Calcitriol adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Calcitriol
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Vitamin D3 analog
Also reported as: Calcitriol Cap, Calcitriol Cap 0 5mcg

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

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

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 2,229 adverse event reports that name Calcitriol. In these reports the drug is a suspect or interacting product.

In the same period, 17,775 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 159 reports in the 12 months to June 2026 and 212 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 159 (under 0.1%) name Calcitriol. Reports from other health professionals were 57.3% of the reports that name Calcitriol and 19.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Calcitriol is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 33 reports that name Calcitriol.
In January to March 2026, FDA received 60.
In April to June 2025, FDA received 64.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 316 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 2,210 of the 2,229 reports (99.1%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 316 terms.

Reaction terms in the reports that name Calcitriol, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,229 reports
Off label useused for a purpose or in a way not on the label	413	18.5%
Abdominal painstomach or belly pain	405	18.2%
Nauseafeeling sick	374	16.8%
Constipation	324	14.5%
Vomitingbeing sick	305	13.7%
General physical health deteriorationgeneral decline in health	298	13.4%
Sepsisa severe body-wide response to infection	295	13.2%
Hypercalcaemiahigh blood calcium	292	13.1%
Hyponatraemialow blood sodium	283	12.7%
Stress	281	12.6%
Multiple organ dysfunction syndromeseveral organs failing	279	12.5%
Ascitesfluid in the abdomen	274	12.3%
Abdominal distensiona bloated abdomen	273	12.2%
Appendicitis	269	12.1%
Appendicolith	267	12%
Cardiogenic shockshock from the heart failing to pump	265	11.9%
Drug ineffectivethe medicine did not work as expected	253	11.4%
Condition aggravatedthe condition being treated got worse	248	11.1%
Anaemialow red blood cells	223	10%
Dyspnoeashortness of breath	223	10%
Ventricular fibrillationa chaotic rhythm from the lower heart chambers	216	9.7%
Dry mouth	200	9%
Blood phosphorus increased	186	8.3%
Somnolencedrowsiness	186	8.3%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	183	8.2%
Drug intolerancethe medicine was not tolerated	174	7.8%
Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease	169	7.6%
Diabetes mellitusdiabetes	161	7.2%
Bacterial infectiona bacterial infection	158	7.1%
Hyperphosphataemia	155	7%
Myasthenia gravis	154	6.9%
Pyrexiafever	154	6.9%
Headachehead pain	150	6.7%
Thrombosis	149	6.7%
Blood cholesterol increasedraised cholesterol	148	6.6%
Swelling	147	6.6%
Intentional product misusedeliberate use not as intended	146	6.6%
Pulmonary embolisma blood clot in the lung	143	6.4%
Blood uric acid increasedraised uric acid	142	6.4%
Hypophosphataemia	142	6.4%
Neuralgia	141	6.3%
Gout	137	6.1%
Incorrect route of product administrationthe product was given by the wrong route	135	6.1%
Product use in unapproved indicationused for a purpose not on the label	132	5.9%
Sleep disordera sleep problem	130	5.8%
Acute kidney injurysudden loss of kidney function	126	5.7%
Painpain, site not specified	122	5.5%
Analgesic therapy	119	5.3%
Milk-alkali syndrome	117	5.2%
Drug therapy	116	5.2%

Download all 316 terms of Calcitriol (CSV)

The counts add to more than 2,229 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Calcitriol, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	7	6	3	1	1	0	0	3	1
2005	16	16	1	1	11	0	0	8	0
2006	7	6	0	0	5	0	0	1	1
2007	5	5	0	2	3	0	0	1	0
2008	21	20	9	1	9	1	0	4	1
2009	79	77	59	1	10	0	0	10	2
2010	23	21	4	0	11	0	0	13	2
2011	25	22	3	3	17	0	0	6	3
2012	34	32	1	5	17	0	0	18	2
2013	65	64	2	2	30	3	3	32	1
2014	72	67	5	2	38	1	1	33	5
2015	35	26	2	0	9	0	0	18	9
2016	55	47	2	0	31	0	0	22	8
2017	49	34	4	1	12	0	0	27	15
2018	88	74	3	3	41	5	0	47	14
2019	140	119	7	5	55	1	1	90	21
2020	189	169	11	17	67	2	0	141	20
2021	263	246	63	5	91	1	0	196	17
2022	192	171	66	8	53	32	1	134	21
2023	200	192	76	43	115	59	2	154	8
2024	282	270	60	53	155	41	5	222	12
2025	233	215	52	46	94	45	32	197	18
2026	149	142	85	57	80	61	46	127	7

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Calcitriol, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Calcitriol, by the year in which FDA received them
Year	Reports
2004	6
2005	15
2006	9
2007	5
2008	19
2009	80
2010	25
2011	26
2012	41
2013	63
2014	72
2015	34
2016	58
2017	52
2018	101
2019	168
2020	198
2021	306
2022	181
2023	206
2024	277
2025	194
2026	93

Reports that name Calcitriol, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Calcitriol
Age	Reports	Share
Under 2	31	1.4%
2 to 11	54	2.4%
12 to 17	34	1.5%
18 to 44	326	14.6%
45 to 64	397	17.8%
65 to 74	209	9.4%
75 and over	440	19.7%
Age not given	738	33.1%

Sex of the patient in the reports that name Calcitriol
Sex	Reports	Share
Female	955	42.8%
Male	801	35.9%
Unknown or not given	473	21.2%

Type of reporter in the reports that name Calcitriol
Reporter	Reports	Share
Physician	523	23.5%
Pharmacist	44	2%
Other health professional	1,278	57.3%
Lawyer	0	0%
Consumer or non-health professional	283	12.7%
Not given	101	4.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 36.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Calcitriol record
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 reporter fills in the indication, and the field is often empty. Each share is of all 2,229 reports.

Drugs in the same reports

Other drugs that the reports of Calcitriol name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	378
Allopurinol	479
Aranesp	381
Betamethasone	312
Calcium	349
Calcium carbonate	594
Gabapentin	316
Metronidazole	354
Potassium chloride	295
Simvastatin	358

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Rayaldee same class
Calcitonin salmon next in the A to Z list
Calcium next in the A to Z list
Calcitonin next in the A to Z list
Calcium acetate next in the A to Z list
Calcipotriene next in the A to Z list
Calcium Ascorbate next in the A to Z list
Calciparine next in the A to Z list
Calcium carbonate next in the A to Z list
Calan next in the A to Z list
Calcium Carbonate Cholecalciferol next in the A to Z list
Caffeine citrate next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for CalcitriolThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Calcitriol: adverse event reports that FDA received. https://reportedreactions.com/drug/calcitriol/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Calcitriol as a suspect or interacting product. The 17,775 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Calcitriol was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Calcitriol?

No. It is a count of what people reported to FDA: 2,229 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (57.3%), physician (23.5%) and consumer or non-health professional (12.7%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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