Drug · FAERS side-effect profile with label screen
Calcifediol side effects: what 2,421 FDA adverse event reports show
Drug class
Vitamin d 3 analog
FDA label, Indications wording
Brand names
Rayaldee
openFDA label
Who reports
2,421 reports · 96% serious · 356 with death outcome · 61% female
openFDA FAERS counts, all years, deduplication not applied
Used for
RAYALDEE is a vitamin D 3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Limitations of Use RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis.
FDA label, Indications and Usage
What it is
Calcifediol, USP, the active ingredient in RAYALDEE, is synthetically manufactured as calcifediol monohydrate. Calcifediol is also known as calcidiol, 25-hydroxycholecalciferol or 25-hydroxyvitamin D 3 .
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 3Likely indication confounding 2Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 32
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. 42 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 |
|---|---|---|---|---|---|---|
| Parkinsonism | 21 | 18.7 12.2–28.6ROR 18.8 · χ² 334 / p 8e-75 | 18.3 EB05 12.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · 100% clinician | no trial data cached |
| Dialysis | 29 | 17.7 12.3–25.4ROR 17.9 · χ² 440 / p 7e-98 | 17.4 EB05 12.6 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 10.4 · 97% clinician | no trial data cached |
| Sopor | 20 | 13.0 8.4–20.1ROR 13.1 · χ² 209 / p 1e-47 | 12.2 EB05 7.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · 100% clinician | no trial data cached |
| Ischaemic stroke | 23 | 11.2 7.4–16.8ROR 11.3 · χ² 203 / p 3e-46 | 10.3 EB05 6.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · ♀ 95% (drug 61%) · 91% clinician | no trial data cached |
| Hypocalcaemia (low calcium) | 23 | 10.6 7.0–15.9ROR 10.7 · χ² 190 / p 2e-43 | 9.7 EB05 6.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 96% clinician | no trial data cached |
| Hospice care | 12 | 10.6 6.0–18.6ROR 10.6 · χ² 94 / p 1e-22 | 8.8 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Clostridium difficile colitis | 12 | 9.8 5.6–17.2ROR 9.8 · χ² 86 / p 8e-21 | 8.1 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Toxic skin eruption | 11 | 9.4 5.2–17.0ROR 9.5 · χ² 75 / p 3e-18 | 7.6 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Hypercalcaemia | 13 | 9.1 5.3–15.7ROR 9.2 · χ² 86 / p 8e-21 | 7.6 EB05 4.5 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 | no trial data cached |
| Thrombotic microangiopathy | 10 | 8.9 4.8–16.6ROR 9.0 · χ² 63 / p 1e-15 | 7.0 EB05 3.9 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Hepatotoxicity (liver damage) | 21 | 8.2 5.4–12.6ROR 8.3 · χ² 126 / p 2e-29 | 7.3 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · 95% clinician | no trial data cached |
| Decreased activity | 10 | 8.1 4.4–15.0ROR 8.1 · χ² 55 / p 5e-14 | 6.3 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Intestinal perforation | 10 | 7.7 4.2–14.3ROR 7.7 · χ² 52 / p 3e-13 | 6.0 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Respiratory tract infection | 22 | 7.3 4.8–11.1ROR 7.4 · χ² 114 / p 6e-27 | 6.5 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · 95% clinician | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 35 | 7.3 5.2–10.1ROR 7.4 · χ² 184 / p 3e-42 | 6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 17% (drug 61%) · 100% clinician | no trial data cached |
| Serotonin syndrome | 16 | 7.2 4.4–11.8ROR 7.3 · χ² 80 / p 2e-19 | 6.2 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| End stage renal disease | 15 | 7.1 4.3–11.7ROR 7.1 · χ² 72 / p 1e-17 | 6.0 EB05 3.8 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.2 | no trial data cached |
| Drug interaction | 129 | 7.0 6.0–8.3ROR 7.4 · χ² 668 / p 2e-147 | 6.9 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · 98% clinician | no trial data cached |
| Hypomagnesaemia | 11 | 6.9 3.8–12.4ROR 6.9 · χ² 49 / p 1e-12 | 5.5 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 116 | 6.6 5.5–7.9ROR 6.9 · χ² 549 / p 9e-122 | 6.4 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 94% clinician | no trial data cached |
| Hepatocellular injury | 10 | 6.1 3.3–11.3ROR 6.1 · χ² 38 / p 4e-10 | 4.9 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Hyperkalaemia (high potassium) | 24 | 6.0 4.0–8.9ROR 6.0 · χ² 94 / p 1e-22 | 5.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 · 92% clinician | no trial data cached |
| Gamma-glutamyltransferase increased | 15 | 5.9 3.5–9.7ROR 5.9 · χ² 56 / p 4e-14 | 5.0 EB05 3.2 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 3.7 | no trial data cached |
| Psychomotor hyperactivity | 11 | 5.7 3.2–10.3ROR 5.7 · χ² 38 / p 3e-10 | 4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Sedation | 17 | 5.7 3.5–9.1ROR 5.7 · χ² 61 / p 4e-15 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Hepatitis (liver inflammation) | 16 | 5.4 3.3–8.8ROR 5.4 · χ² 53 / p 1e-13 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Mucosal inflammation | 16 | 5.3 3.3–8.7ROR 5.3 · χ² 52 / p 3e-13 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Hallucination, visual | 12 | 5.0 2.8–8.7ROR 5.0 · χ² 34 / p 3e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Leukocytosis | 10 | 4.8 2.6–8.9ROR 4.8 · χ² 26 / p 1e-7 | 4.0 EB05 2.4 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Plasma cell myeloma | 21 | 4.7 3.0–7.1ROR 4.7 · χ² 57 / p 3e-14 | 4.3 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 · ♀ 20% (drug 61%) · 100% clinician | no trial data cached |
| Tubulointerstitial nephritis | 10 | 4.6 2.5–8.6ROR 4.6 · χ² 25 / p 3e-7 | 3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Cardiac failure congestive | 40 | 4.3 3.1–5.8ROR 4.3 · χ² 97 / p 3e-23 | 4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 · ♀ 37% (drug 61%) · 92% clinician | no trial data cached |
| Lactic acidosis | 14 | 3.8 2.2–6.4ROR 3.8 · χ² 26 / p 2e-7 | 3.4 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 21 | 3.7 2.4–5.7ROR 3.8 · χ² 40 / p 1e-10 | 3.5 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Pancytopenia (all blood cells low) | 24 | 3.7 2.5–5.6ROR 3.8 · χ² 45 / p 8e-12 | 3.5 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 · 100% clinician | no trial data cached |
| Cognitive disorder | 20 | 3.7 2.4–5.8ROR 3.7 · χ² 37 / p 5e-10 | 3.5 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 · 95% clinician | no trial data cached |
| Epilepsy | 13 | 3.7 2.1–6.3ROR 3.7 · χ² 23 / p 9e-7 | 3.3 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Psoriatic arthropathy | 16 | 3.4 2.1–5.6ROR 3.5 · χ² 25 / p 2e-7 | 3.2 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 17 | 3.3 2.1–5.4ROR 3.4 · χ² 26 / p 2e-7 | 3.1 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Hospitalisation | 53 | 3.0 2.3–3.9ROR 3.1 · χ² 70 / p 3e-17 | 3.0 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 1.9 · 94% clinician | 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 |
|---|---|---|---|---|---|---|
| Drug interaction | 129 | 7.0 6.0–8.3ROR 7.4 · χ² 668 / p 2e-147 | 6.9 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · 98% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 116 | 6.6 5.5–7.9ROR 6.9 · χ² 549 / p 9e-122 | 6.4 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 94% clinician | no trial data cached |
| Hospitalisation | 53 | 3.0 2.3–3.9ROR 3.1 · χ² 70 / p 3e-17 | 3.0 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 1.9 · 94% clinician | no trial data cached |
| Cardiac failure congestive | 40 | 4.3 3.1–5.8ROR 4.3 · χ² 97 / p 3e-23 | 4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 · ♀ 37% (drug 61%) · 92% clinician | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 35 | 7.3 5.2–10.1ROR 7.4 · χ² 184 / p 3e-42 | 6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 17% (drug 61%) · 100% clinician | no trial data cached |
| Dialysis | 29 | 17.7 12.3–25.4ROR 17.9 · χ² 440 / p 7e-98 | 17.4 EB05 12.6 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 10.4 · 97% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 24 | 3.7 2.5–5.6ROR 3.8 · χ² 45 / p 8e-12 | 3.5 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 · 100% clinician | no trial data cached |
| Hyperkalaemia (high potassium) | 24 | 6.0 4.0–8.9ROR 6.0 · χ² 94 / p 1e-22 | 5.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 · 92% clinician | no trial data cached |
| Hypocalcaemia (low calcium) | 23 | 10.6 7.0–15.9ROR 10.7 · χ² 190 / p 2e-43 | 9.7 EB05 6.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 96% clinician | no trial data cached |
| Ischaemic stroke | 23 | 11.2 7.4–16.8ROR 11.3 · χ² 203 / p 3e-46 | 10.3 EB05 6.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · ♀ 95% (drug 61%) · 91% clinician | no trial data cached |
| Respiratory tract infection | 22 | 7.3 4.8–11.1ROR 7.4 · χ² 114 / p 6e-27 | 6.5 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · 95% clinician | no trial data cached |
| Hypoglycaemia (low blood sugar) | 21 | 3.7 2.4–5.7ROR 3.8 · χ² 40 / p 1e-10 | 3.5 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Plasma cell myeloma | 21 | 4.7 3.0–7.1ROR 4.7 · χ² 57 / p 3e-14 | 4.3 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 · ♀ 20% (drug 61%) · 100% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 21 | 8.2 5.4–12.6ROR 8.3 · χ² 126 / p 2e-29 | 7.3 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · 95% clinician | no trial data cached |
| Parkinsonism | 21 | 18.7 12.2–28.6ROR 18.8 · χ² 334 / p 8e-75 | 18.3 EB05 12.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · 100% clinician | 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.
- Parkinsonism — n=21, PRR 18.7
- Sopor — n=20, PRR 13.0
- Ischaemic stroke — n=23, PRR 11.2
- Hypocalcaemia — n=23, PRR 10.6
- Hepatotoxicity — n=21, PRR 8.2
- Respiratory tract infection — n=22, PRR 7.3
- Rhabdomyolysis — n=35, PRR 7.3
- Acute kidney injury — n=116, PRR 6.6
- Plasma cell myeloma — n=21, PRR 4.7
- Hypoglycaemia — n=21, PRR 3.7
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 Calcifediol?
In FDA FAERS, the most frequently co-reported reaction terms for Calcifediol are acute kidney injury, cardiac failure congestive, rhabdomyolysis, dialysis, pancytopenia, hyperkalaemia. 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 Calcifediol have an FDA boxed warning?
No. The FDA label retrieved for Calcifediol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Calcifediol 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 6a95effd-32a5-46b6-a30e-7f4f9bf8cc77, effective 20240119; matched on
openfda.generic_name.exact:"CALCIFEDIOL") - 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, 82 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.