Side-effects of piroxicam (Feldene). A one-year material of 103 reports from Norway

In the first year after registration, 103 reports on suspected adverse reaction to piroxicam (Feldene) were submitted to the Norwegian Adverse Drug Reaction Committee. Eighty-three reactions were classified as probable side-effects, and 73 of these were related to the upper gastrointestinal tract. Peptic ulcer and upper gastrointestinal haemorrhages predominated. Two deaths were classified as probably due to piroxicam. There were 8 life-threatening reactions, all due to haemorrhages. No severe cutaneous reactions were reported. A significant fraction of the gastrointestinal reactions occurred in patients with a previous history of peptic ulcer disease. Nearly every fourth patient with proven ulcer or haematemesis/melaena had simultaneously been taking other drugs with the propensity of causing gastrointestinal haemorrhage. The gastrointestinal adverse reactions to piroxicam can probably be reduced by a more accurate selection of patients.