Spironolactone side effects - from FDA reports


In this review, we analyze Spironolactone side effects by the time on the drug, gender and age of the people who have side effects while taking Spironolactone. The review is based on 56,806 people who have side effects while taking the drug from FDA, and is updated regularly.

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Spironolactone

Spironolactone has active ingredients of spironolactone. It is often used in acne. (latest outcomes from Spironolactone 61,531 users)


On Dec, 13, 2018

56,806 people who take Spironolactone are studied.


Number of reports submitted per year:

Spironolactone side effects.

Most common side effects over time *:

< 1 month:
  • Vomiting
  • Hyperkalaemia (damage to or disease of the kidney)
  • Renal failure acute (rapid kidney dysfunction)
  • Renal failure (kidney dysfunction)
  • Renal impairment (severely reduced kidney function)
  • Hypotension (abnormally low blood pressure)
  • Syncope (loss of consciousness with an inability to maintain postural tone)
  • Somnolence (a state of near-sleep, a strong desire for sleep)
  • Hepatic encephalopathy (spectrum of neuropsychiatric abnormalities in patients with liver failure)
  • Rash
1 - 6 months:
  • Syncope (loss of consciousness with an inability to maintain postural tone)
  • Renal impairment (severely reduced kidney function)
  • Thrombocytopenia (decrease of platelets in blood)
  • Upper respiratory tract infection
  • Pneumonia
  • Ascites (accumulation of fluid in the abdominal cavity)
  • Renal failure (kidney dysfunction)
  • Ventricular tachycardia (rapid heartbeat that originates in one of the lower chambers (the ventricles) of the heart)
  • Weight increased
  • Gynaecomastia (enlargement of the gland tissue of the male breast)
6 - 12 months:
  • Hyperkalaemia (damage to or disease of the kidney)
  • Diarrhoea
  • Renal failure acute (rapid kidney dysfunction)
  • Hypotension (abnormally low blood pressure)
  • Sinus bradycardia (an unusually slow heartbeat due to heart disease)
  • Fall
  • Gynaecomastia (enlargement of the gland tissue of the male breast)
  • Muscular weakness (muscle weakness)
  • Renal impairment (severely reduced kidney function)
  • Dehydration (dryness resulting from the removal of water)
1 - 2 years:
  • Hyperkalaemia (damage to or disease of the kidney)
  • Renal failure acute (rapid kidney dysfunction)
  • Vomiting
  • Skin tightness
  • Syncope (loss of consciousness with an inability to maintain postural tone)
  • Renal impairment (severely reduced kidney function)
  • Blood creatinine increased
  • Bradycardia (abnormally slow heart action)
  • Pain
  • Pulmonary embolism (blockage of the main artery of the lung)
2 - 5 years:
  • Hyperkalaemia (damage to or disease of the kidney)
  • Renal failure acute (rapid kidney dysfunction)
  • Gastrointestinal haemorrhage (bleeding gastrointestinal tract)
  • Weight increased
  • Renal failure (kidney dysfunction)
  • Gynaecomastia (enlargement of the gland tissue of the male breast)
  • Palpitations (feelings or sensations that your heart is pounding or racing)
  • Upper gastrointestinal haemorrhage (upper gastrointestinal bleeding)
  • Clostridium difficile colitis (inflammation of colon by clostridium difficile bacteria infection)
  • Hypotension (abnormally low blood pressure)
5 - 10 years:
  • Hyperkalaemia (damage to or disease of the kidney)
  • Renal failure acute (rapid kidney dysfunction)
  • Gynaecomastia (enlargement of the gland tissue of the male breast)
  • Pneumonia
  • Tremor (trembling or shaking movements in one or more parts of your body)
  • Weight decreased
  • Breast cancer female
  • Gastrointestinal haemorrhage (bleeding gastrointestinal tract)
  • Nephrolithiasis (calculi in the kidneys)
  • Platelet count decreased
10+ years:
  • Syncope (loss of consciousness with an inability to maintain postural tone)
  • Gastrointestinal haemorrhage (bleeding gastrointestinal tract)
  • Pancreatic carcinoma (pancreatic cancer)
  • Presyncope
  • Psychiatric symptom
  • Tooth extraction
  • Urinary tract infection
  • Autoimmune thyroiditis (form of thyroiditis associated with an autoimmune disease)
  • Bone disorder
  • Cardiac failure
not specified:
  • Vomiting
  • Weight decreased
  • Weight increased
  • Death
  • Nausea (feeling of having an urge to vomit)
  • Pneumonia
  • Renal failure acute (rapid kidney dysfunction)
  • Hyperkalaemia (damage to or disease of the kidney)
  • Renal failure (kidney dysfunction)
  • Drug ineffective

Most common side effects by gender *:

female:
  • Vomiting
  • Weight decreased
  • Weight increased
  • Nausea (feeling of having an urge to vomit)
  • Death
  • Pneumonia
  • Urinary tract infection
  • Drug ineffective
  • Pain
  • Renal failure acute (rapid kidney dysfunction)
male:
  • Weight decreased
  • Vomiting
  • Syncope (loss of consciousness with an inability to maintain postural tone)
  • Gastrointestinal haemorrhage (bleeding gastrointestinal tract)
  • Thrombocytopenia (decrease of platelets in blood)
  • Myocardial infarction (destruction of heart tissue resulting from obstruction of the blood supply to the heart muscle)
  • Dyspnoea (difficult or laboured respiration)
  • Ventricular tachycardia (rapid heartbeat that originates in one of the lower chambers (the ventricles) of the heart)
  • Cardiac failure
  • Drug ineffective

Most common side effects by age *:

0-1:
  • Respiratory syncytial virus infection (viral disease of respiratory system)
  • Respiratory failure (inadequate gas exchange by the respiratory system)
  • Pulmonary hypertension (increase in blood pressure in the lung artery)
  • Vomiting
  • Wheezing (a high-pitched whistling sound made while you breath)
  • Viral infection
  • Cardiac failure
  • Death
  • Renal failure (kidney dysfunction)
  • Renal failure acute (rapid kidney dysfunction)
2-9:
  • Pneumonia
  • Pyrexia (fever)
  • Blood ketone body increased
  • Reaction to drug excipients
  • Urinary tract infection
  • Renal failure acute (rapid kidney dysfunction)
  • Vomiting
  • Weight decreased
  • Rash erythematous (redness of the skin)
  • Respiratory syncytial virus infection (viral disease of respiratory system)
10-19:
  • Vomiting
  • Drug rash with eosinophilia and systemic symptoms (adverse drug reactions with rash)
  • Pulmonary hypertension (increase in blood pressure in the lung artery)
  • Pain in extremity
  • Renal impairment (severely reduced kidney function)
  • Weight increased
  • Deep vein thrombosis (blood clot in a major vein that usually develops in the legs and/or pelvis)
  • Drug ineffective
  • Pyrexia (fever)
  • Abdominal pain
20-29:
  • Weight decreased
  • Nausea (feeling of having an urge to vomit)
  • Weight increased
  • Abdominal pain upper
  • Pain
  • Ventricular tachycardia (rapid heartbeat that originates in one of the lower chambers (the ventricles) of the heart)
  • Abdominal pain
  • Vaginal haemorrhage (vaginal bleeding)
  • Drug ineffective
  • Gallbladder disorder
30-39:
  • Vomiting
  • Weight decreased
  • Weight increased
  • Nausea (feeling of having an urge to vomit)
  • Sinusitis (inflammation of sinus)
  • Death
  • Malaise (a feeling of general discomfort or uneasiness)
  • Pulmonary embolism (blockage of the main artery of the lung)
  • Melaena (the passage of black, tarry stools)
  • Pain
40-49:
  • Vomiting
  • Weight increased
  • Weight decreased
  • Nausea (feeling of having an urge to vomit)
  • Drug ineffective
  • Death
  • Rash
  • Urinary tract infection
  • Pyrexia (fever)
  • Syncope (loss of consciousness with an inability to maintain postural tone)
50-59:
  • Vomiting
  • Weight decreased
  • Weight increased
  • Death
  • Nausea (feeling of having an urge to vomit)
  • Renal failure (kidney dysfunction)
  • Pneumonia
  • Renal failure acute (rapid kidney dysfunction)
  • Syncope (loss of consciousness with an inability to maintain postural tone)
  • Myocardial infarction (destruction of heart tissue resulting from obstruction of the blood supply to the heart muscle)
60+:
  • Vomiting
  • Weight decreased
  • Hyperkalaemia (damage to or disease of the kidney)
  • Renal failure acute (rapid kidney dysfunction)
  • Weight increased
  • Death
  • Pneumonia
  • Renal failure (kidney dysfunction)
  • Renal impairment (severely reduced kidney function)
  • Gastrointestinal haemorrhage (bleeding gastrointestinal tract)

* Approximation only. Some reports may have incomplete information.

FDA reports used in this study

You are not alone:

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All Spironolactone side effects from A to Z

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On eHealthMe, Spironolactone (spironolactone) is often used to treat high blood pressure. Find out below the conditions the drugs are used for and how effective they are.

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