Drug Safety Information for SALONPAS (Menthol; methyl salicylate)

FDA Safety-related Labeling Changes for SALONPAS (MENTHOL; METHYL SALICYLATE) Over-the-counter Drug: Safety Information Link

Adverse Drug Reactions for SALONPAS* (Menthol; methyl salicylate)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with SALONPAS
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Application site burn26
2Pain25
3Application site pain23
4Erythema23
5Application site erythema21
6Blister20
7Drug ineffective19
8Chemical injury19
9Application site vesicles18
10Thermal burn18
11Nausea17
12Chronic obstructive pulmonary disease15
13Lower respiratory tract infection13
14Diarrhoea13
15Dizziness13
16Asthenia13
17Burning sensation12
18Dyspnoea12
19Product quality issue12
20Burns second degree11

* This side effect also appears in "Top 10 Side Effects of SALONPAS " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking SALONPAS
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication143
2Pain70
3Back pain61
4Osteoarthritis40
5Neck pain40
6Arthralgia39
7Arthritis36
8Breath odour30
9Myalgia24
10Analgesic therapy22

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for SALONPAS

Total Reports Filed with FDA: 1586


Number of FDA Adverse Event Reports by Patient Age for SALONPAS

Total Reports Filed with FDA: 1586*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Menthol; methyl salicylate (Analgesic balm, Ageless pain relief, Arthritis hot, Care one cool heat, Cvs cold and hot, Equaline cool heat, Imbue, Medistik, Miracle rub, Namman muay, Pain bust r ii, Sun moon star, Eagle, Careall muscle rub, Freezin cold toast, Friccilicont, Kwan loong, Precise, Calypxo pain relief, Cramergesic, Equate cool and heat, Herbal utaplas.tn, Keratek, Max revive, Medicated green oil, Ray dol, Sheng chun herbal, Theragesic creme, Theragesic plus, Ultra balm, Salonpas, Jimin zhuifeng gao, Good sense cool heat, Cool heat, Salonpas pain relief, Banalg)

Charts are based on 1586 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and SALONPAS Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.