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 | |
---|---|---|
1 | Application site burn | 26 |
2 | Pain | 25 |
3 | Application site pain | 23 |
4 | Erythema | 23 |
5 | Application site erythema | 21 |
6 | Blister | 20 |
7 | Drug ineffective | 19 |
8 | Chemical injury | 19 |
9 | Application site vesicles | 18 |
10 | Thermal burn | 18 |
11 | Nausea | 17 |
12 | Chronic obstructive pulmonary disease | 15 |
13 | Lower respiratory tract infection | 13 |
14 | Diarrhoea | 13 |
15 | Dizziness | 13 |
16 | Asthenia | 13 |
17 | Burning sensation | 12 |
18 | Dyspnoea | 12 |
19 | Product quality issue | 12 |
20 | Burns second degree | 11 |
* 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 | |
---|---|---|
1 | Product used for unknown indication | 143 |
2 | Pain | 70 |
3 | Back pain | 61 |
4 | Osteoarthritis | 40 |
5 | Neck pain | 40 |
6 | Arthralgia | 39 |
7 | Arthritis | 36 |
8 | Breath odour | 30 |
9 | Myalgia | 24 |
10 | Analgesic therapy | 22 |
*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.