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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.

BORIC ACID: 155 Adverse Event Reports & Safety Profile

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155
Total FAERS Reports
22 (14.2%)
Deaths Reported
104
Hospitalizations
155
As Primary/Secondary Suspect
15
Life-Threatening
9
Disabilities
U.S. PHARMACEUTICAL CORPORA...
Manufacturer

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?

#1 Most Reported
Drug ineffective
100 reports (64.5%)
#2 Most Reported
Pain in extremity
96 reports (61.9%)
#3 Most Reported
Arthralgia
96 reports (61.9%)

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

YearReportsDeathsHosp.
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

View full timeline →

What Is BORIC ACID Used For?

IndicationReports
Product used for unknown indication 116

BORIC ACID vs Alternatives: Which Is Safer?

BORIC ACID vs BORTEZOMIB BORIC ACID vs BOSENTAN BORIC ACID vs BOSENTAN\BOSENTAN BORIC ACID vs BOSUTINIB BORIC ACID vs BOTOX BORIC ACID vs BOTOX COSMETIC BORIC ACID vs BOTULINUM TOXIN NOS BORIC ACID vs BOTULINUM TOXIN TYPE A BORIC ACID vs BREMELANOTIDE BORIC ACID vs BRENTUXIMAB

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