Drug · FAERS side-effect profile with label screen
Paricalcitol side effects: what 14,043 FDA adverse event reports show
Drug class
Vitamin D2 Analog, Vitamin D Analog
FDA label (Established Pharmacologic Class)
Brand names
Zemplar
openFDA label
Who reports
14,043 reports · 91% serious · 8,428 with death outcome · 44% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ZEMPLAR is a vitamin D analog indicated in adults and pediatric patients 10 years and older for the prevention and treatment of secondary hyperparathyroidism associated with: Chronic kidney disease (CKD) Stages 3 and 4 ( 1.1 ). CKD Stage 5 in patients on hemodialysis or peritoneal dialysis ( 1.2 ).
FDA label, Indications and Usage
What it is
Paricalcitol, USP, the active ingredient in ZEMPLAR capsules, is a synthetically manufactured, metabolically active vitamin D analog of calcitriol with modifications to the side chain (D 2 ) and the A (19-nor) ring.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 2Likely indication confounding 3Reporting / coding artifact 5Lab value / disease marker 5Not in label — unassessed 25
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 978 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Arteriovenous shunt operation | 10 | 359.2 179.9–716.8ROR 359.4 · χ² 2,590 / p <1e-300 | 186.6 EB05 108.4 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious n=10 | no trial data cached |
| Shunt thrombosis | 15 | 263.0 151.8–455.4ROR 263.2 · χ² 3,103 / p <1e-300 | 174.2 EB05 112.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Arteriovenous fistula occlusion | 21 | 202.1 128.1–318.8ROR 202.4 · χ² 3,520 / p <1e-300 | 153.3 EB05 105.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=21 · 76% consumer | no trial data cached |
| Arteriovenous fistula site infection | 14 | 171.8 98.8–298.7ROR 172.0 · χ² 1,979 / p <1e-300 | 127.6 EB05 80.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Parathyroidectomy | 49 | 171.4 127.6–230.3ROR 172.0 · χ² 7,283 / p <1e-300 | 145.0 EB05 114.0 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=49 | no trial data cached |
| Blood phosphorus abnormal | 36 | 125.3 89.2–176.0ROR 125.6 · χ² 3,978 / p <1e-300 | 109.0 EB05 82.3 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=35 · 91% consumer | no trial data cached |
| Skin fibrosis | 37 | 124.1 88.8–173.5ROR 124.4 · χ² 4,054 / p <1e-300 | 108.3 EB05 82.0 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=36 | no trial data cached |
| Arteriovenous fistula thrombosis | 26 | 120.4 80.7–179.5ROR 120.6 · χ² 2,736 / p <1e-300 | 103.1 EB05 74.0 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=26 | no trial data cached |
| Blood parathyroid hormone abnormal | 46 | 115.8 85.8–156.2ROR 116.2 · χ² 4,747 / p <1e-300 | 102.9 EB05 80.3 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=35 | no trial data cached |
| Dialysis related complication | 25 | 112.2 74.8–168.5ROR 112.4 · χ² 2,459 / p <1e-300 | 96.8 EB05 69.0 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=24 · 87% consumer | no trial data cached |
| Arteriovenous fistula operation | 15 | 87.7 52.1–147.5ROR 87.7 · χ² 1,132 / p 2e-248 | 75.2 EB05 48.3 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious n=15 | no trial data cached |
| Shunt occlusion | 28 | 87.4 59.7–127.8ROR 87.5 · χ² 2,176 / p <1e-300 | 78.3 EB05 56.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=28 · 100% clinician | no trial data cached |
| Renal transplant | 168 | 72.9 62.5–85.0ROR 73.7 · χ² 11,280 / p <1e-300 | 69.0 EB05 60.6 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=168 | no trial data cached |
| Arteriovenous fistula site complication | 28 | 72.5 49.6–105.9ROR 72.6 · χ² 1,813 / p <1e-300 | 66.1 EB05 48.0 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=27 | no trial data cached |
| Anti-erythropoietin antibody positive | 11 | 67.5 36.9–123.5ROR 67.5 · χ² 627 / p 1e-138 | 58.4 EB05 34.8 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Calciphylaxis | 79 | 67.4 53.8–84.3ROR 67.7 · χ² 4,876 / p <1e-300 | 63.5 EB05 52.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=77 · 100% clinician | no trial data cached |
| Hyperparathyroidism secondary | 109 | 67.2 55.5–81.3ROR 67.7 · χ² 6,732 / p <1e-300 | 63.6 EB05 54.2 · IC025 +5.3 3/3 methods agree | Likely indication confounding term in indications | serious n=107 | no trial data cached |
| Nephrogenic systemic fibrosis | 123 | 62.5 52.2–74.8ROR 63.0 · χ² 7,082 / p <1e-300 | 59.5 EB05 51.2 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=122 | no trial data cached |
| Infarction | 258 | 57.9 51.2–65.5ROR 59.0 · χ² 13,836 / p <1e-300 | 55.6 EB05 50.1 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 35.5 | no trial data cached |
| Blood parathyroid hormone increased | 103 | 54.5 44.8–66.3ROR 54.9 · χ² 5,167 / p <1e-300 | 52.1 EB05 44.2 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=76 | no trial data cached |
| Chronic kidney disease-mineral and bone disorder | 35 | 50.2 35.8–70.3ROR 50.3 · χ² 1,584 / p <1e-300 | 47.4 EB05 35.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=35 | no trial data cached |
| Arteriovenous fistula | 16 | 50.1 30.5–82.5ROR 50.2 · χ² 698 / p 4e-154 | 46.0 EB05 30.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Skin induration | 64 | 47.7 37.2–61.2ROR 48.0 · χ² 2,792 / p <1e-300 | 45.7 EB05 37.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=63 | no trial data cached |
| Parathyroid disorder | 24 | 45.8 30.5–68.7ROR 45.9 · χ² 977 / p 1e-214 | 43.0 EB05 30.4 · IC025 +3.9 3/3 methods agree | Likely indication confounding term in indications | serious n=23 · 75% consumer | no trial data cached |
| Extremity contracture | 19 | 45.6 28.9–71.9ROR 45.6 · χ² 761 / p 1e-167 | 42.5 EB05 28.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Joint contracture | 31 | 44.4 31.0–63.4ROR 44.5 · χ² 1,234 / p 1e-270 | 42.1 EB05 31.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=31 | no trial data cached |
| Nephrogenic anaemia | 117 | 38.3 31.9–46.0ROR 38.6 · χ² 4,108 / p <1e-300 | 37.2 EB05 31.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=117 | no trial data cached |
| Transplant | 54 | 34.7 26.5–45.4ROR 34.8 · χ² 1,694 / p <1e-300 | 33.6 EB05 26.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=54 | no trial data cached |
| Skin hypertrophy | 62 | 33.8 26.3–43.4ROR 33.9 · χ² 1,896 / p <1e-300 | 32.7 EB05 26.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=62 | no trial data cached |
| Cerebrovascular disorder | 62 | 31.0 24.1–39.9ROR 31.2 · χ² 1,736 / p <1e-300 | 30.2 EB05 24.4 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=62 · 90% clinician | no trial data cached |
| Device related sepsis | 39 | 29.2 21.3–40.1ROR 29.3 · χ² 1,014 / p 8e-223 | 28.3 EB05 21.6 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious n=39 | no trial data cached |
| Infected fistula | 10 | 28.8 15.4–53.8ROR 28.8 · χ² 236 / p 1e-53 | 26.8 EB05 15.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Hyperphosphataemia | 38 | 27.2 19.8–37.5ROR 27.3 · χ² 918 / p 7e-202 | 26.5 EB05 20.1 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=33 | no trial data cached |
| Endocarditis bacterial | 13 | 25.0 14.4–43.2ROR 25.0 · χ² 271 / p 3e-61 | 23.7 EB05 14.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Blood parathyroid hormone decreased | 23 | 23.4 15.5–35.3ROR 23.4 · χ² 463 / p 5e-103 | 22.6 EB05 15.8 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=15 | no trial data cached |
| Abdominal sepsis | 13 | 22.5 13.0–38.9ROR 22.5 · χ² 243 / p 5e-55 | 21.4 EB05 13.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Parathyroid tumour benign | 11 | 22.4 12.3–40.6ROR 22.4 · χ² 201 / p 7e-46 | 21.0 EB05 12.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Renal failure chronic | 110 | 21.4 17.7–25.8ROR 21.5 · χ² 2,084 / p <1e-300 | 21.0 EB05 17.9 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.4 | no trial data cached |
| Vascular calcification | 14 | 19.7 11.6–33.4ROR 19.7 · χ² 227 / p 1e-51 | 18.8 EB05 11.5 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=14 | no trial data cached |
| Fibrosis | 38 | 18.7 13.6–25.7ROR 18.7 · χ² 610 / p 5e-135 | 18.3 EB05 13.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=38 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Death | 3,570 | 6.2 6.0–6.4ROR 8.0 · χ² 16,205 / p <1e-300 | 6.2 EB05 6.0 · IC025 +2.6 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.9 · 91% clinician | no trial data cached |
| Cardiac disorder | 622 | 9.9 9.2–10.7ROR 10.4 · χ² 4,987 / p <1e-300 | 9.9 EB05 9.2 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.3 | no trial data cached |
| Myocardial infarction (heart attack) | 584 | 5.0 4.6–5.4ROR 5.1 · χ² 1,859 / p <1e-300 | 4.9 EB05 4.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Sepsis (blood infection) | 483 | 6.5 5.9–7.1ROR 6.7 · χ² 2,238 / p <1e-300 | 6.4 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Cardio-respiratory arrest | 477 | 17.1 15.7–18.7ROR 17.7 · χ² 7,149 / p <1e-300 | 16.9 EB05 15.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Dyspnoea (shortness of breath) | 393 | 1.0 0.9–1.1ROR 1.0 · χ² 1 / p 0.237 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.8 | no trial data cached |
| Cardiac failure (heart failure) | 348 | 6.5 5.9–7.2ROR 6.6 · χ² 1,610 / p <1e-300 | 6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 | no trial data cached |
| Renal failure (kidney failure) | 308 | 3.4 3.1–3.8ROR 3.5 · χ² 534 / p 2e-118 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Pneumonia (lung infection) | 303 | 1.4 1.3–1.6ROR 1.4 · χ² 35 / p 2e-9 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled (related wording) related wording | serious PRR 0.9 | no trial data cached |
| Nausea | 300 | 0.6 0.5–0.6ROR 0.6 · χ² 102 / p 3e-24 | 0.6 EB05 0.5 · IC025 -1.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.4 | no trial data cached |
| Cerebrovascular accident (stroke) | 285 | 2.5 2.2–2.8ROR 2.5 · χ² 258 / p 2e-58 | 2.5 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Asthenia (weakness) | 277 | 1.1 1.0–1.2ROR 1.1 · χ² 2 / p 0.058 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.8 | no trial data cached |
| Diarrhoea (diarrhea) | 276 | 0.6 0.6–0.7ROR 0.6 · χ² 57 / p 2e-14 | 0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.5 | no trial data cached |
| Vomiting | 271 | 0.9 0.8–1.0ROR 0.9 · χ² 6 / p 0.008 | 0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.7 · ♀ 65% (drug 44%) | no trial data cached |
| Fatigue (tiredness) | 268 | 0.5 0.5–0.6ROR 0.5 · χ² 127 / p 1e-29 | 0.5 EB05 0.5 · IC025 -1.2 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.4 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Arteriovenous fistula occlusion — n=21, PRR 202.1
- Parathyroidectomy — n=49, PRR 171.4
- Skin fibrosis — n=37, PRR 124.1
- Arteriovenous fistula thrombosis — n=26, PRR 120.4
- Shunt occlusion — n=28, PRR 87.4
- Renal transplant — n=168, PRR 72.9
- Calciphylaxis — n=79, PRR 67.4
- Nephrogenic systemic fibrosis — n=123, PRR 62.5
- Infarction — n=258, PRR 57.9
- Chronic kidney disease-mineral and bone disorder — n=35, PRR 50.2
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Paricalcitol?
In FDA FAERS, the most frequently co-reported reaction terms for Paricalcitol are cardiac disorder, myocardial infarction, sepsis, cardio-respiratory arrest, dyspnoea, cardiac failure. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Paricalcitol have an FDA boxed warning?
No. The FDA label retrieved for Paricalcitol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Paricalcitol causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 1b27c026-2d60-47b4-2a9c-ded1818f21b5, effective 20240807; matched on
openfda.generic_name.exact:"PARICALCITOL") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,018 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.