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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.

SODIUM PERBORATE: 49 Adverse Event Reports & Safety Profile

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49
Total FAERS Reports
7 (14.3%)
Deaths Reported
49
Hospitalizations
49
As Primary/Secondary Suspect
7
Life-Threatening
7
Disabilities
Vintage Brands Limited
Manufacturer

Route: ORAL · Manufacturer: Vintage Brands Limited · HUMAN OTC DRUG · FDA Label: Available

First Report: 20080101 · Latest Report: 20080615

What Are the Most Common SODIUM PERBORATE Side Effects?

#1 Most Reported
Therapy non-responder
49 reports (100.0%)
#2 Most Reported
Condition aggravated
49 reports (100.0%)
#3 Most Reported
Treatment failure
48 reports (98.0%)

All SODIUM PERBORATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Condition aggravated 49 100.0% 7 49
Therapy non-responder 49 100.0% 7 49
Arthralgia 48 98.0% 6 48
Arthropathy 48 98.0% 6 48
Drug hypersensitivity 48 98.0% 6 48
Drug ineffective 48 98.0% 6 48
Drug intolerance 48 98.0% 6 48
Gastrointestinal toxicity 48 98.0% 6 48
Hepatotoxicity 48 98.0% 6 48
Infection 48 98.0% 6 48
Joint injury 48 98.0% 6 48
Musculoskeletal pain 48 98.0% 6 48
Musculoskeletal stiffness 48 98.0% 6 48
Neoplasm malignant 48 98.0% 6 48
Pain in extremity 48 98.0% 6 48
Pulmonary toxicity 48 98.0% 6 48
Therapeutic product effect incomplete 48 98.0% 6 48
Treatment failure 48 98.0% 6 48
Joint stiffness 47 95.9% 6 47
Joint swelling 47 95.9% 6 47

Who Reports SODIUM PERBORATE Side Effects? Age & Gender Data

Gender: 100.0% female, 0.0% male. Average age: 42.8 years. Most reports from: CA. View detailed demographics →

Is SODIUM PERBORATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2008 3 2 3

View full timeline →

What Is SODIUM PERBORATE Used For?

IndicationReports
Product used for unknown indication 47

Official FDA Label for SODIUM PERBORATE

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Uses aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth for temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums for temporary use to cleanse canker sores assist in the removal of foreign material from minor wounds

Dosage & Administration

Directions adults and children 6 years of age and older: dissolve one envelope in 1 ounce (30 milliliters) of warm water use immediately. swish solution around in the mouth over the affected area or gargle for at least 1 minute and then spit it out. do not swallow. use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor. children under 12 years of age should be supervised in the use of this product. consult a dentist or doctor for use in children under 6 years of age.

Warnings

Warnings For external use only. Do not use for more than 7 days unless directed by a dentist or doctor. Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days. irritation, pain, or redness persists or worsens swelling, rash, or fever develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

Active ingredient (in each envelope) Sodium perborate monohydrate 1.2g Purpose Oral Debriding Agent/Oral Wound Cleanser

Inactive Ingredients

Inactive ingredients l-tartaric acid, sodium saccharin, peppermint flavor