MENTHOL

N/A

Manufactured by Chattem, Inc.

7,333 FDA adverse event reports analyzed

Last updated: 2026-04-15

About MENTHOL

MENTHOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Chattem, Inc.. The most commonly reported adverse reactions for MENTHOL include DRUG INEFFECTIVE, PAIN, NO ADVERSE EVENT, FATIGUE, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MENTHOL.

Top Adverse Reactions

DRUG INEFFECTIVE432 reports
PAIN286 reports
NO ADVERSE EVENT217 reports
FATIGUE191 reports
DYSPNOEA166 reports
DIARRHOEA156 reports
HEADACHE156 reports
APPLICATION SITE BURN150 reports
PRURITUS141 reports
DIZZINESS133 reports
OFF LABEL USE133 reports
ARTHRALGIA127 reports
COUGH124 reports
NAUSEA122 reports
APPLICATION SITE PAIN118 reports
ERYTHEMA117 reports
BACK PAIN115 reports
FALL106 reports
RASH106 reports
PAIN IN EXTREMITY102 reports
BLISTER98 reports
PNEUMONIA94 reports
INSOMNIA85 reports
ASTHENIA84 reports
BURNING SENSATION80 reports
VOMITING79 reports
NASOPHARYNGITIS77 reports
PYREXIA77 reports
APPLICATION SITE ERYTHEMA73 reports
DECREASED APPETITE73 reports
SKIN BURNING SENSATION72 reports
CONDITION AGGRAVATED71 reports
DRUG HYPERSENSITIVITY70 reports
SINUSITIS69 reports
HYPERSENSITIVITY68 reports
ANXIETY67 reports
DEATH64 reports
HYPERTENSION63 reports
SOMNOLENCE63 reports
THERMAL BURN63 reports
ABDOMINAL DISCOMFORT62 reports
HYPOTENSION62 reports
MALAISE61 reports
INFECTION60 reports
URTICARIA59 reports
BURNS SECOND DEGREE57 reports
CONTUSION56 reports
MYALGIA56 reports
CHEST PAIN54 reports
HYPOAESTHESIA54 reports
PERIPHERAL SWELLING54 reports
OROPHARYNGEAL PAIN53 reports
PRODUCT USE IN UNAPPROVED INDICATION53 reports
CHEMICAL BURN50 reports
ACUTE KIDNEY INJURY49 reports
URINARY TRACT INFECTION49 reports
WEIGHT DECREASED49 reports
PRODUCT USE ISSUE48 reports
SKIN EXFOLIATION48 reports
CHEMICAL INJURY47 reports
DEPRESSION47 reports
APPLICATION SITE VESICLES46 reports
GAIT DISTURBANCE46 reports
COVID 1945 reports
MUSCLE SPASMS45 reports
CONFUSIONAL STATE44 reports
SWELLING44 reports
ABDOMINAL PAIN43 reports
CHILLS43 reports
CONSTIPATION43 reports
INJURY43 reports
FEELING ABNORMAL42 reports
ILLNESS42 reports
INFLUENZA42 reports
ANAEMIA41 reports
ASTHMA41 reports
CHRONIC KIDNEY DISEASE41 reports
SCAR41 reports
ALOPECIA40 reports
DRUG INTOLERANCE40 reports
DRY MOUTH40 reports
NASAL CONGESTION40 reports
RENAL FAILURE39 reports
ABDOMINAL PAIN UPPER38 reports
PRODUCT DOSE OMISSION ISSUE38 reports
PRODUCT QUALITY ISSUE37 reports
SKIN DISCOLOURATION37 reports
EXPOSURE TO CHEMICAL POLLUTION36 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION36 reports
TREMOR36 reports
MIGRAINE35 reports
DRUG INTERACTION34 reports
MUSCULOSKELETAL STIFFNESS34 reports
BLOOD CHOLESTEROL INCREASED33 reports
JOINT SWELLING33 reports
C REACTIVE PROTEIN INCREASED32 reports
MUSCULAR WEAKNESS32 reports
NECK PAIN32 reports
RHINORRHOEA32 reports
BLOOD PRESSURE INCREASED31 reports

Report Outcomes

Out of 3,233 classified reports for MENTHOL:

Serious 60.0%Non-Serious 40.0%

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 Breakdown

Reports by Sex

Female1,928 (67.7%)
Male904 (31.8%)
Unknown14 (0.5%)

Reports by Age

Age 6654 reports
Age 6452 reports
Age 6350 reports
Age 7449 reports
Age 6248 reports
Age 7347 reports
Age 7045 reports
Age 6044 reports
Age 6144 reports
Age 7240 reports
Age 6938 reports
Age 7538 reports
Age 8038 reports
Age 4936 reports
Age 7835 reports
Age 4834 reports
Age 5734 reports
Age 5933 reports
Age 7633 reports
Age 6531 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with MENTHOL?

This profile reflects 7,333 FDA FAERS reports that mention MENTHOL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for MENTHOL?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, PAIN, NO ADVERSE EVENT, FATIGUE, DYSPNOEA, DIARRHOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures MENTHOL?

Labeling and FAERS entries often list Chattem, Inc. in connection with MENTHOL. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.