Two medicines, side by side
Ketoconazole vs nystatin
Ketoconazole and nystatin are both labeled for fungal infections. Drugs@FDA records approvals of ketoconazole since 1981 and of nystatin since 1971. Pharmacies paid $0.249 per gram (Ketoconazole 2% cream) and $0.175 per gram (Nystatin 100,000 unit/g cream) (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, ketoconazole is an azole antifungal and nystatin a polyene antifungal.
Check it at the source: the ketoconazole FDA label on DailyMed (effective January 28, 2026); the nystatin FDA label on DailyMed (effective May 1, 2026).
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
Highlights of the nystatin record
Nystatin (Klayesta) · label of May 1, 2026
Used for
From the label: indicationsNystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.
On the market
- Earliest approval on file
- April 14, 1971
- Generic labelers
- 40 labelers
- Pharmacy cost
- $0.175 per gram
Supply and safety
- Shortage
- No current entry
- Recalls
- 18
Source: FDA drug labels via openFDA (Ketoconazole label of January 28, 2026, Nystatin label of May 1, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do ketoconazole and nystatin differ on the record?
In FDA's classes, ketoconazole is an azole antifungal and nystatin a polyene antifungal.
Generics: ketoconazole since 1999; nystatin since 1964 (Drugs@FDA).
| Ketoconazole | Nystatin | |
|---|---|---|
| Labeled for | Fungal infections | Fungal infections |
| Pharmacologic class | Azole Antifungal | Polyene Antifungal |
| How it works (label) | n/a | n/a |
| Half-life (label) | n/a | n/a |
| Earliest approval on file (Drugs@FDA) | June 12, 1981 | April 14, 1971 |
| First generic approved | June 15, 1999 | July 8, 1964 |
| Generic labelers (NDC) | 30 labelers | 40 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.249 per gram (Ketoconazole 2% cream) | $0.175 per gram (Nystatin 100,000 unit/g cream) |
| 12-month price change | -11% | -3% |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 3 | 18 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 17,282 | 27,281 |
| 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 ketoconazole
- every medicine labeled for the same conditions