75/100 · Elevated
Manufactured by Chattem, Inc.
Moderate Safety Concerns with LIDOCAINE, MENTHOL
98,770 FDA adverse event reports analyzed
Last updated: 2026-05-12
LIDOCAINE, MENTHOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Chattem, Inc.. Based on analysis of 98,770 FDA adverse event reports, LIDOCAINE, MENTHOL has a safety score of 75 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for LIDOCAINE, MENTHOL include DRUG INEFFECTIVE, PAIN, FATIGUE, NAUSEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LIDOCAINE, MENTHOL.
Lidocaine, Menthol has a safety concern score of 75 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 98,770 adverse event reports for this medication, which is primarily manufactured by Chattem, Inc..
The most commonly reported adverse events include Drug Ineffective, Pain, Fatigue. Of classified reports, 72.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. A significant number of reports involve serious adverse events, including death and respiratory issues.
The drug is frequently reported to be ineffective, especially for unapproved indications. There are multiple reports of drug interactions and inappropriate use, indicating potential misuse. Serious reactions such as pneumonia, sepsis, and cardiac arrest are common. The majority of adverse events are non-serious, but the diversity of reactions is concerning.
Patients taking Lidocaine, Menthol should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. LIDOCAINE, MENTHOL has been reported to interact with various drugs, leading to potential toxicity. It is crucial to follow the approved indications and dosing guidelines to avoid adverse interactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lidocaine, Menthol received a safety concern score of 75/100 (elevated concern). This is based on a 72.6% serious event ratio across 46,864 classified reports. The score accounts for 98,770 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: 26,857, Male: 15,613, Unknown: 109. The most frequently reported age groups are age 62 (709 reports), age 66 (696 reports), age 64 (663 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 46,864 classified reports for LIDOCAINE, MENTHOL:
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.
LIDOCAINE, MENTHOL has been reported to interact with various drugs, leading to potential toxicity. It is crucial to follow the approved indications and dosing guidelines to avoid adverse interactions.
If you are taking Lidocaine, Menthol, here are important things to know. The most commonly reported side effects include drug ineffective, pain, fatigue, nausea, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always use LIDOCAINE, MENTHOL as directed by a healthcare provider and for approved indications only. Report any adverse reactions to the FDA's MedWatch program to help improve safety monitoring. 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 continues to monitor the safety of LIDOCAINE, MENTHOL, and has issued warnings about its use in unapproved indications and potential serious adverse events.
The FDA has received approximately 98,770 adverse event reports associated with Lidocaine, Menthol. 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 Lidocaine, Menthol include Drug Ineffective, Pain, Fatigue, Nausea, Headache. By volume, the top reported reactions are: Drug Ineffective (3,629 reports), Pain (3,113 reports), Fatigue (2,874 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Lidocaine, Menthol.
Out of 46,864 classified reports, 34,009 (72.6%) were classified as serious and 12,855 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 Lidocaine, Menthol break down by patient sex as follows: Female: 26,857, Male: 15,613, Unknown: 109. 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 Lidocaine, Menthol adverse events are: age 62: 709 reports, age 66: 696 reports, age 64: 663 reports, age 67: 657 reports, age 74: 653 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 Lidocaine, Menthol adverse event reports is Chattem, Inc.. 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 Lidocaine, Menthol include: Off Label Use, Dyspnoea, Sinusitis, Pneumonia, Diarrhoea. 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 Lidocaine, Menthol 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.
Lidocaine, Menthol has a safety concern score of 75 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. A significant number of reports involve serious adverse events, including death and respiratory issues.
Key safety signals identified in Lidocaine, Menthol's adverse event data include: High frequency of death reports (1623 cases). Multiple reports of serious respiratory issues (pneumonia, bronchitis). Frequent drug ineffectiveness and off-label use. A significant number of reports involving drug interactions and misuse. Common serious reactions such as sepsis, cardiac arrest, and respiratory failure. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
LIDOCAINE, MENTHOL has been reported to interact with various drugs, leading to potential toxicity. It is crucial to follow the approved indications and dosing guidelines to avoid adverse interactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lidocaine, Menthol.
Always use LIDOCAINE, MENTHOL as directed by a healthcare provider and for approved indications only. Report any adverse reactions to the FDA's MedWatch program to help improve safety monitoring.
Lidocaine, Menthol has 98,770 adverse event reports on file with the FDA. The drug is frequently reported to be ineffective, especially for unapproved indications. The volume of reports for Lidocaine, Menthol reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of LIDOCAINE, MENTHOL, and has issued warnings about its use in unapproved indications and 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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