Two medicines, side by side
Ketoconazole vs terbinafine
Ketoconazole and terbinafine are both labeled for fungal infections. Drugs@FDA records approvals of ketoconazole since 1981 and of terbinafine since 1992. Pharmacies paid $0.249 per gram (Ketoconazole 2% 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, ketoconazole is an azole antifungal and terbinafine an allylamine antifungal.
Check it at the source: the ketoconazole FDA label on DailyMed (effective January 28, 2026); the terbinafine FDA label on DailyMed (effective October 17, 2025).
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 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 (Ketoconazole label of January 28, 2026, Terbinafine label of October 17, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do ketoconazole and terbinafine differ on the record?
In FDA's classes, ketoconazole is an azole antifungal and terbinafine an allylamine antifungal.
Generics: ketoconazole since 1999; terbinafine since 2007 (Drugs@FDA).
| Ketoconazole | Terbinafine | |
|---|---|---|
| Labeled for | Fungal infections | Fungal infections |
| Pharmacologic class | Azole 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) | June 12, 1981 | December 30, 1992 |
| First generic approved | June 15, 1999 | July 2, 2007 |
| Generic labelers (NDC) | 30 labelers | 39 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.249 per gram (Ketoconazole 2% cream) | $0.143 per tablet (Terbinafine HCl 250 mg tablet) |
| 12-month price change | -11% | -5% |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 3 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 17,282 | 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 ketoconazole
- every medicine labeled for the same conditions