SPIRONOLACTONE

Spironolactone Adverse Events Reported to the FDA Over Time

How are Spironolactone adverse event reports trending over time?

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

Most Common Spironolactone Adverse Events Reported to the FDA

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

Hyperkalaemia	688 (4.96%)
Renal Failure Acute	507 (3.66%)
Dehydration	269 (1.94%)
Blood Creatinine Increased	234 (1.69%)
Drug Interaction	222 (1.6%)
Hypotension	210 (1.52%)
Nausea	181 (1.31%)
Hyponatraemia	180 (1.3%)
Renal Failure	176 (1.27%)
Vomiting	155 (1.12%)
Diarrhoea	145 (1.05%)
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Asthenia	140 (1.01%)
Dyspnoea	139 (1%)
Atrial Fibrillation	136 (.98%)
Blood Potassium Increased	134 (.97%)
Dizziness	131 (.95%)
Fall	118 (.85%)
Bradycardia	117 (.84%)
Oedema Peripheral	111 (.8%)
Pyrexia	103 (.74%)
Renal Impairment	102 (.74%)
Cardiac Failure	95 (.69%)
Hypertension	95 (.69%)
Syncope	88 (.64%)
Malaise	83 (.6%)
Condition Aggravated	79 (.57%)
Blood Urea Increased	78 (.56%)
Fatigue	77 (.56%)
Blood Pressure Decreased	75 (.54%)
Confusional State	74 (.53%)
Oedema	74 (.53%)
Hypokalaemia	72 (.52%)
Weight Increased	70 (.51%)
Gynaecomastia	68 (.49%)
Anaemia	66 (.48%)
Pruritus	60 (.43%)
Back Pain	57 (.41%)
Haemoglobin Decreased	57 (.41%)
General Physical Health Deteriorati...	56 (.4%)
Therapeutic Agent Toxicity	56 (.4%)
Headache	55 (.4%)
Constipation	54 (.39%)
Gastrooesophageal Reflux Disease	53 (.38%)
Drug Ineffective	52 (.38%)
Rash	52 (.38%)
Blood Pressure Increased	50 (.36%)
Fear Of Eating	50 (.36%)
Oliguria	49 (.35%)
Toxic Epidermal Necrolysis	49 (.35%)
Blood Glucose Increased	48 (.35%)
Death	48 (.35%)
Dyspepsia	46 (.33%)
Haemodialysis	46 (.33%)
Somnolence	46 (.33%)
Decreased Appetite	43 (.31%)
Weight Decreased	43 (.31%)
Atrioventricular Block Complete	42 (.3%)
Erythema	42 (.3%)
Rectal Haemorrhage	42 (.3%)
Ascites	41 (.3%)
Cardiac Failure Congestive	41 (.3%)
International Normalised Ratio Incr...	41 (.3%)
Cardiac Arrest	40 (.29%)
Pain	40 (.29%)
Arthralgia	39 (.28%)
Hyperglycaemia	39 (.28%)
Mesothelioma	39 (.28%)
Chest Pain	37 (.27%)
Cough	37 (.27%)
Hypovolaemia	37 (.27%)
Metabolic Acidosis	37 (.27%)
Stevens-johnson Syndrome	37 (.27%)
Blood Sodium Decreased	36 (.26%)
Lung Neoplasm Malignant	36 (.26%)
Loss Of Consciousness	35 (.25%)
Pneumonia	34 (.25%)
Thrombocytopenia	34 (.25%)
Rhabdomyolysis	33 (.24%)
Muscular Weakness	32 (.23%)
Renal Failure Chronic	31 (.22%)
Abdominal Pain	30 (.22%)
Cardiogenic Shock	30 (.22%)
Hypoglycaemia	30 (.22%)
Renal Pain	30 (.22%)
Depression	29 (.21%)
Fluid Overload	29 (.21%)
Hypersensitivity	29 (.21%)
Rash Maculo-papular	29 (.21%)
Dry Skin	28 (.2%)
Pulmonary Embolism	28 (.2%)
Gait Disturbance	27 (.19%)
Pain In Extremity	27 (.19%)
Pleural Effusion	27 (.19%)
Tremor	27 (.19%)
Acute Prerenal Failure	26 (.19%)
Agitation	26 (.19%)
Completed Suicide	26 (.19%)
Muscle Spasms	26 (.19%)
Myocardial Infarction	26 (.19%)
Abdominal Pain Upper	25 (.18%)
Rash Generalised	25 (.18%)

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

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

Electrolyte And Fluid Balance Condi...	1329 (9.59%)
Renal Disorders	962 (6.94%)
Cardiac Arrhythmias	621 (4.48%)
Epidermal And Dermal Conditions	616 (4.45%)
Neurological	528 (3.81%)
Gastrointestinal Signs	520 (3.75%)
Renal And Urinary Tract Investigati...	403 (2.91%)
Cardiac And Vascular Investigations	377 (2.72%)
Respiratory	370 (2.67%)
Therapeutic And Nontherapeutic Effe...	322 (2.32%)
Decreased And Nonspecific Blood Pre...	288 (2.08%)
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Gastrointestinal Motility And Defec...	275 (1.98%)
Water, Electrolyte And Mineral	239 (1.72%)
Hematology Investigations	220 (1.59%)
Injuries	189 (1.36%)
Heart Failures	188 (1.36%)
Infections - Pathogen Unspecified	188 (1.36%)
Physical Examination Topics	155 (1.12%)
Hepatic And Hepatobiliary	141 (1.02%)
Breast	137 (.99%)
Musculoskeletal And Connective Tiss...	132 (.95%)
Anemias Nonhemolytic And Marrow Dep...	123 (.89%)
Metabolic, Nutritional And Blood Ga...	121 (.87%)
Muscle	120 (.87%)
Vascular Hypertensive	111 (.8%)
Body Temperature Conditions	105 (.76%)
Deliria	105 (.76%)
Anxiety Disorders	102 (.74%)
Gastrointestinal Hemorrhages	98 (.71%)
Appetite And General Nutritional	97 (.7%)
Glucose Metabolism Disorders	95 (.69%)
Hepatobiliary	95 (.69%)
Chemical Injury And Poisoning	93 (.67%)
Urinary Tract Signs	87 (.63%)
Myocardial	85 (.61%)
White Blood Cell	81 (.58%)
Medication Errors	78 (.56%)
Central Nervous System Vascular	76 (.55%)
Joint	73 (.53%)
Vision	73 (.53%)
Acid-base	72 (.52%)
Skin Appendage Conditions	71 (.51%)
Lower Respiratory Tract Disorders	70 (.51%)
Movement Disorders	69 (.5%)
Hematological And Lymphoid Tissue T...	68 (.49%)
Coronary Artery	63 (.45%)
Bacterial Infectious	59 (.43%)
Headaches	58 (.42%)
Fatal Outcomes	57 (.41%)
Cardiac Valve	56 (.4%)
Skin Vascular Abnormalities	56 (.4%)
Vascular	53 (.38%)
Peritoneal And Retroperitoneal Cond...	48 (.35%)
Suicidal And Self-injurious Behavio...	47 (.34%)
Pulmonary Vascular	45 (.32%)
Upper Respiratory Tract Disorders	44 (.32%)
Lifestyle Issues	43 (.31%)
Mesotheliomas	43 (.31%)
Platelet	43 (.31%)
Allergic Conditions	42 (.3%)
Bone And Joint Injuries	42 (.3%)
Toxicology And Therapeutic Drug Mon...	42 (.3%)
Cardiac Disorder Signs	41 (.3%)
Depressed Mood Disorders	41 (.3%)
Enzyme	41 (.3%)
Respiratory And Mediastinal Neoplas...	39 (.28%)
Endocrine Investigations	38 (.27%)
Mental Impairment	38 (.27%)
Protein And Chemistry Analyses	36 (.26%)
Psychiatric	36 (.26%)
Oral Soft Tissue Conditions	35 (.25%)
Gastrointestinal Vascular Condition...	34 (.25%)
Procedural And Device Related Injur...	33 (.24%)
Nephropathies	31 (.22%)
Vascular Hemorrhagic	31 (.22%)
Bronchial Disorders	29 (.21%)
Pleural	28 (.2%)
Thyroid Gland	28 (.2%)
Bone, Calcium, Magnesium And Phosph...	26 (.19%)
Disturbances In Thinking	26 (.19%)
Viral Infectious	26 (.19%)
Eye	25 (.18%)
Gastrointestinal Ulceration And Per...	25 (.18%)
Arteriosclerosis, Stenosis, Vascula...	24 (.17%)
Encephalopathies	24 (.17%)
Skin And Subcutaneous Tissue	22 (.16%)
Gastrointestinal Inflammatory Condi...	21 (.15%)
Inner Ear And Viiith Cranial Nerve	21 (.15%)
Product Quality Issues	21 (.15%)
Sleep Disorders	20 (.14%)
Angiedema And Urticaria	19 (.14%)
Bone Disorders	18 (.13%)
Lipid Analyses	18 (.13%)
Microbiology And Serology	18 (.13%)
Peripheral Neuropathies	18 (.13%)
Personality Disorders	18 (.13%)
Tissue	17 (.12%)
Exocrine Pancreas Conditions	16 (.12%)
Immunology And Allergy	16 (.12%)
Reproductive Tract And Breast Disor...	16 (.12%)
Salivary Gland Conditions	16 (.12%)

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