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UREA PEROXIDE

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Urea Peroxide Adverse Events Reported to the FDA Over Time

How are Urea Peroxide adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Urea Peroxide, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Urea Peroxide is flagged as the suspect drug causing the adverse event.

Most Common Urea Peroxide Adverse Events Reported to the FDA

What are the most common Urea Peroxide adverse events reported to the FDA?

Deafness
91 (14.35%)
Ear Discomfort
72 (11.36%)
Deafness Unilateral
64 (10.09%)
Ear Pain
31 (4.89%)
Deafness Transitory
29 (4.57%)
Drug Administration Error
24 (3.79%)
Tinnitus
24 (3.79%)
Hypoacusis
18 (2.84%)
Ear Haemorrhage
16 (2.52%)
Condition Aggravated
14 (2.21%)
Hearing Impaired
13 (2.05%)
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Dizziness
12 (1.89%)
Otorrhoea
12 (1.89%)
Cerumen Impaction
11 (1.74%)
Drug Ineffective
11 (1.74%)
Expired Drug Administered
10 (1.58%)
Tympanic Membrane Perforation
10 (1.58%)
Auricular Swelling
8 (1.26%)
Ear Infection
8 (1.26%)
Feeling Abnormal
8 (1.26%)
Balance Disorder
7 (1.1%)
Product Quality Issue
7 (1.1%)
Wrong Technique In Drug Usage Proce...
7 (1.1%)
Ear Disorder
6 (.95%)
Headache
6 (.95%)
Nervousness
5 (.79%)
Anxiety
4 (.63%)
Deafness Bilateral
4 (.63%)
Depression
3 (.47%)
Ear Congestion
3 (.47%)
Erythema
3 (.47%)
Otitis Externa
3 (.47%)
Sinusitis
3 (.47%)
Treatment Noncompliance
3 (.47%)
Application Site Bleeding
2 (.32%)
Discomfort
2 (.32%)
Dysphonia
2 (.32%)
Hyperacusis
2 (.32%)
Hypersensitivity
2 (.32%)
Hypoaesthesia Facial
2 (.32%)
Laceration
2 (.32%)
Malaise
2 (.32%)
Open Wound
2 (.32%)
Oropharyngeal Pain
2 (.32%)
Otitis Media
2 (.32%)
Pruritus
2 (.32%)
Somnolence
2 (.32%)
Accidental Drug Intake By Child
1 (.16%)
Activities Of Daily Living Impaired
1 (.16%)
Adverse Event
1 (.16%)
Application Site Discharge
1 (.16%)
Application Site Discomfort
1 (.16%)
Application Site Infection
1 (.16%)
Burning Sensation
1 (.16%)
Caustic Injury
1 (.16%)
Cheilitis
1 (.16%)
Deafness Neurosensory
1 (.16%)
Device Breakage
1 (.16%)
Disturbance In Attention
1 (.16%)
Drug Prescribing Error
1 (.16%)
Dysacusis
1 (.16%)
Dysarthria
1 (.16%)
Dysgeusia
1 (.16%)
Ear Canal Erythema
1 (.16%)
Ear Canal Injury
1 (.16%)
Ear Pruritus
1 (.16%)
Epistaxis
1 (.16%)
Excoriation
1 (.16%)
Fatigue
1 (.16%)
Feeling Hot
1 (.16%)
Gait Disturbance
1 (.16%)
Gastroenteritis Viral
1 (.16%)
Hypoaesthesia Oral
1 (.16%)
Incorrect Dose Administered
1 (.16%)
Inflammation
1 (.16%)
Influenza Like Illness
1 (.16%)
Insomnia
1 (.16%)
Irritability
1 (.16%)
Localised Infection
1 (.16%)
Loss Of Consciousness
1 (.16%)
Mobility Decreased
1 (.16%)
Nausea
1 (.16%)
Neck Pain
1 (.16%)
Nerve Injury
1 (.16%)
No Therapeutic Response
1 (.16%)
Nonspecific Reaction
1 (.16%)
Oedema Mouth
1 (.16%)
Oral Discomfort
1 (.16%)
Oral Mucosal Erythema
1 (.16%)
Pain In Extremity
1 (.16%)
Pallor
1 (.16%)
Paraesthesia
1 (.16%)
Paraesthesia Oral
1 (.16%)
Pyrexia
1 (.16%)
Rash
1 (.16%)
Rhinitis Allergic
1 (.16%)
Scab
1 (.16%)
Sensory Disturbance
1 (.16%)
Sinus Headache
1 (.16%)
Skin Disorder
1 (.16%)
Skin Exfoliation
1 (.16%)

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This graph shows the top adverse events submitted to the FDA for Urea Peroxide, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Urea Peroxide is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Urea Peroxide

What are the most common Urea Peroxide adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Urea Peroxide, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Urea Peroxide is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Urea Peroxide According to Those Reporting Adverse Events

Why are people taking Urea Peroxide, according to those reporting adverse events to the FDA?

Drug Use For Unknown Indication
54
Cerumen Removal
24
Product Used For Unknown Indication
21
Cerumen Impaction
6
Hearing Impaired
6
Ear Disorder
2
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Dry Skin
1
Product Origin Unknown
1
Tinnitus
1
Ear Discomfort
1
Sinus Disorder
1
Hyperkeratosis
1

Urea Peroxide Case Reports

What Urea Peroxide safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Urea Peroxide. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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