Renagel Side Effects

Generic Name: sevelamer

Please note - some side effects for Renagel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Renagel - for the Consumer

Renagel

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Renagel:

Constipation; diarrhea; gas; indigestion; mild stomach pain; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe or persistent constipation or stomach pain; trouble swallowing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Renagel Side Effects - for the Professional

Renagel

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug can not be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a parallel design study of sevelamer hydrochloride with treatment duration of 52 weeks, adverse reactions reported for sevelamer hydrochloride (n=99) were similar to those reported for the active-control group (n=101). Overall adverse reactions among those treated with sevelamer hydrochloride occurring in > 5% of patients included: vomiting (22%), nausea (20%), diarrhea (19%), dyspepsia (16%), abdominal pain (9%), flatulence (8%) and constipation (8%). A total of 27 patients treated with sevelamer and 10 patients treated with comparator withdrew from the study due to adverse reactions.

Based on studies of 8-52 weeks, the most common reason for withdrawal from Renagel was gastrointestinal adverse reactions (3-16%).

In one hundred and forty-three peritoneal dialysis patients studied for 12 weeks most adverse reactions were similar to adverse reactions observed in hemodialysis patients. The most frequently occurring treatment emergent serious adverse reaction was peritonitis (8 reactions in 8 patients [8%] in the sevelamer group and 2 reactions in 2 patients [4%] on active-control). Thirteen patients (14%) in the sevelamer group and 9 patients (20%) in the active-control group discontinued, mostly for gastrointestinal adverse reactions. Patients on peritoneal dialysis should be closely monitored to ensure the reliable use of appropriate aseptic technique with the prompt recognition and management of any signs and symptoms associated with peritonitis.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of sevelamer hydrochloride (Renagel®): pruritus, rash, abdominal pain, fecal impaction and uncommon cases of ileus, intestinal obstruction, and intestinal perforation. Appropriate medical management should be given to patients who develop constipation or have worsening of existing constipation to avoid severe complications.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.

Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects reported have included hypertension, hypotension, and thrombosis.

General

General side effects reported included the body as a whole with complaints of headache, infection, and pain.

Gastrointestinal

Gastrointestinal side effects reported included vomiting (12% to 22%), nausea (7% to 20%), diarrhea (4% to 19%), dyspepsia (5% to 16%), abdominal pain (9%), flatulence (4% to 9%), constipation (2% to 8%) and worsening of existing constipation, and peritonitis (8%). Fecal impaction, abdominal pain, intestinal perforation, intestinal obstruction, and uncommon cases of ileus have been reported during postmarketing experience.

Respiratory

Respiratory side effects reported have included increase in coughing episodes (4%).

Metabolic

Metabolic side effects reported during a postmarketing study (n=18) have included decreases in bicarbonate levels not directly related to the use of sevelamer, but instead caused by the discontinuation of calcium salts.

Dermatologic

Dermatologic side effects including pruritus and rash have been reported during postmarketing experience.

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