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Renvela

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Renvela

Renvela Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Renvela (sevelamer carbonate) is used to reduce blood levels of phosphorus in people with chronic kidney disease who are on dialysis. Renvela is a phosphate binder, in the chelating agent class of drugs. Common side effects include headache, diarrhea, stomach upset, nausea, vomiting, cough, gas, or constipation.

The recommended starting dose of Renvela is 0.8 to 1.6 g taken 3 times/day with meals. Dosage is based on the patient's serum phosphorus level. Some drugs may interact with Renvela including ciprofloxacin, levothyroxine, heart rhythm medications, or seizure medications. Discuss with your doctor all medications you are taking. Renvela should be used only when prescribed during pregnancy. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Our Renvela Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Renvela in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Renvela (Sevelamer Carbonate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Renvela Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, diarrhea, stomach upset, nausea, vomiting, cough, gas, or constipation may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if these unlikely but serious side effects occur: problems with your dialysis access site, severe constipation/inability to have a bowel movement, stomach/abdominal pain or swelling.

Seek immediate medical attention if any of these rare but very serious side effects occur: trouble breathing, chest pain, pain/redness/swelling in the lower legs.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Renvela (Sevelamer Carbonate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Renvela FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

Read the entire FDA prescribing information for Renvela (Sevelamer Carbonate) »

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Renvela - User Reviews

Renvela User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Renvela sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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