MAGNESIUM SALICYLATE: 483 Adverse Event Reports & Safety Profile
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Route: ORAL · Manufacturer: Dr. Reddy's Laboratories Inc. · HUMAN OTC DRUG · FDA Label: Available
First Report: 20160401 · Latest Report: 20250904
What Are the Most Common MAGNESIUM SALICYLATE Side Effects?
All MAGNESIUM SALICYLATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 405 | 83.9% | 1 | 0 |
| Product quality issue | 379 | 78.5% | 1 | 0 |
| Product use in unapproved indication | 11 | 2.3% | 0 | 0 |
| Abdominal discomfort | 9 | 1.9% | 0 | 0 |
| Abdominal pain upper | 7 | 1.5% | 0 | 0 |
| Adverse drug reaction | 7 | 1.5% | 0 | 0 |
| Incorrect dose administered | 6 | 1.2% | 0 | 0 |
| Dizziness | 5 | 1.0% | 0 | 0 |
| Expired product administered | 5 | 1.0% | 0 | 0 |
Who Reports MAGNESIUM SALICYLATE Side Effects? Age & Gender Data
Gender: 54.7% female, 45.3% male. Average age: 61.3 years. Most reports from: US. View detailed demographics →
Is MAGNESIUM SALICYLATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2016 | 2 | 0 | 1 |
| 2017 | 1 | 0 | 0 |
| 2018 | 2 | 0 | 1 |
| 2019 | 13 | 0 | 0 |
| 2020 | 4 | 0 | 0 |
| 2022 | 3 | 0 | 1 |
| 2023 | 1 | 0 | 0 |
| 2024 | 1 | 0 | 0 |
| 2025 | 2 | 0 | 0 |
What Is MAGNESIUM SALICYLATE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 293 |
| Back pain | 149 |
| Pain | 14 |
| Analgesic therapy | 5 |
| Sciatica | 5 |
MAGNESIUM SALICYLATE vs Alternatives: Which Is Safer?
Official FDA Label for MAGNESIUM SALICYLATE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses Temporarily relieves minor aches and pains associated with backache muscular aches
Dosage & Administration
DOSAGE & ADMINISTRATION Directions drink a full glass of water with each dose Adults and children: (12 years and over)
Take
2 caplets every 6 hours, not to exceed 8 caplets in 24 hours. Children under 12 years: Do not use unless directed by a doctor
Warnings
WARNINGS Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Magnesium salicylate may cause a severe allergic reaction, which may include: hives facial swelling asthma (wheezing) shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is 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 prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcohol drinks every day while using this product take more or for a longer time than directed DO NOT USE Do not use if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer.
Ask Doctor
Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic ASK DOCTOR/PHARMACIST Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis STOP USE Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or loss of hearing occurs new symptoms occur pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition.
Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use magnesium salicylate at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Active Ingredient
ACTIVE INGREDIENT Active ingredient (in each caplet)
Magnesium Salicylate
Tetrahydrate (NSAID*) 580 mg (equivalent to 467.2 mg of anhydrous magnesium salicylate) *nonsteroidal anti-inflammatory drug
Inactive Ingredients
INACTIVE INGREDIENT Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetin