Corvelam Adverse Reactions

Summary of the safety profile: The most frequently occurring (≥5% of patients) adverse reactions were all in the gastrointestinal disorders system organ class. Most of these adverse reactions were mild to moderate in intensity.
List of adverse reactions: The safety of sevelamer (as either carbonate and hydrochloride salts) has been investigated in numerous clinical trials involving a total of 969 hemodialysis patients with treatment duration of 4 to 50 weeks (724 patients treated with sevelamer hydrochloride and 245 with sevelamer carbonate), 97 peritoneal dialysis patients with treatment duration of 12 weeks (all treated with sevelamer hydrochloride) and 128 patients with CKD not on dialysis with treatment duration of 8 to 12 weeks (79 patients treatment with sevelamer hydrochloride and 49 with sevelamer carbonate).
Adverse reactions are listed by frequency as follows. The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Gastrointestinal disorders: Very common: Nausea, vomiting, upper abdominal pain, constipation.
Common: Diarrhea, dyspepsia, flatulence, abdominal pain.
Not known: Intestinal obstruction, ileus/subileus, and intestinal perforation.
Skin and subcutaneous tissue disorders: Not known: Pruritus, rash.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.