Renvela Side Effects

Generic name: sevelamer

Note: This document contains side effect information about sevelamer. Some of the dosage forms listed on this page may not apply to the brand name Renvela.

Some side effects of Renvela may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to sevelamer: oral powder for reconstitution, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking sevelamer (the active ingredient contained in Renvela) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using sevelamer and call your doctor at once if you have a serious side effect such as:

• black, bloody, or tarry stools;

• constipation that gets worse or does not clear up;

• severe constipation with stomach pain; or

• fever, chills, body aches, flu symptoms.

Less serious side effects of sevelamer may include:

• nausea, vomiting, stomach pain, loss of appetite;

• upset stomach, gas, bloating;

• diarrhea, mild constipation;

• tired feeling;

• itching; or

• joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to sevelamer: oral capsule, oral powder for reconstitution, oral tablet

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 (the active ingredient contained in Renvela) 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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