75/100 · Elevated
Manufactured by RB Health (US) LLC
Menthol Safety Profile: Common Reactions Include Fatigue and Pain
4,344 FDA adverse event reports analyzed
Last updated: 2026-05-12
MENTHOL, UNSPECIFIED FORM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by RB Health (US) LLC. Based on analysis of 4,344 FDA adverse event reports, MENTHOL, UNSPECIFIED FORM 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 MENTHOL, UNSPECIFIED FORM include FATIGUE, PAIN, DRUG INEFFECTIVE, OFF LABEL USE, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MENTHOL, UNSPECIFIED FORM.
Menthol, Unspecified Form 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 4,344 adverse event reports for this medication, which is primarily manufactured by Rb Health (Us) Llc.
The most commonly reported adverse events include Fatigue, Pain, Drug Ineffective. Of classified reports, 72.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and pain are the most common reactions reported.
Serious reactions, such as pneumonia and death, are noted but less frequent. A wide variety of reactions are reported, indicating diverse safety concerns. Report volume is substantial, with over 4,300 reports.
Patients taking Menthol, Unspecified Form should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. No specific drug interactions are noted, but caution is advised for off-label use and in patients with pre-existing conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Menthol, Unspecified Form received a safety concern score of 75/100 (elevated concern). This is based on a 72.8% serious event ratio across 1,478 classified reports. The score accounts for 4,344 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: 925, Male: 418, Unknown: 2. The most frequently reported age groups are age 66 (38 reports), age 73 (38 reports), age 74 (36 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 1,478 classified reports for MENTHOL, UNSPECIFIED FORM:
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.
No specific drug interactions are noted, but caution is advised for off-label use and in patients with pre-existing conditions.
If you are taking Menthol, Unspecified Form, here are important things to know. The most commonly reported side effects include fatigue, pain, drug ineffective, off label use, dyspnoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Use menthol products only as directed and for approved indications. Report any adverse reactions to the FDA's MedWatch program. 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 menthol products, particularly in elderly and at-risk populations.
The FDA has received approximately 4,344 adverse event reports associated with Menthol, Unspecified Form. 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 Menthol, Unspecified Form include Fatigue, Pain, Drug Ineffective, Off Label Use, Dyspnoea. By volume, the top reported reactions are: Fatigue (140 reports), Pain (130 reports), Drug Ineffective (119 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Menthol, Unspecified Form.
Out of 1,478 classified reports, 1,076 (72.8%) were classified as serious and 402 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 Menthol, Unspecified Form break down by patient sex as follows: Female: 925, Male: 418, 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 Menthol, Unspecified Form adverse events are: age 66: 38 reports, age 73: 38 reports, age 74: 36 reports, age 61: 33 reports, age 63: 31 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 Menthol, Unspecified Form adverse event reports is Rb Health (Us) 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 Menthol, Unspecified Form include: Diarrhoea, Headache, Pruritus, Cough, Arthralgia. 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 Menthol, Unspecified Form 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.
Menthol, Unspecified Form 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. Fatigue and pain are the most common reactions reported.
Key safety signals identified in Menthol, Unspecified Form's adverse event data include: Pain and fatigue are the most frequent reactions.. Serious reactions like pneumonia and death are reported but less common.. A diverse range of reactions, including respiratory and gastrointestinal issues, are observed.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
No specific drug interactions are noted, but caution is advised for off-label use and in patients with pre-existing conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Menthol, Unspecified Form.
Use menthol products only as directed and for approved indications. Report any adverse reactions to the FDA's MedWatch program.
Menthol, Unspecified Form has 4,344 adverse event reports on file with the FDA. Serious reactions, such as pneumonia and death, are noted but less frequent. The volume of reports for Menthol, Unspecified Form reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of menthol products, particularly in elderly and at-risk populations. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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