Brand name · Lanthanum carbonate
Fosrenol: adverse event reports filed with FDA
2,159 reports list it as a suspect or interacting product, 2005–2026. Class: Phosphate binder.
- 2,159
- reports as suspect product
- 0% of all reports · about 101 a year
- 34
- reports, 12 months to June 2026
- 29 in the 12 months before
- 85.9%
- marked serious by the reporter
- 49.7% across the class
- 36.3%
- record death among outcomes, as reported
- 784 reports · not verified by FDA
Between February 2005 and June 2026, 2,159 adverse event reports received by FDA list the brand name Fosrenol (lanthanum carbonate) as a suspect or interacting product. Reports that mention it only as a concomitant medication (1,841) are left out of every figure here.
In the 12 months to June 2026, 34 reports listed it, up 17% from 29 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 101 reports a year and 0% of the 20,646,523 reports in the database, and 19.2% 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 death (20.1%), nausea (9.6%) and vomiting (9.5%). A report can list several reactions, so shares add to more than 100%; 388 different terms appear across these reports. Death is recorded in 20.1% of these reports, about the same share as in the median phosphate binder drug (20.1%).
85.9% of the reports are marked serious by the reporter (49.7% across the class); 36.3% record death among the outcomes and 41% record hospitalisation, as reported. 45.1% of the reports came from consumers, 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 Fosrenol reports recording the termmedian drug in phosphate binder
- Deaththe patient died; cause not stated by this term20.1%433
- Nauseafeeling sick9.6%207
- Vomitingbeing sick9.5%206
- Constipationconstipation8.2%178
- Abdominal painstomach or belly pain6.9%149
- Blood phosphorus increased6.2%133
- Sepsisa severe body-wide response to infection6.1%131
- Abdominal distensiona bloated abdomen5.9%127
- Condition aggravatedthe condition being treated got worse5.3%114
- General physical health deteriorationgeneral decline in health5.3%114
- Hyponatraemialow blood sodium5.3%114
- Off label useused for a purpose or in a way not on the label5.3%114
- Multiple organ dysfunction syndromeseveral organs failing5.2%113
- Ascitesfluid in the abdomen5%108
- Appendicitis5%107
- Stressstress5%107
- Appendicolith4.9%105
- Cardiogenic shockshock from the heart failing to pump4.7%102
- Anaemialow red blood cells4.5%98
- Ventricular fibrillationa chaotic rhythm from the lower heart chambers4.5%97
- Somnolencedrowsiness4.3%92
- Dyspnoeashortness of breath4%86
- Drug ineffectivethe medicine did not work as expected3.9%85
- Dry mouthdry mouth3.7%80
- Myasthenia gravis3.6%78
- Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease3.4%74
- Diarrhoealoose or frequent stools3.4%74
- Incorrect route of product administrationthe product was given by the wrong route3.3%71
- Medication residue present3.3%71
- Diabetes mellitusdiabetes3.2%70
Top 30 of 388 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. 57.3% 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 | 1,104 | 51.1% |
| Blood phosphorus increased | 125 | 5.8% |
| Renal failure chronic | 88 | 4.1% |
| Chronic kidney disease | 17 | 0.8% |
| Dialysis | 14 | 0.6% |
| Renal failure | 12 | 0.6% |
The indication field is filled in by the reporter and is often blank; shares are of all 2,159 reports.
In context
| Measure | Fosrenol | Phosphate binder | All reports |
|---|---|---|---|
| Reports as suspect product | 2,159 | 11,219 | 20,646,523 |
| Share of that pool | — | 19.2% | 0% |
| Reports, latest 12 months | 34 | — | 1,332,454 |
| Marked serious | 85.9% | 49.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 363 | 249 | 91 |
| Hospitalisation recorded, per 1,000 reports | 410 | 186 | 213 |
| Consumer-filed share | 45.1% | 26.2% | 45.8% |
| Top term, share of reports | Death 20.1% | median 20.1% | 4.1% |
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% |
| Sevelamer carbonate | generic | 766 | 41 | 46.5% |
| 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 Fosrenol reports
How many adverse event reports has FDA received for Fosrenol?
2,159 reports list Fosrenol as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 34 of them arrived in the latest 12 months. Another 1,841 list it only as a concomitant medication.
What reactions are recorded in Fosrenol reports?
death (20.1%), nausea (9.6%), vomiting (9.5%), constipation (8.2%) and abdominal pain (6.9%). 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 Fosrenol was responsible.
How serious are the reports?
85.9% are marked serious by the reporter. Among the outcomes recorded, 36.3% of reports include death and 41% 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?
consumer or non-health professional (45.1%), other health professional (27.7%) and physician (19.8%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Fosrenol rising?
34 reports in the 12 months to June 2026, up 17% from 29 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 Fosrenol 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 Fosrenol?
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 Fosrenol as a suspect or interacting product; reports listing it only as a concomitant medication (1,841) 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.