KETOROLAC TROMETHAMINE

Ketorolac Tromethamine Adverse Events Reported to the FDA Over Time

How are Ketorolac Tromethamine adverse event reports trending over time?

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

Most Common Ketorolac Tromethamine Adverse Events Reported to the FDA

What are the most common Ketorolac Tromethamine adverse events reported to the FDA?

Renal Failure Acute	82 (2.19%)
Dyspnoea	62 (1.65%)
Nausea	42 (1.12%)
Medication Error	40 (1.07%)
Drug Ineffective	38 (1.01%)
Haemorrhage	36 (.96%)
Vision Blurred	36 (.96%)
Eye Pain	35 (.93%)
Vomiting	34 (.91%)
Anaphylactic Reaction	33 (.88%)
Ulcerative Keratitis	33 (.88%)
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Anaemia	32 (.85%)
Eye Irritation	32 (.85%)
Pain In Extremity	32 (.85%)
Drug Hypersensitivity	31 (.83%)
Pain	31 (.83%)
Headache	30 (.8%)
Hypotension	30 (.8%)
Oedema Peripheral	27 (.72%)
Pruritus	26 (.69%)
Ocular Hyperaemia	24 (.64%)
Asthenia	23 (.61%)
Blood Pressure Increased	23 (.61%)
Chest Pain	23 (.61%)
Visual Acuity Reduced	23 (.61%)
Diarrhoea	22 (.59%)
Erythema	22 (.59%)
Fatigue	22 (.59%)
Gastric Ulcer	22 (.59%)
Hypersensitivity	22 (.59%)
Dizziness	21 (.56%)
Urticaria	20 (.53%)
Completed Suicide	19 (.51%)
Abdominal Pain Upper	18 (.48%)
Haematemesis	18 (.48%)
Muscle Spasms	18 (.48%)
Post Procedural Haemorrhage	18 (.48%)
Renal Failure	18 (.48%)
Tremor	18 (.48%)
Arthralgia	17 (.45%)
Cardiac Arrest	17 (.45%)
Convulsion	17 (.45%)
Hyperhidrosis	17 (.45%)
Lacrimation Increased	17 (.45%)
Melaena	17 (.45%)
Rash	17 (.45%)
Drug Interaction	16 (.43%)
Duodenal Ulcer	16 (.43%)
Insomnia	16 (.43%)
Intraocular Pressure Increased	15 (.4%)
Tachycardia	14 (.37%)
Abdominal Pain	13 (.35%)
Gastritis Erosive	13 (.35%)
Hiatus Hernia	13 (.35%)
Post Procedural Complication	13 (.35%)
Retroperitoneal Fibrosis	13 (.35%)
Back Pain	12 (.32%)
Blood Creatinine Increased	12 (.32%)
Blood Pressure Decreased	12 (.32%)
Confusional State	12 (.32%)
Feeling Abnormal	12 (.32%)
Gastrointestinal Haemorrhage	12 (.32%)
Malaise	12 (.32%)
Pyrexia	12 (.32%)
Swollen Tongue	12 (.32%)
Eye Inflammation	11 (.29%)
Injection Site Pain	11 (.29%)
Oxygen Saturation Decreased	11 (.29%)
Paraesthesia	11 (.29%)
Respiratory Arrest	11 (.29%)
Throat Tightness	11 (.29%)
Wheezing	11 (.29%)
Abasia	10 (.27%)
Blindness Unilateral	10 (.27%)
Dystonia	10 (.27%)
Erosive Duodenitis	10 (.27%)
Haematuria	10 (.27%)
Haemoglobin Decreased	10 (.27%)
Hepatocellular Injury	10 (.27%)
Hyperkalaemia	10 (.27%)
Hypoaesthesia	10 (.27%)
Keratitis	10 (.27%)
Migraine	10 (.27%)
Muscular Weakness	10 (.27%)
Abdominal Distension	9 (.24%)
Agitation	9 (.24%)
Anuria	9 (.24%)
Chest Discomfort	9 (.24%)
Coma	9 (.24%)
Condition Aggravated	9 (.24%)
Corneal Disorder	9 (.24%)
Disseminated Intravascular Coagulat...	9 (.24%)
Eye Swelling	9 (.24%)
Fall	9 (.24%)
Joint Swelling	9 (.24%)
Loss Of Consciousness	9 (.24%)
Metabolic Acidosis	9 (.24%)
Nasal Discomfort	9 (.24%)
Organ Failure	9 (.24%)
Purpura Fulminans	9 (.24%)
Renal Impairment	9 (.24%)

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

What are the most common Ketorolac Tromethamine adverse events reported to the FDA?

Respiratory	167 (4.45%)
Ocular Infections, Irritations And ...	148 (3.94%)
Epidermal And Dermal Conditions	143 (3.81%)
Renal Disorders	142 (3.78%)
Gastrointestinal Signs	137 (3.65%)
Neurological	137 (3.65%)
Allergic Conditions	98 (2.61%)
Eye	95 (2.53%)
Vision	92 (2.45%)
Medication Errors	91 (2.43%)
Gastrointestinal Ulceration And Per...	90 (2.4%)
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Therapeutic And Nontherapeutic Effe...	78 (2.08%)
Gastrointestinal Hemorrhages	63 (1.68%)
Musculoskeletal And Connective Tiss...	63 (1.68%)
Cardiac And Vascular Investigations	62 (1.65%)
Procedural And Device Related Injur...	62 (1.65%)
Injuries	54 (1.44%)
Muscle	53 (1.41%)
Cardiac Arrhythmias	52 (1.39%)
Hepatic And Hepatobiliary	52 (1.39%)
Headaches	47 (1.25%)
Movement Disorders	46 (1.23%)
Decreased And Nonspecific Blood Pre...	45 (1.2%)
Infections - Pathogen Unspecified	44 (1.17%)
Anemias Nonhemolytic And Marrow Dep...	43 (1.15%)
Administration Site Reactions	42 (1.12%)
Vascular Hemorrhagic	38 (1.01%)
Joint	36 (.96%)
Gastrointestinal Motility And Defec...	35 (.93%)
Metabolic, Nutritional And Blood Ga...	35 (.93%)
Urinary Tract Signs	34 (.91%)
Anterior Eye Structural Change, Dep...	33 (.88%)
Suicidal And Self-injurious Behavio...	33 (.88%)
Anxiety Disorders	30 (.8%)
Sleep Disorders	30 (.8%)
Angiedema And Urticaria	29 (.77%)
Hematology Investigations	29 (.77%)
Renal And Urinary Tract Investigati...	29 (.77%)
Seizures	28 (.75%)
Bronchial Disorders	27 (.72%)
Skin Appendage Conditions	25 (.67%)
Upper Respiratory Tract Disorders	25 (.67%)
Nephropathies	24 (.64%)
Electrolyte And Fluid Balance Condi...	22 (.59%)
Neurological, Special Senses And Ps...	22 (.59%)
Lifestyle Issues	21 (.56%)
Peritoneal And Retroperitoneal Cond...	20 (.53%)
Lower Respiratory Tract Disorders	19 (.51%)
Tongue Conditions	18 (.48%)
Oral Soft Tissue Conditions	16 (.43%)
Skin Vascular Abnormalities	16 (.43%)
Vascular	16 (.43%)
Central Nervous System Vascular	15 (.4%)
Arteriosclerosis, Stenosis, Vascula...	14 (.37%)
Bone And Joint Injuries	14 (.37%)
Deliria	14 (.37%)
Disturbances In Thinking	14 (.37%)
Abdominal Hernias And Other Abdomin...	13 (.35%)
Cardiac Disorder Signs	13 (.35%)
Gastrointestinal Inflammatory Condi...	13 (.35%)
Tissue	13 (.35%)
White Blood Cell	13 (.35%)
Body Temperature Conditions	12 (.32%)
Chemical Injury And Poisoning	12 (.32%)
Mental Impairment	12 (.32%)
Coagulopathies And Bleeding Diathes...	11 (.29%)
Embolism And Thrombosis	11 (.29%)
Hepatobiliary	11 (.29%)
Physical Examination Topics	11 (.29%)
Hearing	10 (.27%)
Hemolyses And Related Conditions	10 (.27%)
Ocular Sensory Symptoms	10 (.27%)
Psychiatric	10 (.27%)
Acid-base	9 (.24%)
Hematological And Lymphoid Tissue T...	9 (.24%)
Personality Disorders	9 (.24%)
Appetite And General Nutritional	8 (.21%)
Coronary Artery	8 (.21%)
Fatal Outcomes	8 (.21%)
Gastrointestinal	8 (.21%)
Heart Failures	8 (.21%)
Inner Ear And Viiith Cranial Nerve	8 (.21%)
Ocular Hemorrhages And Vascular	8 (.21%)
Vascular Hypertensive	8 (.21%)
Water, Electrolyte And Mineral	8 (.21%)
Bacterial Infectious	7 (.19%)
Enzyme	7 (.19%)
Fungal Infectious	7 (.19%)
Gastrointestinal Vascular Condition...	7 (.19%)
Pleural	7 (.19%)
Product Quality Issues	7 (.19%)
Pulmonary Vascular	7 (.19%)
Cranial Nerve Disorders	6 (.16%)
Exocrine Pancreas Conditions	6 (.16%)
Gastrointestinal Conditions	6 (.16%)
Mood Disorders	6 (.16%)
Myocardial	6 (.16%)
Urolithiases	6 (.16%)
Bone Disorders	5 (.13%)
Cardiac Valve	5 (.13%)
Depressed Mood Disorders	5 (.13%)

Share/Embed Graph Export Data

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