ENALAPRIL

Enalapril Adverse Events Reported to the FDA Over Time

How are Enalapril adverse event reports trending over time?

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

Most Common Enalapril Adverse Events Reported to the FDA

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

Renal Failure Acute	595 (2.21%)
Hypotension	479 (1.78%)
Hyperkalaemia	475 (1.77%)
Dyspnoea	473 (1.76%)
Cardiac Failure	423 (1.57%)
Drug Interaction	357 (1.33%)
Dehydration	274 (1.02%)
Diarrhoea	273 (1.02%)
Dizziness	265 (.99%)
Renal Failure	258 (.96%)
Vomiting	251 (.93%)
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Disease Progression	245 (.91%)
Angioedema	242 (.9%)
Nausea	228 (.85%)
Blood Creatinine Increased	224 (.83%)
Malaise	210 (.78%)
Hyponatraemia	207 (.77%)
Asthenia	205 (.76%)
Decreased Appetite	194 (.72%)
Fall	189 (.7%)
Cough	185 (.69%)
Renal Impairment	184 (.68%)
Blood Pressure Increased	179 (.67%)
Concomitant Disease Progression	178 (.66%)
Atrial Fibrillation	171 (.64%)
Oedema Peripheral	171 (.64%)
Condition Aggravated	168 (.63%)
Hypoglycaemia	161 (.6%)
Drug Ineffective	159 (.59%)
Fatigue	155 (.58%)
Syncope	155 (.58%)
Hypertension	151 (.56%)
Chest Pain	149 (.55%)
Bradycardia	143 (.53%)
Abdominal Pain	137 (.51%)
Lactic Acidosis	131 (.49%)
Loss Of Consciousness	128 (.48%)
Completed Suicide	124 (.46%)
Headache	123 (.46%)
Pneumonia	112 (.42%)
Anaemia	111 (.41%)
Pyrexia	110 (.41%)
Cardiac Arrest	109 (.41%)
Blood Glucose Increased	103 (.38%)
Blood Pressure Decreased	102 (.38%)
Cardiac Failure Congestive	101 (.38%)
Confusional State	98 (.36%)
General Physical Health Deteriorati...	98 (.36%)
Urinary Tract Infection	91 (.34%)
Blood Urea Increased	89 (.33%)
Swollen Tongue	87 (.32%)
Blood Potassium Increased	84 (.31%)
Metabolic Acidosis	84 (.31%)
Somnolence	82 (.31%)
Blood Pressure Inadequately Control...	80 (.3%)
Dialysis	79 (.29%)
Hypokalaemia	78 (.29%)
Rash	77 (.29%)
Haemoglobin Decreased	76 (.28%)
Pulmonary Oedema	76 (.28%)
Oedema	74 (.28%)
Tachycardia	72 (.27%)
Haemodialysis	71 (.26%)
Drug Hypersensitivity	70 (.26%)
Electrocardiogram Qrs Complex Prolo...	69 (.26%)
Orthostatic Hypotension	68 (.25%)
Pleural Effusion	66 (.25%)
Cardio-respiratory Arrest	65 (.24%)
Drug Exposure During Pregnancy	62 (.23%)
Swelling Face	62 (.23%)
Alanine Aminotransferase Increased	60 (.22%)
Depression	60 (.22%)
Ventricular Tachycardia	60 (.22%)
Constipation	59 (.22%)
Inappropriate Antidiuretic Hormone ...	59 (.22%)
Pruritus	59 (.22%)
Death	58 (.22%)
Depressed Level Of Consciousness	58 (.22%)
Interstitial Lung Disease	58 (.22%)
Pain	58 (.22%)
Tremor	58 (.22%)
Coronary Artery Disease	57 (.21%)
Shock	57 (.21%)
Sepsis	56 (.21%)
Weight Decreased	56 (.21%)
Abdominal Pain Upper	55 (.2%)
Face Oedema	55 (.2%)
Overdose	55 (.2%)
Hyperglycaemia	54 (.2%)
Hypersensitivity	54 (.2%)
Hyperhidrosis	53 (.2%)
Renal Failure Chronic	53 (.2%)
Thrombocytopenia	53 (.2%)
Arthralgia	52 (.19%)
Cardiomegaly	52 (.19%)
Abdominal Distension	51 (.19%)
Orthopnoea	51 (.19%)
Pallor	51 (.19%)
Toxic Epidermal Necrolysis	51 (.19%)
Weight Increased	51 (.19%)
Dyspnoea Exertional	50 (.19%)

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

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

Renal Disorders	1316 (4.9%)
Respiratory	1297 (4.83%)
Neurological	1214 (4.52%)
Electrolyte And Fluid Balance Condi...	1160 (4.32%)
Cardiac Arrhythmias	1082 (4.03%)
Gastrointestinal Signs	903 (3.36%)
Decreased And Nonspecific Blood Pre...	760 (2.83%)
Cardiac And Vascular Investigations	741 (2.76%)
Heart Failures	688 (2.56%)
Epidermal And Dermal Conditions	682 (2.54%)
Infections - Pathogen Unspecified	681 (2.53%)
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Therapeutic And Nontherapeutic Effe...	627 (2.33%)
Renal And Urinary Tract Investigati...	444 (1.65%)
Hematology Investigations	408 (1.52%)
Hepatic And Hepatobiliary	369 (1.37%)
Gastrointestinal Motility And Defec...	354 (1.32%)
Appetite And General Nutritional	314 (1.17%)
Glucose Metabolism Disorders	303 (1.13%)
Injuries	302 (1.12%)
Angiedema And Urticaria	295 (1.1%)
Medication Errors	292 (1.09%)
Lower Respiratory Tract Disorders	286 (1.06%)
Water, Electrolyte And Mineral	266 (.99%)
Coronary Artery	263 (.98%)
Metabolic, Nutritional And Blood Ga...	248 (.92%)
Acid-base	230 (.86%)
Anemias Nonhemolytic And Marrow Dep...	223 (.83%)
Hepatobiliary	215 (.8%)
Central Nervous System Vascular	200 (.74%)
Chemical Injury And Poisoning	195 (.73%)
Suicidal And Self-injurious Behavio...	185 (.69%)
Bacterial Infectious	182 (.68%)
Muscle	181 (.67%)
Vascular Hypertensive	179 (.67%)
Urinary Tract Signs	177 (.66%)
Joint	173 (.64%)
Myocardial	173 (.64%)
Allergic Conditions	171 (.64%)
Musculoskeletal And Connective Tiss...	168 (.63%)
Hematological And Lymphoid Tissue T...	162 (.6%)
Physical Examination Topics	151 (.56%)
Deliria	150 (.56%)
White Blood Cell	143 (.53%)
Headaches	138 (.51%)
Movement Disorders	136 (.51%)
Tongue Conditions	135 (.5%)
Gastrointestinal Ulceration And Per...	133 (.49%)
Upper Respiratory Tract Disorders	133 (.49%)
Body Temperature Conditions	130 (.48%)
Anxiety Disorders	127 (.47%)
Bronchial Disorders	121 (.45%)
Skin Appendage Conditions	120 (.45%)
Fatal Outcomes	110 (.41%)
Vascular	110 (.41%)
Arteriosclerosis, Stenosis, Vascula...	107 (.4%)
Cardiac Disorder Signs	101 (.38%)
Enzyme	101 (.38%)
Nephropathies	99 (.37%)
Oral Soft Tissue Conditions	98 (.36%)
Pleural	97 (.36%)
Bone And Joint Injuries	91 (.34%)
Exocrine Pancreas Conditions	88 (.33%)
Gastrointestinal Hemorrhages	87 (.32%)
Mental Impairment	84 (.31%)
Gastrointestinal Inflammatory Condi...	83 (.31%)
Protein And Chemistry Analyses	78 (.29%)
Lifestyle Issues	76 (.28%)
Depressed Mood Disorders	71 (.26%)
Gallbladder	71 (.26%)
Platelet	68 (.25%)
Sleep Disorders	68 (.25%)
Hypothalamus And Pituitary Gland	67 (.25%)
Viral Infectious	67 (.25%)
Vision	65 (.24%)
Skin Vascular Abnormalities	64 (.24%)
Pulmonary Vascular	63 (.23%)
Psychiatric	60 (.22%)
Seizures	59 (.22%)
Toxicology And Therapeutic Drug Mon...	57 (.21%)
Eye	56 (.21%)
Inner Ear And Viiith Cranial Nerve	56 (.21%)
Cardiac Valve	55 (.2%)
Gastrointestinal Neoplasms Malignan...	55 (.2%)
Immunology And Allergy	54 (.2%)
Neuromuscular	53 (.2%)
Procedural And Device Related Injur...	53 (.2%)
Product Quality Issues	53 (.2%)
Vascular Hemorrhagic	52 (.19%)
Gastrointestinal Conditions	50 (.19%)
Encephalopathies	49 (.18%)
Therapeutic Procedures And Supporti...	49 (.18%)
Cardiac Therapeutic Procedures	44 (.16%)
Increased Intracranial Pressure And...	43 (.16%)
Ocular Infections, Irritations And ...	43 (.16%)
Bone Disorders	42 (.16%)
Fetal Complications	42 (.16%)
Coagulopathies And Bleeding Diathes...	41 (.15%)
Embolism And Thrombosis	41 (.15%)
Hemolyses And Related Conditions	40 (.15%)
Disturbances In Thinking	38 (.14%)
Metastases	38 (.14%)

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