Metformin side effects - from FDA reports


In this review, we analyze Metformin side effects by the time on the drug, gender and age of the people who have side effects while taking Metformin. The review is based on 251,434 people who have side effects while taking the drug from FDA, and is updated regularly.

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Metformin

Metformin has active ingredients of metformin hydrochloride. It is often used in diabetes. (latest outcomes from Metformin 259,096 users)


On Jan, 10, 2019

251,434 people who take Metformin are studied.


Number of reports submitted per year:

Metformin side effects.

Most common side effects over time *:

< 1 month:
  • Vomiting
  • Hypoglycaemia (deficiency of glucose in the bloodstream)
  • Lactic acidosis (low ph in body tissues)
  • Nausea (feeling of having an urge to vomit)
  • Somnolence (a state of near-sleep, a strong desire for sleep)
  • Diarrhoea
  • Renal failure acute (rapid kidney dysfunction)
  • Suicide attempt
  • Weight decreased
  • Urticaria (rash of round, red welts on the skin that itch intensely)
1 - 6 months:
  • Diarrhoea
  • Lactic acidosis (low ph in body tissues)
  • Agranulocytosis (a deficiency of granulocytes in the blood, causing increased vulnerability to infection)
  • Blood glucose increased
  • Metabolic acidosis (body produces too much acid, or when the kidneys are not removing enough acid from the body)
  • Weight decreased
  • Nausea (feeling of having an urge to vomit)
  • Syncope (loss of consciousness with an inability to maintain postural tone)
  • Malaise (a feeling of general discomfort or uneasiness)
  • Bladder cancer
6 - 12 months:
  • Hypoglycaemia (deficiency of glucose in the bloodstream)
  • Vomiting
  • Lactic acidosis (low ph in body tissues)
  • Renal failure acute (rapid kidney dysfunction)
  • Bladder cancer
  • Metabolic acidosis (body produces too much acid, or when the kidneys are not removing enough acid from the body)
  • Presyncope
  • Sopor (sleep)
  • Nausea (feeling of having an urge to vomit)
  • Weight decreased
1 - 2 years:
  • Bladder cancer
  • Hypoglycaemia (deficiency of glucose in the bloodstream)
  • Renal failure acute (rapid kidney dysfunction)
  • Death
  • Renal failure (kidney dysfunction)
  • Weight decreased
  • Hypoglycaemic coma (coma due to deficiency of glucose in the bloodstream)
  • Myocardial infarction (destruction of heart tissue resulting from obstruction of the blood supply to the heart muscle)
  • Vomiting
  • Lactic acidosis (low ph in body tissues)
2 - 5 years:
  • Bladder cancer
  • Renal failure acute (rapid kidney dysfunction)
  • Death
  • Vomiting
  • Hypoglycaemia (deficiency of glucose in the bloodstream)
  • Lactic acidosis (low ph in body tissues)
  • Myocardial infarction (destruction of heart tissue resulting from obstruction of the blood supply to the heart muscle)
  • Pancreatitis acute (sudden inflammation of pancreas)
  • Renal failure (kidney dysfunction)
  • Weight decreased
5 - 10 years:
  • Bladder cancer
  • Renal failure acute (rapid kidney dysfunction)
  • Metabolic acidosis (body produces too much acid, or when the kidneys are not removing enough acid from the body)
  • Lactic acidosis (low ph in body tissues)
  • Weight decreased
  • Myocardial infarction (destruction of heart tissue resulting from obstruction of the blood supply to the heart muscle)
  • Vomiting
  • Death
  • Hypoglycaemia (deficiency of glucose in the bloodstream)
  • Renal failure (kidney dysfunction)
10+ years:
  • Bladder cancer
  • Vomiting
  • Lactic acidosis (low ph in body tissues)
  • Myocardial infarction (destruction of heart tissue resulting from obstruction of the blood supply to the heart muscle)
  • Metabolic acidosis (body produces too much acid, or when the kidneys are not removing enough acid from the body)
  • Syncope (loss of consciousness with an inability to maintain postural tone)
  • Urinary tract infection
  • Gastrointestinal haemorrhage (bleeding gastrointestinal tract)
  • Weight increased
  • Diarrhoea
not specified:
  • Weight decreased
  • Vomiting
  • Blood glucose increased
  • Nausea (feeling of having an urge to vomit)
  • Weight increased
  • Drug ineffective
  • Death
  • Lactic acidosis (low ph in body tissues)
  • Diarrhoea
  • Pain

Most common side effects by gender *:

female:
  • Weight decreased
  • Vomiting
  • Nausea (feeling of having an urge to vomit)
  • Weight increased
  • Blood glucose increased
  • Drug ineffective
  • Urinary tract infection
  • Pain
  • Diarrhoea
  • Lactic acidosis (low ph in body tissues)
male:
  • Weight decreased
  • Vomiting
  • Diarrhoea
  • Lactic acidosis (low ph in body tissues)
  • Renal failure (kidney dysfunction)
  • Pneumonia
  • Pain
  • Rash
  • Hypoglycaemia (deficiency of glucose in the bloodstream)
  • Somnolence (a state of near-sleep, a strong desire for sleep)

Most common side effects by age *:

0-1:
  • Premature baby
  • Small for dates baby (an unborn baby is growing more slowly and is smaller than most babies are at the same age)
  • Foetal exposure during pregnancy (exposing your unborn child to contraindicated in pregnancy leads birth defect)
  • Ventricular septal defect (a hole in the heart, is a common heart defect that's present at birth (congenital))
  • Large for dates baby (a baby looks older than gestational period by weight and appearance)
  • Talipes
  • Vesicoureteric reflux (urine flows from the bladder, back up the ureter, and back into the kidneys)
  • Hypoglycaemia neonatal (deficiency of glucose in the bloodstream in neonatal)
  • Polycythaemia (proportion of blood volume that is occupied by red blood cells increases)
  • Accidental poisoning
2-9:
  • Hypoglycaemia (deficiency of glucose in the bloodstream)
  • Accidental drug intake by child
  • Hypertriglyceridaemia (excess of triglycerides in the blood)
  • Loss of consciousness
  • Respiratory tract infection
  • Weight decreased
  • Accidental exposure
  • Vomiting
  • Grand mal convulsion (a type of generalized seizure that affects the entire brain)
  • Headache (pain in head)
10-19:
  • Vomiting
  • Suicide attempt
  • Weight increased
  • Completed suicide (act of taking one's own life)
  • Somnolence (a state of near-sleep, a strong desire for sleep)
  • Pain
  • Lactic acidosis (low ph in body tissues)
  • Weight decreased
  • Overdose
  • Pancreatitis (inflammation of pancreas)
20-29:
  • Weight decreased
  • Diabetic ketoacidosis (diabetic ketoacidosis (dka) is high concentrations of ketone bodies)
  • Overdose
  • Cholecystitis chronic (long lasting infection of gallbladder)
  • Abdominal pain
  • Deep vein thrombosis (blood clot in a major vein that usually develops in the legs and/or pelvis)
  • Blood glucose increased
  • Injury
  • Cholelithiasis (the presence or formation of gallstones in the gallbladder or bile ducts)
  • Pancreatitis acute (sudden inflammation of pancreas)
30-39:
  • Vomiting
  • Weight decreased
  • Completed suicide (act of taking one's own life)
  • Nausea (feeling of having an urge to vomit)
  • Weight increased
  • Pulmonary embolism (blockage of the main artery of the lung)
  • Pain
  • Agitation (state of anxiety or nervous excitement)
  • Diabetic ketoacidosis (diabetic ketoacidosis (dka) is high concentrations of ketone bodies)
  • Deep vein thrombosis (blood clot in a major vein that usually develops in the legs and/or pelvis)
40-49:
  • Weight decreased
  • Vomiting
  • Nausea (feeling of having an urge to vomit)
  • Blood glucose increased
  • Weight increased
  • Diabetic ketoacidosis (diabetic ketoacidosis (dka) is high concentrations of ketone bodies)
  • Drug ineffective
  • Pain
  • Completed suicide (act of taking one's own life)
  • Pancreatitis (inflammation of pancreas)
50-59:
  • Weight decreased
  • Vomiting
  • Blood glucose increased
  • Nausea (feeling of having an urge to vomit)
  • Weight increased
  • Drug ineffective
  • Myocardial infarction (destruction of heart tissue resulting from obstruction of the blood supply to the heart muscle)
  • Pancreatitis (inflammation of pancreas)
  • Pain
  • Completed suicide (act of taking one's own life)
60+:
  • Weight decreased
  • Vomiting
  • Blood glucose increased
  • Nausea (feeling of having an urge to vomit)
  • Weight increased
  • Renal failure acute (rapid kidney dysfunction)
  • Lactic acidosis (low ph in body tissues)
  • Drug ineffective
  • Urinary tract infection
  • Death

* Approximation only. Some reports may have incomplete information.

FDA reports used in this study

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