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Renagel

"Today the U.S. Food and Drug Administration allowed marketing of the NephroCheck test, a first-of-a-kind laboratory test to help determine if certain critically ill hospitalized patients are at risk of developing moderate to severe acute kidney i"...

Renagel

Renagel Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Renagel (sevelamer hydrochloride) is a polymeric amine that binds phosphate; it is available in generic form. Renagel is indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. The safety and efficacy of Renagel in CKD patients who are not on dialysis have not been studied. Some side effects include but are not limited to severe stomach pain, constipation, fever, chills, body aches, 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. Renegel decreases ciprofloxacin by about 50% but had no effect on Lanoxin (digoxin), Coumadin (warfarin), Vasotec (enalapril), Lopressor, Toprol XL (metoprolol), and iron. The effect of Renagel on the absorption of vitamins and other nutrients has not been studied in pregnant women. The effect of Renagel on labor and delivery in humans are not known. The safety and effectiveness of Renagel in the pediatric population has not been established.

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.

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.

Renagel 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 Renagel (Sevelamer Hcl) »

What is Patient Information Overview?

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

Renagel 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 Renagel (Sevelamer Hcl)»

What is Prescribing information?

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

Renagel 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.

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®): 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 - User Reviews

Renagel 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 Renagel 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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