CARBAMIDE PEROXIDE 6.5%

N/A

Manufactured by Bionpharma Inc.

120 FDA adverse event reports analyzed

Last updated: 2026-04-15

About CARBAMIDE PEROXIDE 6.5%

CARBAMIDE PEROXIDE 6.5% is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bionpharma Inc.. The most commonly reported adverse reactions for CARBAMIDE PEROXIDE 6.5% include DIARRHOEA, DRUG INEFFECTIVE, PAIN, ASTHENIA, BLOOD GLUCOSE INCREASED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CARBAMIDE PEROXIDE 6.5%.

Top Adverse Reactions

DIARRHOEA4 reports
DRUG INEFFECTIVE3 reports
PAIN3 reports
ASTHENIA2 reports
BLOOD GLUCOSE INCREASED2 reports
DRUG DOSE OMISSION2 reports
ERYTHEMA2 reports
EYE IRRITATION2 reports
FATIGUE2 reports
MALAISE2 reports
NERVE COMPRESSION2 reports
OROPHARYNGEAL PAIN2 reports
PRURITUS2 reports
VOMITING2 reports
WEIGHT DECREASED2 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS2 reports
ABDOMINAL DISCOMFORT1 reports
ABDOMINAL PAIN1 reports
ABDOMINAL PAIN UPPER1 reports
ACNE1 reports
ADMINISTRATION SITE LACERATION1 reports
ADVERSE DRUG REACTION1 reports
ALOPECIA1 reports
AMNESIA1 reports
ANAEMIA1 reports
ATRIAL FIBRILLATION1 reports
BACK PAIN1 reports
BALANCE DISORDER1 reports
BENIGN PROSTATIC HYPERPLASIA1 reports
BLOOD PRESSURE INCREASED1 reports
BLOOD PRODUCT TRANSFUSION DEPENDENT1 reports
CANDIDIASIS1 reports
CHEST PAIN1 reports
CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR1 reports
CONCUSSION1 reports
CONFUSIONAL STATE1 reports
CONTUSION1 reports
COUGH1 reports
DACRYOCYSTITIS1 reports
DEAFNESS UNILATERAL1 reports
DECREASED APPETITE1 reports
DEEP VEIN THROMBOSIS1 reports
DEMENTIA1 reports
DEPRESSION1 reports
DEVICE PHYSICAL PROPERTY ISSUE1 reports
DISTURBANCE IN ATTENTION1 reports
DIZZINESS1 reports
DRUG EFFECT DECREASED1 reports
DRUG EXPOSURE DURING PREGNANCY1 reports
DRUG INTOLERANCE1 reports
DRY SKIN1 reports
DYSPEPSIA1 reports
DYSTONIA1 reports
EPISTAXIS1 reports
EYE INFECTION BACTERIAL1 reports
EYE INJURY1 reports
FALL1 reports
FEELING ABNORMAL1 reports
FEELING HOT1 reports
FLUSHING1 reports
FOOT FRACTURE1 reports
FULL BLOOD COUNT DECREASED1 reports
GASTRIC HAEMORRHAGE1 reports
GASTRITIS1 reports
HAEMOLYSIS1 reports
HEAD DISCOMFORT1 reports
HEADACHE1 reports
HYPERSENSITIVITY1 reports
HYPOACUSIS1 reports
HYPOAESTHESIA1 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION1 reports
INCORRECT PRODUCT FORMULATION ADMINISTERED1 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION1 reports
INFECTION1 reports
INFLUENZA1 reports
INSTILLATION SITE HAEMORRHAGE1 reports
INTENTIONAL PRODUCT USE ISSUE1 reports
JAUNDICE CHOLESTATIC1 reports
LIP BLISTER1 reports
LOCAL SWELLING1 reports
LOW DENSITY LIPOPROTEIN DECREASED1 reports
MEMORY IMPAIRMENT1 reports
MIDDLE EAR EFFUSION1 reports
MIGRAINE1 reports
MOVEMENT DISORDER1 reports
MYOCARDIAL INFARCTION1 reports
NAUSEA1 reports
NIGHT SWEATS1 reports
OCULAR HYPERAEMIA1 reports
OEDEMA PERIPHERAL1 reports
OROPHARYNGEAL BLISTERING1 reports
OSTEOARTHRITIS1 reports
OVERDOSE1 reports
PALPITATIONS1 reports
PARAESTHESIA1 reports
PNEUMONIA1 reports
PRODUCT DISPENSING ERROR1 reports
PRODUCT DOSE OMISSION ISSUE1 reports
PRODUCT PACKAGING CONFUSION1 reports
PRODUCT QUALITY ISSUE1 reports

Report Outcomes

Out of 44 classified reports for CARBAMIDE PEROXIDE 6.5%:

Serious 52.3%Non-Serious 47.7%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female25 (59.5%)
Male17 (40.5%)

Reports by Age

Age 142 reports
Age 602 reports
Age 662 reports
Age 732 reports
Age 932 reports
Age 91 reports
Age 121 reports
Age 151 reports
Age 171 reports
Age 281 reports
Age 381 reports
Age 491 reports
Age 541 reports
Age 581 reports
Age 591 reports
Age 631 reports
Age 721 reports
Age 791 reports
Age 801 reports
Age 841 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with CARBAMIDE PEROXIDE 6.5%?

This profile reflects 120 FDA FAERS reports that mention CARBAMIDE PEROXIDE 6.5%. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CARBAMIDE PEROXIDE 6.5%?

Frequently reported terms in FAERS include DIARRHOEA, DRUG INEFFECTIVE, PAIN, ASTHENIA, BLOOD GLUCOSE INCREASED, DRUG DOSE OMISSION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CARBAMIDE PEROXIDE 6.5%?

Labeling and FAERS entries often list Bionpharma Inc. in connection with CARBAMIDE PEROXIDE 6.5%. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.