Prucalopride Succinate Side Effects

6 ADVERSE REACTIONS Most common adverse reactions (≥2%) are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1- 800-417-9175 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below represent 2530 patients (1251 received prucalopride tablets 2 mg once daily and 1279 received placebo) with CIC from 6 double-blind, placebo-controlled clinical trials of 12 weeks to 24 weeks in duration.

In these trials overall, patients were primarily female (76%) and white (76%).

The mean age was 47 years (range 17 to 95 years) [see Clinical Studies (14)] .

Common Adverse Reactions Table 2 below summarizes the incidence (%) of common adverse reactions occurring in at least 2% of patients with CIC receiving either 2 mg of prucalopride tablets once daily or placebo and at an incidence greater than in the placebo group from the six double-blind placebo-controlled trials described above.

Table 2: Common Adverse Reactions* in Double-Blind Placebo-Controlled Trials of CIC of at least 12 Weeks Duration Adverse Reaction PRUCALOPRIDE TABLET 2 mg Once Daily N=1251 † % Placebo N=1279 % Headache 19 9 Abdominal pain ‡ 16 11 Nausea 14 7 Diarrhea 13 5 Abdominal distension 5 4 Dizziness 4 2 Vomiting 3 2 Flatulence 3 2 Fatigue 2 1 *Reported in ≥2% of patients receiving prucalopride tablet and a rate higher than patients receiving placebo.

†Includes 93 patients who started on prucalopride tablet 1 mg and increased to prucalopride tablet 2 mg.

ǂIncludes abdominal pain, upper abdominal pain, lower abdominal pain, abdominal tenderness, abdominal discomfort, and epigastric discomfort.

Less Common Adverse Reactions Less common adverse reactions occurring in <2% of patients receiving prucalopride tablet 2 mg once daily include: Gastrointestinal disorders : abnormal gastrointestinal sounds Metabolism and nutrition disorders : decreased appetite Nervous system disorders : migraine Renal and urinary disorders : pollakiuria Diarrhea Of the patients who reported diarrhea, 70% (110 out of 157) reported it in the first week of treatment.