Two medicines, side by side
Fluconazole vs itraconazole
Fluconazole and itraconazole are both labeled for fungal infections. Drugs@FDA records approvals of fluconazole since 1990 and of itraconazole since 1992. Pharmacies paid $0.380 per fluconazole 200 mg tablet and $0.910 per itraconazole 100 mg capsule (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Only the itraconazole label carries a boxed warning.
Check it at the source: the fluconazole FDA label on DailyMed (effective April 7, 2026); the itraconazole FDA label on DailyMed (effective July 13, 2026).
Highlights of the fluconazole record
Fluconazole (Diflucan) · label of April 7, 2026
Used for
From the label: indicationsFluconazole tablets are indicated for the treatment of: Vaginal candidiasis (vaginal yeast infections due to Candida ). Oropharyngeal and esophageal candidiasis. […]
On the market
- Earliest approval on file
- January 29, 1990
- Generic labelers
- 41 labelers
- Pharmacy cost
- $0.380 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 18
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 (Fluconazole label of April 7, 2026, Itraconazole label of July 13, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do fluconazole and itraconazole differ on the record?
Only the itraconazole label carries a boxed warning.
Both are in FDA's class azole antifungals.
Half-life, in each label's words: Fluconazole, “Peak plasma concentrations (C max ) in fasted normal volunteers occur between 1 and 2 hours with a terminal plasma …”; Itraconazole, “The terminal half-life of itraconazole generally ranges from 16 to 28 hours after single dose and increases to 34 to 42 …”
Generics: fluconazole since 2004; itraconazole since 2004 (Drugs@FDA).
| Fluconazole | Itraconazole | |
|---|---|---|
| Labeled for | Fungal infections, Urinary tract infections | Fungal infections |
| Pharmacologic class | Azole Antifungal | Azole Antifungal |
| How it works (label) | n/a | 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) | Peak plasma concentrations (C max ) in fasted normal volunteers occur between 1 and 2 hours with a terminal plasma elimination half-life of approximately 30 hours (range: 20 to 50 hours) after oral administration. | 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) | January 29, 1990 | September 11, 1992 |
| First generic approved | July 29, 2004 | May 28, 2004 |
| Generic labelers (NDC) | 41 labelers | 11 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.380 per tablet (Fluconazole 200 mg tablet) | $0.910 per capsule (Itraconazole 100 mg capsule) |
| 12-month price change | -10% | -4% |
| Boxed warning | No | Yes |
| Shortage now | No current entry | A presentation being discontinued |
| Recalls recorded | 18 | 1 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 69,671 | 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 fluconazole
- every medicine labeled for the same conditions