Two medicines, side by side
Fluconazole vs nystatin
Fluconazole and nystatin are both labeled for fungal infections. Drugs@FDA records approvals of fluconazole since 1990 and of nystatin since 1971. Pharmacies paid $0.380 per fluconazole 200 mg tablet 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, fluconazole is an azole antifungal and nystatin a polyene antifungal.
Check it at the source: the fluconazole FDA label on DailyMed (effective April 7, 2026); the nystatin FDA label on DailyMed (effective May 1, 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 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 (Fluconazole label of April 7, 2026, Nystatin label of May 1, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do fluconazole and nystatin differ on the record?
In FDA's classes, fluconazole is an azole antifungal and nystatin a polyene antifungal.
Generics: fluconazole since 2004; nystatin since 1964 (Drugs@FDA).
| Fluconazole | Nystatin | |
|---|---|---|
| Labeled for | Fungal infections, Urinary tract infections | Fungal infections |
| Pharmacologic class | Azole Antifungal | Polyene 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 | April 14, 1971 |
| First generic approved | July 29, 2004 | July 8, 1964 |
| Generic labelers (NDC) | 41 labelers | 40 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.380 per tablet (Fluconazole 200 mg tablet) | $0.175 per gram (Nystatin 100,000 unit/g cream) |
| 12-month price change | -10% | -3% |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 18 | 18 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 69,671 | 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 fluconazole
- every medicine labeled for the same conditions