MOTRIN

Adverse Events

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Motrin Adverse Events Reported to the FDA Over Time

How are Motrin adverse event reports trending over time?

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

Most Common Motrin Adverse Events Reported to the FDA

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

Product Quality Issue	2348 (6.77%)
Completed Suicide	1498 (4.32%)
Drug Ineffective	746 (2.15%)
Pyrexia	699 (2.02%)
Drug Toxicity	686 (1.98%)
Vomiting	677 (1.95%)
Death	512 (1.48%)
Cardiac Arrest	493 (1.42%)
Cardio-respiratory Arrest	445 (1.28%)
Respiratory Arrest	442 (1.27%)
Convulsion	421 (1.21%)
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Overdose	347 (1%)
Diarrhoea	343 (.99%)
Nausea	327 (.94%)
Intentional Drug Misuse	273 (.79%)
Abdominal Pain Upper	271 (.78%)
Dyspnoea	257 (.74%)
Hypersensitivity	257 (.74%)
Rash	251 (.72%)
Malaise	241 (.7%)
Intentional Overdose	240 (.69%)
Dizziness	228 (.66%)
Somnolence	226 (.65%)
Loss Of Consciousness	210 (.61%)
Pneumonia	209 (.6%)
Headache	207 (.6%)
Insomnia	197 (.57%)
Multiple Drug Overdose	187 (.54%)
Incorrect Dose Administered	175 (.5%)
Weight Decreased	169 (.49%)
Urticaria	164 (.47%)
Suicide Attempt	160 (.46%)
Wrong Drug Administered	159 (.46%)
Drug Abuse	158 (.46%)
Poisoning	155 (.45%)
Hypotension	152 (.44%)
Fatigue	148 (.43%)
Multiple Drug Overdose Intentional	144 (.42%)
Febrile Convulsion	142 (.41%)
Tachycardia	138 (.4%)
Dehydration	137 (.4%)
Hallucination	135 (.39%)
Heart Rate Increased	135 (.39%)
Transmission Of An Infectious Agent...	128 (.37%)
Coma	124 (.36%)
Toxic Epidermal Necrolysis	123 (.35%)
Drug Interaction	122 (.35%)
Accidental Overdose	121 (.35%)
Lethargy	121 (.35%)
Pain	118 (.34%)
Oedema Peripheral	116 (.33%)
Asthma	111 (.32%)
Pruritus	111 (.32%)
Unresponsive To Stimuli	107 (.31%)
Accidental Drug Intake By Child	106 (.31%)
Anxiety	106 (.31%)
Stevens-johnson Syndrome	105 (.3%)
Swelling Face	105 (.3%)
Tremor	105 (.3%)
Drug Hypersensitivity	103 (.3%)
Agitation	100 (.29%)
Hypertension	100 (.29%)
Eye Swelling	99 (.29%)
Asthenia	98 (.28%)
Chest Pain	98 (.28%)
Medication Error	98 (.28%)
Condition Aggravated	97 (.28%)
Cough	95 (.27%)
Alanine Aminotransferase Increased	93 (.27%)
Feeling Abnormal	93 (.27%)
Abdominal Pain	92 (.27%)
Aspartate Aminotransferase Increase...	92 (.27%)
Confusional State	92 (.27%)
Pulmonary Oedema	91 (.26%)
Chills	87 (.25%)
Haematochezia	87 (.25%)
Back Pain	84 (.24%)
Bacterial Infection	82 (.24%)
Hyperhidrosis	81 (.23%)
Ear Infection	79 (.23%)
Mydriasis	78 (.22%)
Erythema	76 (.22%)
Fall	76 (.22%)
Abasia	75 (.22%)
Delirium	75 (.22%)
Blood Glucose Increased	74 (.21%)
Blood Pressure Increased	73 (.21%)
Haematemesis	69 (.2%)
Renal Failure	68 (.2%)
Renal Failure Acute	68 (.2%)
Crying	67 (.19%)
Abnormal Behaviour	66 (.19%)
Depression	66 (.19%)
Decreased Appetite	65 (.19%)
Pain In Extremity	65 (.19%)
Inappropriate Schedule Of Drug Admi...	63 (.18%)
Abdominal Discomfort	62 (.18%)
Mental Status Changes	62 (.18%)
Drug Screen Positive	61 (.18%)
Off Label Use	61 (.18%)
Arthralgia	60 (.17%)

Share/Embed Graph Export Data

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

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

Product Quality Issues	2557 (7.37%)
Medication Errors	1879 (5.42%)
Suicidal And Self-injurious Behavio...	1722 (4.97%)
Gastrointestinal Signs	1660 (4.79%)
Neurological	1652 (4.76%)
Cardiac Arrhythmias	1363 (3.93%)
Respiratory	1248 (3.6%)
Epidermal And Dermal Conditions	1237 (3.57%)
Therapeutic And Nontherapeutic Effe...	1064 (3.07%)
Chemical Injury And Poisoning	977 (2.82%)
Infections - Pathogen Unspecified	767 (2.21%)
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Body Temperature Conditions	760 (2.19%)
Seizures	669 (1.93%)
Fatal Outcomes	619 (1.79%)
Psychiatric	611 (1.76%)
Cardiac And Vascular Investigations	493 (1.42%)
Allergic Conditions	478 (1.38%)
Gastrointestinal Motility And Defec...	446 (1.29%)
Physical Examination Topics	371 (1.07%)
Injuries	369 (1.06%)
Hematology Investigations	351 (1.01%)
Anxiety Disorders	343 (.99%)
Hepatobiliary	334 (.96%)
Gastrointestinal Hemorrhages	313 (.9%)
Hepatic And Hepatobiliary	312 (.9%)
Bacterial Infectious	301 (.87%)
Renal Disorders	277 (.8%)
Sleep Disorders	265 (.76%)
Movement Disorders	255 (.74%)
Musculoskeletal And Connective Tiss...	252 (.73%)
Lower Respiratory Tract Disorders	247 (.71%)
Disturbances In Thinking	244 (.7%)
Metabolic, Nutritional And Blood Ga...	240 (.69%)
Muscle	237 (.68%)
Headaches	236 (.68%)
Electrolyte And Fluid Balance Condi...	224 (.65%)
Deliria	215 (.62%)
Angiedema And Urticaria	214 (.62%)
Decreased And Nonspecific Blood Pre...	197 (.57%)
Bronchial Disorders	193 (.56%)
Renal And Urinary Tract Investigati...	180 (.52%)
Toxicology And Therapeutic Drug Mon...	165 (.48%)
Viral Infectious	159 (.46%)
Lifestyle Issues	158 (.46%)
Eye	154 (.44%)
Ocular Neuromuscular	154 (.44%)
Oral Soft Tissue Conditions	153 (.44%)
Gastrointestinal Ulceration And Per...	151 (.44%)
Water, Electrolyte And Mineral	149 (.43%)
Urinary Tract Signs	148 (.43%)
Therapeutic Procedures And Supporti...	142 (.41%)
Ancillary Infectious Topics	140 (.4%)
Appetite And General Nutritional	140 (.4%)
Central Nervous System Vascular	140 (.4%)
Skin Appendage Conditions	138 (.4%)
Joint	136 (.39%)
Cardiac Disorder Signs	134 (.39%)
Gastrointestinal Conditions	131 (.38%)
Vision	124 (.36%)
Vascular Hypertensive	115 (.33%)
Upper Respiratory Tract Disorders	112 (.32%)
Mental Impairment	110 (.32%)
Gastrointestinal Inflammatory Condi...	107 (.31%)
Depressed Mood Disorders	93 (.27%)
Vascular	92 (.27%)
Mood Disorders	91 (.26%)
Neuromuscular	86 (.25%)
Psychiatric And Behavioural Symptom...	81 (.23%)
Acid-base	76 (.22%)
Coronary Artery	76 (.22%)
Changes In Physical Activity	75 (.22%)
Ocular Infections, Irritations And ...	74 (.21%)
Communication Disorders	72 (.21%)
Enzyme	72 (.21%)
Vascular Hemorrhagic	70 (.2%)
Inner Ear And Viiith Cranial Nerve	67 (.19%)
Personality Disorders	63 (.18%)
Skin Vascular Abnormalities	62 (.18%)
Tissue	61 (.18%)
Increased Intracranial Pressure And...	60 (.17%)
Encephalopathies	58 (.17%)
Heart Failures	58 (.17%)
Anemias Nonhemolytic And Marrow Dep...	57 (.16%)
Tongue Conditions	56 (.16%)
Legal Issues	54 (.16%)
White Blood Cell	53 (.15%)
Administration Site Reactions	52 (.15%)
Bone Disorders	47 (.14%)
Hematological And Lymphoid Tissue T...	46 (.13%)
Myocardial	45 (.13%)
Salivary Gland Conditions	45 (.13%)
Neurological, Special Senses And Ps...	43 (.12%)
Cranial Nerve Disorders	42 (.12%)
Bone And Joint Injuries	41 (.12%)
Platelet	41 (.12%)
Procedural And Device Related Injur...	41 (.12%)
Arteriosclerosis, Stenosis, Vascula...	40 (.12%)
Glucose Metabolism Disorders	38 (.11%)
Aural	35 (.1%)
Eating Disorders	35 (.1%)
Neonatal And Perinatal Conditions	33 (.1%)

Share/Embed Graph Export Data

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

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

Drug Use For Unknown Indication	1884
Product Used For Unknown Indication	1338
Pyrexia	1191
Premedication	1021
Pain	924
Suicide Attempt	462
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Headache	355
Nasopharyngitis	257
Hypersensitivity	243
Prophylaxis	182
Insomnia	176
Back Pain	172
Teething	126
Ill-defined Disorder	123
Pruritus	121
Arthralgia	120
Arthritis	120
Cough	100
Nasal Congestion	97
Ear Infection	80
Sleep Disorder	77
Oropharyngeal Pain	64
Migraine	63
Multiple Allergies	62
Pain In Extremity	61
Accidental Exposure	58
Sinus Disorder	56
Sinusitis	54
Influenza	52
Rash	51
Completed Suicide	48
Seasonal Allergy	48
Upper Respiratory Tract Infection	47
Myalgia	46
Sinus Headache	45
Malaise	44
Rheumatoid Arthritis	43
Dysmenorrhoea	42
Intentional Overdose	41
Rhinitis	39
Sinus Congestion	39
Analgesic Therapy	38
Osteoarthritis	38
Musculoskeletal Pain	38
Fibromyalgia	34
Inflammation	34
Muscle Spasms	33
Pain Management	31
Toothache	29
Sleep Disorder Therapy	29
Chest Pain	28

Drug Labels

Label	Labeler	Effective
Childrens Motrincold	McNeil Consumer Healthcare Div McNeil-PPC, Inc	08-OCT-09
Motrin Pm	McNeil Consumer Healthcare Div McNeil-PPC, Inc	17-DEC-09
Childrens Motrin	McNeil Consumer Healthcare Div. McNeil-PPC, Inc	04-OCT-10
Motrin Ib	McNeil Consumer Healthcare Div McNeil-PPC, Inc	22-NOV-10
Motrin Junior Strength	McNeil Consumer Healthcare Div. McNeil-PPC, Inc	18-MAR-11
Motrin Junior Strength	McNeil Consumer Healthcare Div. McNeil-PPC, Inc	09-JUN-11
Childrens Motrin	McNeil Consumer Healthcare Div. McNeil-PPC, Inc	22-FEB-12
Infants Motrin	McNeil Consumer Healthcare Div McNeil-PPC, Inc	06-MAR-12
Motrininfants	McNeil Consumer Healthcare Div McNeil-PPC, Inc	05-JUN-12
Childrens Motrin	McNeil Consumer Healthcare Div. McNeil-PPC, Inc	27-JUN-12
Motrin Ib	Lil' Drug Store Products, Inc.	27-DEC-12
Motrin Ib	McNeil Consumer Healthcare Div McNeil-PPC, Inc	25-MAR-13

Motrin Case Reports

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

About Results

This report contains aggregated drug side effects and adverse events for 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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