Brand name · Calcifediol
Rayaldee: adverse event reports filed with FDA
612 reports list it as a suspect or interacting product, 2017–2026. Class: Vitamin D3 analog.
- 612
- reports as suspect product
- 0% of all reports · about 69 a year
- 142
- reports, 12 months to June 2026
- 171 in the 12 months before
- 95.9%
- marked serious by the reporter
- 92.5% across the class
- 34.8%
- record death among outcomes, as reported
- 213 reports · not verified by FDA
612 adverse event reports received by FDA list the brand name Rayaldee (calcifediol) as a suspect or interacting product, from September 2017 to June 2026. A further 87 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 142 reports listed it, down 17% from 171 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 69 reports a year and 0% of the 20,646,523 reports in the database, and 21.5% of the reports for the vitamin D3 analog class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded death (28.8%), hospitalisation (8.3%) and dialysis (4.4%). A report can list several reactions, so shares add to more than 100%; 136 different terms appear across these reports. Death is recorded in 28.8% of these reports, a larger share than in the median vitamin D3 analog drug (16.9%).
95.9% of the reports are marked serious by the reporter (92.5% across the class); 34.8% record death among the outcomes and 53.4% record hospitalisation, as reported. 78.1% of the reports came from pharmacists, and the largest patient age group is 75 and over (47.5%). 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 Rayaldee reports recording the termmedian drug in vitamin d3 analog
- Deaththe patient died; cause not stated by this term28.8%176
- Hospitalisationadmission to hospital8.3%51
- Dialysisdialysis4.4%27
- Dyspnoeashortness of breath4.4%27
- Pneumonialung infection3.3%20
- Off label useused for a purpose or in a way not on the label2.6%16
- Cardiac failure congestivecongestive heart failure2.5%15
- Cerebrovascular accidentstroke2.5%15
- Urinary tract infectionbladder or urinary infection2.5%15
- Cardiac disorder2.3%14
- Falla fall2.3%14
- Hospice care2%12
- Dehydrationdehydration1.6%10
- End stage renal diseasekidney failure needing dialysis or transplant1.6%10
- Myocardial infarctionheart attack1.6%10
- Covid-19COVID-19 infection1.5%9
- Anaemialow red blood cells1.3%8
- Hypertensionhigh blood pressure1.3%8
- Rehabilitation therapy1.3%8
- Hypercalcaemiahigh blood calcium1.1%7
- Acute kidney injurysudden loss of kidney function1%6
- Cellulitisa skin infection0.8%5
- Hyperkalaemiahigh blood potassium0.8%5
- Hypervolaemia0.8%5
- Influenzaflu0.8%5
- Pulmonary oedemafluid in the lungs0.8%5
- Renal failurekidney failure0.8%5
- Renal impairmentreduced kidney function0.8%5
- Therapy interrupted0.8%5
Top 30 of 136 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 2 drugs in the vitamin d3 analog 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 2,841 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. 95.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Chronic kidney disease | 334 | 54.6% |
| Hyperparathyroidism secondary | 88 | 14.4% |
| Hyperparathyroidism | 49 | 8% |
| Vitamin d deficiency | 30 | 4.9% |
| End stage renal disease | 2 | 0.3% |
| Nephropathy | 2 | 0.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 612 reports.
In context
| Measure | Rayaldee | Vitamin D3 analog | All reports |
|---|---|---|---|
| Reports as suspect product | 612 | 2,841 | 20,646,523 |
| Share of that pool | — | 21.5% | 0% |
| Reports, latest 12 months | 142 | — | 1,332,454 |
| Marked serious | 95.9% | 92.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 348 | 257 | 91 |
| Hospitalisation recorded, per 1,000 reports | 534 | 451 | 213 |
| Consumer-filed share | 6% | 11.3% | 45.8% |
| Top term, share of reports | Death 28.8% | median 16.9% | 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 vitamin d3 analog class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Calcitriol | generic | 2,229 | 159 | 91.6% |
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 Rayaldee reports
How many adverse event reports has FDA received for Rayaldee?
612 reports list Rayaldee as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 142 of them arrived in the latest 12 months. Another 87 list it only as a concomitant medication.
What reactions are recorded in Rayaldee reports?
death (28.8%), hospitalisation (8.3%), dialysis (4.4%), dyspnoea (4.4%) and pneumonia (3.3%). 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 Rayaldee was responsible.
How serious are the reports?
95.9% are marked serious by the reporter. Among the outcomes recorded, 34.8% of reports include death and 53.4% 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?
pharmacist (78.1%), other health professional (11.6%) and consumer or non-health professional (6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Rayaldee rising?
142 reports in the 12 months to June 2026, down 17% from 171 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 Rayaldee 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 Rayaldee?
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 Rayaldee as a suspect or interacting product; reports listing it only as a concomitant medication (87) 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.