Zemplarparicalcitol
According to the FDA label: 1 INDICATIONS & USAGE 1.1 Chronic Kidney Disease Stages 3 and 4 Paricalcitol Capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4. Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (Paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
14,034 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Zemplar in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Death 3,570 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Cardiac Disorder 622 reports
A general report of a problem with the heart, used when no more specific condition is named.
Full definition in the glossary →Myocardial Infarction 583 reports
The medical term for a heart attack.
Full definition in the glossary →Sepsis 483 reports
A serious, body-wide response to an infection that can become life threatening and needs urgent care.
Full definition in the glossary →Cardio-Respiratory Arrest 476 reports
A sudden stop in both heartbeat and breathing. It is a medical emergency.
Full definition in the glossary →Dyspnoea 393 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Cardiac Failure 348 reports
A condition where the heart cannot pump blood as well as it should, often called heart failure.
Full definition in the glossary →Renal Failure 308 reports
A serious decline in kidney function, where the kidneys can no longer filter waste properly.
Full definition in the glossary →Pneumonia 302 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Nausea 300 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Cerebrovascular Accident 285 reports
The medical term for a stroke, which happens when blood flow to part of the brain is interrupted.
Full definition in the glossary →Asthenia 277 reports
Physical weakness or lack of strength.
Full definition in the glossary →Diarrhoea 275 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Vomiting 271 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Fatigue 268 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 7,559 |
| Female | 6,012 |
| Unknown | 94 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 47 |
| 18-34 | 480 |
| 35-49 | 1,064 |
| 50-64 | 2,152 |
| 65-74 | 1,570 |
| 75+ | 1,165 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Zemplar. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Death | 8,428 |
| Hospitalization | 3,635 |
| Other Serious | 2,829 |
| Non-Serious | 1,327 |
| Life-Threatening | 251 |
| Disability | 175 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Zemplar. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 29 |
| 2005 | 71 |
| 2006 | 148 |
| 2007 | 158 |
| 2008 | 335 |
| 2009 | 705 |
| 2010 | 449 |
| 2011 | 498 |
| 2012 | 368 |
| 2013 | 1,819 |
| 2014 | 2,367 |
| 2015 | 2,117 |
| 2016 | 1,826 |
| 2017 | 797 |
| 2018 | 628 |
| 2019 | 515 |
| 2020 | 377 |
| 2021 | 268 |
| 2022 | 246 |
| 2023 | 212 |
| 2024 | 60 |
| 2025 | 31 |
| 2026 (partial) | 10 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Zemplar
In FDA adverse event reports that mention Zemplar, these medications appeared most often in the same report.
- Furosemide (1,056 reports)
- Aspirin (858 reports)
- Omeprazole (780 reports)
- Carvedilol (673 reports)
- Metoprolol (653 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026