ALDACTONE (Spironolactone Tablets, USP) 8 Adverse Reactions

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8.1 Adverse Reaction Overview

The following adverse reactions have been reported in association with ALDACTONE (spironolactone):

Blood and lymphatic system disorders:  Leukopenia (including agranulocytosis), thrombocytopenia, anemia.

Gastrointestinal disorders: Diarrhea and cramping, gastric bleeding, gastritis, nausea, ulceration, vomiting.

General disorders and administration site conditions: Malaise, ataxia.

Hepatobiliary disorders: Abnormal hepatic function. A few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration.

Immune system disorders: Drug fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis, pruritus, rash.

Metabolism and nutrition disorders: Electrolyte disturbances, hyperkalemia.

Musculoskeletal and connective tissue disorders: Leg cramps, muscle spasms, rhabdomyolysis, myalgia, weakness

Nervous system/psychiatric disorders: Mental confusion, ataxia, headache, drowsiness, lethargy, dizziness, change in libido.

Renal and urinary disorders: Renal dysfunction (including acute renal failure).

Reproductive system and breast disorders: gynecomastia* (see 7 WARNINGS and PRECAUTIONS-, Carcinogenesis and Mutagenesis), erectile dysfunction (inability to achieve or maintain erection), abnormal semen (decreased motility and sperm count), irregular menses or amenorrhea, postmenopausal bleeding, benign breast neoplasm, breast pain, breast carcinoma (including male patients)

Respiratory, thoracic and mediastinal disorders: Dysphonia, dyspnea.

Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, hypertrichosis.

*Gynecomastia may develop with the use of spironolactone, and physicians should be advised of its possible occurrence. Development of gynecomastia is related to both dose and duration of therapy. If gynecomastia develops, discontinue the drug. Gynecomastia is usually reversible when spironolactone is discontinued, although in rare instances some breast enlargement may persist.

Adverse reactions are usually reversible upon discontinuation of the drug.

8.5 Post-Market Adverse Reactions

The frequency of the event listed in Table 3 are evaluated as very rare: (<1/10,000; <0.01%)

Table 3 - Post Market Adverse Events for ALDACTONE

Blood and lymphatic system disorders

Disseminated intravascular coagulation, Bone marrow failure, Lymphadenopathy

Neutropenia Pancytopenia, Lymphopenia, Splenomegaly, Coagulopathy


Cardiac disorders

Cardiac arrest, Cardio-respiratory/Sinus arrest, Torsade de pointes, Atrioventricular block (1st/2nd degree, complete), Bundle branch block (left), Sinoatrial block, Myocardial infarction, Myocardial ischaemia, Defect conduction intraventricular, Ventricular/Supraventricular tachycardia, Ventricular/Supraventricular extrasystoles, Cardiomegaly, Cardiomyopathy Cardiogenic shock, Sick sinus syndrome, Cardiac failure, Ventricular fibrillation, Atrial fibrillation/flutter, Tachycardia, Coronary artery disease, Cardiovascular disorder, Sinus bradycardia, Angina unstable, Angina pectoris, Tricuspid valve incompetence, Mitral valve incompetence, Palpitations, Arrhythmia, Pericardial effusion, Cyanosis, Coronary artery occlusion

Ear and labyrinth disorders

Deafness, Hypoacusis, Vertigo, Ear disorder, Ear pain, Tinnitus

Endocrine disorders

Hyperthyroidism, Hypothyroidism, Inappropriate antidiuretic hormone


Eye disorders

Diabetic retinopathy, Cataract, Vision blurred, Visual impairment

Gastrointestinal disorders

Pancreatitis, GI haemorrhage, Varices oesophageal, Intestinal obstruction, Large intestine polyp, Diverticulum, Hiatus hernia, Ileus paralytic, Melaena, Coeliac disease, Gastrooesophageal reflux disease, Haemorrhoids, Duodenitis, Retching, Gastric disorder, Gastrointestinal disorder, Abdominal distension, Dyspepsia, Dysphagia, Constipation

General disorders and administration

site conditions

Sudden death, Multi-organ failure, Hypothermia, Peripheral swelling, Face oedema, Chest pain/discomfort, General physical health deterioration, Gait disturbance, Swelling, Chills, Pain, Asthenia, Fatigue

Hepatobiliary disorders

Hepatitis, Hepatic failure/necrosis/cirrhosis/steatosis

Portal hypertension, Hepatorenal syndrome, Portal vein thrombosis

Jaundice cholestatic, Hepatic Hepatomegaly, Cholecystitis, Cholelithiasis

Jaundice, Hyperbilirubinaemia, Gallbladder disorder

Immune system

Anaphylactic shock

Infections and infestations

Septic shock, Pneumonia, Sepsis, Respiratory tract infection, Empyema, Bronchitis, Pyelonephritis, Bacterial/fungal/viral infection, Urinary tract infection, Herpes zoster, Diverticulitis, Gastroenteritis, Mastitis, Cystitis, Cellulitis, Sinusitis, Onychomycosis Infection

Injury, poisoning and procedural complications

Head injury, Fall, Ankle fracture, Lower limb fracture, Contusion, Road traffic accident, Injury


Electrocardiogram QT prolonged, Electrocardiogram QRS complex prolonged, Electrocardiogram abnormal, Blood creatinine increased, Blood pressure increased/decreased, , Blood bilirubin increased, Transaminases increased, Aspartate aminotransferase increased, International normalised ratio increased, Alanine aminotransferase increased, Gamma-glutamyltransferase increased, Liver function test abnormal, Blood alkaline phosphatase increased, Haematocrit decreased, Blood glucose increased/decreased, Blood lactate dehydrogenase increased, Blood potassium decreased, Amylase increased, Blood chloride decreased, Occult blood positive, Blood aldosterone increased, Blood uric acid increased, Urine output decreased, White blood cell count increased, Eosinophil count increased, Weight decreased/increased

Metabolism and nutrition disorders

Diabetes mellitus, Hypo/hyperglycaemia, Fluid retention, Hypovolaemia

Dehydration, Hypomagnesaemia, Hypo/hypercalcaemia, Metabolic alkalosis

Hyperammonaemia, Gout, Malnutrition, Obesity, Decreased appetite

Musculoskeletal and connective tissue


Rhabdomyolysis, Systemic lupus erythematosus/lupus like syndrome, Rheumatoid arthritis, Osteoarthritis, Muscle haemorrhage, Osteopenia, Osteoporosis, Muscle spasms/weakness/pain, Bursitis, Limb discomfort, Arthropathy, Myalgia, Arthralgia, Back pain, Pain in extremity

Neoplasms benign, malignant and


Pancreatic carcinoma, Lung neoplasm malignant, Hepatic cancer. Neoplasm malignant, Colon cancer, Gastrointestinal carcinoma, Lymphoma

Nervous system disorders

Cerebral haemorrhage, Cerebral infarction, Cerebrovascular accident, Coma, Depressed/altered level of consciousness, Transient ischaemic attack, Hepatic encephalopathy, Hydrocephalus, Encephalopathy, Cerebral atrophy, Paralysis, Convulsion, Parkinson's disease, VIIth nerve paralysis, Diabetic neuropathy, Neuropathy peripheral, Syncope, Presyncope, Dementia, Memory impairment, Cognitive disorder, Paraesthesia, Hypoaesthesia, Dysarthria, Stupor, Ageusia, Asterixis, Tremor, Disturbance in attention, Hypokinesia, Nystagmus, Speech disorder, Balance disorder

Psychiatric disorders

Suicide/Suicide attempt/suicidal ideation, Hallucination, Depression, Psychotic disorder, Abnormal behaviour, Apathy, Visual disorientation, Delirium, Insomnia, Anxiety, Agitation, Drug abuse

Renal and urinary disorders

Anuria, Chronic Renal failure, Renal tubular necrosis, Tubulointerstitial nephritis, Nephropathy toxic, Diabetic nephropathy, Prerenal failure, Proteinuria, Nephrolithiasis, Renal cyst, Urinary retention, Haematuria, Dysuria, Chromaturia, Pollakiuria, Oliguria, Polyuria

Reproductive system and breast


Breast mass, Breast swelling Genital haemorrhage, Uterine disorder

Respiratory, thoracic and mediastinal


Respiratory arrest/disorder/distress/failure

Pulmonary embolism, Pulmonary oedema, Pulmonary hypertension

Atelectasis, Bronchospasm, Pneumonitis, Interstitial lung disease, Pneumonia aspiration, Asthma, Wheezing, Pleural effusion, Chronic obstructive pulmonary disease, Haemoptysis, Sleep apnoea syndrome, Hypoxia, Lung disorder, Oropharyngeal pain, Epistaxis, Cough, Rales

Skin and subcutaneous tissue disorders

Toxic skin eruption, Angioedema, Skin necrosis/exfoliation, Lichenoid keratosis, Drug eruption, Dermatitis bullous/exfoliative, Erythema multiforme, Photosensitivity reaction, Hyperhidrosis, Lichen planus, Skin ulcer, Eczema, Pemphigoid, Dermatitis, Erythema, Purpura, Blister, Dry skin, Skin discolouration, Cold sweat

Surgical and medical procedures

Surgery, Hysterectomy, Knee arthroplasty

Vascular disorders

Circulatory collapse, Hypovolaemic shock, Shock haemorrhagic, Shock, Infarction, Haemorrhage, Thrombosis, Hypotension, Orthostatic hypotension, Peripheral arterial occlusive disease, Arteriosclerosis, Deep vein thrombosis, Peripheral vascular disorder, Peripheral venous disease, Phlebitis, Angiopathy, Lymphoedema, Haematoma, Flushing, Hot flush