An extended study of indomethacin. I. Clinical pharmacology

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Abstract
The effects of indomethacin were studied in the human on long-term therapy in 234 patient-trials and on large-dose, acute toxicity trials in 6 patients. Side effects were limited to the central nervous system (CNS), with symptoms of headache, vertigo, light-headedness, and disturbed sensorium, and to the gastrointestinal system, with symptoms of epigastric pain, cramping, and peptic ulceration. The CNS side effects were quite frequent, reaching a total incidence of 47.1% and were severe enough in 20% to require discontinuance of the drug. These side effects are of a transient nature without residuals or sequelae and disappear promptly on cessation of the drug. The gastrointestinal symptoms were less frequent, and in only 12.5% were they severe enough to warrant cessation of the drug. The high incidence of side effects was influenced by the exceptionally high doses used in this experimental study; the incidence in clinical therapy would be much lower. No other complications or side effects could be detected.