IBUPROFEN

Ibuprofen Adverse Events Reported to the FDA Over Time

How are Ibuprofen adverse event reports trending over time?

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

Most Common Ibuprofen Adverse Events Reported to the FDA

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

Completed Suicide	2163 (3.16%)
Renal Failure Acute	1067 (1.56%)
Drug Ineffective	916 (1.34%)
Vomiting	916 (1.34%)
Drug Toxicity	913 (1.34%)
Overdose	879 (1.29%)
Nausea	749 (1.1%)
Cardiac Arrest	703 (1.03%)
Death	661 (.97%)
Intentional Overdose	618 (.9%)
Suicide Attempt	572 (.84%)
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Respiratory Arrest	568 (.83%)
Hypotension	552 (.81%)
Gastrointestinal Haemorrhage	517 (.76%)
Cardio-respiratory Arrest	510 (.75%)
Dyspnoea	507 (.74%)
Somnolence	480 (.7%)
Dizziness	474 (.69%)
Drug Interaction	459 (.67%)
Pyrexia	437 (.64%)
Multiple Drug Overdose Intentional	421 (.62%)
Diarrhoea	403 (.59%)
Headache	399 (.58%)
Multiple Drug Overdose	389 (.57%)
Malaise	376 (.55%)
Renal Failure	372 (.54%)
Haematemesis	364 (.53%)
Rash	357 (.52%)
Hypersensitivity	355 (.52%)
Pain	347 (.51%)
Tachycardia	345 (.5%)
Intentional Drug Misuse	342 (.5%)
Blood Creatinine Increased	329 (.48%)
Abdominal Pain Upper	325 (.48%)
Dehydration	325 (.48%)
Metabolic Acidosis	325 (.48%)
Coma	312 (.46%)
Loss Of Consciousness	312 (.46%)
Fatigue	306 (.45%)
Abdominal Pain	304 (.44%)
Asthenia	298 (.44%)
Poisoning	294 (.43%)
Urticaria	294 (.43%)
Anaemia	292 (.43%)
Haemoglobin Decreased	283 (.41%)
Pruritus	274 (.4%)
Alanine Aminotransferase Increased	260 (.38%)
Gastric Ulcer	259 (.38%)
Confusional State	252 (.37%)
Convulsion	248 (.36%)
Gastritis	242 (.35%)
Melaena	241 (.35%)
Incorrect Dose Administered	239 (.35%)
Heart Rate Increased	237 (.35%)
Insomnia	236 (.35%)
Weight Decreased	233 (.34%)
Stevens-johnson Syndrome	220 (.32%)
Drug Abuse	219 (.32%)
Hypertension	219 (.32%)
Drug Hypersensitivity	218 (.32%)
Condition Aggravated	213 (.31%)
Abdominal Discomfort	207 (.3%)
Chest Pain	200 (.29%)
Agitation	197 (.29%)
Toxic Epidermal Necrolysis	195 (.29%)
Sepsis	191 (.28%)
Hepatic Failure	190 (.28%)
Pain In Extremity	189 (.28%)
Back Pain	183 (.27%)
Oedema Peripheral	182 (.27%)
Accidental Overdose	181 (.26%)
Swelling Face	179 (.26%)
Aspartate Aminotransferase Increase...	175 (.26%)
Feeling Abnormal	173 (.25%)
Respiratory Failure	172 (.25%)
Renal Tubular Necrosis	168 (.25%)
Renal Impairment	167 (.24%)
International Normalised Ratio Incr...	166 (.24%)
Fall	162 (.24%)
Arthralgia	159 (.23%)
Blood Urea Increased	159 (.23%)
Erythema	156 (.23%)
Constipation	152 (.22%)
Cough	150 (.22%)
Angioedema	148 (.22%)
Gastric Haemorrhage	148 (.22%)
Medication Error	148 (.22%)
Hyperhidrosis	146 (.21%)
Duodenal Ulcer	143 (.21%)
Hyperkalaemia	143 (.21%)
Multi-organ Failure	142 (.21%)
Atrial Fibrillation	139 (.2%)
General Physical Health Deteriorati...	138 (.2%)
Pneumonia	138 (.2%)
Syncope	138 (.2%)
Dysphagia	136 (.2%)
Pulmonary Oedema	136 (.2%)
Upper Gastrointestinal Haemorrhage	136 (.2%)
Depressed Level Of Consciousness	135 (.2%)
Haemorrhage	135 (.2%)
Jaundice	134 (.2%)

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

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

Medication Errors	3471 (5.08%)
Neurological	3240 (4.74%)
Gastrointestinal Signs	3170 (4.64%)
Suicidal And Self-injurious Behavio...	2900 (4.24%)
Epidermal And Dermal Conditions	2667 (3.9%)
Respiratory	2434 (3.56%)
Cardiac Arrhythmias	2316 (3.39%)
Renal Disorders	2228 (3.26%)
Therapeutic And Nontherapeutic Effe...	1718 (2.51%)
Gastrointestinal Hemorrhages	1705 (2.49%)
Chemical Injury And Poisoning	1481 (2.17%)
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Hepatic And Hepatobiliary	1438 (2.1%)
Infections - Pathogen Unspecified	1332 (1.95%)
Hematology Investigations	1244 (1.82%)
Gastrointestinal Ulceration And Per...	1197 (1.75%)
Cardiac And Vascular Investigations	882 (1.29%)
Electrolyte And Fluid Balance Condi...	864 (1.26%)
Hepatobiliary	857 (1.25%)
Allergic Conditions	833 (1.22%)
Psychiatric	826 (1.21%)
Decreased And Nonspecific Blood Pre...	782 (1.14%)
Fatal Outcomes	772 (1.13%)
Renal And Urinary Tract Investigati...	771 (1.13%)
Musculoskeletal And Connective Tiss...	717 (1.05%)
Gastrointestinal Motility And Defec...	715 (1.05%)
Gastrointestinal Inflammatory Condi...	680 (.99%)
Injuries	644 (.94%)
Lower Respiratory Tract Disorders	629 (.92%)
Muscle	560 (.82%)
Body Temperature Conditions	549 (.8%)
Physical Examination Topics	536 (.78%)
Acid-base	498 (.73%)
Anemias Nonhemolytic And Marrow Dep...	494 (.72%)
Joint	487 (.71%)
Oral Soft Tissue Conditions	480 (.7%)
Headaches	479 (.7%)
Angiedema And Urticaria	464 (.68%)
Urinary Tract Signs	463 (.68%)
Anxiety Disorders	457 (.67%)
Deliria	433 (.63%)
Metabolic, Nutritional And Blood Ga...	402 (.59%)
Seizures	402 (.59%)
Movement Disorders	397 (.58%)
Water, Electrolyte And Mineral	395 (.58%)
Bacterial Infectious	385 (.56%)
Coronary Artery	359 (.53%)
Nephropathies	354 (.52%)
Sleep Disorders	348 (.51%)
White Blood Cell	314 (.46%)
Upper Respiratory Tract Disorders	312 (.46%)
Appetite And General Nutritional	306 (.45%)
Central Nervous System Vascular	295 (.43%)
Lifestyle Issues	288 (.42%)
Vision	284 (.42%)
Toxicology And Therapeutic Drug Mon...	271 (.4%)
Vascular Hypertensive	262 (.38%)
Disturbances In Thinking	257 (.38%)
Skin Appendage Conditions	246 (.36%)
Enzyme	222 (.32%)
Vascular	220 (.32%)
Ocular Neuromuscular	218 (.32%)
Vascular Hemorrhagic	217 (.32%)
Mental Impairment	214 (.31%)
Hematological And Lymphoid Tissue T...	213 (.31%)
Gastrointestinal Conditions	211 (.31%)
Eye	209 (.31%)
Procedural And Device Related Injur...	208 (.3%)
Bronchial Disorders	197 (.29%)
Therapeutic Procedures And Supporti...	193 (.28%)
Cardiac Disorder Signs	189 (.28%)
Heart Failures	181 (.26%)
Tongue Conditions	181 (.26%)
Platelet	168 (.25%)
Bone Disorders	162 (.24%)
Depressed Mood Disorders	162 (.24%)
Tissue	162 (.24%)
Coagulopathies And Bleeding Diathes...	160 (.23%)
Ocular Infections, Irritations And ...	150 (.22%)
Administration Site Reactions	149 (.22%)
Viral Infectious	149 (.22%)
Gastrointestinal Stenosis And Obstr...	141 (.21%)
Product Quality Issues	140 (.2%)
Exocrine Pancreas Conditions	138 (.2%)
Neuromuscular	133 (.19%)
Glucose Metabolism Disorders	130 (.19%)
Encephalopathies	127 (.19%)
Mood Disorders	124 (.18%)
Ureteric	122 (.18%)
Personality Disorders	120 (.18%)
Bone And Joint Injuries	118 (.17%)
Pleural	112 (.16%)
Psychiatric And Behavioural Symptom...	112 (.16%)
Inner Ear And Viiith Cranial Nerve	109 (.16%)
Skin Vascular Abnormalities	108 (.16%)
Fungal Infectious	100 (.15%)
Spleen, Lymphatic And Reticulendoth...	97 (.14%)
Increased Intracranial Pressure And...	94 (.14%)
Hearing	92 (.13%)
Embolism And Thrombosis	91 (.13%)
Myocardial	90 (.13%)
Microbiology And Serology	89 (.13%)

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This graph shows the top categories of adverse events submitted to the FDA for Ibuprofen, 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 Ibuprofen 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.