Lamisilterbinafine
According to the FDA label: Terbinafine tablets, USP 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.
6,972 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Lamisil in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 694 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Rash 398 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Pruritus 320 reports
Fatigue 304 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Nausea 287 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →- Ageusia 272 reports
Pain 269 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Off Label Use 263 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Headache 231 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Drug Interaction 227 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →Diarrhoea 220 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Malaise 217 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Drug Resistance 199 reports
A situation where a medication becomes less effective against the condition it was meant to treat, such as an infection no longer responding to an antibiotic.
Full definition in the glossary →Chronic Kidney Disease 196 reports
A long-term, gradual loss of kidney function over months or years.
Full definition in the glossary →Anxiety 195 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 3,139 |
| Male | 2,984 |
| Unknown | 33 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 202 |
| 18-34 | 684 |
| 35-49 | 1,067 |
| 50-64 | 1,539 |
| 65-74 | 1,010 |
| 75+ | 643 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Lamisil. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 4,167 |
| Hospitalization | 1,885 |
| Non-Serious | 1,363 |
| Death | 433 |
| Disability | 379 |
| Life-Threatening | 298 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Lamisil. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2003 | 1 |
| 2004 | 9 |
| 2005 | 34 |
| 2006 | 26 |
| 2007 | 17 |
| 2008 | 5 |
| 2009 | 12 |
| 2010 | 43 |
| 2011 | 19 |
| 2012 | 102 |
| 2013 | 216 |
| 2014 | 262 |
| 2015 | 390 |
| 2016 | 444 |
| 2017 | 445 |
| 2018 | 716 |
| 2019 | 625 |
| 2020 | 672 |
| 2021 | 541 |
| 2022 | 474 |
| 2023 | 553 |
| 2024 | 710 |
| 2025 | 546 |
| 2026 (partial) | 110 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Lamisil
In FDA adverse event reports that mention Lamisil, these medications appeared most often in the same report.
- Omeprazole (650 reports)
- Prednisone (510 reports)
- Aspirin (497 reports)
- Metformin (455 reports)
- Amlodipine (453 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026