Two medicines, side by side
Terbinafine vs itraconazole
Terbinafine and itraconazole are both labeled for fungal infections. Drugs@FDA records approvals of terbinafine since 1992 and of itraconazole since 1992. Pharmacies paid $0.143 per terbinafine HCl 250 mg tablet and $0.910 per itraconazole 100 mg capsule (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, terbinafine is an allylamine antifungal and itraconazole an azole antifungal.
Check it at the source: the terbinafine FDA label on DailyMed (effective October 17, 2025); the itraconazole FDA label on DailyMed (effective July 13, 2026).
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
Highlights of the itraconazole record
Itraconazole (Sporanox) · label of July 13, 2026
Congestive Heart Failure, Cardiac Effects and Drug Interactions Congestive Heart Failure and Cardiac Effects SPORANOX ® (itraconazole) Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF. If signs or symptoms of congestive heart failure occur during administration of SPORANOX ® Capsules, discontinue administration.
Used for
From the label: indicationsSPORANOX ® (itraconazole) Capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: Blastomycosis, pulmonary and extrapulmonary Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. […]
On the market
- Earliest approval on file
- September 11, 1992
- Generic labelers
- 11 labelers
- Pharmacy cost
- $0.910 per capsule
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 1
Source: FDA drug labels via openFDA (Terbinafine label of October 17, 2025, Itraconazole label of July 13, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do terbinafine and itraconazole differ on the record?
In FDA's classes, terbinafine is an allylamine antifungal and itraconazole an azole antifungal.
How each works, in its label's words: Terbinafine, “Terbinafine is an allylamine antifungal [see Clinical Pharmacology (12.4) ].”; Itraconazole, “Mechanism of Action In vitro studies have demonstrated that itraconazole inhibits the cytochrome P450-dependent synthesis of ergosterol, which is a vital component of fungal cell membranes.”
Half-life, in each label's words: Terbinafine, “eady-state, in comparison to a single dose, the peak concentration of terbinafine is 25% higher and plasma AUC …”; Itraconazole, “The terminal half-life of itraconazole generally ranges from 16 to 28 hours after single dose and increases to 34 to 42 …”
Only the itraconazole label carries a boxed warning.
Generics: terbinafine since 2007; itraconazole since 2004 (Drugs@FDA).
| Terbinafine | Itraconazole | |
|---|---|---|
| Labeled for | Fungal infections | Fungal infections |
| Pharmacologic class | Allylamine Antifungal | Azole Antifungal |
| How it works (label) | Terbinafine is an allylamine antifungal [see Clinical Pharmacology (12.4) ]. | Mechanism of Action In vitro studies have demonstrated that itraconazole inhibits the cytochrome P450-dependent synthesis of ergosterol, which is a vital component of fungal cell membranes. |
| Half-life (label) | 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; … | The terminal half-life of itraconazole generally ranges from 16 to 28 hours after single dose and increases to 34 to 42 hours with repeated dosing. |
| Earliest approval on file (Drugs@FDA) | December 30, 1992 | September 11, 1992 |
| First generic approved | July 2, 2007 | May 28, 2004 |
| Generic labelers (NDC) | 39 labelers | 11 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.143 per tablet (Terbinafine HCl 250 mg tablet) | $0.910 per capsule (Itraconazole 100 mg capsule) |
| 12-month price change | -5% | -4% |
| Boxed warning | No | Yes |
| Shortage now | No current entry | A presentation being discontinued |
| Recalls recorded | 0 | 1 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 8,847 | 11,610 |
| 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 terbinafine
- every medicine labeled for the same conditions