Table 1 Depiction of adverse events in both package information leaflets
Simplified-PIL | Standard-PIL | |
|---|---|---|
Adverse events | Adverse events | |
Gastrointestinal conditions
Ibuprofen caused stomach and bowel discomforts in about 1 in 100 people. About 99 out of 100 people did not have stomach or bowel discomforts from ibuprofen. | For the evaluation of adverse events, the following scheme is used: | |
Very often: | More than 1 patients of 10 | |
Often: | 1 to 10 patients of 100 | |
Occasional: | 1 to 10 patients of 1,000 | |
Rare: | 1 to 10 patients of 10,000 | |
Very rare: | Less than 1 patient of 10,000 | |
Unknown: | Frequencies unknown because of availability of data | |
Diseases of the gastrointestinal system: Very often: gastrointestinal conditions such as heartburn, stomach ache, nausea, vomiting, flatulence, diarrhoea and obstipation. | ||
Serious (rare) adverse events | Serious (rare) adverse events | |
Some people reported other problems while taking ibuprofen. There is some evidence suggesting that ibuprofen may be connected to stomach or bowel bleeding, ulcers or perforations, and severe (in rare cases life-threatening) skin reactions. But there are no good studies that provide information on the frequency of these side effects. | Often: gastric/duodenal ulcer (peptic ulcer) under circumstances with bleeding and rupture, stomatitis with ulcer (ulcerative stomatitis), potentiation of ulcerative colitis or Crohn’s disease Occasional: gastritis Very rare: oesophagitis and pancreatitis, intestinal diaphragmatic narrowing | |
