Prescription medicine
Sevelamer Brand names: Renvela; first approved as Renagel
Sevelamer (Renvela) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 35 generic labelers, and pharmacies paid $0.214 per sevelamer carbonate 800 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the sevelamer FDA label on DailyMed (effective November 25, 2025, Sanofi-Aventis U.S. LLC); the NDA 20926 record on Drugs@FDA; every sevelamer label on DailyMed.
Highlights of the record
FDA label of November 25, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSevelamer carbonate is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.
Forms and strengths
- 0.8 g
- 2.4 g
- 400 mg
- 800 mg
- 2400 mg
Film-coated tablet; powder for suspension; tablet; for suspension.
On the market
- Earliest approval on file
- October 30, 1998 Renagel, Genzyme; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 32 first June 13, 2017; 23 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 37 of which 35 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 6, 2030 Renvela for oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.214 per tablet Sevelamer carbonate 800 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest June 26, 2024; 1 more by firms not listed as its makers
- FAERS reports
- 11,977 through July 30, 2026
What is sevelamer used for?
From the label: indications and usageSevelamer carbonate is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis. Sevelamer carbonate is a phosphate binder indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on dialysis.
FDA pharmacologic class: Phosphate Binder.
Source: FDA drug label (Sevelamer Carbonate), Sanofi-Aventis U.S. LLC, effective November 25, 2025 (SPL set 3abc32fe-1bfc-4759-8f7c-36095e221b06), via openFDA; the full label on DailyMed
Is there a generic for sevelamer (Renvela)?
The FDA approved the first generic sevelamer on June 13, 2017. 32 generic applications are approved; 23 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists sevelamer from 35 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Renvela for oral suspension, the last expiring on December 6, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1998 earliest approval on file
- 2017 first generic approved
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for sevelamer (Renvela)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.214 per Sevelamer carbonate 800 mg tablet, about the same as a year earlier. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Sevelamer carbonate 800 mg tablet (generic)
- Renvela 800 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Sevelamer 0.8 g powder packet | Generic | $0.920 per packet | n/a | -32% |
| Sevelamer 2.4 g powder packet | Generic | $1.01 per packet | n/a | -26% |
| Sevelamer carbonate 800 mg tablet | Generic | $0.214 per tablet | $6.42 | -0.6% |
| Sevelamer HCl 800 mg tablet | Generic | $0.695 per tablet | $20.86 | -49% |
| Renvela 800 mg tablet | Brand | $5.69 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $170.55 | -0.4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has sevelamer been recalled?
The FDA's Enforcement Report lists 3 recalls naming sevelamer since 2013: 0 Class I (the most serious), 2 Class II, 1 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of sevelamer and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 26, 2024 | Class III | Dr. Reddy's Laboratories, Inc. | Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; SEVELAMER HCl Tablet, 800 mg may be potentially mislabeled as RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W002857, EXP … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling:Label Mixup; SEVELAMER CARBONATE Tablet, 800 mg may be potentially mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD46265_16 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the sevelamer label say about other medicines?
The sevelamer label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name sevelamer. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Ciprofloxacin | drug interactions | Ciprofloxacin; Take at least 2 hours before or 6 hours after sevelamer |
| Cyclosporine | drug interactions | For oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy (e.g., cyclosporine, tacrolimus, levothyroxine), consider separation of the timing of the administration of the two drugs [see Clinical Pharmacology (12.3) ]. |
| Digoxin | drug interactions | Sevelamer Drug Interactions Oral drugs for which sevelamer did not alter the pharmacokinetics when administered concomitantly Digoxin Enalapril Iron Metoprolol Warfarin Oral drugs that have demonstrated interaction with sevelamer and are to be dosed separately from sevelamer carbonate Dosing Recommendations … |
| Enalapril | drug interactions | Sevelamer Drug Interactions Oral drugs for which sevelamer did not alter the pharmacokinetics when administered concomitantly Digoxin Enalapril Iron Metoprolol Warfarin Oral drugs that have demonstrated interaction with sevelamer and are to be dosed separately from sevelamer carbonate Dosing Recommendations … |
| Levothyroxine | drug interactions | For oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy (e.g., cyclosporine, tacrolimus, levothyroxine), consider separation of the timing of the administration of the two drugs [see Clinical Pharmacology (12.3) ]. |
| Metoprolol | drug interactions | Sevelamer Drug Interactions Oral drugs for which sevelamer did not alter the pharmacokinetics when administered concomitantly Digoxin Enalapril Iron Metoprolol Warfarin Oral drugs that have demonstrated interaction with sevelamer and are to be dosed separately from sevelamer carbonate Dosing Recommendations … |
| Mycophenolate mofetil | drug interactions | Mycophenolate mofetil; Take at least 2 hours before sevelamer |
| Tacrolimus | drug interactions | For oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy (e.g., cyclosporine, tacrolimus, levothyroxine), consider separation of the timing of the administration of the two drugs [see Clinical Pharmacology (12.3) ]. |
| Warfarin | drug interactions | Sevelamer Drug Interactions Oral drugs for which sevelamer did not alter the pharmacokinetics when administered concomitantly Digoxin Enalapril Iron Metoprolol Warfarin Oral drugs that have demonstrated interaction with sevelamer and are to be dosed separately from sevelamer carbonate Dosing Recommendations … |
Other labels that name sevelamer
Source: FDA drug label (Sevelamer Carbonate), Sanofi-Aventis U.S. LLC, effective November 25, 2025 (SPL set 3abc32fe-1bfc-4759-8f7c-36095e221b06), via openFDA; the full label on DailyMed
What do FAERS reports show for sevelamer?
The FDA Adverse Event Reporting System holds 11,977 reports that list sevelamer among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,318 are coded as a death and 3,362 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other phosphate binders
- the pharmacologic class, with prices and generics
- Sevelamer side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other