Two medicines, side by side
Nystatin vs terbinafine
Nystatin and terbinafine are both labeled for fungal infections. Drugs@FDA records approvals of nystatin since 1971 and of terbinafine since 1992. Pharmacies paid $0.175 per gram (Nystatin 100,000 unit/g cream) and $0.143 per terbinafine HCl 250 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, nystatin is a polyene antifungal and terbinafine an allylamine antifungal.
Check it at the source: the nystatin FDA label on DailyMed (effective May 1, 2026); the terbinafine FDA label on DailyMed (effective October 17, 2025).
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
Highlights of the terbinafine record
Terbinafine (Lamisil) · label of October 17, 2025
Used for
From the label: indicationsINDICATIONS AND USAGE Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. […]
On the market
- Earliest approval on file
- December 30, 1992
- Generic labelers
- 39 labelers
- Pharmacy cost
- $0.143 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Source: FDA drug labels via openFDA (Nystatin label of May 1, 2026, Terbinafine label of October 17, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do nystatin and terbinafine differ on the record?
In FDA's classes, nystatin is a polyene antifungal and terbinafine an allylamine antifungal.
Generics: nystatin since 1964; terbinafine since 2007 (Drugs@FDA).
| Nystatin | Terbinafine | |
|---|---|---|
| Labeled for | Fungal infections | Fungal infections |
| Pharmacologic class | Polyene Antifungal | Allylamine Antifungal |
| How it works (label) | n/a | Terbinafine is an allylamine antifungal [see Clinical Pharmacology (12.4) ]. |
| Half-life (label) | n/a | eady-state, in comparison to a single dose, the peak concentration of terbinafine is 25% higher and plasma AUC increases by a factor of 2.5; … |
| Earliest approval on file (Drugs@FDA) | April 14, 1971 | December 30, 1992 |
| First generic approved | July 8, 1964 | July 2, 2007 |
| Generic labelers (NDC) | 40 labelers | 39 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.175 per gram (Nystatin 100,000 unit/g cream) | $0.143 per tablet (Terbinafine HCl 250 mg tablet) |
| 12-month price change | -3% | -5% |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 18 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 27,281 | 8,847 |
| 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 nystatin
- every medicine labeled for the same conditions