Ibuprofen side effects - from FDA reports


In this review, we analyze Ibuprofen side effects by the time on the drug, gender and age of the people who have side effects while taking Ibuprofen. The review is based on 102,070 people who have side effects while taking the drug from FDA, and is updated regularly.

Ibuprofen

Ibuprofen has active ingredients of ibuprofen. It is often used in pain. (latest outcomes from Ibuprofen 107,282 users)


On Jun, 30, 2018

102,070 people who take Ibuprofen are studied.


Number of reports submitted per year:

Ibuprofen side effects.

Most common side effects over time *:

< 1 month:
  • Vomiting
  • Urticaria (rash of round, red welts on the skin that itch intensely)
  • Renal failure acute (rapid kidney dysfunction)
  • Suicide attempt
  • Melaena (the passage of black, tarry stools)
  • Gastrointestinal haemorrhage (bleeding gastrointestinal tract)
  • Tachycardia (a heart rate that exceeds the range of 100 beats/min)
  • Somnolence (a state of near-sleep, a strong desire for sleep)
  • Thrombocytopenia (decrease of platelets in blood)
  • Dyspnoea (difficult or laboured respiration)
1 - 6 months:
  • Renal failure acute (rapid kidney dysfunction)
  • Vomiting
  • Drug ineffective
  • Renal impairment (severely reduced kidney function)
  • Upper gastrointestinal haemorrhage (upper gastrointestinal bleeding)
  • Anaemia (lack of blood)
  • Weight decreased
  • Agranulocytosis (a deficiency of granulocytes in the blood, causing increased vulnerability to infection)
  • Gastric haemorrhage (bleeding stomach)
  • Haematemesis (vomiting of blood)
6 - 12 months:
  • Renal failure acute (rapid kidney dysfunction)
  • Ventricular septal defect (a hole in the heart, is a common heart defect that's present at birth (congenital))
  • Death
  • Renal failure (kidney dysfunction)
  • Wound
  • Gastrointestinal haemorrhage (bleeding gastrointestinal tract)
  • Renal impairment (severely reduced kidney function)
  • Vomiting
  • Melaena (the passage of black, tarry stools)
  • Syncope (loss of consciousness with an inability to maintain postural tone)
1 - 2 years:
  • Sepsis (a severe blood infection that can lead to organ failure and death)
  • Haematemesis (vomiting of blood)
  • Melaena (the passage of black, tarry stools)
  • Renal failure acute (rapid kidney dysfunction)
  • Weight decreased
  • Loose tooth
  • Pulmonary embolism (blockage of the main artery of the lung)
  • Death
  • Pyrexia (fever)
  • Thrombosis (formation of a blood clot inside a blood vessel)
2 - 5 years:
  • Vomiting
  • Liver function test abnormal
  • Pulmonary embolism (blockage of the main artery of the lung)
  • Tubulointerstitial nephritis (a form of nephritis affecting the interstitium of the kidneys surrounding the tubules)
  • Colonic polyp (extra part of colon tissue grow in intestine)
  • Deep vein thrombosis (blood clot in a major vein that usually develops in the legs and/or pelvis)
  • Drug ineffective
  • Myocardial infarction (destruction of heart tissue resulting from obstruction of the blood supply to the heart muscle)
  • Thrombosis (formation of a blood clot inside a blood vessel)
  • Transient ischaemic attack (a transient episode of neurologic dysfunction caused by ischemia (loss of blood flow))
5 - 10 years:
  • Pulmonary embolism (blockage of the main artery of the lung)
  • Renal impairment (severely reduced kidney function)
  • Anxiety
  • Deep vein thrombosis (blood clot in a major vein that usually develops in the legs and/or pelvis)
  • Weight decreased
  • Electrocardiogram qt prolonged
  • Hypophosphataemia (electrolyte disturbance in which there is an abnormally low level of phosphate in the blood)
  • Abortion spontaneous (naturally occurring miscarriage)
  • Gastrointestinal haemorrhage (bleeding gastrointestinal tract)
  • General physical health deterioration (weak health status)
10+ years:
  • Pulmonary embolism (blockage of the main artery of the lung)
  • Perforated ulcer
  • Vomiting
  • Gastrointestinal haemorrhage (bleeding gastrointestinal tract)
  • Liver disorder (liver diseases)
  • Blood cholesterol increased
  • Coarctation of the aorta (narrowing of the part of aorta)
  • Injury
  • Syncope (loss of consciousness with an inability to maintain postural tone)
  • Blood pressure decreased
not specified:
  • Vomiting
  • Drug ineffective
  • Weight decreased
  • Drug hypersensitivity
  • Nausea (feeling of having an urge to vomit)
  • Pulmonary embolism (blockage of the main artery of the lung)
  • Weight increased
  • Completed suicide (act of taking one's own life)
  • Urticaria (rash of round, red welts on the skin that itch intensely)
  • Death

Most common side effects by gender *:

female:
  • Vomiting
  • Drug ineffective
  • Weight decreased
  • Pulmonary embolism (blockage of the main artery of the lung)
  • Nausea (feeling of having an urge to vomit)
  • Weight increased
  • Drug hypersensitivity
  • Urticaria (rash of round, red welts on the skin that itch intensely)
  • Deep vein thrombosis (blood clot in a major vein that usually develops in the legs and/or pelvis)
  • Urinary tract infection
male:
  • Vomiting
  • Weight decreased
  • Drug ineffective
  • Renal failure acute (rapid kidney dysfunction)
  • Death
  • Pyrexia (fever)
  • Completed suicide (act of taking one's own life)
  • Urticaria (rash of round, red welts on the skin that itch intensely)
  • Nausea (feeling of having an urge to vomit)
  • Drug hypersensitivity

Most common side effects by age *:

0-1:
  • Vomiting
  • Hypothermia (body temperature drops below the required temperature for normal metabolism and body functions)
  • Ventricular septal defect (a hole in the heart, is a common heart defect that's present at birth (congenital))
  • Intestinal perforation (complete penetration of the wall of the intestine)
  • Small for dates baby (an unborn baby is growing more slowly and is smaller than most babies are at the same age)
  • Premature baby
  • Necrotising colitis (inflammation in the intestines (usually the colon) that can be life-threatening)
  • Sepsis (a severe blood infection that can lead to organ failure and death)
  • Drug ineffective
  • Patent ductus arteriosus (condition in which the ductus arteriosus does not close)
2-9:
  • Vomiting
  • Urticaria (rash of round, red welts on the skin that itch intensely)
  • Toxic epidermal necrolysis (a rare, life-threatening skin condition that is usually caused by a reaction to drugs causes wide spread skin destruction)
  • Pyrexia (fever)
  • Renal failure acute (rapid kidney dysfunction)
  • Stevens-johnson syndrome (an immune-complex-mediated hypersensitivity disorder. it ranges from mild skin and mucous membrane lesions to a severe)
  • Hypothermia (body temperature drops below the required temperature for normal metabolism and body functions)
  • Angioedema (rapid swelling of the dermis)
  • Renal tubular necrosis (death of kidney tubules)
  • Ureteric obstruction
10-19:
  • Vomiting
  • Suicide attempt
  • Urticaria (rash of round, red welts on the skin that itch intensely)
  • Completed suicide (act of taking one's own life)
  • Pulmonary embolism (blockage of the main artery of the lung)
  • Angioedema (rapid swelling of the dermis)
  • Nausea (feeling of having an urge to vomit)
  • Abdominal pain
  • Renal failure acute (rapid kidney dysfunction)
  • Weight decreased
20-29:
  • Pulmonary embolism (blockage of the main artery of the lung)
  • Vomiting
  • Uterine perforation (accidental puncture of the uterus)
  • Deep vein thrombosis (blood clot in a major vein that usually develops in the legs and/or pelvis)
  • Completed suicide (act of taking one's own life)
  • Cholecystitis chronic (long lasting infection of gallbladder)
  • Nausea (feeling of having an urge to vomit)
  • Injury
  • Weight decreased
  • Suicide attempt
30-39:
  • Vomiting
  • Pulmonary embolism (blockage of the main artery of the lung)
  • Deep vein thrombosis (blood clot in a major vein that usually develops in the legs and/or pelvis)
  • Weight increased
  • Completed suicide (act of taking one's own life)
  • Nausea (feeling of having an urge to vomit)
  • Urticaria (rash of round, red welts on the skin that itch intensely)
  • Weight decreased
  • Drug ineffective
  • Pyrexia (fever)
40-49:
  • Vomiting
  • Pulmonary embolism (blockage of the main artery of the lung)
  • Weight decreased
  • Weight increased
  • Nausea (feeling of having an urge to vomit)
  • Completed suicide (act of taking one's own life)
  • Drug ineffective
  • Deep vein thrombosis (blood clot in a major vein that usually develops in the legs and/or pelvis)
  • Somnolence (a state of near-sleep, a strong desire for sleep)
  • Drug hypersensitivity
50-59:
  • Vomiting
  • Weight decreased
  • Drug ineffective
  • Drug hypersensitivity
  • Nausea (feeling of having an urge to vomit)
  • Weight increased
  • Death
  • Rash
  • Urticaria (rash of round, red welts on the skin that itch intensely)
  • Completed suicide (act of taking one's own life)
60+:
  • Vomiting
  • Weight decreased
  • Drug ineffective
  • Renal failure acute (rapid kidney dysfunction)
  • Drug hypersensitivity
  • Gastrointestinal haemorrhage (bleeding gastrointestinal tract)
  • Nausea (feeling of having an urge to vomit)
  • Death
  • Urinary tract infection
  • Weight increased

* Approximation only. Some reports may have incomplete information.

How to use the study: print a copy of the study and bring it to your health teams to ensure drug risks and benefits are fully discussed and understood.

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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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