BORIC ACID: 155 Adverse Event Reports & Safety Profile
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Route: VAGINAL · Manufacturer: U.S. PHARMACEUTICAL CORPORATION · HUMAN OTC DRUG · FDA Label: Available
First Report: 20080101 · Latest Report: 20240501
What Are the Most Common BORIC ACID Side Effects?
All BORIC ACID Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 100 | 64.5% | 6 | 73 |
| Arthralgia | 96 | 61.9% | 6 | 73 |
| Pain in extremity | 96 | 61.9% | 6 | 73 |
| Musculoskeletal stiffness | 95 | 61.3% | 6 | 73 |
| Condition aggravated | 94 | 60.7% | 7 | 73 |
| Gastrointestinal toxicity | 94 | 60.7% | 6 | 73 |
| Hepatotoxicity | 94 | 60.7% | 6 | 73 |
| Infection | 94 | 60.7% | 6 | 73 |
| Musculoskeletal pain | 94 | 60.7% | 6 | 73 |
| Neoplasm malignant | 94 | 60.7% | 6 | 73 |
| Therapy non-responder | 94 | 60.7% | 7 | 73 |
| Joint injury | 93 | 60.0% | 6 | 72 |
| Pulmonary toxicity | 93 | 60.0% | 6 | 72 |
| Treatment failure | 93 | 60.0% | 6 | 72 |
| Joint swelling | 92 | 59.4% | 6 | 72 |
| C-reactive protein abnormal | 86 | 55.5% | 1 | 65 |
| Joint stiffness | 86 | 55.5% | 6 | 64 |
| Drug hypersensitivity | 78 | 50.3% | 6 | 72 |
| Arthropathy | 76 | 49.0% | 6 | 72 |
| Drug intolerance | 75 | 48.4% | 6 | 71 |
Who Reports BORIC ACID Side Effects? Age & Gender Data
Gender: 87.7% female, 12.3% male. Average age: 44.8 years. Most reports from: CA. View detailed demographics →
Is BORIC ACID Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 3 | 2 | 3 |
| 2013 | 1 | 1 | 0 |
| 2015 | 1 | 0 | 0 |
| 2018 | 1 | 0 | 0 |
| 2019 | 4 | 2 | 3 |
| 2020 | 2 | 0 | 0 |
| 2021 | 1 | 0 | 0 |
| 2022 | 3 | 0 | 2 |
| 2023 | 4 | 2 | 3 |
| 2024 | 1 | 0 | 0 |
What Is BORIC ACID Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 116 |
BORIC ACID vs Alternatives: Which Is Safer?
Official FDA Label for BORIC ACID
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses treats and relieves symptoms of vaginal and urinary infections rebalances vaginal pH and restores normal vaginal health helps relieve symptoms of external and internal vaginal burning, itching, irritation and dryness helps reduce vaginal odor due to vaginal infections
Dosage & Administration
Directions
- Wet the area: Begin by splashing water on the external vaginal area or take this step while in the shower or bath to ensure the area is moist.
- Apply the wash: Pump a small amount of the foam onto your hand. The foam should be rich and airy. Typically, two pumps are sufficient.
- Gentle Cleansing: Gently apply foam to the delicate areas. Use your hand to spread the foam, covering the entire area with gentle, circular motions. Avoid using sponges or washcloths, as they can be too abrasive.
- Rinse thoroughly: After cleansing, rinse thoroughly with warm water. Ensure all traces of the wash are removed to avoid irritation.
- Pat dry: Gently pat the area with a clean towel. Avoid rubbing, as this may cause irritation. It's important to ensure the area is completely dry before dressing to prevent moisture buildup, which can lead to irritation or infections.
Known Adverse Reactions
Adverse reactions and side effects The adverse effects are considered mild and may include watery discharge, erythema, or slight burning sensation. You should contact your healthcare provider for medical advice about adverse events or report a serious adverse event, by contacting US Pharmaceutical Corporation at the address listed below. Distributed by: US Pharmaceutical Corporation 2443 Park Central Blvd Decatur, GA 30035, USA
Warnings
Warnings For external Vaginal use only. Do not use
- If you never had a vaginal yeast infection diagnosed by your doctor.
- If you are allergic to any of the ingredients. When using this product
- mild increase in vaginal irritation or burning may occur. Stop use and ask a doctor if
- If symptoms persist or inflammation increases after 7 days of use or if the infection increases.
- Increase in abdominal pain or foul discharge. Pregnant or Breast Feeding
- Ask a Health Professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Active Ingredient
Active Ingredient Purpose
- Lactic Acid 0.5%: Maintains natural pH levels, fostering a healthy environment to prevent irritation and infections.
- Boric Acid 0.5%: Restores and stabilizes acidic pH levels, effectively preventing yeast infections.
- Chlorhexidine Digluconate 1%: Offers potent antibacterial protection, reducing the risk of bacterial infections without disrupting the vaginal flora.
- Cnidium Monnieri Fruit Extract 0.5%: Provides anti-inflammatory properties, soothing the skin and reducing any potential irritation.
- Bisabolol 0.3%: Calms and soothes the skin, reducing redness and providing a gentle, comforting effect upon application.
Inactive Ingredients
Inactive ingredients Maltodextrin, Antioxidants-Vitamin E (DL-Alpha-Tocopheryl Acetate) & Vitamin C (Ascorbic Acid), Lactobacillus casei (KE-99), Lactobacillus gasseri and Capsule Ingredient (Pullulan). Adverse reactions and side effects The adverse effects are considered mild and may include watery discharge, erythema, or slight burning sensation. You should contact your healthcare provider for medical advice about adverse events or report a serious adverse event, by contacting BeBe & Bella, LLC. at the address listed below. Distributed by : BeBe & Bella, LLC 2443 Park Central Blvd. Decatur, GA 30035, USA