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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.

For the Consumer

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

Along with its needed effects, sevelamer (the active ingredient contained in Renvela) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sevelamer:

Incidence Not Known

  • Bloody, black, or tarry stools
  • heartburn
  • indigestion
  • nausea
  • severe abdominal or stomach pain, cramping, or burning
  • severe constipation
  • severe vomiting
  • trouble with breathing
  • vomiting
  • vomiting of material that looks like coffee grounds, severe and continuing

Some side effects of sevelamer may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Acid or sour stomach
  • belching
  • bloating
  • constipation
  • diarrhea
  • excess air or gas in the stomach or intestines
  • full feeling
  • passing gas
  • stomach discomfort or upset

Incidence Not Known

  • Itching skin
  • rash

For Healthcare Professionals

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

General

The most frequently occurring adverse reactions included nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, and constipation.[Ref]

Gastrointestinal

Gastrointestinal events are the most common adverse reactions reported with this drug. Based on studies of 8 to 52 weeks, the most common reason for drug withdrawal are gastrointestinal adverse reactions (3% to 16%).[Ref]

Very common (10% or more): Vomiting (22%), nausea (20%), diarrhea (19%), dyspepsia (16%)

Common (1% to 10%): Abdominal pain, flatulence, constipation, gastrointestinal reflux disease

Frequency not reported: Dysphagia, diverticulitis

Postmarketing reports: Fecal impaction, ileus, intestinal obstruction, intestinal perforation[Ref]

Immunologic

Common (1% to 10%): Peritonitis[Ref]

A clinical study in patients receiving peritoneal dialysis (n=143) found the most frequently occurring treatment emergent serious adverse reaction was peritonitis. Peritonitis occurred in 8 patients receiving sevelamer and 2 patients on active control.[Ref]

Metabolic

Common (1% to 10%): Anorexia

Uncommon (0.1% to 1%): Acidosis, increased serum chloride levels, decreased carbon dioxide[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis, bronchitis

Common (1% to 10%): Cough, upper respiratory tract infection, dyspnea[Ref]

Dermatologic

Postmarketing reports: Pruritus, rash[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Cardiovascular

Common (1% to 10%): Hypertension[Ref]

Local

Common (1% to 10%): Arteriovenous fistula site complication, arteriovenous fistula site hemorrhage, arteriovenous fistula thrombosis[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache[Ref]

Other

Common (1% to 10%): Fatigue, fever[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, muscle spasms, extremity pain[Ref]

References

1. "Product Information. Renagel (sevelamer)." Genzyme Corporation, Cambridge, MA.

2. "Product Information. Renvela (sevelamer)." Genzyme Corporation, Cambridge, MA.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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