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MOTRIN IB

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Motrin Ib Adverse Events Reported to the FDA Over Time

How are Motrin Ib adverse event reports trending over time?

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

Most Common Motrin Ib Adverse Events Reported to the FDA

What are the most common Motrin Ib adverse events reported to the FDA?

Product Quality Issue
170 (2.37%)
Completed Suicide
140 (1.95%)
Drug Toxicity
139 (1.93%)
Vomiting
131 (1.82%)
Nausea
123 (1.71%)
Drug Ineffective
95 (1.32%)
Loss Of Consciousness
93 (1.29%)
Diarrhoea
92 (1.28%)
Dizziness
91 (1.27%)
Death
86 (1.2%)
Dyspnoea
81 (1.13%)
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Overdose
78 (1.09%)
Malaise
68 (.95%)
Insomnia
67 (.93%)
Hypersensitivity
66 (.92%)
Headache
65 (.9%)
Abdominal Pain Upper
62 (.86%)
Convulsion
60 (.84%)
Incorrect Dose Administered
57 (.79%)
Intentional Overdose
57 (.79%)
Cardiac Arrest
56 (.78%)
Somnolence
51 (.71%)
Heart Rate Increased
46 (.64%)
Tremor
45 (.63%)
Asthenia
44 (.61%)
Cardio-respiratory Arrest
44 (.61%)
Feeling Abnormal
43 (.6%)
Drug Interaction
42 (.58%)
Hypertension
42 (.58%)
Intentional Drug Misuse
41 (.57%)
Pyrexia
41 (.57%)
Chest Pain
39 (.54%)
Rash
39 (.54%)
Multiple Drug Overdose
38 (.53%)
Sudden Infant Death Syndrome
37 (.52%)
Fatigue
36 (.5%)
Palpitations
36 (.5%)
Tachycardia
36 (.5%)
Blood Pressure Increased
35 (.49%)
Respiratory Arrest
34 (.47%)
Accidental Drug Intake By Child
32 (.45%)
Abdominal Pain
31 (.43%)
Hyperhidrosis
30 (.42%)
Anxiety
29 (.4%)
Back Pain
28 (.39%)
Drug Exposure During Pregnancy
28 (.39%)
Hallucination
28 (.39%)
Medication Error
28 (.39%)
Renal Failure Acute
28 (.39%)
Jaundice
27 (.38%)
Pneumonia
26 (.36%)
Weight Decreased
26 (.36%)
Drug Hypersensitivity
25 (.35%)
Fall
25 (.35%)
Renal Impairment
25 (.35%)
Suicide Attempt
25 (.35%)
Urticaria
25 (.35%)
Confusional State
24 (.33%)
Dehydration
24 (.33%)
Expired Drug Administered
24 (.33%)
Oedema Peripheral
24 (.33%)
Pruritus
24 (.33%)
Anoxic Encephalopathy
23 (.32%)
Chills
23 (.32%)
Muscle Spasms
23 (.32%)
Swelling Face
23 (.32%)
Drug Administration Error
22 (.31%)
Drug Screen Positive
22 (.31%)
Unresponsive To Stimuli
22 (.31%)
Accidental Overdose
21 (.29%)
Erythema
21 (.29%)
Alanine Aminotransferase Increased
20 (.28%)
Arrhythmia
20 (.28%)
Aspartate Aminotransferase Increase...
20 (.28%)
Cerebrovascular Accident
20 (.28%)
Pain
20 (.28%)
Restlessness
20 (.28%)
Wrong Drug Administered
20 (.28%)
Decreased Appetite
19 (.26%)
Eye Swelling
19 (.26%)
Haematemesis
19 (.26%)
Haematochezia
19 (.26%)
Irritability
19 (.26%)
Coma
18 (.25%)
Hypoaesthesia
18 (.25%)
Hypotension
18 (.25%)
Multiple Drug Overdose Intentional
18 (.25%)
Musculoskeletal Stiffness
18 (.25%)
Myocardial Infarction
18 (.25%)
Ulcer
18 (.25%)
Agitation
17 (.24%)
Crying
17 (.24%)
Drug Abuse
17 (.24%)
Dry Mouth
17 (.24%)
Dysphagia
17 (.24%)
Liver Disorder
17 (.24%)
Renal Failure
17 (.24%)
Throat Tightness
17 (.24%)
Anaphylactic Shock
16 (.22%)
Depression
16 (.22%)
Dysgeusia
16 (.22%)

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This graph shows the top adverse events submitted to the FDA for Motrin Ib, 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 Motrin Ib 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 Motrin Ib

What are the most common Motrin Ib adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Motrin Ib, 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 Motrin Ib 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 Motrin Ib According to Those Reporting Adverse Events

Why are people taking Motrin Ib, according to those reporting adverse events to the FDA?

Drug Use For Unknown Indication
275
Product Used For Unknown Indication
178
Nasopharyngitis
150
Hypersensitivity
118
Nasal Congestion
79
Pain
77
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Headache
54
Cough
50
Rhinitis
39
Sinus Disorder
39
Sinusitis
36
Pyrexia
33
Sinus Headache
33
Seasonal Allergy
31
Multiple Allergies
31
Ill-defined Disorder
30
Upper Respiratory Tract Infection
30
Sinus Congestion
29
Arthralgia
27
Suicide Attempt
27
Influenza
25
Rhinitis Allergic
24
Back Pain
18
Accidental Exposure
18
Nasal Decongestion Therapy
15
Rhinorrhoea
12
Dysmenorrhoea
12
Intentional Overdose
11
Arthritis
10
Toothache
9
Sneezing
7
Myalgia
7
Respiratory Tract Congestion
7
Migraine
6
Chronic Sinusitis
6
Muscle Spasms
6
Completed Suicide
6
Analgesic Therapy
6
Respiratory Disorder
6
Joint Injury
5
Inflammation
5
Asthma
5
Oropharyngeal Pain
5
Bronchitis
5
Teething
5
Pharyngitis
5
Influenza Like Illness
5
Limb Injury
4
Ear Pain
4
Respiratory Tract Infection
4
Postnasal Drip
4

Drug Labels

LabelLabelerEffective
Motrin IbMcNeil Consumer Healthcare Div McNeil-PPC, Inc22-NOV-10
Motrin IbLil' Drug Store Products, Inc.27-DEC-12
Motrin IbMcNeil Consumer Healthcare Div McNeil-PPC, Inc25-MAR-13

Motrin Ib Case Reports

What Motrin Ib 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 Motrin Ib. 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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