Two medicines, side by side
Itraconazole vs ketoconazole
Itraconazole and ketoconazole are both labeled for fungal infections. Drugs@FDA records approvals of itraconazole since 1992 and of ketoconazole since 1981. Pharmacies paid $0.910 per itraconazole 100 mg capsule and $0.249 per gram (Ketoconazole 2% cream) (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 itraconazole FDA label on DailyMed (effective July 13, 2026); the ketoconazole FDA label on DailyMed (effective January 28, 2026).
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
Highlights of the ketoconazole record
Ketoconazole (Nizoral) · label of January 28, 2026
Used for
From the label: indicationsKetoconazole Cream 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.
On the market
- Earliest approval on file
- June 12, 1981
- Generic labelers
- 30 labelers
- Pharmacy cost
- $0.249 per gram
Supply and safety
- Shortage
- No current entry
- Recalls
- 3
Source: FDA drug labels via openFDA (Itraconazole label of July 13, 2026, Ketoconazole label of January 28, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do itraconazole and ketoconazole differ on the record?
Only the itraconazole label carries a boxed warning.
Both are in FDA's class azole antifungals.
Generics: itraconazole since 2004; ketoconazole since 1999 (Drugs@FDA).
| Itraconazole | Ketoconazole | |
|---|---|---|
| Labeled for | Fungal infections | Fungal infections |
| Pharmacologic class | Azole Antifungal | Azole Antifungal |
| How it works (label) | 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. | n/a |
| Half-life (label) | 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. | n/a |
| Earliest approval on file (Drugs@FDA) | September 11, 1992 | June 12, 1981 |
| First generic approved | May 28, 2004 | June 15, 1999 |
| Generic labelers (NDC) | 11 labelers | 30 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.910 per capsule (Itraconazole 100 mg capsule) | $0.249 per gram (Ketoconazole 2% cream) |
| 12-month price change | -4% | -11% |
| Boxed warning | Yes | No |
| Shortage now | A presentation being discontinued | No current entry |
| Recalls recorded | 1 | 3 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 11,610 | 17,282 |
| 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)
Do their labels mention each other?
Itraconazole label, drug interactionsAlthough 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 ® .
Itraconazole label, drug interactionsAlthough many of the clinical drug interactions in Table 4 are based on information with a similar azole antifungal, ketoconazole, these interactions are expected to occur with itraconazole.
Source: FDA drug labels via openFDA
What next?
- Alternatives to itraconazole
- every medicine labeled for the same conditions