Fosfamer Adverse Reactions

The most frequently occurring adverse reactions for the Sevelamer Carbonate tablets in a short term (8-week cross-over) study were: nausea (3%) and vomiting (3%). Most frequently occurring treatment related adverse events for Sevelamer Carbonate powder in a short term (4-week cross-over) study were: nausea (7%), constipation (3%) and vomiting (3%). In long-term studies with Sevelamer hydrochloride, which contains the same active moiety as Sevelamer Carbonate, the most common adverse events included: vomiting (22%), nausea (20%), diarrhea (19%), dyspepsia (16%), abdominal pain (9%), flatulence (8%) and constipation (8%).
In a parallel study with a treatment duration of 12 weeks, the adverse events reported for Sevelamer hydrochloride in peritoneal dialysis patients (N=97) were similar to adverse events observed in hemodialysis patients. Adverse events possibly related to Sevelamer hydrochloride included dyspepsia (12.4%), diarrhea (5.2%), nausea (5.2%), constipation (4.1%), pruritus (4.1%), abdominal distension (3.1%), vomiting (3.1%), fatigue (3.1%), and anorexia (3.1%).
In a double-blind, placebo-controlled, dose titration study with a treatment duration of 8 weeks, the adverse events experienced by the patients in the Sevelamer Carbonate and placebo groups were similar. The most frequently reported treatment-related events were gastrointestinal disorders. Adverse reactions among those treated with Sevelamer Carbonate included: constipation (7.4%), abdominal distension (4.4%), and abdominal discomfort (3.0%).
During post-marketing experience, the following adverse events have been reported in patients receiving Sevelamer Carbonate although no direct relationship to Sevelamer Carbonate could be established: hypersensitivity, pruritus, rash, abdominal pain and uncommon cases of ileus, intestinal obstruction and intestinal perforation.
Sevelamer Carbonate has also been studied in patients with CKD not on dialysis.