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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

METHYL SALICYLATE: 59 Adverse Event Reports & Safety Profile

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59
Total FAERS Reports
4 (6.8%)
Deaths Reported
6
Hospitalizations
59
As Primary/Secondary Suspect
1
Life-Threatening
7
Disabilities
Menper Distributors Inc.
Manufacturer

Route: TOPICAL · Manufacturer: Menper Distributors Inc. · HUMAN OTC DRUG · FDA Label: Available

First Report: 20120612 · Latest Report: 20220117

What Are the Most Common METHYL SALICYLATE Side Effects?

#1 Most Reported
Pruritus
40 reports (67.8%)
#2 Most Reported
Hypertension
39 reports (66.1%)
#3 Most Reported
Dyspepsia
39 reports (66.1%)

All METHYL SALICYLATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pruritus 40 67.8% 0 3
Drug ineffective 39 66.1% 0 3
Dyspepsia 39 66.1% 0 3
Hypertension 39 66.1% 0 3
Rheumatoid arthritis 38 64.4% 0 3
Angioedema 37 62.7% 0 3
Food intolerance 37 62.7% 0 3
Hepatic enzyme increased 37 62.7% 0 3
Injection site inflammation 37 62.7% 0 3
Pneumonia 37 62.7% 0 3
Urosepsis 37 62.7% 0 3
Drug intolerance 36 61.0% 0 3
Loss of personal independence in daily activities 26 44.1% 0 3
Off label use 25 42.4% 0 3
Pain 25 42.4% 0 4
Arthropathy 24 40.7% 0 3
Condition aggravated 24 40.7% 0 3
Musculoskeletal stiffness 24 40.7% 0 3
Pulmonary fibrosis 24 40.7% 0 3
Synovitis 24 40.7% 0 3

Who Reports METHYL SALICYLATE Side Effects? Age & Gender Data

Gender: 80.0% female, 20.0% male. Average age: 68.2 years. Most reports from: CA. View detailed demographics →

Is METHYL SALICYLATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2012 1 0 1
2014 2 0 0
2015 6 0 0
2016 1 0 0
2017 1 0 0
2019 1 0 1
2021 2 2 0
2022 1 0 1

View full timeline →

What Is METHYL SALICYLATE Used For?

IndicationReports
Rheumatoid arthritis 31
Product used for unknown indication 12

Official FDA Label for METHYL SALICYLATE

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: do not use, consult a doctor For easy application: partially peel back protective film and apply exposed patch to the site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesion.

Dosage & Administration

Directions Adults and children 18 years of age and older: Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time. - Clean and dry the affected area. - Open pouch and remove one patch. - Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope. - Wash hands with soap and water after handling the patches. - Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope. - Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them. Children under 18 years: Ask a physician

Warnings

Warnings For external use only Stomach bleeding warning : This product contains an NSAID, which may cause stomach bleeding. The chance is small but higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed Do not use
  • on the face or rashes
  • on wounds or damaged skin
  • if allergic to aspirin or other NSAIDs
  • with a heating pad
  • when sweating (such as from exercise or heat)
  • any patch from a pouch that has been open for 14 or more days
  • right before or after heart surgery Ask a doctor before use if
  • you are allergic to topical products
  • the stomach bleeding warning applies to you
  • you have high blood pressure, heart disease, or kidney disease
  • you are taking a diuretic When using this product
  • wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if
  • stomach pain or upset gets worse or lasts
  • you feel faint, vomit blood, or have bloody or black stools These are signs of stomach bleeding.
  • rash, itching or skin irritation develops
  • condition worsens
  • symptoms last for more than 3 days
  • symptoms clear up and occur again within a few days If pregnant or breast-feeding, ask a doctor before use while breast-feeding and during the first 6 months of pregnancy. Do not use during the last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. If put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches after folding sticky ends together.

Active Ingredient

Drug Facts Active Ingredients Purpose Methyl Salicate 10.5%..............................................................External Analgesic

Inactive Ingredients

Inactive ingredients Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine Methyl Salicylate 40 % Cream NDC: 50488-6040-6 6 0 gram Manufactured for: Alexso, Inc 2317 Cotner Ave Los Angeles, CA 90064