A five-year evaluation of reports of overdose with indinavir sulfate.

Purpose: To describe the adverse event profile for indinavir sulfate overdose.

Methods: Analysis of indinavir overdose reports in Merck & Co., Inc.'s safety database through the first 5 years following US licensure of indinavir. Reports were classified as acute (single high dose in excess of 2400 mg), chronic (multiple extra doses, not exceeding 2400 mg per dose), single extra dose (not exceeding 2400 mg) and dose not reported.

Results: Seventy-nine reports of indinavir overdose were reviewed (15 acute, 43 chronic, 13 single extra dose and 8 dose not reported). A total of 52/79 (66%) reports were associated with adverse events. For acute overdose reports with adverse events, indinavir doses ranged from 2.8 g to 48 g (median 6 g; mean 13 g); for acute overdose reports without adverse events, indinavir doses ranged from 4 g to 80 g (median 56 g; mean 45 g). Adverse events following acute and chronic exposures were similar; the most commonly reported adverse events included nausea, vomiting, abdominal pain and nephrolithiasis. Of the 52 patients with adverse events, 39 recovered, 6 had not recovered at the time of reporting and no information regarding outcome was provided in 7 reports.

Conclusions: Overdose with indinavir was associated with adverse events in the majority of reports. These were most commonly gastrointestinal and renal events, and were generally consistent with the known safety profile of indinavir. The majority of patients recovered.