Pharmacologic class (EPC) · 2 drug pages

Vitamin D3 analog: adverse event reports filed with FDA

2,841 reports list a drug in this class as a suspect or interacting product, 2004–2026.

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.

2,841
reports across the class: 0% of all reports; 301
reports, 12 months to June 2026: 383 in the 12 months before; 92.5%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Vitamin D3 analog is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 2,841 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026.

301 reports arrived in the 12 months to June 2026, down 21% from 383 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 92.5% of the class's reports are marked serious, 25.7% record death among the outcomes and 45.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are off label use (15.1%), abdominal pain (14.3%) and nausea (13.2%). 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
Calcitriol	generic	2,229	159	91.6%	Off label use
RayaldeeCalcifediol	brand	612	142	95.9%	Death

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

Off label useused for a purpose or in a way not on the label15.1%429
Abdominal painstomach or belly pain14.3%405
Nauseafeeling sick13.2%376
Constipationconstipation11.5%328
Vomitingbeing sick10.8%306
General physical health deteriorationgeneral decline in health10.6%300
Hypercalcaemiahigh blood calcium10.5%299
Sepsisa severe body-wide response to infection10.5%298
Deaththe patient died; cause not stated by this term10.1%286
Hyponatraemialow blood sodium10%283
Stressstress9.9%281
Multiple organ dysfunction syndromeseveral organs failing9.8%279
Ascitesfluid in the abdomen9.6%274
Abdominal distensiona bloated abdomen9.6%273
Appendicitis9.5%269
Appendicolith9.4%267
Cardiogenic shockshock from the heart failing to pump9.3%265
Drug ineffectivethe medicine did not work as expected8.9%253
Dyspnoeashortness of breath8.8%250
Condition aggravatedthe condition being treated got worse8.7%248
Anaemialow red blood cells8.1%231
Ventricular fibrillationa chaotic rhythm from the lower heart chambers7.6%216
Dry mouthdry mouth7%200
Blood phosphorus increased6.5%186
Somnolencedrowsiness6.5%186

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death25.7%731

Life-threatening9.5%269

Hospitalisation (initial or prolonged)45.1%1,282

Disability8.9%254

Congenital anomaly3.2%91

Other serious56.2%1,596

Not serious7.5%213

Patient age

Under 21.1%31

2 to 112%56

12 to 171.2%34

18 to 4411.7%332

45 to 6416.8%477

65 to 7412.7%362

75 and over25.7%731

Age not given28.8%818

Who reported

Physician18.7%531

Pharmacist18.4%522

Other health professional47.5%1,349

Lawyer0%0

Consumer or non-health professional11.3%320

Not given4.2%119

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 Vitamin D3 analog reports

Which drugs are in the Vitamin D3 analog class on this site?

Calcitriol and Rayaldee. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

2,841 reports through June 2026, 301 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?

off label use (15.1%), abdominal pain (14.3%), nausea (13.2%), constipation (11.5%) and vomiting (10.8%).

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.