Prucalopride headache, abdominal pain

Placebo-controlled studies The efficacy and safety of prucalopride 2 or 4 mg/day for 12 weeks has been assessed in a double-blind, placebo-controlled trial in patients with severe chronic constipation [15 ]. The most common drug-related adverse events included headache, abdominal pain, nausea, and diarrhea (which occurred mainly on day 1 of treatment). However, there were no differences in the incidences of serious adverse effects or cardiovascular events compared with placebo. 

Observational studies Prucalopride has been evaluated in an open long-term study in 1455 patients (90% women) with chronic constipation for up to 24 months 8% stopped taking prucalopride because of adverse events, mostly gastrointestinal events (3.3%) and headache (1%) [15 ]. During the first 3 months, the most frequent adverse events that led to prucalopride withdrawal were abdominal pain, diarrhea, nausea, and headache, which accounted for 74% of withdrawals because of adverse reactions (43 out of 58). Most of these events (30 out of 43) occurred in... 

Headache was the most common nervous system disorder prucalopride 2 mg/day, 4/66 prucalopride 4 mg/day, 5/64 placebo 3/66. Severe abdominal pain and headache were slightly more common with prucalopride 4 mg/day than placebo. Abdominal pain was the most common reason for withdrawal in all groups. There were no consistent differences in electrocardiography, including heart rate, PR and QTc intervals, and QRS width. 

In a double-blind, randomized, placebo-controlled trial of prucalopride 2 or 4 mg/day for 12 weeks in 716 patients with chronic constipation, the most common drug-related adverse events were headache, nausea, abdominal pain, and diarrhea [16 "]. The overall incidence of prolongation of the QT interval was low and similar among all treatment groups. Withdrawals as a result of these adverse events accounted for a higher dropout rate in those who took prucalopride 4 mg/day (15%), than in the other treatment groups (6.3% and 6.7% with 2 mg/day and placebo respectively). 

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