65/100 · Elevated
Manufactured by Bayer HealthCare LLC.
Tolnaftate Adverse Events: Moderate Safety Concerns
2,800 FDA adverse event reports analyzed
Last updated: 2026-05-12
TOLNAFTATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bayer HealthCare LLC.. Based on analysis of 2,800 FDA adverse event reports, TOLNAFTATE has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for TOLNAFTATE include DRUG INEFFECTIVE, PAIN, FATIGUE, NAUSEA, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TOLNAFTATE.
Tolnaftate has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 2,800 adverse event reports for this medication, which is primarily manufactured by Bayer Healthcare Llc..
The most commonly reported adverse events include Drug Ineffective, Pain, Fatigue. Of classified reports, 60.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Pain and fatigue are the most common adverse reactions, with a significant number of reports involving serious conditions like acute kidney injury and chronic kidney disease.
A diverse range of reactions, including respiratory, gastrointestinal, and neurological issues, indicates a broad safety profile. The majority of adverse events are non-serious, but the high percentage of serious events (60.5%) is concerning. Drug ineffectiveness and off-label use are also reported, suggesting potential misuse or inefficacy issues.
Patients taking Tolnaftate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Tolnaftate has been associated with serious adverse events such as acute kidney injury and chronic kidney disease, and there are warnings about potential drug interactions, particularly with other renal medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Tolnaftate received a safety concern score of 65/100 (elevated concern). This is based on a 60.5% serious event ratio across 1,255 classified reports. The score accounts for 2,800 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 656, Male: 532, Unknown: 2. The most frequently reported age groups are age 62 (27 reports), age 70 (26 reports), age 75 (25 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 1,255 classified reports for TOLNAFTATE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Tolnaftate has been associated with serious adverse events such as acute kidney injury and chronic kidney disease, and there are warnings about potential drug interactions, particularly with other renal medications.
If you are taking Tolnaftate, here are important things to know. The most commonly reported side effects include drug ineffective, pain, fatigue, nausea, dyspnoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow the prescribed dosage and usage instructions carefully to avoid potential adverse reactions. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA should continue to monitor the safety of Tolnaftate, especially for patients with pre-existing kidney conditions, and healthcare providers should be vigilant about potential serious adverse events.
The FDA has received approximately 2,800 adverse event reports associated with Tolnaftate. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Tolnaftate include Drug Ineffective, Pain, Fatigue, Nausea, Dyspnoea. By volume, the top reported reactions are: Drug Ineffective (116 reports), Pain (87 reports), Fatigue (81 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Tolnaftate.
Out of 1,255 classified reports, 759 (60.5%) were classified as serious and 496 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Tolnaftate break down by patient sex as follows: Female: 656, Male: 532, Unknown: 2. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Tolnaftate adverse events are: age 62: 27 reports, age 70: 26 reports, age 75: 25 reports, age 61: 22 reports, age 59: 21 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Tolnaftate adverse event reports is Bayer Healthcare Llc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Tolnaftate include: Diarrhoea, Off Label Use, Anxiety, Headache, Vomiting. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Tolnaftate to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Tolnaftate has a safety concern score of 65 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Pain and fatigue are the most common adverse reactions, with a significant number of reports involving serious conditions like acute kidney injury and chronic kidney disease.
Key safety signals identified in Tolnaftate's adverse event data include: Acute kidney injury and chronic kidney disease are key safety signals, indicating potential renal toxicity.. A high number of serious events (759 out of 1255, 60.5%) is a significant safety concern.. A diverse range of reactions, including respiratory and gastrointestinal issues, suggests a complex safety profile.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Tolnaftate has been associated with serious adverse events such as acute kidney injury and chronic kidney disease, and there are warnings about potential drug interactions, particularly with other renal medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Tolnaftate.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow the prescribed dosage and usage instructions carefully to avoid potential adverse reactions.
Tolnaftate has 2,800 adverse event reports on file with the FDA. A diverse range of reactions, including respiratory, gastrointestinal, and neurological issues, indicates a broad safety profile. The volume of reports for Tolnaftate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA should continue to monitor the safety of Tolnaftate, especially for patients with pre-existing kidney conditions, and healthcare providers should be vigilant about potential serious adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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