Zemplar (paricalcitol) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Paricalcitol
Class: Vitamin D analog
Also reported as: Zemplar Capsules 1mcg, Zemplar Capsules 2mcg, Zemplar Injection

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 July 2004 to February 2026, FDA received 11,348 adverse event reports that name Zemplar. In these reports the drug is a suspect or interacting product.

In the same period, 1,823 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 5 reports in the 12 months to June 2026 and 6 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, 5 (under 0.1%) name Zemplar. Reports from physicians were 53.6% of the reports that name Zemplar and 21.9% 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 Zemplar 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 0 reports that name Zemplar.
In January to March 2026, FDA received 2.
In April to June 2025, FDA received 0.

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 341 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 11,302 of the 11,348 reports (99.6%).

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 341 terms.

Reaction terms in the reports that name Zemplar, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 11,348 reports
Deaththe patient died; cause not stated by this term	3,439	30.3%
Cardiac disorder	601	5.3%
Myocardial infarctionheart attack	537	4.7%
Cardio-respiratory arrestthe heart and breathing stopped	436	3.8%
Sepsisa severe body-wide response to infection	396	3.5%
Cardiac failureheart failure	301	2.7%
Infarction	253	2.2%
Cerebrovascular accidentstroke	247	2.2%
Dyspnoeashortness of breath	220	1.9%
Cardiac arrestthe heart stopped	213	1.9%
Adverse eventan unwanted medical event, type not specified	194	1.7%
Pneumonialung infection	189	1.7%
Respiratory arrestbreathing stopped	188	1.7%
Infectionan infection, type not specified	185	1.6%
Falla fall	176	1.6%
General physical health deteriorationgeneral decline in health	168	1.5%
Acute myocardial infarction	164	1.4%
Renal transplant	157	1.4%
Pyrexiafever	156	1.4%
Cardiovascular disorder	151	1.3%
Astheniaweakness or lack of energy	141	1.2%
Fatiguetiredness	139	1.2%
Malaisegeneral feeling of being unwell	132	1.2%
Vomitingbeing sick	127	1.1%
Diarrhoealoose or frequent stools	124	1.1%
Dizzinesslight-headedness or unsteadiness	120	1.1%
Pulmonary oedemafluid in the lungs	115	1%
Unevaluable eventthe event could not be assessed	115	1%
Headachehead pain	112	1%
Painpain, site not specified	112	1%
Chest pain	111	1%
Device related infectionan infection related to the device	109	1%
Pain in extremitypain in an arm or leg	109	1%
Abdominal painstomach or belly pain	106	0.9%
Hypertensionhigh blood pressure	106	0.9%
Nauseafeeling sick	101	0.9%
Anaemialow red blood cells	81	0.7%
Renal failurekidney failure	78	0.7%
Hypotensionlow blood pressure	73	0.6%
Arthralgiajoint pain	72	0.6%
Gait disturbancedifficulty walking	72	0.6%
Cough	70	0.6%
Pruritusitching	67	0.6%
Urinary tract infectionbladder or urinary infection	66	0.6%
Blood parathyroid hormone increased	62	0.5%
Weight decreasedweight loss	58	0.5%
Respiratory failurethe lungs could not supply enough oxygen	57	0.5%
Back pain	56	0.5%
Cerebrovascular disorder	56	0.5%
Gastrointestinal haemorrhagebleeding in the stomach or bowel	56	0.5%

Download all 341 terms of Zemplar (CSV)

The counts add to more than 11,348 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.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Paricalcitol with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Paricalcitol	Generic name	297
Zemplar (this page)	Brand name	11,348

Sum of the separately reported names: 11,645. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

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.

Outcomes by year

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

Outcomes in the reports that name Zemplar, 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	5	3	1	0	1	0	0	1	2
2005	51	49	12	6	37	2	0	13	2
2006	105	103	35	13	78	2	0	27	2
2007	111	91	41	2	60	0	0	17	20
2008	350	158	44	12	108	3	0	43	192
2009	434	189	62	4	142	2	0	48	245
2010	264	169	80	4	107	2	0	36	95
2011	280	225	82	12	141	7	0	66	55
2012	198	187	71	7	114	6	0	52	11
2013	1,509	1,463	1,261	9	205	6	0	86	46
2014	2,343	2,319	2,192	4	117	3	0	86	24
2015	2,004	1,994	1,774	3	192	11	0	128	10
2016	1,660	1,658	1,384	9	227	10	0	189	2
2017	608	604	360	5	214	3	1	168	4
2018	363	358	168	2	188	3	0	99	5
2019	271	268	118	7	154	3	0	99	3
2020	218	216	84	6	140	3	0	78	2
2021	181	179	74	6	122	7	0	88	2
2022	185	185	60	17	129	4	0	108	0
2023	169	169	36	28	131	5	0	116	0
2024	34	32	8	5	22	0	0	22	2
2025	3	1	0	0	0	1	0	0	2
2026	2	1	0	0	0	0	0	1	1

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 Zemplar, 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 Zemplar, by the year in which FDA received them
Year	Reports
2004	3
2005	45
2006	107
2007	105
2008	200
2009	521
2010	266
2011	326
2012	250
2013	1,709
2014	2,189
2015	1,953
2016	1,656
2017	605
2018	359
2019	273
2020	225
2021	190
2022	184
2023	148
2024	29
2025	3
2026	2

Reports that name Zemplar, 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 Zemplar
Age	Reports	Share
Under 2	1	under 0.1%
2 to 11	4	under 0.1%
12 to 17	18	0.2%
18 to 44	840	7.4%
45 to 64	1,937	17.1%
65 to 74	1,125	9.9%
75 and over	737	6.5%
Age not given	6,686	58.9%

Sex of the patient in the reports that name Zemplar
Sex	Reports	Share
Female	4,772	42.1%
Male	6,275	55.3%
Unknown or not given	301	2.7%

Type of reporter in the reports that name Zemplar
Reporter	Reports	Share
Physician	6,077	53.6%
Pharmacist	35	0.3%
Other health professional	1,550	13.7%
Lawyer	0	0%
Consumer or non-health professional	2,959	26.1%
Not given	727	6.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 9.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Zemplar record
Indication as recorded (MedDRA)	Reports	Share
Hyperparathyroidism secondary	3,090	27.2%
Nephropathy	2,543	22.4%
Renal failure	2,272	20%
Renal failure chronic	939	8.3%
Hyperparathyroidism	546	4.8%
Chronic kidney disease	337	3%

The reporter fills in the indication, and the field is often empty. Each share is of all 11,348 reports.

Drugs in the same reports

Other drugs that the reports of Zemplar name, in any role, in order of name
Drug	Reports that name the two
Allopurinol	177
Amlodipine	275
Aspirin	242
Carvedilol	227
Clonidine	211
Folic acid	362
Furosemide	296
Losartan	274
Metoprolol	165
Omeprazole	313

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

Paricalcitol same ingredient
Calcipotriene same class
Zemaira next in the A to Z list
Zemuron next in the A to Z list
Zelnorm next in the A to Z list
Zenapax next in the A to Z list
Zelmac next in the A to Z list
Zenatane next in the A to Z list
Zelitrex next in the A to Z list
Zenhale next in the A to Z list
Zeldox next in the A to Z list
Zenpep 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 ZemplarThe 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. Zemplar: adverse event reports that FDA received. https://reportedreactions.com/drug/zemplar/ 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 Zemplar as a suspect or interacting product. The 1,823 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 Zemplar 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 Zemplar?

No. It is a count of what people reported to FDA: 11,348 reports from July 2004 to February 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?

Physician (53.6%), consumer or non-health professional (26.1%) and other health professional (13.7%). 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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