AMIODARONE

Amiodarone Adverse Events Reported to the FDA Over Time

How are Amiodarone adverse event reports trending over time?

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

Most Common Amiodarone Adverse Events Reported to the FDA

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

Drug Interaction	962 (2.38%)
Dyspnoea	627 (1.55%)
Atrial Fibrillation	608 (1.5%)
Bradycardia	486 (1.2%)
Hyperthyroidism	482 (1.19%)
Interstitial Lung Disease	421 (1.04%)
International Normalised Ratio Incr...	413 (1.02%)
Asthenia	378 (.94%)
Ventricular Tachycardia	358 (.89%)
Hypothyroidism	350 (.87%)
Electrocardiogram Qt Prolonged	347 (.86%)
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Renal Failure Acute	345 (.85%)
Torsade De Pointes	344 (.85%)
Dizziness	343 (.85%)
Pulmonary Fibrosis	342 (.85%)
Fatigue	331 (.82%)
Renal Failure	325 (.8%)
Hypotension	320 (.79%)
Condition Aggravated	318 (.79%)
Fall	304 (.75%)
Nausea	302 (.75%)
Cardiac Arrest	294 (.73%)
Pneumonia	290 (.72%)
Cardiac Failure	283 (.7%)
Lung Disorder	266 (.66%)
Syncope	257 (.64%)
Pulmonary Toxicity	233 (.58%)
Drug Ineffective	232 (.57%)
Pleural Effusion	225 (.56%)
Vomiting	223 (.55%)
Rhabdomyolysis	219 (.54%)
Malaise	217 (.54%)
Alanine Aminotransferase Increased	206 (.51%)
Oedema Peripheral	205 (.51%)
Tremor	197 (.49%)
Anaemia	196 (.48%)
Weight Decreased	191 (.47%)
Respiratory Failure	186 (.46%)
General Physical Health Deteriorati...	184 (.46%)
Aspartate Aminotransferase Increase...	181 (.45%)
Arrhythmia	180 (.45%)
Drug Toxicity	173 (.43%)
Pyrexia	163 (.4%)
Cough	161 (.4%)
Paraesthesia	159 (.39%)
Hypokalaemia	157 (.39%)
Diarrhoea	155 (.38%)
Ventricular Fibrillation	155 (.38%)
Acute Respiratory Distress Syndrome	154 (.38%)
Loss Of Consciousness	153 (.38%)
Pneumonitis	153 (.38%)
Blood Creatinine Increased	151 (.37%)
Cardiac Failure Congestive	148 (.37%)
Hyponatraemia	148 (.37%)
Cardiogenic Shock	147 (.36%)
Dehydration	146 (.36%)
Hyperkalaemia	138 (.34%)
Confusional State	134 (.33%)
Feeling Abnormal	132 (.33%)
Liver Function Test Abnormal	132 (.33%)
Multi-organ Failure	131 (.32%)
Pulmonary Oedema	129 (.32%)
Muscular Weakness	125 (.31%)
Haemoglobin Decreased	123 (.3%)
Thrombocytopenia	123 (.3%)
Cytolytic Hepatitis	119 (.29%)
Gait Disturbance	119 (.29%)
Hepatic Failure	118 (.29%)
Cardiac Murmur	114 (.28%)
Cholestasis	114 (.28%)
Overdose	113 (.28%)
Sinus Bradycardia	112 (.28%)
Headache	111 (.27%)
Chest Pain	109 (.27%)
Oedema	108 (.27%)
Cardio-respiratory Arrest	105 (.26%)
Gamma-glutamyltransferase Increased	105 (.26%)
Hypoxia	105 (.26%)
Pain	105 (.26%)
Blood Alkaline Phosphatase Increase...	104 (.26%)
Hyperhidrosis	103 (.25%)
Renal Impairment	103 (.25%)
Ventricular Extrasystoles	102 (.25%)
Jaundice	101 (.25%)
Blood Creatine Phosphokinase Increa...	95 (.24%)
Dyspnoea Exertional	95 (.24%)
Hepatic Enzyme Increased	95 (.24%)
Heart Rate Decreased	94 (.23%)
Hepatotoxicity	93 (.23%)
Liver Disorder	93 (.23%)
Constipation	91 (.23%)
Death	91 (.23%)
Tachycardia	91 (.23%)
Coma	90 (.22%)
Venous Pressure Jugular Increased	90 (.22%)
Abdominal Pain	87 (.22%)
Myocardial Infarction	83 (.21%)
Vision Blurred	83 (.21%)
Left Ventricular Dysfunction	82 (.2%)
Lung Infiltration	82 (.2%)
Photosensitivity Reaction	82 (.2%)

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

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

Cardiac Arrhythmias	3585 (8.87%)
Respiratory	2040 (5.05%)
Lower Respiratory Tract Disorders	1897 (4.69%)
Neurological	1889 (4.67%)
Therapeutic And Nontherapeutic Effe...	1391 (3.44%)
Cardiac And Vascular Investigations	1304 (3.23%)
Hepatic And Hepatobiliary	1293 (3.2%)
Epidermal And Dermal Conditions	1124 (2.78%)
Hematology Investigations	1007 (2.49%)
Thyroid Gland	1007 (2.49%)
Renal Disorders	943 (2.33%)
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Infections - Pathogen Unspecified	914 (2.26%)
Hepatobiliary	877 (2.17%)
Gastrointestinal Signs	861 (2.13%)
Heart Failures	700 (1.73%)
Muscle	688 (1.7%)
Electrolyte And Fluid Balance Condi...	650 (1.61%)
Injuries	568 (1.41%)
Decreased And Nonspecific Blood Pre...	530 (1.31%)
Movement Disorders	434 (1.07%)
Medication Errors	408 (1.01%)
Vision	367 (.91%)
Myocardial	347 (.86%)
Physical Examination Topics	331 (.82%)
Anemias Nonhemolytic And Marrow Dep...	314 (.78%)
White Blood Cell	300 (.74%)
Renal And Urinary Tract Investigati...	296 (.73%)
Enzyme	276 (.68%)
Pleural	271 (.67%)
Gastrointestinal Motility And Defec...	269 (.67%)
Chemical Injury And Poisoning	257 (.64%)
Bacterial Infectious	232 (.57%)
Coronary Artery	230 (.57%)
Musculoskeletal And Connective Tiss...	224 (.55%)
Gastrointestinal Hemorrhages	222 (.55%)
Skin Appendage Conditions	217 (.54%)
Deliria	205 (.51%)
Cardiac Disorder Signs	204 (.5%)
Appetite And General Nutritional	201 (.5%)
Central Nervous System Vascular	196 (.48%)
Body Temperature Conditions	192 (.48%)
Administration Site Reactions	190 (.47%)
Water, Electrolyte And Mineral	177 (.44%)
Metabolic, Nutritional And Blood Ga...	174 (.43%)
Endocrine Investigations	170 (.42%)
Platelet	165 (.41%)
Peripheral Neuropathies	162 (.4%)
Urinary Tract Signs	161 (.4%)
Anxiety Disorders	153 (.38%)
Bronchial Disorders	146 (.36%)
Procedural And Device Related Injur...	145 (.36%)
Vascular	145 (.36%)
Anterior Eye Structural Change, Dep...	141 (.35%)
Fatal Outcomes	140 (.35%)
Pericardial	138 (.34%)
Toxicology And Therapeutic Drug Mon...	135 (.33%)
Mental Impairment	124 (.31%)
Ocular Structural Change, Deposit A...	124 (.31%)
Pulmonary Vascular	118 (.29%)
Skin Vascular Abnormalities	117 (.29%)
Headaches	113 (.28%)
Cardiac Valve	112 (.28%)
Protein And Chemistry Analyses	112 (.28%)
Hematological And Lymphoid Tissue T...	111 (.27%)
Vascular Hemorrhagic	110 (.27%)
Glucose Metabolism Disorders	108 (.27%)
Bone And Joint Injuries	107 (.26%)
Disturbances In Thinking	105 (.26%)
Allergic Conditions	101 (.25%)
Suicidal And Self-injurious Behavio...	98 (.24%)
Sleep Disorders	97 (.24%)
Joint	96 (.24%)
Peritoneal And Retroperitoneal Cond...	95 (.24%)
Lifestyle Issues	94 (.23%)
Seizures	94 (.23%)
Vascular Hypertensive	89 (.22%)
Depressed Mood Disorders	87 (.22%)
Respiratory And Pulmonary Investiga...	84 (.21%)
Eye	83 (.21%)
Embolism And Thrombosis	80 (.2%)
Gastrointestinal Inflammatory Condi...	76 (.19%)
Viral Infectious	76 (.19%)
Neuromuscular	75 (.19%)
Upper Respiratory Tract Disorders	71 (.18%)
Acid-base	68 (.17%)
Encephalopathies	65 (.16%)
Gastrointestinal Ulceration And Per...	65 (.16%)
Fungal Infectious	64 (.16%)
Vascular Inflammations	64 (.16%)
Tissue	62 (.15%)
Bone, Calcium, Magnesium And Phosph...	60 (.15%)
Immunology And Allergy	60 (.15%)
Coagulopathies And Bleeding Diathes...	59 (.15%)
Dissociative	59 (.15%)
Cardiac Therapeutic Procedures	57 (.14%)
Exocrine Pancreas Conditions	57 (.14%)
Arteriosclerosis, Stenosis, Vascula...	56 (.14%)
Gallbladder	55 (.14%)
Therapeutic Procedures And Supporti...	55 (.14%)
Gastrointestinal Vascular Condition...	51 (.13%)
Nephropathies	51 (.13%)

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