Two medicines, side by side
Fluconazole vs ketoconazole
Fluconazole and ketoconazole are both labeled for fungal infections. Drugs@FDA records approvals of fluconazole since 1990 and of ketoconazole since 1981. Pharmacies paid $0.380 per fluconazole 200 mg tablet and $0.249 per gram (Ketoconazole 2% cream) (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like.
Check it at the source: the fluconazole FDA label on DailyMed (effective April 7, 2026); the ketoconazole FDA label on DailyMed (effective January 28, 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 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 (Fluconazole label of April 7, 2026, Ketoconazole label of January 28, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do fluconazole and ketoconazole differ on the record?
Both are in FDA's class azole antifungals.
Generics: fluconazole since 2004; ketoconazole since 1999 (Drugs@FDA).
| Fluconazole | Ketoconazole | |
|---|---|---|
| Labeled for | Fungal infections, Urinary tract infections | Fungal infections |
| Pharmacologic class | Azole Antifungal | Azole Antifungal |
| How it works (label) | n/a | n/a |
| 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. | n/a |
| Earliest approval on file (Drugs@FDA) | January 29, 1990 | June 12, 1981 |
| First generic approved | July 29, 2004 | June 15, 1999 |
| Generic labelers (NDC) | 41 labelers | 30 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.380 per tablet (Fluconazole 200 mg tablet) | $0.249 per gram (Ketoconazole 2% cream) |
| 12-month price change | -10% | -11% |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 18 | 3 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 69,671 | 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)
What next?
- Alternatives to fluconazole
- every medicine labeled for the same conditions