SODIUM BORATE: 114 Adverse Event Reports & Safety Profile
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Route: SUBLINGUAL · Manufacturer: SEVENE USA · HUMAN OTC DRUG · FDA Label: Available
First Report: 20080101 · Latest Report: 20220512
What Are the Most Common SODIUM BORATE Side Effects?
All SODIUM BORATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 109 | 95.6% | 6 | 91 |
| Therapeutic product effect incomplete | 90 | 79.0% | 6 | 90 |
| Arthralgia | 86 | 75.4% | 6 | 68 |
| Gastrointestinal toxicity | 86 | 75.4% | 6 | 68 |
| Hepatotoxicity | 86 | 75.4% | 6 | 68 |
| Musculoskeletal pain | 86 | 75.4% | 6 | 68 |
| Musculoskeletal stiffness | 86 | 75.4% | 6 | 68 |
| Neoplasm malignant | 86 | 75.4% | 6 | 68 |
| Pain in extremity | 86 | 75.4% | 6 | 68 |
| Condition aggravated | 85 | 74.6% | 7 | 68 |
| Infection | 85 | 74.6% | 6 | 68 |
| Joint injury | 85 | 74.6% | 6 | 67 |
| Pulmonary toxicity | 85 | 74.6% | 6 | 67 |
| Therapy non-responder | 85 | 74.6% | 7 | 68 |
| Joint swelling | 84 | 73.7% | 6 | 67 |
| Treatment failure | 84 | 73.7% | 6 | 67 |
| C-reactive protein abnormal | 78 | 68.4% | 1 | 60 |
| Joint stiffness | 71 | 62.3% | 6 | 54 |
| Arthropathy | 68 | 59.7% | 6 | 67 |
| Drug hypersensitivity | 68 | 59.7% | 6 | 68 |
Who Reports SODIUM BORATE Side Effects? Age & Gender Data
Gender: 98.1% female, 1.9% male. Average age: 50.7 years. Most reports from: CA. View detailed demographics →
Is SODIUM BORATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 3 | 2 | 3 |
| 2022 | 1 | 0 | 1 |
What Is SODIUM BORATE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 109 |
SODIUM BORATE vs Alternatives: Which Is Safer?
Official FDA Label for SODIUM BORATE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses* temporarily relieves symptoms of canker sores or minor mouth and gum irritations such as: pain soreness discomfort Tube- Canker Sores*
Dosage & Administration
DOSAGE Adults: Mix 4-6 drops in 1/2 cup of water, take orally three times daily or as directed by a physician. Children (2 years and older): Take half the adult dose.
Warnings
WARNINGS This product is to be used for self-limiting conditions If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product Keep this and all medication out of reach of children Do not use if capseal is broken or missing. Close the cap tightly after use.
Active Ingredient
Active ingedient** (in each pellet)
Borax
6C HPUS (0.44 mg) The letters "HPUS" indicate that the component in this product is offically monographed in the Homeopathic Pharmacopoeia of the United States.
Inactive Ingredients
INACTIVE INGREDIENTS Active: As Above; Inactive: ENA 50% v/v and Purified Water q.s.