CARBAMIDE PEROXIDE

N/A

Manufactured by Medtech Products Inc.

928 FDA adverse event reports analyzed

Last updated: 2026-04-15

About CARBAMIDE PEROXIDE

CARBAMIDE PEROXIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Medtech Products Inc.. The most commonly reported adverse reactions for CARBAMIDE PEROXIDE include DIARRHOEA, FATIGUE, PAIN, CHRONIC KIDNEY DISEASE, FALL. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CARBAMIDE PEROXIDE.

Top Adverse Reactions

DIARRHOEA29 reports
FATIGUE24 reports
PAIN20 reports
CHRONIC KIDNEY DISEASE18 reports
FALL18 reports
HEADACHE18 reports
NAUSEA18 reports
PNEUMONIA18 reports
DEATH17 reports
DEAFNESS16 reports
DIZZINESS16 reports
OFF LABEL USE16 reports
HYPOACUSIS15 reports
ACUTE KIDNEY INJURY14 reports
ANXIETY14 reports
HYPERTENSION14 reports
TINNITUS14 reports
URINARY TRACT INFECTION14 reports
WEIGHT DECREASED14 reports
DEPRESSION13 reports
EAR DISCOMFORT13 reports
EAR PAIN13 reports
ABDOMINAL PAIN12 reports
ARTHRALGIA12 reports
ASTHENIA12 reports
VOMITING12 reports
BLOOD CREATININE INCREASED11 reports
COUGH11 reports
DYSPNOEA11 reports
GAIT DISTURBANCE11 reports
PRODUCT DOSE OMISSION ISSUE11 reports
PYREXIA11 reports
INFECTION10 reports
RASH10 reports
BACK PAIN9 reports
CONDITION AGGRAVATED9 reports
DEHYDRATION9 reports
EMOTIONAL DISTRESS9 reports
HAEMOGLOBIN DECREASED9 reports
PRODUCTIVE COUGH9 reports
SEPSIS9 reports
ANAEMIA8 reports
CERUMEN IMPACTION8 reports
CHEST PAIN8 reports
CONSTIPATION8 reports
DRUG HYPERSENSITIVITY8 reports
DRUG INEFFECTIVE8 reports
EAR INFECTION8 reports
HYPOTENSION8 reports
INSOMNIA8 reports
INTERNATIONAL NORMALISED RATIO INCREASED8 reports
MALIGNANT NEOPLASM PROGRESSION8 reports
MUSCLE SPASMS8 reports
PAIN IN EXTREMITY8 reports
RENAL FAILURE8 reports
ATRIAL FIBRILLATION7 reports
END STAGE RENAL DISEASE7 reports
HYPOXIA7 reports
NASOPHARYNGITIS7 reports
NEPHROGENIC ANAEMIA7 reports
OEDEMA PERIPHERAL7 reports
PRURITUS7 reports
SOMNOLENCE7 reports
ALOPECIA6 reports
BALANCE DISORDER6 reports
BLOOD GLUCOSE INCREASED6 reports
DEAFNESS NEUROSENSORY6 reports
ECONOMIC PROBLEM6 reports
ENCEPHALOPATHY6 reports
FEBRILE NEUTROPENIA6 reports
INFLUENZA6 reports
MUSCULAR WEAKNESS6 reports
NEUTROPENIA6 reports
OROPHARYNGEAL PAIN6 reports
PULMONARY EMBOLISM6 reports
SEIZURE6 reports
TYMPANIC MEMBRANE PERFORATION6 reports
WEIGHT INCREASED6 reports
ABDOMINAL PAIN UPPER5 reports
ACUTE MYOCARDIAL INFARCTION5 reports
AMNESIA5 reports
CARDIAC FAILURE CONGESTIVE5 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE5 reports
DYSPHAGIA5 reports
GASTROOESOPHAGEAL REFLUX DISEASE5 reports
HAEMATOCRIT DECREASED5 reports
HOSPITALISATION5 reports
HYPERSENSITIVITY5 reports
HYPOAESTHESIA5 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME5 reports
MYALGIA5 reports
NEUROPATHY PERIPHERAL5 reports
OXYGEN SATURATION DECREASED5 reports
TOOTH DISORDER5 reports
TREMOR5 reports
UPPER RESPIRATORY TRACT INFECTION5 reports
URINARY RETENTION5 reports
ABDOMINAL DISCOMFORT4 reports
ANHEDONIA4 reports
BLOOD BILIRUBIN INCREASED4 reports

Report Outcomes

Out of 421 classified reports for CARBAMIDE PEROXIDE:

Serious 75.1%Non-Serious 24.9%

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

Male194 (50.1%)
Female191 (49.4%)
Unknown2 (0.5%)

Reports by Age

Age 599 reports
Age 699 reports
Age 789 reports
Age 708 reports
Age 687 reports
Age 757 reports
Age 777 reports
Age 817 reports
Age 857 reports
Age 536 reports
Age 606 reports
Age 636 reports
Age 656 reports
Age 806 reports
Age 615 reports
Age 625 reports
Age 645 reports
Age 725 reports
Age 795 reports
Age 825 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?

This profile reflects 928 FDA FAERS reports that mention CARBAMIDE PEROXIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CARBAMIDE PEROXIDE?

Frequently reported terms in FAERS include DIARRHOEA, FATIGUE, PAIN, CHRONIC KIDNEY DISEASE, FALL, HEADACHE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CARBAMIDE PEROXIDE?

Labeling and FAERS entries often list Medtech Products Inc. in connection with CARBAMIDE PEROXIDE. 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.