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CHILDREN'S BENADRYL ALLERGY

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Children's Benadryl Allergy Adverse Events Reported to the FDA Over Time

How are Children's Benadryl Allergy adverse event reports trending over time?

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

Most Common Children's Benadryl Allergy Adverse Events Reported to the FDA

What are the most common Children's Benadryl Allergy adverse events reported to the FDA?

Product Quality Issue
194 (17.18%)
Wrong Drug Administered
49 (4.34%)
Off Label Use
46 (4.07%)
Pyrexia
32 (2.83%)
Vomiting
28 (2.48%)
Dyspnoea
24 (2.13%)
Nausea
17 (1.51%)
Abnormal Behaviour
16 (1.42%)
Expired Drug Administered
12 (1.06%)
Hypersensitivity
12 (1.06%)
Malaise
12 (1.06%)
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Urticaria
12 (1.06%)
Feeling Abnormal
11 (.97%)
Abdominal Pain Upper
10 (.89%)
Drug Ineffective
10 (.89%)
Withdrawal Syndrome
10 (.89%)
Ear Infection
9 (.8%)
Overdose
9 (.8%)
Condition Aggravated
8 (.71%)
Dyskinesia
8 (.71%)
Erythema
8 (.71%)
Pruritus
8 (.71%)
Rash
8 (.71%)
Aggression
7 (.62%)
Anxiety
7 (.62%)
Death
7 (.62%)
Irritability
7 (.62%)
Mood Swings
7 (.62%)
Myalgia
7 (.62%)
Nightmare
7 (.62%)
Pneumonia
7 (.62%)
Somnolence
7 (.62%)
Speech Disorder
7 (.62%)
Unresponsive To Stimuli
7 (.62%)
Akathisia
6 (.53%)
Blood Urine Present
6 (.53%)
Convulsion
6 (.53%)
Diarrhoea
6 (.53%)
Eye Swelling
6 (.53%)
Foaming At Mouth
6 (.53%)
Hallucination
6 (.53%)
Increased Appetite
6 (.53%)
Joint Swelling
6 (.53%)
Movement Disorder
6 (.53%)
Mucous Membrane Disorder
6 (.53%)
Muscle Spasms
6 (.53%)
Obsessive Thoughts
6 (.53%)
Onychophagia
6 (.53%)
Palpitations
6 (.53%)
Presyncope
6 (.53%)
Psychomotor Hyperactivity
6 (.53%)
Respiration Abnormal
6 (.53%)
Restlessness
6 (.53%)
Staring
6 (.53%)
Suicidal Ideation
6 (.53%)
Thirst
6 (.53%)
Tremor
6 (.53%)
Viral Infection
6 (.53%)
Abdominal Distension
5 (.44%)
Anaphylactic Reaction
5 (.44%)
Bacterial Infection
5 (.44%)
Confusional State
5 (.44%)
Cough
5 (.44%)
Drug Ineffective For Unapproved Ind...
5 (.44%)
Flatulence
5 (.44%)
Heart Rate Increased
5 (.44%)
Oedema Peripheral
5 (.44%)
Product Contamination
5 (.44%)
Product Contamination Physical
5 (.44%)
Sleep Terror
5 (.44%)
Swelling
5 (.44%)
Abasia
4 (.35%)
Asthma
4 (.35%)
Cold Sweat
4 (.35%)
Decreased Appetite
4 (.35%)
Feeling Jittery
4 (.35%)
Heart Rate Irregular
4 (.35%)
Hospitalisation
4 (.35%)
Lethargy
4 (.35%)
Lip Swelling
4 (.35%)
Liver Abscess
4 (.35%)
Muscle Twitching
4 (.35%)
Petechiae
4 (.35%)
Pneumonia Bacterial
4 (.35%)
Product Measured Potency Issue
4 (.35%)
Weight Decreased
4 (.35%)
Accidental Drug Intake By Child
3 (.27%)
Adverse Reaction
3 (.27%)
Body Temperature Increased
3 (.27%)
Cyanosis
3 (.27%)
Disorientation
3 (.27%)
Erythema Multiforme
3 (.27%)
Fatigue
3 (.27%)
Febrile Convulsion
3 (.27%)
Gait Disturbance
3 (.27%)
Hyperhidrosis
3 (.27%)
Incorrect Dose Administered
3 (.27%)
Loss Of Consciousness
3 (.27%)
Pain In Extremity
3 (.27%)
Personality Change
3 (.27%)
Poor Quality Drug Administered
3 (.27%)

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This graph shows the top adverse events submitted to the FDA for Children's Benadryl Allergy, 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 Children's Benadryl Allergy 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 Children's Benadryl Allergy

What are the most common Children's Benadryl Allergy adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Children's Benadryl Allergy, 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 Children's Benadryl Allergy 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 Children's Benadryl Allergy According to Those Reporting Adverse Events

Why are people taking Children's Benadryl Allergy, according to those reporting adverse events to the FDA?

Drug Use For Unknown Indication
50
Hypersensitivity
46
Product Used For Unknown Indication
24
Rhinorrhoea
8
Pyrexia
8
Rash
8
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Pruritus
7
Seasonal Allergy
6
Cough
6
Nasopharyngitis
6
Multiple Allergies
6
Accidental Exposure
5
Malaise
5
Urticaria
4
Conjunctivitis
4
Swelling
4
Food Allergy
3
Nasal Congestion
3
Sleep Disorder Therapy
3
Pain
2
Sleep Disorder
2
Arthropod Sting
2
Dermatitis Allergic
2
Asthma
2
Lacrimation Increased
2
Sneezing
2
Eczema
2
Drug Hypersensitivity
2
Suicide Attempt
1
Urticaria Pigmentosa
1
Arthropod Bite
1
Mastocytosis
1
Sinus Congestion
1
Growing Pains
1
Nasal Discomfort
1
Rash Generalised
1
Insomnia
1
Middle Ear Effusion
1

Children's Benadryl Allergy Case Reports

What Children's Benadryl Allergy 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 Children's Benadryl Allergy. 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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