Renvela Side Effects

Generic Name: sevelamer

Please note - some side effects for Renvela 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 Renvela - for the Consumer

Renvela

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 Renvela:

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

Seek medical attention right away if any of these SEVERE side effects occur when using Renvela:

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.

Renvela Powder Packets

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 Renvela Powder Packets:

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

Seek medical attention right away if any of these SEVERE side effects occur when using Renvela Powder Packets:

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.

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.

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Renvela Side Effects - for the Professional

Renvela

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.

There are limited data on the safety of Renvela. However, based on the fact that it contains the same active ingredient as the hydrochloride salt, the adverse event profiles of the two salts should be similar. In a cross-over study in hemodialysis patients with treatment durations of eight weeks each and no washout the adverse reactions on sevelamer carbonate tablets were similar to those reported for sevelamer hydrochloride. In another cross-over study in hemodialysis patients, with treatment durations of four weeks each and no washout between treatment periods, the adverse reactions on sevelamer carbonate powder were similar to those reported for sevelamer hydrochloride.

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-comparator 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 sevelamer hydrochloride was gastrointestinal adverse reactions (3-16%).

In one hundred and forty-three peritoneal dialysis patients studied for 12 weeks using sevelamer hydrochloride, 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

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

The following adverse reactions have been identified during post-approval use of sevelamer hydrochloride, which has the same active moiety as sevelamer carbonate: 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.

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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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