Note: This document contains side effect information about sevelamer. Some dosage forms listed on this page may not apply to the brand name Renvela.
Applies to sevelamer: oral powder for suspension, oral tablet.
Serious side effects of Renvela
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
- Bloating
- bloody, black, or tarry stools
- constipation
- diarrhea
- fast heartbeat
- fever
- heartburn
- hives, itching, rash
- hoarseness
- indigestion
- irritation
- joint pain, stiffness, or swelling
- nausea or vomiting
- redness of the skin
- stomach pain, cramping, burning, or tenderness
- swelling of the eyelids, face, lips, hands, or feet
- tightness in the chest
- troubled breathing or swallowing
- vomiting of material that looks like coffee grounds, severe and continuing
Other side effects of Renvela
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
- excess air or gas in the stomach or intestines
- full feeling
- passing gas
- stomach discomfort or upset
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]