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 47,128 people who have side effects while taking the drug from FDA, and is updated regularly.

Spironolactone

Spironolactone has active ingredients of spironolactone. It is often used in acne. (latest outcomes from Spironolactone 49,301 users)


On Jun, 07, 2018

47,128 people who take Spironolactone are studied.


Number of reports submitted per year:

Spironolactone side effects.

Most common side effects over time *:

< 1 month:
  • Renal failure acute (rapid kidney dysfunction)
  • Hyperkalaemia (damage to or disease of the kidney)
  • Vomiting
  • Renal failure (kidney dysfunction)
  • Renal impairment (severely reduced kidney function)
  • Syncope (loss of consciousness with an inability to maintain postural tone)
  • Drug rash with eosinophilia and systemic symptoms (adverse drug reactions with rash)
  • Hepatic failure (liver failure)
  • Toxic epidermal necrolysis (a rare, life-threatening skin condition that is usually caused by a reaction to drugs causes wide spread skin destruction)
  • Weight increased
1 - 6 months:
  • Renal failure acute (rapid kidney dysfunction)
  • Hyperkalaemia (damage to or disease of the kidney)
  • Vomiting
  • Ascites (accumulation of fluid in the abdominal cavity)
  • Syncope (loss of consciousness with an inability to maintain postural tone)
  • Renal failure (kidney dysfunction)
  • Thrombocytopenia (decrease of platelets in blood)
  • Gynaecomastia (enlargement of the gland tissue of the male breast)
  • Pneumonia
  • Sinus arrest (sinus pause)
6 - 12 months:
  • Hyperkalaemia (damage to or disease of the kidney)
  • Diarrhoea
  • Renal failure acute (rapid kidney dysfunction)
  • Gynaecomastia (enlargement of the gland tissue of the male breast)
  • Muscular weakness (muscle weakness)
  • Dehydration (dryness resulting from the removal of water)
  • Hypotension (abnormally low blood pressure)
  • Patent ductus arteriosus (condition in which the ductus arteriosus does not close)
  • Syncope (loss of consciousness with an inability to maintain postural tone)
  • X-ray abnormal
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)
  • Blood creatinine increased
  • Bradycardia (abnormally slow heart action)
  • Pain
  • Pulmonary embolism (blockage of the main artery of the lung)
  • Death
2 - 5 years:
  • Hyperkalaemia (damage to or disease of the kidney)
  • Renal failure acute (rapid kidney dysfunction)
  • Gastrointestinal haemorrhage (bleeding gastrointestinal tract)
  • Gynaecomastia (enlargement of the gland tissue of the male breast)
  • Palpitations (feelings or sensations that your heart is pounding or racing)
  • Renal failure (kidney dysfunction)
  • Clostridium difficile colitis (inflammation of colon by clostridium difficile bacteria infection)
  • Hypotension (abnormally low blood pressure)
  • Somnolence (a state of near-sleep, a strong desire for sleep)
  • Upper gastrointestinal haemorrhage (upper gastrointestinal bleeding)
5 - 10 years:
  • Hyperkalaemia (damage to or disease of the kidney)
  • Renal failure acute (rapid kidney dysfunction)
  • Tremor (trembling or shaking movements in one or more parts of your body)
  • Weight decreased
  • Breast cancer female
  • Gastrointestinal haemorrhage (bleeding gastrointestinal tract)
  • Gynaecomastia (enlargement of the gland tissue of the male breast)
  • Nephrolithiasis (calculi in the kidneys)
  • Platelet count decreased
  • Pneumonia
10+ years:
  • Gastrointestinal haemorrhage (bleeding gastrointestinal tract)
  • Syncope (loss of consciousness with an inability to maintain postural tone)
  • Upper gastrointestinal haemorrhage (upper gastrointestinal bleeding)
  • Pulmonary embolism (blockage of the main artery of the lung)
  • Atrial fibrillation (fibrillation of the muscles of the atria of the heart)
  • Hyperkalaemia (damage to or disease of the kidney)
  • Oedema peripheral (superficial swelling)
  • Pain
  • Pancreatic carcinoma (pancreatic cancer)
  • Presyncope
not specified:
  • Vomiting
  • Weight decreased
  • Weight increased
  • Death
  • Renal failure acute (rapid kidney dysfunction)
  • Nausea (feeling of having an urge to vomit)
  • Pneumonia
  • 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
  • Renal failure acute (rapid kidney dysfunction)
  • Pneumonia
  • Urinary tract infection
  • Drug ineffective
  • Pain
male:
  • Renal failure acute (rapid kidney dysfunction)
  • Hyperkalaemia (damage to or disease of the kidney)
  • Vomiting
  • Weight decreased
  • Death
  • Weight increased
  • Renal failure (kidney dysfunction)
  • Pneumonia
  • Thrombocytopenia (decrease of platelets in blood)
  • Hypotension (abnormally low blood pressure)

Most common side effects by age *:

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

* Approximation only. Some reports may have incomplete information.

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Want to find out more about the FDA reports used in the study? You can request them from FDA.

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