INDOMETHACIN

Indomethacin Adverse Events Reported to the FDA Over Time

How are Indomethacin adverse event reports trending over time?

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

Most Common Indomethacin Adverse Events Reported to the FDA

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

Renal Failure Acute	160 (2.28%)
Drug Ineffective	136 (1.94%)
Drug Exposure During Pregnancy	67 (.96%)
Vomiting	66 (.94%)
Dehydration	65 (.93%)
Gastrointestinal Haemorrhage	64 (.91%)
Dizziness	61 (.87%)
Retinopathy Of Prematurity	61 (.87%)
Blood Creatinine Increased	57 (.81%)
Necrotising Colitis	55 (.78%)
Dyspnoea	52 (.74%)
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Drug Interaction	51 (.73%)
Headache	51 (.73%)
Neonatal Disorder	48 (.68%)
Pyrexia	44 (.63%)
Premature Baby	43 (.61%)
Asthenia	41 (.58%)
Blood Urea Increased	41 (.58%)
Nausea	41 (.58%)
Bronchopulmonary Dysplasia	40 (.57%)
Confusional State	40 (.57%)
Diarrhoea	40 (.57%)
Renal Impairment	39 (.56%)
Anaemia	38 (.54%)
Intestinal Perforation	38 (.54%)
Renal Failure	38 (.54%)
Hypotension	37 (.53%)
Gastric Ulcer	36 (.51%)
Haemoglobin Decreased	36 (.51%)
Thrombocytopenia	33 (.47%)
Completed Suicide	32 (.46%)
Hepatic Failure	32 (.46%)
Condition Aggravated	31 (.44%)
Hyperhidrosis	31 (.44%)
Metabolic Acidosis	29 (.41%)
General Physical Health Deteriorati...	28 (.4%)
Gout	28 (.4%)
Rash	28 (.4%)
Shock	28 (.4%)
Caesarean Section	27 (.38%)
Cardiac Failure	27 (.38%)
Convulsion	27 (.38%)
Malaise	27 (.38%)
Myocardial Infarction	27 (.38%)
Hyponatraemia	26 (.37%)
Intraventricular Haemorrhage Neonat...	26 (.37%)
Melaena	26 (.37%)
Sepsis	26 (.37%)
White Blood Cell Count Increased	26 (.37%)
Abdominal Pain	25 (.36%)
Urinary Tract Infection	25 (.36%)
Cardiac Failure Congestive	24 (.34%)
Blood Pressure Decreased	23 (.33%)
Gastritis	23 (.33%)
Hyperkalaemia	23 (.33%)
Pleural Effusion	23 (.33%)
Abdominal Pain Upper	22 (.31%)
Hypoxia	22 (.31%)
Procedural Vomiting	22 (.31%)
Ductus Arteriosus Premature Closure	20 (.29%)
Fatigue	20 (.29%)
Oedema Peripheral	20 (.29%)
Periventricular Leukomalacia	20 (.29%)
Anuria	19 (.27%)
Blood Glucose Increased	19 (.27%)
Blood Sodium Decreased	19 (.27%)
Drug Rash With Eosinophilia And Sys...	19 (.27%)
Fall	19 (.27%)
Gastritis Erosive	19 (.27%)
Hepatic Enzyme Increased	19 (.27%)
Loss Of Consciousness	19 (.27%)
Pulmonary Hypertension	19 (.27%)
Abdominal Distension	18 (.26%)
Blood Potassium Increased	18 (.26%)
Coma	18 (.26%)
Death	18 (.26%)
Drug Eruption	18 (.26%)
Encephalopathy	18 (.26%)
Gastric Haemorrhage	18 (.26%)
Gastrointestinal Perforation	18 (.26%)
Haematemesis	18 (.26%)
Neonatal Respiratory Distress Syndr...	18 (.26%)
Renal Tubular Necrosis	18 (.26%)
Syncope	18 (.26%)
Drug Toxicity	17 (.24%)
Hypokalaemia	17 (.24%)
Oliguria	17 (.24%)
Respiratory Failure	17 (.24%)
Somnolence	17 (.24%)
Tremor	17 (.24%)
Upper Gastrointestinal Haemorrhage	17 (.24%)
Weight Increased	17 (.24%)
Anxiety	16 (.23%)
Haematochezia	16 (.23%)
Haematocrit Decreased	16 (.23%)
Haemorrhage Intracranial	16 (.23%)
Hypertension	16 (.23%)
Migraine	16 (.23%)
Overdose	16 (.23%)
Pulmonary Haemorrhage	16 (.23%)
Renal Failure Chronic	16 (.23%)

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

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

Renal Disorders	328 (4.68%)
Neurological	263 (3.75%)
Gastrointestinal Signs	220 (3.14%)
Therapeutic And Nontherapeutic Effe...	216 (3.08%)
Gastrointestinal Ulceration And Per...	211 (3.01%)
Epidermal And Dermal Conditions	196 (2.79%)
Gastrointestinal Hemorrhages	183 (2.61%)
Respiratory	178 (2.54%)
Electrolyte And Fluid Balance Condi...	165 (2.35%)
Hepatic And Hepatobiliary	153 (2.18%)
Hematology Investigations	143 (2.04%)
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Renal And Urinary Tract Investigati...	134 (1.91%)
Gastrointestinal Inflammatory Condi...	127 (1.81%)
Cardiac Arrhythmias	119 (1.7%)
Infections - Pathogen Unspecified	117 (1.67%)
Chemical Injury And Poisoning	113 (1.61%)
Neonatal And Perinatal Conditions	101 (1.44%)
Cardiac And Vascular Investigations	89 (1.27%)
Central Nervous System Vascular	89 (1.27%)
Decreased And Nonspecific Blood Pre...	83 (1.18%)
Medication Errors	79 (1.13%)
Ocular Structural Change, Deposit A...	76 (1.08%)
Neonatal Respiratory	73 (1.04%)
Metabolic, Nutritional And Blood Ga...	70 (1%)
Anemias Nonhemolytic And Marrow Dep...	68 (.97%)
Headaches	68 (.97%)
Heart Failures	68 (.97%)
Water, Electrolyte And Mineral	68 (.97%)
Deliria	67 (.96%)
Coronary Artery	66 (.94%)
Joint	66 (.94%)
Gastrointestinal Motility And Defec...	63 (.9%)
Hepatobiliary	59 (.84%)
Urinary Tract Signs	56 (.8%)
Bacterial Infectious	52 (.74%)
Encephalopathies	52 (.74%)
Lower Respiratory Tract Disorders	50 (.71%)
Muscle	50 (.71%)
Body Temperature Conditions	46 (.66%)
Acid-base	45 (.64%)
Cardiac And Vascular Disorders Cong...	45 (.64%)
Physical Examination Topics	45 (.64%)
Procedural And Device Related Injur...	45 (.64%)
Suicidal And Self-injurious Behavio...	45 (.64%)
Movement Disorders	43 (.61%)
Injuries	42 (.6%)
Platelet	42 (.6%)
Enzyme	41 (.58%)
Seizures	41 (.58%)
Gastrointestinal Conditions	40 (.57%)
Gastrointestinal Stenosis And Obstr...	39 (.56%)
Hematological And Lymphoid Tissue T...	39 (.56%)
Peritoneal And Retroperitoneal Cond...	39 (.56%)
Skin Vascular Abnormalities	39 (.56%)
Musculoskeletal And Connective Tiss...	37 (.53%)
Arteriosclerosis, Stenosis, Vascula...	36 (.51%)
Skin Appendage Conditions	35 (.5%)
Anxiety Disorders	34 (.48%)
Allergic Conditions	33 (.47%)
Protein And Chemistry Analyses	33 (.47%)
Gastrointestinal Vascular Condition...	32 (.46%)
Nephropathies	32 (.46%)
Cardiac Disorder Signs	31 (.44%)
Purine And Pyrimidine Metabolism	30 (.43%)
White Blood Cell	30 (.43%)
Coagulopathies And Bleeding Diathes...	29 (.41%)
Fetal Complications	29 (.41%)
Pulmonary Vascular	29 (.41%)
Obstetric And Gynecological Therape...	28 (.4%)
Myocardial	27 (.38%)
Exocrine Pancreas Conditions	26 (.37%)
Pleural	25 (.36%)
Fatal Outcomes	24 (.34%)
Inner Ear And Viiith Cranial Nerve	24 (.34%)
Psychiatric	24 (.34%)
Spleen, Lymphatic And Reticulendoth...	24 (.34%)
Mental Impairment	23 (.33%)
Neurological, Special Senses And Ps...	23 (.33%)
Administration Site Reactions	22 (.31%)
Ocular Neuromuscular	22 (.31%)
Vascular	22 (.31%)
Angiedema And Urticaria	21 (.3%)
Glucose Metabolism Disorders	21 (.3%)
Hearing	21 (.3%)
Oral Soft Tissue Conditions	20 (.29%)
Abortions And Stillbirth	19 (.27%)
Cardiac Valve	19 (.27%)
Upper Respiratory Tract Disorders	19 (.27%)
Vascular Hypertensive	19 (.27%)
Appetite And General Nutritional	18 (.26%)
Lifestyle Issues	18 (.26%)
Microbiology And Serology	18 (.26%)
Therapeutic Procedures And Supporti...	18 (.26%)
Hemolyses And Related Conditions	17 (.24%)
Peripheral Neuropathies	16 (.23%)
Vascular Hemorrhagic	16 (.23%)
Vision	16 (.23%)
Adrenal Gland	15 (.21%)
Hematological	15 (.21%)
Immunology And Allergy	15 (.21%)
Bone And Joint Injuries	14 (.2%)

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