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Renagel

Last reviewed on RxList: 12/12/2016
Renagel Side Effects Center

Last reviewed on RxList 01/19/2017

Renagel (sevelamer hydrochloride) is a polymeric amine that binds phosphate indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Renagel is available in generic form. Side effects of Renagel include:

Tell your doctor if you have serious side effects of Renagel including:

  • severe stomach or abdominal pain or swelling,
  • severe constipation,
  • fever,
  • chills,
  • body aches,
  • problems with your dialysis access site, or
  • flu symptoms.

Renagel is available in 400 and 800mg tablets. The recommended starting dose of Renagel is 800 to 1600mg in patients with chronic kidney disease on dialysis. Renagel may interact with ciprofloxacin, levothyroxine, heart rhythm medications, or seizure medications. Avoid taking any other medicines within 1 hour before or 3 hours after you take Renagel. Renagel can bind to other medications and make them less effective. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant while using Renagel; it is unknown if it will harm a fetus. It is unknown if Renagel passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Renagel (sevelamer hydrochloride) 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.

Renagel Consumer Information

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 Renagel (Sevelamer Hcl)

Renagel Professional Information

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. �

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-control 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 Renagel was gastrointestinal adverse reactions (3-16%).

In one hundred and forty-three peritoneal dialysis patients studied for 12 weeks, 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

The following adverse reactions have been identified during post-approval use of sevelamer hydrochloride (Renagel ® ): hypersensitivity, 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.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Renagel (Sevelamer Hcl)

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© Renagel Patient Information is supplied by Cerner Multum, Inc. and Renagel Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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