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Sevelamer Side Effects

For the Consumer

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

As well as its needed effects, sevelamer may cause unwanted side effects that require medical attention.

Severity: Major

If any of the following side effects occur while taking sevelamer, check with your doctor immediately:

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

Severity: Minor

Some sevelamer side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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. "Australian Product Information." O 0

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

It is possible that some side effects of sevelamer may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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