeal Candidiasis (OPC) (adults)
- Noxafil Oral Suspension: Loading dose 100 mg (2.5 mL) twice a day on the first day
- Maintenance dose 100 mg (2.5 mL) once a day thereafter
- Loading dose: 1 day; Maintenance dose: 13 days
- OPC Refractory (rOPC) to Itraconazole and/or Fluconazole (adults)
- Noxafil Oral Suspension: 400 mg (10 mL) twice a day
- Duration of therapy is based on the severity of the patient's underlying disease and clinical response
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Noxafil formulations are supplied in different dose strengths of posaconazole, are approved for different indications, age groups, and weights, have different dosages and duration of therapy; and have different preparation and administration instructions. ( 2.1 ) Noxafil oral suspension is not substitutable with Noxafil delayed-release tablets or Noxafil PowderMix for delayed-release oral suspension due to the differences in the dosing of each formulation. Therefore, follow the specific dosage recommendations for each of the formulations. ( 2.1 , 2.2 , 2.3 ) Noxafil injection must be administered through an in-line filter. ( 2.6 ) Administer Noxafil injection by intravenous infusion over approximately 90 minutes via a central venous line. ( 2.1 , 2.6 ) Do NOT administer Noxafil injection as an intravenous bolus injection. ( 2.1 ) Administer Noxafil delayed-release tablets with or without food. ( 2.1 ) Administer Noxafil oral suspension with a full meal. ( 2.1 ) Administer Noxafil PowderMix for delayed-release oral suspension with food. ( 2.1 ) Administer Noxafil PowderMix for delayed-release oral suspension with the provided notched tip syringes only. ( 2.1 ) See the full prescribing information for important administration instructions and preparation instructions for Noxafil (injection, delayed-release tablets, and oral suspension) and Noxafil PowderMix delayed-release oral suspension ( 2.5 , 2.6 , 2.7 , 2.8 , 2.9 , 2.10 ) For adult and pediatric patients aged 2 years of age and older, see the Full Prescribing Information for dosing recommendations for Noxafil injection, Noxafil delayed-release tablets, Noxafil oral suspension, and/or Noxafil PowderMix for delayed-release oral suspension based on the indication, age, and weight associated with the dosage form ( 1.1 , 1.2 , 1.3 , 2.1 , 2.2 , 2.3 , 2.4 ) 2.1 Important Administration Instructions Noxafil injection, Noxafil delayed-release tablets, Noxafil oral suspension and Noxafil PowderMix for delayed-release oral suspension are supplied in different dose strengths of posaconazole, are approved for different indications, age groups and weights; have different dosages and duration of therapy; and have different preparation and administration instructions.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Posaconazole side effects
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The most common side effects reported include:
Common side effects
- Diarrhea
- Nausea and vomiting
- Fever
- Headache
- Cough
- Low potassium (hypokalemia)
- Low magnesium
- Rash
When to get medical help
- Call your doctor right away if you have a fast, pounding or irregular heartbeat, fainting or dizziness. Posaconazole can affect heart rhythm (QT prolongation and torsades de pointes).
- Get help for signs of liver problems, since liver test elevations can occur.
- Tell your doctor if you have new or worsening high blood pressure or swelling, which can be signs of pseudoaldosteronism (a hormone-related effect).
- Report severe diarrhea or vomiting, because the medicine may not be absorbed well and infections can break through.
- Tell your doctor about muscle pain or weakness if you are also taking a statin.
- Report numbness, tingling or nerve symptoms if you are also receiving vincristine.
- Report pain or redness at the infusion site if you receive the injection.
Seek help for heart rhythm symptoms, signs of liver trouble, rising blood pressure or severe diarrhea and vomiting.
Posaconazole warnings and precautions
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- Heart rhythm: can prolong the QT interval and cause torsades de pointes. Use caution with proarrhythmic conditions.
- Electrolytes: potassium, magnesium and calcium should be corrected before and during treatment.
- Liver: liver tests can rise and should be monitored.
- Pseudoaldosteronism: watch blood pressure and potassium.
- Kidneys: avoid the injection in moderate or severe kidney impairment unless the benefit justifies it.
- Vomiting or diarrhea: can lead to breakthrough fungal infections.
- Vincristine: reserve azoles for patients with no alternatives, due to neurotoxicity.
Posaconazole interactions
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Posaconazole is a strong CYP3A4 inhibitor, so it affects many other drugs.
- Sirolimus, pimozide, quinidine, atorvastatin, lovastatin, simvastatin and ergot alkaloids: contraindicated.
- Venetoclax: contraindicated at initiation and ramp-up in CLL or SLL.
- Tacrolimus and cyclosporine: doses reduced, levels monitored.
- Rifabutin, phenytoin, efavirenz: may lower posaconazole levels.
- Midazolam, calcium channel blockers, digoxin, glipizide: need closer monitoring.
Interactions listed in the FDA-approved label
From the Posaconazole prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Efavirenz: Concomitant use with UDP-glucuronidase inducers such as efavirenz may decrease posaconazole exposure and reduce its effectiveness. Avoid concomitant use unless the benefit outweighs the risks.
- Rifabutin: May decrease posaconazole exposure and reduce its effectiveness. Avoid unless the benefit to the patient outweighs the risk; if needed, monitor closely for breakthrough fungal infections.
- Phenytoin: May decrease posaconazole exposure and reduce its effectiveness. Avoid unless the benefit outweighs the risk; if needed, monitor for breakthrough fungal infections.
- Fosamprenavir: May lead to decreased posaconazole plasma concentrations, which may reduce its effectiveness. If concomitant use is needed, monitor closely for breakthrough fungal infections.
- Cimetidine and esomeprazole (Noxafil oral suspension): Resulted in decreased posaconazole plasma concentrations, which may reduce effectiveness. Avoid concomitant use unless the benefit outweighs the risks; if needed, monitor closely for breakthrough fungal infections.
- Metoclopramide (Noxafil oral suspension): Decreased posaconazole plasma concentrations, which may reduce effectiveness of the oral suspension. Closely monitor for breakthrough fungal infections.
- Alcohol (Noxafil PowderMix): Posaconazole releases faster from PowderMix in the presence of alcohol, which may interfere with its delayed-release characteristics. Administration with alcohol is not recommended.
- Digoxin: Increased digoxin plasma concentrations have been reported with concomitant posaconazole. Monitor digoxin plasma concentrations during concomitant use.
- Sirolimus: Posaconazole is a strong CYP3A4 inhibitor and may increase sirolimus plasma concentrations. Contraindicated.
- Tacrolimus: Plasma concentrations of tacrolimus (a CYP3A4 substrate) may be increased by posaconazole. At initiation of posaconazole, reduce tacrolimus dosage to approximately one-third of the original dosage; monitor whole blood trough concentrations frequently during and at discontinuation of posaconazole and adjust dosage.
Read the label’s full interactions text
7 DRUG INTERACTIONS Posaconazole is primarily metabolized via UDP glucuronosyltransferase and is a substrate of p-glycoprotein (P-gp) efflux. Therefore, inhibitors or inducers of these clearance pathways may affect posaconazole plasma concentrations. Coadministration of drugs that can decrease the plasma concentrations of posaconazole should generally be avoided unless the benefit outweighs the risk. If such drugs are necessary, patients should be monitored closely for breakthrough fungal infections. Posaconazole is also a strong inhibitor of CYP3A4. Therefore, plasma concentrations of drugs predominantly metabolized by CYP3A4 may be increased by posaconazole [see Clinical Pharmacology ( 12.3 )]. The following information was derived from data with Noxafil ® oral suspension or early tablet formulation unless otherwise noted. All drug interactions with Noxafil ® oral suspension, except for those that affect the absorption of posaconazole (via gastric pH and motility), are considered relevant to posaconazole delayed-release tablet, as well [see Drug Interactions ( 7.9 ) and ( 7.13 )]. Interaction Drug Interaction Rifabutin, phenytoin, efavirenz, cimetidine Avoid coadministration unless the benefit outweighs the risks ( 7.6 , 7.7 , 7.8 , 7.9 ) Other drugs metabolized by CYP3A4 Consider dosage adjustment and monitor for adverse effects and toxicity ( 7.1 , 7.10 , 7.11 ) Digoxin Monitor digoxin plasma concentrations ( 7.12 ) Fosamprenavir Monitor for breakthrough fungal infections ( 7.6 , 7.13 ) 7.1 Immunosuppressants Metabolized by CYP3A4 Sirolimus : Concomitant administration of posaconazole with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity. Therefore, posaconazole is contraindicated with sirolimus [see Contraindications ( 4.2 ) and Clinical Pharmacology ( 12.3 )]. Tacrolimus : Posaconazole has been shown to significantly increase the C max and AUC of tacrolimus.
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.
Before taking Posaconazole
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- Do not use if allergic to posaconazole or other azoles.
- Tell your doctor if you are pregnant or planning pregnancy, since animal data show possible fetal harm.
- Discuss breastfeeding with your doctor.
- Tell your doctor about heart rhythm, liver, kidney or electrolyte problems.
- Safety is not established under 2 years of age.
- Older adults use the same dosing as younger adults.
Posaconazole overdose
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There is no experience with overdose of the injection. In trials, some people took oral suspension up to 1,600 mg a day, and one took a very high dose for 3 days, without different side effects. Posaconazole is not removed by hemodialysis. If you suspect an overdose, contact a doctor or poison control right away.
What Posaconazole does in the body
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Posaconazole weakens the fungal cell membrane by lowering ergosterol. In prevention studies using the oral suspension, lower blood levels were linked to more treatment failures. In the aspergillosis treatment study, blood levels were not linked to how well it worked.
How your body processes Posaconazole
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Posaconazole is mostly bound to blood proteins (over 98%). It circulates mainly as the unchanged drug and is broken down mainly through glucuronidation. It is also moved by the P-gp pump, so drugs affecting these pathways can change its levels. The half-life is about 24 hours for the injection and about 31 hours for the delayed-release tablets in healthy volunteers.
How to store Posaconazole
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Store Noxafil injection vial refrigerated at 2 to 8°C (36 to 46°F). for the diluted Noxafil infusion solution are presented in another section of the prescribing information . Store at 20 to 25°C (68 to 77°F), excursions permitted to 15 to 30°C (59 to 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Posaconazole
17 supplements and herbal products have documented interactions with Posaconazole in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
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.
Posaconazole: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Posaconazole — the kind of thing our pharmacy team would talk through with you at the counter.
What is posaconazole for?
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How should I take it?
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What side effects are common?
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When should I call my doctor?
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Can I take it with my other medicines?
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Is it safe in pregnancy?
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Is Posaconazole available over the counter?
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When was Posaconazole first available?
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Who makes Posaconazole?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Posaconazole on HelloPharmacist
Posaconazole forms and strengths (how it comes)
Posaconazole is available in 5 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Posaconazole inactive ingredients by manufacturer.
Delayed-release tablet
How this form is used
- Posaconazole delayed-release tablets are used to help prevent invasive Aspergillus and Candida infections in people at high risk.
- Some Posaconazole delayed-release tablet products are also used to treat invasive aspergillosis.
- Posaconazole delayed-release tablets can be taken with or without food.
- Posaconazole oral suspension is not substitutable with Posaconazole delayed-release tablets.
Injection
How this form is used
- Noxafil injection is used to treat invasive aspergillosis and to help prevent invasive Aspergillus and Candida infections.
- Posaconazole injection is used for the same two purposes.
- Noxafil injection is given as an intravenous infusion over about 90 minutes through a central venous line.
- Posaconazole injection must be given through an in-line filter and not as a bolus injection.
Oral suspension
How this form is used
- Noxafil oral suspension helps prevent invasive Aspergillus and Candida infections in adults and children 13 and older.
- Noxafil oral suspension treats oropharyngeal candidiasis, including thrush that has not responded to itraconazole or fluconazole.
- Noxafil oral suspension should be taken with a full meal.
- Noxafil oral suspension is not substitutable with the delayed-release tablets.
Tablet
How this form is used
- Noxafil delayed-release tablets are used to treat invasive aspergillosis and to help prevent invasive Aspergillus and Candida infections.
- Noxafil delayed-release tablets can be taken with or without food.
- Posaconazole delayed-release tablets can be taken with or without food.
Oral solution
Posaconazole on the U.S. market: products, makers and brands
How Posaconazole 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.
29 companies list 37 Posaconazole product records with the FDA, mostly as delayed-release tablet, injection, oral suspension; the earliest marketing or approval year on record is 2006. Brand names on the directory include Noxafil, Noxafil PowderMix; the rest are generics.
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 (20) · Granule (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Posaconazole is used (Medicaid data)
A general measure of how commonly Posaconazole 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 Posaconazole 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.
How commonly is Posaconazole prescribed? Of the 1,601 medications we measure, Posaconazole ranks #961 by Medicaid prescriptions — more than 40% of them.
Utilization by Posaconazole 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.
posaconazole 100 MG Delayed Release Oral Tablet Most dispensed
Summed across the 11 of 41 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1482908
posaconazole 40 MG/ML Oral Suspension
Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 665019
16.7 ML posaconazole 18 MG/ML Injection
Summed across the 3 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1492043
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 Posaconazole, 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 16 of 54 listed Posaconazole NDCs with Medicaid activity.
Compare Posaconazole products
A representative set of FDA-listed product records for Posaconazole — 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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Delayed-release tablet | ||||
| 100 mg | Oral | A2A Integrated Pharmaceuticals | ANDA | View NDC → |
| 100 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 100 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 100 mg | Oral | Atlantic Biologicals Corp. | ANDA | View NDC → |
| 100 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 100 mg | Oral | AvKARE | ANDA | View NDC → |
| 100 mg | Oral | AvPAK | ANDA | View NDC → |
| 100 mg | Oral | Biocon Phama Inc. | ANDA | View NDC → |
| 100 mg | Oral | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
| 100 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Dr.Reddys Laboratories Inc | ANDA | View NDC → |
| 100 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 100 mg | Oral | i3 Pharmaceuticals, LLC | ANDA | View NDC → |
| 100 mg | Oral | Lannett Company Inc. | ANDA | View NDC → |
| 100 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 100 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 100 mg | Oral | SpecGx LLC | ANDA | View NDC → |
| 💊Injection | ||||
| 18 mg/mL | Intravenous | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 18 mg/mL | Intravenous | Eugia US LLC | ANDA | View NDC → |
| 18 mg/mL | Intravenous | Fresensius Kabi USA, LLC | ANDA | View NDC → |
| 18 mg/mL | Intravenous | Gland Pharma Limited | ANDA | View NDC → |
| 18 mg/mL | Intravenous | Glenmark Pharmaceuticals Inc., Usa × 2 listings | ANDA | View NDC → |
| 18 mg/mL | Intravenous | Merck Sharp & Dohme LLC | NDA | View NDC → |
| 18 mg/mL | Intravenous | Mylan Institutional LLC | ANDA | View NDC → |
| 18 mg/mL | Intravenous | Par Health USA, LLC | ANDA | View NDC → |
| 💊Oral suspension | ||||
| 40 mg/mL | Oral | ENDO USA, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 40 mg/mL | Oral | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 40 mg/mL | Oral | Merck Sharp & Dohme LLC | NDA | View NDC → |
| 300 mg | Oral | Merck Sharp & Dohme LLC | NDA | View NDC → |
| 💊Tablet | ||||
| 100 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 100 mg | Oral | ENDO USA, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 100 mg | Oral | Merck Sharp & Dohme LLC | NDA | View NDC → |
| 100 mg | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
Showing 37 of 37 products — FDA National Drug Code Directory. See every product, package size and price: browse all 37 Posaconazole NDCs →
Posaconazole side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Posaconazole — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Posaconazole are febrile neutropenia, drug interaction, death; about 86% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Posaconazole in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Posaconazole FDA approval history
How Posaconazole went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Posaconazole was first approved by the FDA in 2006 (Brand: NOXAFIL · Schering); the first generic version was approved in 2019. It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Posaconazole 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 2 Posaconazole recalls since July 2021. One of them is still ongoing and is listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Sharp & Doohme LLC, Rahway, NJ 07056 USA, Manufactured by: N.V. Or… Lots: Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026 FDA record D-0242-2026 →
- Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099… Lots: Lot #: BF21003163, BF21003246, BF21003161, Exp. Sep-2023; BF21004742, Exp. Dec-2023; BF22003359, Exp. Sep-2025 FDA record D-0268-2023 →
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.
RxCUI 282446 4 dose forms · 4 strengths
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Dose form (SCDF) Delayed Release Oral Tablet RxCUI 1482907In current FDA listingsClinical drug / strength (SCD) 100 MGRxCUI 1482908 -
Dose form (SCDF) Injection RxCUI 1724193In current FDA listingsClinical drug / strength (SCD) 16.7 ML posaconazole 18 MG/MLRxCUI 1492043 -
Dose form (SCDF) Oral Suspension RxCUI 665018In current FDA listingsClinical drug / strength (SCD) 40 MG/MLRxCUI 665019 -
Dose form (SCDF) Powder for Oral Suspension RxCUI 2558602In current FDA listingsClinical drug / strength (SCD) 300 MGRxCUI 2558603
Look up RxCUI 282446 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.
Posaconazole supply and shortage status
Whether Posaconazole is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Posaconazole is not in shortage right now; the FDA has 1 past shortage record for it.
✅No current shortage of Posaconazole on recordRead the full Posaconazole shortage page — affected NDCs, other makers, and what to do →
Source: openFDA, from the FDA Drug Shortages database.
💵 What Posaconazole costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Delayed Release · Oral | 100 mg | $2.03 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Posaconazole brand names
Posaconazole is sold under 2 brand names in the FDA directory — Noxafil, Noxafil PowderMix. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Posaconazole: manufacturers and labelers
29 companies list Posaconazole products with the FDA. By number of product records, the largest are Merck Sharp & Dohme LLC, Bryant Ranch Prepack, Camber Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 5 more on the FDA NDC directory.
Posaconazole drug class (RxNorm)
Posaconazole belongs to the Azole Antifungal class.
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 Posaconazole 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.
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. Merck Sharp & Dohme LLC 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 →