MENTHOL, METHYL SALICYLATE

N/A

Manufactured by Hisamitsu Pharmaceutical Co., Inc.

1,107 FDA adverse event reports analyzed

Last updated: 2026-04-15

About MENTHOL, METHYL SALICYLATE

MENTHOL, METHYL SALICYLATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Hisamitsu Pharmaceutical Co., Inc.. The most commonly reported adverse reactions for MENTHOL, METHYL SALICYLATE include DRUG INEFFECTIVE, APPLICATION SITE PAIN, INTENTIONAL PRODUCT MISUSE, APPLICATION SITE ERYTHEMA, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MENTHOL, METHYL SALICYLATE.

Top Adverse Reactions

DRUG INEFFECTIVE99 reports
APPLICATION SITE PAIN67 reports
INTENTIONAL PRODUCT MISUSE42 reports
APPLICATION SITE ERYTHEMA35 reports
DYSPNOEA29 reports
PAIN27 reports
FATIGUE26 reports
APPLICATION SITE PRURITUS24 reports
APPLICATION SITE RASH24 reports
DIARRHOEA22 reports
DIZZINESS22 reports
HEADACHE21 reports
ARTHRALGIA20 reports
APPLICATION SITE BURN19 reports
ASTHENIA19 reports
NAUSEA19 reports
COUGH16 reports
OFF LABEL USE16 reports
PAIN IN EXTREMITY15 reports
PERIPHERAL SWELLING15 reports
RASH14 reports
APPLICATION SITE IRRITATION13 reports
BACK PAIN13 reports
FALL13 reports
APPLICATION SITE VESICLES12 reports
CONSTIPATION11 reports
DEATH11 reports
PRURITUS11 reports
WEIGHT DECREASED11 reports
MALAISE10 reports
ABDOMINAL PAIN UPPER9 reports
APPLICATION SITE EXFOLIATION9 reports
CHEST PAIN9 reports
DECREASED APPETITE9 reports
DERMATITIS CONTACT9 reports
GAIT DISTURBANCE9 reports
INSOMNIA9 reports
MUSCULOSKELETAL STIFFNESS9 reports
PNEUMONIA9 reports
ANXIETY8 reports
COVID 198 reports
ERYTHEMA8 reports
HYPOTENSION8 reports
MYALGIA8 reports
TREMOR8 reports
APPLICATION SITE BRUISE7 reports
APPLICATION SITE SWELLING7 reports
APPLICATION SITE WARMTH7 reports
INFUSION SITE PAIN7 reports
MEDICATION ERROR7 reports
MUSCLE SPASMS7 reports
THROAT IRRITATION7 reports
VOMITING7 reports
WEIGHT INCREASED7 reports
ARTHRITIS6 reports
BURNING SENSATION6 reports
FLATULENCE6 reports
GASTROOESOPHAGEAL REFLUX DISEASE6 reports
JOINT SWELLING6 reports
NECK PAIN6 reports
PRODUCT DOSE OMISSION ISSUE6 reports
URINARY TRACT INFECTION6 reports
ABDOMINAL DISCOMFORT5 reports
ABDOMINAL PAIN5 reports
BLOOD PRESSURE INCREASED5 reports
DEPRESSION5 reports
DISEASE PROGRESSION5 reports
HEART RATE INCREASED5 reports
HYPERSENSITIVITY5 reports
ILLNESS5 reports
MEMORY IMPAIRMENT5 reports
MOBILITY DECREASED5 reports
NASOPHARYNGITIS5 reports
OEDEMA PERIPHERAL5 reports
ORAL PAIN5 reports
OSTEOPOROSIS5 reports
PALPITATIONS5 reports
PYREXIA5 reports
RHINORRHOEA5 reports
SOMNOLENCE5 reports
UNEVALUABLE EVENT5 reports
ALOPECIA4 reports
APPLICATION SITE DRYNESS4 reports
APPLICATION SITE SCAB4 reports
BRONCHITIS4 reports
CANDIDA INFECTION4 reports
CONTUSION4 reports
DYSPNOEA EXERTIONAL4 reports
EAR PAIN4 reports
EPISTAXIS4 reports
EYE PAIN4 reports
FEELING ABNORMAL4 reports
GASTROINTESTINAL DISORDER4 reports
HYPOAESTHESIA4 reports
INFECTION4 reports
INFUSION SITE PRURITUS4 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES4 reports
MIGRAINE4 reports
MUSCULAR WEAKNESS4 reports
MUSCULOSKELETAL CHEST PAIN4 reports

Report Outcomes

Out of 535 classified reports for MENTHOL, METHYL SALICYLATE:

Serious 27.7%Non-Serious 72.3%

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

Female377 (72.9%)
Male139 (26.9%)
Unknown1 (0.2%)

Reports by Age

Age 7115 reports
Age 6611 reports
Age 7410 reports
Age 8010 reports
Age 8610 reports
Age 699 reports
Age 729 reports
Age 608 reports
Age 658 reports
Age 758 reports
Age 768 reports
Age 788 reports
Age 798 reports
Age 587 reports
Age 627 reports
Age 737 reports
Age 777 reports
Age 837 reports
Age 496 reports
Age 616 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, METHYL SALICYLATE?

This profile reflects 1,107 FDA FAERS reports that mention MENTHOL, METHYL SALICYLATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for MENTHOL, METHYL SALICYLATE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, APPLICATION SITE PAIN, INTENTIONAL PRODUCT MISUSE, APPLICATION SITE ERYTHEMA, DYSPNOEA, PAIN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures MENTHOL, METHYL SALICYLATE?

Labeling and FAERS entries often list Hisamitsu Pharmaceutical Co., Inc. in connection with MENTHOL, METHYL SALICYLATE. 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.