Two medicines, side by side
Posaconazole vs itraconazole
Posaconazole and itraconazole are both labeled for fungal infections. Drugs@FDA records approvals of posaconazole since 2006 and of itraconazole since 1992. Pharmacies paid $2.03 per posaconazole DR 100 mg tablet and $0.910 per itraconazole 100 mg capsule (NADAC, October 7, 2026). How each works, in its label's words: Posaconazole, “Posaconazole is an azole antifungal agent [see Clinical Pharmacology (12.4) ].”; Itraconazole, “Mechanism of Action In vitro studies have demonstrated that itraconazole inhibits the cytochrome P450-dependent synthesis of ergosterol, which is a vital component of fungal cell membranes.”
Check it at the source: the posaconazole FDA label on DailyMed (effective August 3, 2026); the itraconazole FDA label on DailyMed (effective July 13, 2026).
Highlights of the posaconazole record
Posaconazole (Noxafil) · label of August 3, 2026
Used for
From the label: indicationsPosaconazole is an azole antifungal indicated as follows: Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies […]
On the market
- Earliest approval on file
- September 15, 2006
- Generic labelers
- 27 labelers
- Pharmacy cost
- $2.03 per tablet
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 2
Highlights of the itraconazole record
Itraconazole (Sporanox) · label of July 13, 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.
Used for
From the label: indicationsSPORANOX ® (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. […]
On the market
- Earliest approval on file
- September 11, 1992
- Generic labelers
- 11 labelers
- Pharmacy cost
- $0.910 per capsule
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 1
Source: FDA drug labels via openFDA (Posaconazole label of August 3, 2026, Itraconazole label of July 13, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do posaconazole and itraconazole differ on the record?
How each works, in its label's words: Posaconazole, “Posaconazole is an azole antifungal agent [see Clinical Pharmacology (12.4) ].”; Itraconazole, “Mechanism of Action In vitro studies have demonstrated that itraconazole inhibits the cytochrome P450-dependent synthesis of ergosterol, which is a vital component of fungal cell membranes.”
Only the itraconazole label carries a boxed warning.
Both are in FDA's class azole antifungals.
Half-life, in each label's words: Posaconazole, “Posaconazole delayed-release tablet is eliminated with a mean half-life (t ½ ) ranging between 26 to 31 hours.”; Itraconazole, “The terminal half-life of itraconazole generally ranges from 16 to 28 hours after single dose and increases to 34 to 42 …”
Generics: posaconazole since 2019; itraconazole since 2004 (Drugs@FDA).
| Posaconazole | Itraconazole | |
|---|---|---|
| Labeled for | Fungal infections | Fungal infections |
| Pharmacologic class | Azole Antifungal | Azole Antifungal |
| How it works (label) | Posaconazole is an azole antifungal agent [see Clinical Pharmacology (12.4) ]. | Mechanism of Action In vitro studies have demonstrated that itraconazole inhibits the cytochrome P450-dependent synthesis of ergosterol, which is a vital component of fungal cell membranes. |
| Half-life (label) | Posaconazole delayed-release tablet is eliminated with a mean half-life (t ½ ) ranging between 26 to 31 hours. | The terminal half-life of itraconazole generally ranges from 16 to 28 hours after single dose and increases to 34 to 42 hours with repeated dosing. |
| Earliest approval on file (Drugs@FDA) | September 15, 2006 | September 11, 1992 |
| First generic approved | August 21, 2019 | May 28, 2004 |
| Generic labelers (NDC) | 27 labelers | 11 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $2.03 per tablet (Posaconazole DR 100 mg tablet) | $0.910 per capsule (Itraconazole 100 mg capsule) |
| 12-month price change | -46% | -4% |
| Boxed warning | No | Yes |
| Shortage now | A presentation being discontinued | A presentation being discontinued |
| Recalls recorded | 2 | 1 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 16,154 | 11,610 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to posaconazole
- every medicine labeled for the same conditions