DIGOXIN

Digoxin Adverse Events Reported to the FDA Over Time

How are Digoxin adverse event reports trending over time?

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

Most Common Digoxin Adverse Events Reported to the FDA

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

Economic Problem	3178 (2.14%)
Dizziness	2337 (1.57%)
Pain	2261 (1.52%)
Multiple Injuries	2218 (1.49%)
Atrial Fibrillation	2209 (1.49%)
Nausea	2197 (1.48%)
Therapeutic Agent Toxicity	1986 (1.34%)
Dyspnoea	1941 (1.31%)
Injury	1870 (1.26%)
Cardiac Failure Congestive	1831 (1.23%)
Asthenia	1754 (1.18%)
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Anxiety	1748 (1.18%)
Fatigue	1557 (1.05%)
Hypotension	1506 (1.01%)
Vomiting	1466 (.99%)
Bradycardia	1444 (.97%)
Hypertension	1211 (.82%)
Fall	1069 (.72%)
Renal Failure	1034 (.7%)
Diarrhoea	1027 (.69%)
Chest Pain	979 (.66%)
Palpitations	948 (.64%)
Renal Failure Acute	946 (.64%)
Oedema Peripheral	896 (.6%)
Myocardial Infarction	861 (.58%)
Unevaluable Event	843 (.57%)
Mitral Valve Incompetence	823 (.55%)
Dehydration	805 (.54%)
Cardioactive Drug Level Increased	795 (.54%)
Weight Decreased	779 (.52%)
Confusional State	740 (.5%)
Coronary Artery Disease	739 (.5%)
Anaemia	738 (.5%)
Cough	706 (.48%)
Pneumonia	706 (.48%)
Malaise	704 (.47%)
Decreased Appetite	694 (.47%)
Surgery	694 (.47%)
Cardiomegaly	691 (.47%)
Cardiac Arrest	690 (.46%)
Cardiac Disorder	684 (.46%)
Anhedonia	681 (.46%)
Syncope	678 (.46%)
Urinary Tract Infection	621 (.42%)
Back Pain	617 (.42%)
Heart Rate Irregular	613 (.41%)
Death	612 (.41%)
Arrhythmia	597 (.4%)
Ill-defined Disorder	594 (.4%)
Depression	580 (.39%)
Chronic Obstructive Pulmonary Disea...	574 (.39%)
Headache	574 (.39%)
Condition Aggravated	566 (.38%)
Pleural Effusion	556 (.37%)
Tricuspid Valve Incompetence	552 (.37%)
Cardiomyopathy	543 (.37%)
Ventricular Tachycardia	540 (.36%)
Abdominal Pain	538 (.36%)
Hyperkalaemia	533 (.36%)
Cardiac Murmur	525 (.35%)
Cerebrovascular Accident	520 (.35%)
Pain In Extremity	500 (.34%)
Heart Rate Decreased	498 (.34%)
Loss Of Consciousness	478 (.32%)
Cardiac Failure	470 (.32%)
Chest Discomfort	467 (.31%)
International Normalised Ratio Incr...	449 (.3%)
Pulmonary Hypertension	440 (.3%)
Emotional Disorder	435 (.29%)
Pyrexia	430 (.29%)
Heart Rate Increased	419 (.28%)
Arthralgia	413 (.28%)
Dyspnoea Exertional	407 (.27%)
Blood Glucose Increased	394 (.27%)
Emotional Distress	394 (.27%)
Hyperlipidaemia	393 (.26%)
Feeling Abnormal	387 (.26%)
Left Ventricular Dysfunction	385 (.26%)
Bronchitis	384 (.26%)
Renal Failure Chronic	384 (.26%)
Respiratory Failure	378 (.25%)
Drug Interaction	377 (.25%)
Tachycardia	372 (.25%)
Ventricular Extrasystoles	366 (.25%)
Mental Disorder	358 (.24%)
Hypokalaemia	347 (.23%)
Left Ventricular Hypertrophy	346 (.23%)
Weight Increased	346 (.23%)
Pulmonary Oedema	344 (.23%)
Hyperhidrosis	343 (.23%)
Diabetes Mellitus	342 (.23%)
Gait Disturbance	339 (.23%)
Insomnia	339 (.23%)
Vision Blurred	338 (.23%)
Paraesthesia	332 (.22%)
Social Problem	328 (.22%)
Ejection Fraction Decreased	327 (.22%)
Oedema	324 (.22%)
Visual Impairment	323 (.22%)
Mental Status Changes	322 (.22%)
Overdose	320 (.22%)

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

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

Cardiac Arrhythmias	10349 (6.97%)
Neurological	6651 (4.48%)
Injuries	6319 (4.25%)
Respiratory	6122 (4.12%)
Gastrointestinal Signs	5766 (3.88%)
Cardiac And Vascular Investigations	5026 (3.38%)
Infections - Pathogen Unspecified	3812 (2.57%)
Myocardial	3487 (2.35%)
Economic And Housing Issues	3318 (2.23%)
Renal Disorders	3226 (2.17%)
Coronary Artery	2998 (2.02%)
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Heart Failures	2721 (1.83%)
Cardiac Valve	2437 (1.64%)
Electrolyte And Fluid Balance Condi...	2417 (1.63%)
Anxiety Disorders	2382 (1.6%)
Chemical Injury And Poisoning	2334 (1.57%)
Musculoskeletal And Connective Tiss...	2081 (1.4%)
Cardiac Disorder Signs	1987 (1.34%)
Decreased And Nonspecific Blood Pre...	1822 (1.23%)
Gastrointestinal Motility And Defec...	1741 (1.17%)
Appetite And General Nutritional	1565 (1.05%)
Joint	1458 (.98%)
Physical Examination Topics	1451 (.98%)
Lower Respiratory Tract Disorders	1425 (.96%)
Toxicology And Therapeutic Drug Mon...	1419 (.96%)
Hematology Investigations	1392 (.94%)
Central Nervous System Vascular	1378 (.93%)
Lifestyle Issues	1361 (.92%)
Depressed Mood Disorders	1351 (.91%)
Vascular Hypertensive	1325 (.89%)
Bronchial Disorders	1109 (.75%)
Vision	1097 (.74%)
Deliria	1064 (.72%)
Epidermal And Dermal Conditions	1012 (.68%)
Mood Disorders	1004 (.68%)
Glucose Metabolism Disorders	981 (.66%)
Urinary Tract Signs	964 (.65%)
Anemias Nonhemolytic And Marrow Dep...	961 (.65%)
Arteriosclerosis, Stenosis, Vascula...	958 (.64%)
Metabolic, Nutritional And Blood Ga...	882 (.59%)
Therapeutic Procedures And Supporti...	880 (.59%)
Bacterial Infectious	833 (.56%)
Medication Errors	833 (.56%)
Renal And Urinary Tract Investigati...	791 (.53%)
Psychiatric	782 (.53%)
Therapeutic And Nontherapeutic Effe...	777 (.52%)
Fatal Outcomes	769 (.52%)
Muscle	726 (.49%)
Lipid Metabolism	721 (.49%)
Bone And Joint Injuries	702 (.47%)
Pleural	681 (.46%)
Water, Electrolyte And Mineral	674 (.45%)
Headaches	651 (.44%)
Hepatic And Hepatobiliary	633 (.43%)
Gastrointestinal Hemorrhages	623 (.42%)
Mental Impairment	613 (.41%)
Pulmonary Vascular	608 (.41%)
Vascular	607 (.41%)
Skin Appendage Conditions	598 (.4%)
Body Temperature Conditions	487 (.33%)
Movement Disorders	484 (.33%)
Procedural And Device Related Injur...	475 (.32%)
Sleep Disorders	449 (.3%)
Upper Respiratory Tract Disorders	444 (.3%)
Hepatobiliary	416 (.28%)
Gastrointestinal Inflammatory Condi...	409 (.28%)
Investigations, Imaging And Histopa...	359 (.24%)
Gallbladder	347 (.23%)
Thyroid Gland	347 (.23%)
Family Issues	342 (.23%)
Cardiac Therapeutic Procedures	340 (.23%)
Musculoskeletal And Connective Tiss...	332 (.22%)
Peripheral Neuropathies	320 (.22%)
Hematological And Lymphoid Tissue T...	302 (.2%)
Embolism And Thrombosis	297 (.2%)
Bone Disorders	290 (.2%)
Gastrointestinal Ulceration And Per...	281 (.19%)
Seizures	279 (.19%)
Tissue	259 (.17%)
Viral Infectious	254 (.17%)
Disturbances In Thinking	246 (.17%)
Product Quality Issues	237 (.16%)
Inner Ear And Viiith Cranial Nerve	235 (.16%)
Lipid Analyses	234 (.16%)
Personality Disorders	233 (.16%)
Enzyme	228 (.15%)
Diverticular	225 (.15%)
White Blood Cell	225 (.15%)
Pericardial	212 (.14%)
Gastrointestinal Conditions	209 (.14%)
Vascular Hemorrhagic	205 (.14%)
Abdominal Hernias And Other Abdomin...	204 (.14%)
Skin Vascular Abnormalities	195 (.13%)
Acid-base	193 (.13%)
Peritoneal And Retroperitoneal Cond...	190 (.13%)
Coagulopathies And Bleeding Diathes...	187 (.13%)
Encephalopathies	185 (.12%)
Gastrointestinal Vascular Condition...	182 (.12%)
Platelet	176 (.12%)
Vascular Therapeutic Procedures	175 (.12%)
Fungal Infectious	169 (.11%)

Share/Embed Graph Export Data

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