Generic name
Sevelamer carbonate: adverse event reports filed with FDA
766 reports list it as a suspect or interacting product, 2011–2026. Class: Phosphate binder. Also reported as Sevelamer Carbonate Tablets.
- 766
- reports as suspect product
- 0% of all reports · about 52 a year
- 41
- reports, 12 months to June 2026
- 88 in the 12 months before
- 46.5%
- marked serious by the reporter
- 49.7% across the class
- 3.4%
- record death among outcomes, as reported
- 26 reports · not verified by FDA
Between November 2011 and June 2026, 766 adverse event reports received by FDA list sevelamer carbonate, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (1,013) are left out of every figure here.
In the 12 months to June 2026, 41 reports listed it, down 53% from 88 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 52 reports a year and 0% of the 20,646,523 reports in the database, and 6.8% of the reports for the phosphate binder class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are constipation (21.3%), pruritus (8.5%) and diarrhoea (6.5%). A report can list several reactions, so shares add to more than 100%; 176 different terms appear across these reports. Constipation is recorded in 21.3% of these reports, about the same share as in the median phosphate binder drug (21.3%).
46.5% of the reports are marked serious by the reporter (49.7% across the class); 3.4% record death among the outcomes and 24.8% record hospitalisation, as reported. 56.1% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (20.4%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Sevelamer carbonate reports recording the termmedian drug in phosphate binder
- Constipationconstipation21.3%163
- Pruritusitching8.5%65
- Diarrhoealoose or frequent stools6.5%50
- Nauseafeeling sick6.1%47
- Colitisinflamed bowel5.7%44
- Crystal deposit intestine4.7%36
- Vomitingbeing sick3.8%29
- Abdominal painstomach or belly pain3.7%28
- Hyperphosphataemia3.5%27
- Haematocheziablood in the stool3.3%25
- Off label useused for a purpose or in a way not on the label3.3%25
- Large intestinal ulcer2.9%22
- Colitis ischaemic2.6%20
- Drug ineffectivethe medicine did not work as expected2.2%17
- Anaemialow red blood cells1.8%14
- Gastrointestinal haemorrhagebleeding in the stomach or bowel1.8%14
- Drug interactionan interaction between medicines1.7%13
- Gastrointestinal injury1.6%12
- Rashskin rash1.6%12
- Overdosea dose above the recommended amount1.4%11
- Blood phosphorus increased1.3%10
- Abdominal discomfortstomach discomfort1.2%9
- Arthralgiajoint pain1.2%9
- Dyspnoeashortness of breath1.2%9
- Gastrointestinal necrosis1.2%9
- Haemoglobin decreasedlow haemoglobin1.2%9
- Rectal ulcer1.2%9
- Deaththe patient died; cause not stated by this term1%8
Top 30 of 176 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 5 drugs in the phosphate binder class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 11,219 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 83.3% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Hyperphosphataemia | 152 | 19.8% |
| End stage renal disease | 64 | 8.4% |
| Chronic kidney disease | 22 | 2.9% |
| Hyperparathyroidism secondary | 9 | 1.2% |
| Blood phosphorus increased | 6 | 0.8% |
| Gastrointestinal inflammation | 4 | 0.5% |
The indication field is filled in by the reporter and is often blank; shares are of all 766 reports.
In context
| Measure | Sevelamer carbonate | Phosphate binder | All reports |
|---|---|---|---|
| Reports as suspect product | 766 | 11,219 | 20,646,523 |
| Share of that pool | — | 6.8% | 0% |
| Reports, latest 12 months | 41 | — | 1,332,454 |
| Marked serious | 46.5% | 49.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 34 | 249 | 91 |
| Hospitalisation recorded, per 1,000 reports | 248 | 186 | 213 |
| Consumer-filed share | 18.1% | 26.2% | 45.8% |
| Top term, share of reports | Constipation 21.3% | median 21.3% | 1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the phosphate binder class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Renvela | brand | 5,209 | 18 | 18.4% |
| Velphoro | brand | 2,440 | 77 | 72.9% |
| Fosrenol | brand | 2,159 | 34 | 85.9% |
| Lanthanum carbonate | generic | 645 | 89 | 97.4% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Sevelamer carbonate reports
How many adverse event reports has FDA received for Sevelamer carbonate?
766 reports list Sevelamer carbonate as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 41 of them arrived in the latest 12 months. Another 1,013 list it only as a concomitant medication.
What reactions are recorded in Sevelamer carbonate reports?
constipation (21.3%), pruritus (8.5%), diarrhoea (6.5%), nausea (6.1%) and colitis (5.7%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Sevelamer carbonate was responsible.
How serious are the reports?
46.5% are marked serious by the reporter. Among the outcomes recorded, 3.4% of reports include death and 24.8% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (56.1%), physician (21.5%) and consumer or non-health professional (18.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Sevelamer carbonate rising?
41 reports in the 12 months to June 2026, down 53% from 88 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Sevelamer carbonate was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Sevelamer carbonate?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Sevelamer carbonate as a suspect or interacting product; reports listing it only as a concomitant medication (1,013) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.