What the label lists and what reports show
Terbinafine side effects
Terbinafine's FDA label: “The most frequently reported adverse events observed in the 3 US/Canadian placebo-controlled trials are listed in the Table 1.” FAERS holds 8,847 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is rash (499 reports).
- Generic listed
Check it at the source: the terbinafine FDA label on DailyMed (effective October 17, 2025, PD-Rx Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Terbinafine tablets?Terbinafine tablets may cause serious side effects, including: See " What is the most important information I should know about Terbinafine tablets? " Change in your sense of taste or loss of taste is common with Terbinafine tablets, but can also be severe. This may improve within several weeks after you stop taking Terbinafine tablets, but may last for a long time or may become permanent. Tell your doctor if you develop any of the following: change in your sense of taste or loss of taste poor appetite weight loss anxiousness change in your mood or depressive symptoms. See the list of depressive symptoms below. Change in your sense of smell or loss of smell may happen with Terbinafine tablets. This may improve after you stop taking Terbinafine tablets, but may last for a long time or may become permanent. Tell your doctor if you have a change in your sense of smell or loss of smell. […]
Source: FDA drug label, PD-Rx Pharmaceuticals, Inc., effective October 17, 2025 (SPL set 2df111dc-ecac-4161-9e22-38436eb37c1f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most frequently reported adverse events observed in the 3 US/Canadian placebo-controlled trials are listed in the Table 1.
Table 1. Most frequently reported adverse events observed in the 3 US/Canadian placebo-controlled trials
| Reaction | Terbinafine tablets (%) n=465 | Placebo (%) n=137 | Terbinafine tablets (%) n=465 | Placebo (%) n=137 |
|---|---|---|---|---|
| Headache | 12.9 | 9.5 | 0.2 | 0.0 |
| Diarrhea | 5.6 | 2.9 | 0.6 | 0.0 |
| Dyspepsia | 4.3 | 2.9 | 0.4 | 0.0 |
| Abdominal Pain | 2.4 | 1.5 | 0.4 | 0.0 |
| Nausea | 2.6 | 2.9 | 0.2 | 0.0 |
| Flatulence | 2.2 | 2.2 | 0.0 | 0.0 |
| Rash | 5.6 | 2.2 | 0.9 | 0.7 |
| Pruritus | 2.8 | 1.5 | 0.2 | 0.0 |
| Urticaria | 1.1 | 0.0 | 0.0 | 0.0 |
| Liver Enzyme Abnormalities Liver enzyme abnormalities greater than or equal to 2× the… | 3.3 | 1.4 | 0.2 | 0.0 |
| Taste Disturbance | 2.8 | 0.7 | 0.2 | 0.0 |
| Visual Disturbance | 1.1 | 1.5 | 0.9 | 0.0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedADVERSE REACTIONS Common (greater than 2% of patients treated with Terbinafine tablets) reported adverse events include headache, diarrhea, rash, dyspepsia, liver enzyme abnormalities, pruritus, taste disturbance, nausea, abdominal pain, and flatulence. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical, Inc. at 1-800-367-3395, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequently reported adverse events observed in the 3 US/Canadian placebo-controlled trials are listed in the Table 1. The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia, and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. Changes in the ocular lens and retina have been reported following the use of Terbinafine tablets in controlled trials. The clinical significance of these changes is unknown. In general, the adverse events were mild, transient, and did not lead to discontinuation from study participation. Table 1.
Source: FDA drug label, PD-Rx Pharmaceuticals, Inc., effective October 17, 2025 (SPL set 2df111dc-ecac-4161-9e22-38436eb37c1f), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,847 reports list terbinafine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 532 are coded as a death and 2,352 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Terbinafine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions