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CHILDREN'S MOTRIN

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Children's Motrin Adverse Events Reported to the FDA Over Time

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

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

Most Common Children's Motrin Adverse Events Reported to the FDA

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

Product Quality Issue
1465 (19.67%)
Pyrexia
419 (5.63%)
Drug Ineffective
309 (4.15%)
Vomiting
267 (3.59%)
Convulsion
156 (2.1%)
Rash
119 (1.6%)
Abdominal Pain Upper
112 (1.5%)
Malaise
100 (1.34%)
Diarrhoea
97 (1.3%)
Pneumonia
85 (1.14%)
Transmission Of An Infectious Agent...
85 (1.14%)
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Wrong Drug Administered
83 (1.11%)
Dyspnoea
80 (1.07%)
Hypersensitivity
71 (.95%)
Urticaria
70 (.94%)
Weight Decreased
68 (.91%)
Stevens-johnson Syndrome
65 (.87%)
Hallucination
61 (.82%)
Toxic Epidermal Necrolysis
58 (.78%)
Asthma
55 (.74%)
Febrile Convulsion
54 (.73%)
Bacterial Infection
51 (.68%)
Eye Swelling
51 (.68%)
Dehydration
49 (.66%)
Ear Infection
46 (.62%)
Nausea
46 (.62%)
Headache
44 (.59%)
Cough
43 (.58%)
Inappropriate Schedule Of Drug Admi...
41 (.55%)
Abasia
40 (.54%)
Accidental Drug Intake By Child
39 (.52%)
Erythema Multiforme
39 (.52%)
Accidental Overdose
38 (.51%)
Chills
38 (.51%)
Lethargy
38 (.51%)
Lip Swelling
38 (.51%)
Oedema Peripheral
38 (.51%)
Swelling Face
38 (.51%)
Haematochezia
35 (.47%)
Product Measured Potency Issue
32 (.43%)
Hospitalisation
31 (.42%)
Arthralgia
27 (.36%)
Abnormal Behaviour
26 (.35%)
Incorrect Dose Administered
26 (.35%)
Infection
26 (.35%)
Rash Generalised
26 (.35%)
Viral Infection
26 (.35%)
Dizziness
25 (.34%)
Eating Disorder
25 (.34%)
Insomnia
25 (.34%)
Relapsing Fever
25 (.34%)
Abdominal Pain
24 (.32%)
Gastric Disorder
24 (.32%)
Fatigue
23 (.31%)
Gastrointestinal Disorder
23 (.31%)
Condition Aggravated
22 (.3%)
Duodenal Ulcer Perforation
22 (.3%)
Hypothermia
22 (.3%)
Wheezing
22 (.3%)
Loss Of Consciousness
21 (.28%)
Skin Discolouration
21 (.28%)
Blood Urine Present
20 (.27%)
Erythema
20 (.27%)
Haematemesis
20 (.27%)
Joint Swelling
20 (.27%)
Overdose
20 (.27%)
Abdominal Discomfort
19 (.26%)
Adverse Event
19 (.26%)
Crying
19 (.26%)
Drug Hypersensitivity
19 (.26%)
Heart Rate Increased
19 (.26%)
Intentional Drug Misuse
19 (.26%)
Cyanosis
18 (.24%)
Kidney Infection
18 (.24%)
Upper Respiratory Tract Infection
18 (.24%)
Abnormal Faeces
17 (.23%)
Gastroenteritis Viral
17 (.23%)
Renal Failure
17 (.23%)
Restlessness
17 (.23%)
Somnolence
17 (.23%)
Urinary Retention
17 (.23%)
Appetite Disorder
16 (.21%)
Death
16 (.21%)
Decreased Appetite
16 (.21%)
Gait Disturbance
16 (.21%)
Oropharyngeal Pain
16 (.21%)
Product Contamination
16 (.21%)
Aphasia
15 (.2%)
Mucous Stools
15 (.2%)
Muscle Twitching
15 (.2%)
Product Contamination Microbial
15 (.2%)
Throat Irritation
15 (.2%)
Blood Count Abnormal
14 (.19%)
Cardiac Murmur
14 (.19%)
Faeces Discoloured
14 (.19%)
Red Blood Cell Sedimentation Rate I...
14 (.19%)
Sensory Disturbance
14 (.19%)
Viith Nerve Paralysis
14 (.19%)
Back Pain
13 (.17%)
Blister
13 (.17%)
Campylobacter Infection
13 (.17%)

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

What are the most common Children's Motrin 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 Motrin, 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 Motrin 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 Motrin According to Those Reporting Adverse Events

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

Pyrexia
730
Drug Use For Unknown Indication
231
Product Used For Unknown Indication
75
Headache
63
Nasopharyngitis
58
Teething
56
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Pain
54
Ear Infection
51
Oropharyngeal Pain
47
Malaise
31
Cough
29
Viral Infection
19
Abdominal Pain Upper
16
Multiple Allergies
16
Accidental Exposure
15
Ill-defined Disorder
14
Pain In Extremity
14
Rhinorrhoea
9
Pharyngitis
9
Upper Respiratory Tract Infection
9
Gastroenteritis Viral
8
Conjunctivitis
7
Influenza
7
Sinus Disorder
6
Immunisation
6
Ear Pain
6
Discomfort
6
Upper Limb Fracture
5
Pharyngolaryngeal Pain
5
Lymph Node Pain
5
Sinusitis
5
Streptococcal Infection
4
Migraine
4
Vomiting
4
Gingival Disorder
4
Tonsillitis
4
Urinary Tract Infection
3
Respiratory Disorder
3
Pain Management
3
Thrombosis
3
Feeling Cold
3
Inflammation
3
Procedural Pain
3
Febrile Convulsion
3
Nasal Congestion
3
Back Pain
2
Pharyngitis Streptococcal
2
Chills
2
Terminal State
2
Irritability
2
Hand Fracture
2

Children's Motrin Case Reports

What Children's Motrin 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 Motrin. 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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