Generic name
Calcitriol: adverse event reports filed with FDA
2,229 reports list it as a suspect or interacting product, 2004–2026. Class: Vitamin D3 analog. Also reported as Calcitriol Cap, Calcitriol Cap 0 5mcg.
- 2,229
- reports as suspect product
- 0% of all reports · about 99 a year
- 159
- reports, 12 months to June 2026
- 212 in the 12 months before
- 91.6%
- marked serious by the reporter
- 92.5% across the class
- 23.2%
- record death among outcomes, as reported
- 518 reports · not verified by FDA
Between January 2004 and June 2026, 2,229 adverse event reports received by FDA list calcitriol, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (17,775) are left out of every figure here.
In the 12 months to June 2026, 159 reports listed it, down 25% from 212 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 99 reports a year and 0% of the 20,646,523 reports in the database, and 78.5% 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.
The reactions recorded most often are off label use (18.5%), abdominal pain (18.2%) and nausea (16.8%). A report can list several reactions, so shares add to more than 100%; 556 different terms appear across these reports. Off label use is recorded in 18.5% of these reports, a larger share than in the median vitamin D3 analog drug (10.6%).
91.6% of the reports are marked serious by the reporter (92.5% across the class); 23.2% record death among the outcomes and 42.8% record hospitalisation, as reported. 57.3% of the reports came from other health professionals, and the largest patient age group is 75 and over (19.7%). 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 Calcitriol reports recording the termmedian drug in vitamin d3 analog
- Off label useused for a purpose or in a way not on the label18.5%413
- Abdominal painstomach or belly pain18.2%405
- Nauseafeeling sick16.8%374
- Constipationconstipation14.5%324
- Vomitingbeing sick13.7%305
- General physical health deteriorationgeneral decline in health13.4%298
- Sepsisa severe body-wide response to infection13.2%295
- Hypercalcaemiahigh blood calcium13.1%292
- Hyponatraemialow blood sodium12.7%283
- Stressstress12.6%281
- Multiple organ dysfunction syndromeseveral organs failing12.5%279
- Ascitesfluid in the abdomen12.3%274
- Abdominal distensiona bloated abdomen12.2%273
- Appendicitis12.1%269
- Appendicolith12%267
- Cardiogenic shockshock from the heart failing to pump11.9%265
- Drug ineffectivethe medicine did not work as expected11.4%253
- Condition aggravatedthe condition being treated got worse11.1%248
- Anaemialow red blood cells10%223
- Dyspnoeashortness of breath10%223
- Ventricular fibrillationa chaotic rhythm from the lower heart chambers9.7%216
- Dry mouthdry mouth9%200
- Blood phosphorus increased8.3%186
- Somnolencedrowsiness8.3%186
- Drug hypersensitivityan allergic-type reaction to a medicine8.2%183
- Drug intolerancethe medicine was not tolerated7.8%174
- Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease7.6%169
- Diabetes mellitusdiabetes7.2%161
- Bacterial infectiona bacterial infection7.1%158
- Hyperphosphataemia7%155
Top 30 of 556 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. 36.4% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Hypocalcaemia | 173 | 7.8% |
| Vitamin d | 167 | 7.5% |
| Hypoparathyroidism | 120 | 5.4% |
| Vitamin supplementation | 53 | 2.4% |
| Anaemia | 30 | 1.3% |
| Hyperparathyroidism secondary | 29 | 1.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 2,229 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Calcitriol reports |
|---|---|---|
| Calcium carbonate | 594 | 26.6% |
| Allopurinol | 479 | 21.5% |
| Aranesp | 381 | 17.1% |
| Acetaminophen | 378 | 17% |
| Simvastatin | 358 | 16.1% |
| Metronidazole | 354 | 15.9% |
| Calcium | 349 | 15.7% |
| Gabapentin | 316 | 14.2% |
| Betamethasone | 312 | 14% |
| Potassium chloride | 295 | 13.2% |
Other products listed in reports where Calcitriol is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Calcitriol | Vitamin D3 analog | All reports |
|---|---|---|---|
| Reports as suspect product | 2,229 | 2,841 | 20,646,523 |
| Share of that pool | — | 78.5% | 0% |
| Reports, latest 12 months | 159 | — | 1,332,454 |
| Marked serious | 91.6% | 92.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 232 | 257 | 91 |
| Hospitalisation recorded, per 1,000 reports | 428 | 451 | 213 |
| Consumer-filed share | 12.7% | 11.3% | 45.8% |
| Top term, share of reports | Off label use 18.5% | median 10.6% | 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 |
|---|---|---|---|---|
| Rayaldee | brand | 612 | 142 | 95.9% |
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 Calcitriol reports
How many adverse event reports has FDA received for Calcitriol?
2,229 reports list Calcitriol as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 159 of them arrived in the latest 12 months. Another 17,775 list it only as a concomitant medication.
What reactions are recorded in Calcitriol reports?
off label use (18.5%), abdominal pain (18.2%), nausea (16.8%), constipation (14.5%) and vomiting (13.7%). 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 Calcitriol was responsible.
How serious are the reports?
91.6% are marked serious by the reporter. Among the outcomes recorded, 23.2% of reports include death and 42.8% 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 (57.3%), physician (23.5%) and consumer or non-health professional (12.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Calcitriol rising?
159 reports in the 12 months to June 2026, down 25% from 212 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 Calcitriol 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 Calcitriol?
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 Calcitriol as a suspect or interacting product; reports listing it only as a concomitant medication (17,775) 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.