Pharmacologic class (EPC) · 5 drug pages

Phosphate binder: adverse event reports filed with FDA

11,219 reports list a drug in this class as a suspect or interacting product, 2005–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

11,219
reports across the class: 0.1% of all reports; 259
reports, 12 months to June 2026: 379 in the 12 months before; 49.7%
marked serious by the reporter: 57.4% across all reports; 5
drugs with a page: brand and generic names counted separately

Phosphate binder is a pharmacologic class (an FDA Established Pharmacologic Class) with 5 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 11,219 adverse event reports received by FDA, 0.1% of the database, from February 2005 to June 2026.

259 reports arrived in the 12 months to June 2026, down 32% from 379 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 49.7% of the class's reports are marked serious, 24.9% record death among the outcomes and 18.6% record hospitalisation, as reported.

Across the class the reactions recorded most often are constipation (25.5%), death (17.3%) and nausea (9.2%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
RenvelaSevelamer carbonate	brand	5,209	18	18.4%	Constipation
VelphoroSucroferric oxyhydroxide	brand	2,440	77	72.9%	Death
FosrenolLanthanum carbonate	brand	2,159	34	85.9%	Death
Sevelamer carbonate	generic	766	41	46.5%	Constipation
Lanthanum carbonate	generic	645	89	97.4%	Hyponatraemia

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Constipationconstipation25.5%2,862
Deaththe patient died; cause not stated by this term17.3%1,944
Nauseafeeling sick9.2%1,032
Diarrhoealoose or frequent stools9.1%1,019
Pruritusitching8.3%935
Vomitingbeing sick7.2%808
Abdominal painstomach or belly pain5.2%584
Off label useused for a purpose or in a way not on the label3.7%412
Abdominal distensiona bloated abdomen3.5%389
Sepsisa severe body-wide response to infection3.4%383
Hyponatraemialow blood sodium3.2%363
General physical health deteriorationgeneral decline in health3.2%361
Multiple organ dysfunction syndromeseveral organs failing3.2%355
Hyperphosphataemia3%341
Stressstress3%341
Appendicitis3%337
Ascitesfluid in the abdomen3%333
Appendicolith2.9%328
Blood phosphorus increased2.9%325
Cardiogenic shockshock from the heart failing to pump2.9%320
Condition aggravatedthe condition being treated got worse2.8%314
Ventricular fibrillationa chaotic rhythm from the lower heart chambers2.8%309
Somnolencedrowsiness2.4%272
Anaemialow red blood cells2.4%271
Drug intolerancethe medicine was not tolerated2.3%257

Solid bar: share of all class reports. Hollow bar: the median share across the 5 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death24.9%2,793

Life-threatening3.7%415

Hospitalisation (initial or prolonged)18.6%2,090

Disability3.6%401

Congenital anomaly1.2%138

Other serious21.7%2,429

Not serious50.3%5,641

Patient age

Under 20.1%7

2 to 110.4%50

12 to 170.1%10

18 to 442.9%322

45 to 6411.8%1,329

65 to 748.3%926

75 and over10.3%1,153

Age not given66.2%7,422

Who reported

Physician10.1%1,132

Pharmacist4.8%536

Other health professional57.4%6,438

Lawyer0%2

Consumer or non-health professional26.2%2,934

Not given1.6%177

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Phosphate binder reports

Which drugs are in the Phosphate binder class on this site?

Renvela, Velphoro, Fosrenol, Sevelamer carbonate and Lanthanum carbonate. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

11,219 reports through June 2026, 259 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

constipation (25.5%), death (17.3%), nausea (9.2%), diarrhoea (9.1%) and pruritus (8.3%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.