Drug · FAERS side-effect profile with label screen
Calcitriol side effects: what 20,153 FDA adverse event reports show
Drug class
Vitamin D3 Analog
FDA label (Established Pharmacologic Class)
Who reports
20,153 reports · 77% serious · 2,661 with death outcome · 56% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Predialysis Patients Calcitriol Oral Solution is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters.
FDA label, Indications and Usage
What it is
DESCRIPTION Calcitriol Oral Solution is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol oral solution contains 1 mcg/mL of calcitriol.
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 6Reporting / coding artifact 5Lab value / disease marker 4Not in label — unassessed 23
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. 1,160 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 |
|---|---|---|---|---|---|---|
| Appendicolith | 274 | 2,782.0 2,215.4–3,493.5ROR 2,820.3 · χ² 204,410 / p <1e-300 | 712.4 EB05 644.4 · IC025 +8.1 3/3 methods agree | Not in label — unassessed | serious n=274 · ♀ 7% (drug 56%) · 96% clinician | not reported in cached trials |
| Antacid therapy | 80 | 2,103.5 1,434.9–3,083.8ROR 2,111.9 · χ² 54,412 / p <1e-300 | 591.8 EB05 490.7 · IC025 +6.7 3/3 methods agree | Reporting / coding artifact | serious n=80 · ♀ 22% (drug 56%) · 100% clinician | not reported in cached trials |
| Sleep disorder therapy | 112 | 1,595.2 1,186.8–2,144.1ROR 1,604.1 · χ² 69,201 / p <1e-300 | 564.2 EB05 481.8 · IC025 +7.1 3/3 methods agree | Reporting / coding artifact | serious n=112 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Zoonotic bacterial infection | 14 | 797.6 396.7–1,603.4ROR 798.1 · χ² 5,825 / p <1e-300 | 278.4 EB05 176.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Analgesic therapy | 124 | 710.4 565.2–892.8ROR 714.8 · χ² 51,474 / p <1e-300 | 394.4 EB05 339.5 · IC025 +7.0 3/3 methods agree | Reporting / coding artifact | serious n=124 · ♀ 14% (drug 56%) · 97% clinician | not reported in cached trials |
| Drug therapy | 121 | 636.3 507.4–798.0ROR 640.2 · χ² 46,972 / p <1e-300 | 370.0 EB05 317.9 · IC025 +6.9 3/3 methods agree | Reporting / coding artifact | serious n=121 · ♀ 15% (drug 56%) · 100% clinician | not reported in cached trials |
| Anticoagulant therapy | 80 | 422.9 326.0–548.5ROR 424.6 · χ² 23,542 / p <1e-300 | 279.7 EB05 231.9 · IC025 +6.3 3/3 methods agree | Reporting / coding artifact | serious n=80 · ♀ 22% (drug 56%) · 100% clinician | not reported in cached trials |
| Recalled product | 473 | 389.9 351.1–433.1ROR 399.3 · χ² 132,666 / p <1e-300 | 279.6 EB05 259.1 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious n=453 · ♀ 90% (drug 56%) | not reported in cached trials |
| Malignant melanoma stage 0 | 49 | 386.5 278.4–536.7ROR 387.5 · χ² 13,405 / p <1e-300 | 253.3 EB05 199.1 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=49 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Congenital hiatus hernia | 59 | 378.1 280.6–509.5ROR 379.3 · χ² 15,939 / p <1e-300 | 253.8 EB05 204.0 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=59 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Heart failure with preserved ejection fraction | 68 | 367.0 278.3–484.0ROR 368.3 · χ² 18,010 / p <1e-300 | 251.4 EB05 205.2 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=68 · ♀ 100% (drug 56%) | not reported in cached trials |
| Milk-alkali syndrome | 135 | 358.7 295.0–436.1ROR 361.1 · χ² 35,408 / p <1e-300 | 256.3 EB05 222.0 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=134 · 96% clinician | not reported in cached trials |
| Central nervous system lupus | 42 | 250.4 178.8–350.8ROR 250.9 · χ² 8,186 / p <1e-300 | 184.6 EB05 142.4 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 100% (drug 56%) | not reported in cached trials |
| Body mass index abnormal | 43 | 238.4 171.1–332.1ROR 238.9 · χ² 8,055 / p <1e-300 | 178.4 EB05 137.9 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious n=43 · ♀ 100% (drug 56%) | not reported in cached trials |
| Vaginal flatulence | 50 | 203.5 150.3–275.5ROR 204.0 · χ² 8,238 / p <1e-300 | 159.7 EB05 125.9 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=50 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Hypervitaminosis d | 19 | 198.8 121.7–324.9ROR 199.0 · χ² 2,969 / p <1e-300 | 143.0 EB05 96.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Hungry bone syndrome | 25 | 165.4 108.4–252.3ROR 165.6 · χ² 3,378 / p <1e-300 | 128.8 EB05 91.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=25 · 100% clinician | not reported in cached trials |
| Hyperparathyroidism secondary | 327 | 154.4 137.6–173.3ROR 156.9 · χ² 43,184 / p <1e-300 | 133.3 EB05 121.6 · IC025 +6.6 3/3 methods agree | Likely indication confounding term in indications | serious n=327 | not reported in cached trials |
| Hypercalciuria | 62 | 149.6 114.6–195.2ROR 150.1 · χ² 7,857 / p <1e-300 | 125.7 EB05 101.6 · IC025 +5.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=57 | not reported in cached trials |
| Bacteroides infection | 32 | 146.5 101.2–212.1ROR 146.7 · χ² 3,920 / p <1e-300 | 119.3 EB05 88.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 128 | 140.5 116.9–169.0ROR 141.4 · χ² 15,474 / p <1e-300 | 121.5 EB05 104.8 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=128 · 100% clinician | not reported in cached trials |
| Mycobacterium test positive | 23 | 131.0 84.9–202.2ROR 131.2 · χ² 2,518 / p <1e-300 | 106.3 EB05 74.6 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=23 · 100% clinician | not reported in cached trials |
| Microsporidia infection | 37 | 120.8 86.0–169.8ROR 121.1 · χ² 3,827 / p <1e-300 | 102.6 EB05 77.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=37 · ♀ 0% (drug 56%) | not reported in cached trials |
| Hyperphosphataemia | 202 | 109.6 94.9–126.6ROR 110.7 · χ² 19,542 / p <1e-300 | 98.2 EB05 87.4 · IC025 +6.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=201 · ♀ 23% (drug 56%) · 91% clinician | not reported in cached trials |
| Hypoparathyroidism | 67 | 99.9 77.7–128.3ROR 100.2 · χ² 5,886 / p <1e-300 | 88.9 EB05 72.4 · IC025 +5.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=64 · ♀ 91% (drug 56%) | not reported in cached trials |
| Blood phosphorus increased | 238 | 99.5 87.2–113.6ROR 100.7 · χ² 21,075 / p <1e-300 | 90.2 EB05 81.0 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | serious n=230 · ♀ 21% (drug 56%) · 90% clinician | not reported in cached trials |
| Shunt stenosis | 24 | 97.3 64.0–147.8ROR 97.4 · χ² 2,002 / p <1e-300 | 83.2 EB05 58.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=24 · 100% clinician | not reported in cached trials |
| Nephrogenic anaemia | 364 | 87.8 79.0–97.7ROR 89.4 · χ² 28,707 / p <1e-300 | 80.6 EB05 73.9 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=364 | not reported in cached trials |
| Serositis | 42 | 85.8 62.6–117.5ROR 86.0 · χ² 3,170 / p <1e-300 | 76.6 EB05 59.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 100% (drug 56%) | not reported in cached trials |
| Nephrocalcinosis | 79 | 74.4 59.2–93.4ROR 74.7 · χ² 5,265 / p <1e-300 | 68.3 EB05 56.6 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=78 · 100% clinician | not reported in cached trials |
| Lung diffusion test decreased | 25 | 70.0 46.7–105.0ROR 70.1 · χ² 1,529 / p <1e-300 | 62.6 EB05 44.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=25 · 100% clinician | not reported in cached trials |
| Calciphylaxis | 113 | 68.4 56.6–82.8ROR 68.8 · χ² 6,978 / p <1e-300 | 63.6 EB05 54.3 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=113 · ♀ 79% (drug 56%) · 95% clinician | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 54 | 65.1 49.4–85.6ROR 65.2 · χ² 3,144 / p <1e-300 | 60.0 EB05 47.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=54 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Skin fibrosis | 28 | 64.1 43.8–93.9ROR 64.2 · χ² 1,578 / p <1e-300 | 58.1 EB05 42.2 · IC025 +4.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=28 | not reported in cached trials |
| Mycobacterium marinum infection | 18 | 63.7 39.5–102.4ROR 63.7 · χ² 987 / p 6e-217 | 56.6 EB05 37.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Anti-erythropoietin antibody positive | 14 | 60.6 35.3–103.8ROR 60.6 · χ² 719 / p 1e-158 | 53.3 EB05 33.8 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=14 | not reported in cached trials |
| Blood calcium abnormal | 82 | 54.2 43.4–67.6ROR 54.4 · χ² 4,015 / p <1e-300 | 50.9 EB05 42.3 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=71 · ♀ 77% (drug 56%) | not reported in cached trials |
| Shunt occlusion | 23 | 49.4 32.5–75.1ROR 49.5 · χ² 996 / p 7e-219 | 45.6 EB05 32.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 35% (drug 56%) · 100% clinician | not reported in cached trials |
| Blood parathyroid hormone increased | 119 | 44.1 36.7–53.0ROR 44.4 · χ² 4,767 / p <1e-300 | 42.1 EB05 36.1 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=92 | not reported in cached trials |
| Arteriovenous fistula thrombosis | 14 | 43.5 25.5–74.3ROR 43.5 · χ² 518 / p 7e-115 | 39.7 EB05 25.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Calcitriol as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT00658788 — Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis (N=305, PHASE3; 9 AE terms posted; arms: Sequential Treatment Regimen)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Nausea | 1,463 | 1.9 1.8–2.0ROR 2.0 · χ² 680 / p 4e-150 | 1.9 EB05 1.8 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.0 | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,191 | 1.9 1.8–2.0ROR 2.0 · χ² 547 / p 3e-121 | 1.9 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.7 | not reported in cached trials |
| Off label use (used outside approved label) | 1,135 | 1.4 1.3–1.4ROR 1.4 · χ² 113 / p 1e-26 | 1.4 EB05 1.3 · IC025 +0.3 | Reporting / coding artifact | serious PRR 1.5 | not reported in cached trials |
| Chronic kidney disease | 1,113 | 15.3 14.5–16.2ROR 16.2 · χ² 14,712 / p <1e-300 | 15.1 EB05 14.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 | not reported in cached trials |
| Vomiting | 1,093 | 2.4 2.3–2.6ROR 2.5 · χ² 936 / p 9e-206 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,074 | 2.0 1.9–2.1ROR 2.0 · χ² 531 / p 9e-118 | 2.0 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 1.7 | not reported in cached trials |
| Renal failure (kidney failure) | 1,057 | 8.3 7.8–8.8ROR 8.7 · χ² 6,744 / p <1e-300 | 8.2 EB05 7.8 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.2 | not reported in cached trials |
| Fatigue (tiredness) | 1,031 | 1.4 1.3–1.5ROR 1.4 · χ² 112 / p 2e-26 | 1.4 EB05 1.3 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.4 | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 958 | 6.6 6.2–7.0ROR 6.9 · χ² 4,530 / p <1e-300 | 6.5 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 | not reported in cached trials |
| Death | 894 | 1.1 1.0–1.2ROR 1.1 · χ² 5 / p 0.010 | 1.1 EB05 1.0 · IC025 +0.0 | Outcome field, not a reaction | serious PRR 0.8 | not reported in cached trials |
| Drug hypersensitivity | 866 | 4.7 4.4–5.0ROR 4.8 · χ² 2,493 / p <1e-300 | 4.6 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 · 95% clinician | not reported in cached trials |
| Drug ineffective (drug did not work) | 805 | 0.6 0.6–0.7ROR 0.6 · χ² 179 / p 5e-41 | 0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | not reported in cached trials |
| Abdominal pain | 774 | 3.5 3.2–3.7ROR 3.6 · χ² 1,370 / p 4e-300 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | not reported in cached trials |
| Headache | 764 | 1.3 1.2–1.4ROR 1.3 · χ² 45 / p 1e-11 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.4 | not reported in cached trials |
| Asthenia (weakness) | 754 | 2.1 1.9–2.2ROR 2.1 · χ² 433 / p 2e-96 | 2.1 EB05 2.0 · IC025 +0.9 | Not in label — unassessed | serious PRR 1.9 | not reported in cached trials |
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.
- Appendicolith — n=274, PRR 2,782.0
- Recalled product — n=473, PRR 389.9
- Malignant melanoma stage 0 — n=49, PRR 386.5
- Congenital hiatus hernia — n=59, PRR 378.1
- Heart failure with preserved ejection fraction — n=68, PRR 367.0
- Milk-alkali syndrome — n=135, PRR 358.7
- Central nervous system lupus — n=42, PRR 250.4
- Vaginal flatulence — n=50, PRR 203.5
- Hungry bone syndrome — n=25, PRR 165.4
- Bacteroides infection — n=32, PRR 146.5
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 Calcitriol?
In FDA FAERS, the most frequently co-reported reaction terms for Calcitriol are nausea, diarrhoea, chronic kidney disease, vomiting, dyspnoea, renal 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 Calcitriol have an FDA boxed warning?
No. The FDA label retrieved for Calcitriol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Calcitriol 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 1bd717a4-5fdf-4697-a6b2-9df55c6517bb, effective 20250418; matched on
openfda.generic_name.exact:"CALCITRIOL") - 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, 1,200 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 - ClinicalTrials.gov API v2 (query
CALCITRIOL, results-bearing studies sorted by enrollment)
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.