IBUPROFEN TABLETS

Ibuprofen Tablets Adverse Events Reported to the FDA Over Time

How are Ibuprofen Tablets adverse event reports trending over time?

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

Most Common Ibuprofen Tablets Adverse Events Reported to the FDA

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

Renal Failure Acute	78 (2.73%)
Death	44 (1.54%)
Overdose	39 (1.36%)
Vomiting	39 (1.36%)
Gastrointestinal Haemorrhage	32 (1.12%)
Nausea	30 (1.05%)
Diarrhoea	29 (1.01%)
Rash	29 (1.01%)
Completed Suicide	26 (.91%)
Drug Interaction	26 (.91%)
Blood Creatinine Increased	25 (.87%)
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Dyspnoea	24 (.84%)
Weight Decreased	24 (.84%)
Abdominal Pain	23 (.8%)
Respiratory Failure	23 (.8%)
Anaemia	22 (.77%)
Haematemesis	22 (.77%)
Oropharyngeal Pain	22 (.77%)
Suicide Attempt	22 (.77%)
Acute Respiratory Distress Syndrome	21 (.73%)
Muscular Weakness	21 (.73%)
Pyrexia	21 (.73%)
Haemoptysis	20 (.7%)
Melaena	20 (.7%)
Anorexia	19 (.66%)
Cough	19 (.66%)
Drug Toxicity	19 (.66%)
Lower Respiratory Tract Infection	19 (.66%)
Renal Tubular Necrosis	19 (.66%)
Alveolitis	18 (.63%)
Dermatomyositis	18 (.63%)
Intentional Overdose	18 (.63%)
Coma	17 (.59%)
Loss Of Consciousness	17 (.59%)
Drug Eruption	16 (.56%)
Chest Pain	15 (.52%)
Dehydration	15 (.52%)
Malaise	15 (.52%)
Metabolic Acidosis	15 (.52%)
Tachycardia	15 (.52%)
Condition Aggravated	14 (.49%)
Hypersensitivity	14 (.49%)
Hypotension	14 (.49%)
Pneumonia	14 (.49%)
Tubulointerstitial Nephritis	14 (.49%)
Urticaria	14 (.49%)
Cardiac Arrest	13 (.45%)
Convulsion	13 (.45%)
Drug Ineffective	13 (.45%)
Gastric Ulcer	13 (.45%)
Toxic Epidermal Necrolysis	13 (.45%)
Unresponsive To Stimuli	13 (.45%)
Vision Blurred	13 (.45%)
Cardio-respiratory Arrest	12 (.42%)
Duodenal Ulcer	12 (.42%)
Gastric Haemorrhage	12 (.42%)
Renal Failure	12 (.42%)
Dizziness	11 (.38%)
Gastritis	11 (.38%)
Haemoglobin Decreased	11 (.38%)
Hyperbilirubinaemia	11 (.38%)
Hypertension	11 (.38%)
Respiratory Depression	11 (.38%)
Stevens-johnson Syndrome	11 (.38%)
Urinary Tract Infection	11 (.38%)
Arthralgia	10 (.35%)
Blood Urea Increased	10 (.35%)
Faeces Discoloured	10 (.35%)
Gastric Ulcer Haemorrhage	10 (.35%)
Gastritis Erosive	10 (.35%)
Multiple Drug Overdose Intentional	10 (.35%)
Asthenia	9 (.31%)
Confusional State	9 (.31%)
Drug Hypersensitivity	9 (.31%)
Hepatic Failure	9 (.31%)
Oedema Peripheral	9 (.31%)
Vasculitis	9 (.31%)
Acidosis	8 (.28%)
Atrial Fibrillation	8 (.28%)
Chills	8 (.28%)
Drug Rash With Eosinophilia And Sys...	8 (.28%)
Dysphagia	8 (.28%)
Fatigue	8 (.28%)
General Physical Health Deteriorati...	8 (.28%)
Myocardial Infarction	8 (.28%)
Pain In Extremity	8 (.28%)
Perforated Ulcer	8 (.28%)
Sepsis	8 (.28%)
Somnolence	8 (.28%)
Speech Disorder	8 (.28%)
Swollen Tongue	8 (.28%)
Toxic Skin Eruption	8 (.28%)
Alanine Aminotransferase Increased	7 (.24%)
Anaphylactic Reaction	7 (.24%)
Back Pain	7 (.24%)
Depressed Level Of Consciousness	7 (.24%)
Drug Effect Decreased	7 (.24%)
Eye Pain	7 (.24%)
Gastrointestinal Ulcer	7 (.24%)
Headache	7 (.24%)
Heart Rate Increased	7 (.24%)

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

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

Epidermal And Dermal Conditions	168 (5.87%)
Respiratory	142 (4.96%)
Gastrointestinal Signs	138 (4.82%)
Renal Disorders	133 (4.65%)
Neurological	129 (4.51%)
Gastrointestinal Hemorrhages	107 (3.74%)
Medication Errors	97 (3.39%)
Infections - Pathogen Unspecified	81 (2.83%)
Gastrointestinal Ulceration And Per...	79 (2.76%)
Hepatic And Hepatobiliary	66 (2.31%)
Cardiac Arrhythmias	63 (2.2%)
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Lower Respiratory Tract Disorders	59 (2.06%)
Suicidal And Self-injurious Behavio...	51 (1.78%)
Therapeutic And Nontherapeutic Effe...	51 (1.78%)
Renal And Urinary Tract Investigati...	50 (1.75%)
Gastrointestinal Motility And Defec...	47 (1.64%)
Fatal Outcomes	45 (1.57%)
Hematology Investigations	40 (1.4%)
Muscle	38 (1.33%)
Electrolyte And Fluid Balance Condi...	36 (1.26%)
Allergic Conditions	33 (1.15%)
Chemical Injury And Poisoning	32 (1.12%)
Cardiac And Vascular Investigations	31 (1.08%)
Physical Examination Topics	31 (1.08%)
Anemias Nonhemolytic And Marrow Dep...	30 (1.05%)
Hepatobiliary	30 (1.05%)
Gastrointestinal Inflammatory Condi...	28 (.98%)
Vision	28 (.98%)
Acid-base	27 (.94%)
Body Temperature Conditions	26 (.91%)
Musculoskeletal And Connective Tiss...	26 (.91%)
Appetite And General Nutritional	25 (.87%)
Joint	25 (.87%)
Decreased And Nonspecific Blood Pre...	23 (.8%)
Injuries	20 (.7%)
Angiedema And Urticaria	19 (.66%)
Nephropathies	19 (.66%)
Oral Soft Tissue Conditions	19 (.66%)
Seizures	19 (.66%)
Coronary Artery	18 (.63%)
Psychiatric	18 (.63%)
Eye	16 (.56%)
Vascular Hypertensive	16 (.56%)
Bacterial Infectious	15 (.52%)
Central Nervous System Vascular	14 (.49%)
Urinary Tract Signs	13 (.45%)
White Blood Cell	13 (.45%)
Deliria	12 (.42%)
Headaches	12 (.42%)
Movement Disorders	12 (.42%)
Upper Respiratory Tract Disorders	12 (.42%)
Bronchial Disorders	11 (.38%)
Tissue	11 (.38%)
Cardiac Disorder Signs	10 (.35%)
Bone, Calcium, Magnesium And Phosph...	9 (.31%)
Hematological And Lymphoid Tissue T...	9 (.31%)
Lifestyle Issues	9 (.31%)
Therapeutic Procedures And Supporti...	9 (.31%)
Vascular	9 (.31%)
Vascular Inflammations	9 (.31%)
Water, Electrolyte And Mineral	9 (.31%)
Exocrine Pancreas Conditions	8 (.28%)
Musculoskeletal And Connective Tiss...	8 (.28%)
Tongue Conditions	8 (.28%)
Encephalopathies	7 (.24%)
Enzyme	7 (.24%)
Gastrointestinal Conditions	7 (.24%)
Glucose Metabolism Disorders	7 (.24%)
Neuromuscular	7 (.24%)
Developmental	6 (.21%)
Hearing	6 (.21%)
Pleural	6 (.21%)
Skin Appendage Conditions	6 (.21%)
Viral Infectious	6 (.21%)
Abortions And Stillbirth	5 (.17%)
Bone And Joint Therapeutic Procedur...	5 (.17%)
Coagulopathies And Bleeding Diathes...	5 (.17%)
Connective Tissue Disorders	5 (.17%)
Disturbances In Thinking	5 (.17%)
Gastrointestinal	5 (.17%)
Gastrointestinal Stenosis And Obstr...	5 (.17%)
Mental Impairment	5 (.17%)
Metabolic, Nutritional And Blood Ga...	5 (.17%)
Microbiology And Serology	5 (.17%)
Platelet	5 (.17%)
Sleep Disorders	5 (.17%)
Toxicology And Therapeutic Drug Mon...	5 (.17%)
Vascular Hemorrhagic	5 (.17%)
Anterior Eye Structural Change, Dep...	4 (.14%)
Anxiety Disorders	4 (.14%)
Bone And Joint Injuries	4 (.14%)
Chromosomal Abnormalities And Abnor...	4 (.14%)
Demyelinating	4 (.14%)
Heart Failures	4 (.14%)
Hemolyses And Related Conditions	4 (.14%)
Miscellaneous And Site Unspecified ...	4 (.14%)
Mood Disorders	4 (.14%)
Ocular Neuromuscular	4 (.14%)
Personality Disorders	4 (.14%)
Procedural And Device Related Injur...	4 (.14%)
Uterine, Pelvic And Broad Ligament	4 (.14%)

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