Drug · FAERS side-effect profile with label screen
Calcitriol 0.25 side effects: what 19,921 FDA adverse event reports show
Drug class
Vitamin D3 Analog
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Calcitriol Capsules 0.25 Mcg (Calcitriol)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
19,921 reports · 78% serious · 2,655 with death outcome · 56% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Predialysis Patients Calcitriol capsule 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 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. Calcitrio.
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. 1,161 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 | 2,814.4 2,241.2–3,534.2ROR 2,853.6 · χ² 206,794 / p <1e-300 | 720.3 EB05 651.5 · 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 | 2,128.1 1,451.6–3,119.7ROR 2,136.6 · χ² 55,047 / p <1e-300 | 597.7 EB05 495.6 · 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 | 1,613.8 1,200.6–2,169.1ROR 1,622.9 · χ² 70,008 / p <1e-300 | 570.1 EB05 486.9 · 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 | 806.9 401.4–1,622.1ROR 807.5 · χ² 5,893 / p <1e-300 | 280.4 EB05 177.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Analgesic therapy | 124 | 718.7 571.8–903.2ROR 723.2 · χ² 52,076 / p <1e-300 | 398.7 EB05 343.2 · 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 | 643.7 513.3–807.3ROR 647.7 · χ² 47,522 / p <1e-300 | 374.0 EB05 321.4 · 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 | 427.8 329.8–554.9ROR 429.5 · χ² 23,817 / p <1e-300 | 282.7 EB05 234.4 · 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 | 394.5 355.2–438.1ROR 404.0 · χ² 134,220 / p <1e-300 | 282.8 EB05 262.0 · 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 | 391.0 281.6–543.0ROR 392.0 · χ² 13,562 / p <1e-300 | 255.9 EB05 201.2 · 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 | 382.6 283.9–515.5ROR 383.7 · χ² 16,126 / p <1e-300 | 256.5 EB05 206.1 · IC025 +6.0 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 | 371.3 281.6–489.6ROR 372.6 · χ² 18,221 / p <1e-300 | 254.2 EB05 207.4 · 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 | 362.8 298.4–441.2ROR 365.3 · χ² 35,823 / p <1e-300 | 259.2 EB05 224.5 · 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 | 253.3 180.8–354.9ROR 253.9 · χ² 8,282 / p <1e-300 | 186.6 EB05 143.9 · 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 | 241.1 173.1–335.9ROR 241.7 · χ² 8,150 / p <1e-300 | 180.3 EB05 139.4 · 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 | 205.8 152.0–278.7ROR 206.4 · χ² 8,335 / p <1e-300 | 161.4 EB05 127.2 · 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 | 201.1 123.1–328.7ROR 201.3 · χ² 3,004 / p <1e-300 | 144.5 EB05 97.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Hungry bone syndrome | 25 | 167.3 109.7–255.2ROR 167.5 · χ² 3,417 / p <1e-300 | 130.1 EB05 92.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=25 · 100% clinician | not reported in cached trials |
| Hyperparathyroidism secondary | 327 | 156.2 139.2–175.3ROR 158.8 · χ² 43,694 / p <1e-300 | 134.8 EB05 123.0 · IC025 +6.6 3/3 methods agree | Likely indication confounding term in indications | serious n=327 | not reported in cached trials |
| Hypercalciuria | 62 | 151.3 116.0–197.5ROR 151.8 · χ² 7,950 / p <1e-300 | 127.1 EB05 102.7 · IC025 +5.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=57 | not reported in cached trials |
| Bacteroides infection | 32 | 148.2 102.4–214.6ROR 148.4 · χ² 3,966 / p <1e-300 | 120.6 EB05 89.5 · IC025 +4.9 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 | 142.2 118.3–170.9ROR 143.1 · χ² 15,657 / p <1e-300 | 122.9 EB05 106.0 · 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 | 132.6 85.9–204.6ROR 132.7 · χ² 2,547 / p <1e-300 | 107.4 EB05 75.4 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=23 · 100% clinician | not reported in cached trials |
| Microsporidia infection | 37 | 122.2 87.0–171.8ROR 122.5 · χ² 3,873 / p <1e-300 | 103.7 EB05 78.6 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=37 · ♀ 0% (drug 56%) | not reported in cached trials |
| Hyperphosphataemia | 202 | 110.9 96.0–128.1ROR 112.0 · χ² 19,774 / p <1e-300 | 99.3 EB05 88.4 · 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 | 101.0 78.6–129.8ROR 101.4 · χ² 5,956 / p <1e-300 | 89.9 EB05 73.2 · 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 | 100.7 88.2–114.9ROR 101.9 · χ² 21,325 / p <1e-300 | 91.2 EB05 81.9 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=230 · ♀ 21% (drug 56%) · 90% clinician | not reported in cached trials |
| Shunt stenosis | 24 | 98.4 64.8–149.5ROR 98.5 · χ² 2,026 / p <1e-300 | 84.1 EB05 59.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=24 · 100% clinician | not reported in cached trials |
| Nephrogenic anaemia | 364 | 88.9 79.9–98.8ROR 90.5 · χ² 29,050 / p <1e-300 | 81.6 EB05 74.8 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=364 | not reported in cached trials |
| Serositis | 42 | 86.8 63.4–118.9ROR 87.0 · χ² 3,208 / p <1e-300 | 77.4 EB05 59.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 100% (drug 56%) | not reported in cached trials |
| Nephrocalcinosis | 79 | 75.3 59.9–94.5ROR 75.6 · χ² 5,328 / p <1e-300 | 69.1 EB05 57.2 · 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 | 70.9 47.3–106.2ROR 71.0 · χ² 1,547 / p <1e-300 | 63.3 EB05 45.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=25 · 100% clinician | not reported in cached trials |
| Calciphylaxis | 113 | 69.2 57.3–83.7ROR 69.6 · χ² 7,061 / p <1e-300 | 64.3 EB05 54.9 · IC025 +5.4 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 | 65.8 50.0–86.6ROR 66.0 · χ² 3,181 / p <1e-300 | 60.7 EB05 48.3 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=54 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Skin fibrosis | 28 | 64.8 44.3–95.0ROR 64.9 · χ² 1,597 / p <1e-300 | 58.8 EB05 42.7 · 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 | 64.4 40.0–103.6ROR 64.4 · χ² 999 / p 2e-219 | 57.2 EB05 38.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Anti-erythropoietin antibody positive | 14 | 61.3 35.8–105.0ROR 61.3 · χ² 728 / p 1e-160 | 53.9 EB05 34.1 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=14 | not reported in cached trials |
| Blood calcium abnormal | 82 | 54.8 43.9–68.4ROR 55.0 · χ² 4,064 / p <1e-300 | 51.5 EB05 42.8 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=71 · ♀ 77% (drug 56%) | NCT01350934: 12/108 (11.1%) on Calcitriol 0.25 |
| Shunt occlusion | 23 | 50.0 32.9–76.0ROR 50.1 · χ² 1,008 / p 2e-221 | 46.1 EB05 32.3 · 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 | 44.6 37.2–53.6ROR 44.9 · χ² 4,825 / p <1e-300 | 42.6 EB05 36.5 · 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 | 44.0 25.8–75.1ROR 44.0 · χ² 524 / p 3e-116 | 40.1 EB05 25.4 · 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 0.25 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 (1 of 40 signal terms matched).
- NCT01350934 — A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the (N=219, PHASE4; 17 AE terms posted; arms: Fosamax Plus; Calcitriol)
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 | 1,448 | 1.9 1.8–2.0ROR 2.0 · χ² 675 / p 3e-149 | 1.9 EB05 1.8 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.0 | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,173 | 1.9 1.8–2.0ROR 2.0 · χ² 532 / p 5e-118 | 1.9 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.7 | NCT01350934: 6/108 (5.6%) on Calcitriol 0.25 |
| Off label use (used outside approved label) | 1,132 | 1.4 1.3–1.5ROR 1.4 · χ² 119 / p 5e-28 | 1.4 EB05 1.3 · IC025 +0.4 | Reporting / coding artifact | serious PRR 1.5 | not reported in cached trials |
| Chronic kidney disease | 1,111 | 15.5 14.6–16.4ROR 16.3 · χ² 14,850 / p <1e-300 | 15.2 EB05 14.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 | not reported in cached trials |
| Vomiting | 1,090 | 2.4 2.3–2.6ROR 2.5 · χ² 953 / p 1e-209 | 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) | 1,068 | 2.0 1.9–2.1ROR 2.0 · χ² 538 / p 3e-119 | 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) | 1,056 | 8.4 7.9–8.9ROR 8.8 · χ² 6,830 / p <1e-300 | 8.3 EB05 7.9 · 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) | 1,018 | 1.4 1.3–1.5ROR 1.4 · χ² 110 / p 5e-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) | 956 | 6.6 6.2–7.1ROR 6.9 · χ² 4,579 / p <1e-300 | 6.6 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 | 892 | 1.1 1.0–1.2ROR 1.1 · χ² 7 / p 0.005 | 1.1 EB05 1.0 · IC025 +0.0 | Outcome field, not a reaction | serious PRR 0.8 | not reported in cached trials |
| Drug hypersensitivity | 865 | 4.7 4.4–5.0ROR 4.9 · χ² 2,531 / p <1e-300 | 4.7 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) | 775 | 0.6 0.6–0.7ROR 0.6 · χ² 193 / p 3e-44 | 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 | 772 | 3.5 3.3–3.8ROR 3.6 · χ² 1,389 / p <1e-300 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | NCT01350934: 3/108 (2.8%) on Calcitriol 0.25 |
| Asthenia (weakness) | 751 | 2.1 2.0–2.3ROR 2.1 · χ² 441 / p 4e-98 | 2.1 EB05 2.0 · IC025 +0.9 | Not in label — unassessed | serious PRR 1.9 | not reported in cached trials |
| Headache | 748 | 1.3 1.2–1.3ROR 1.3 · χ² 40 / p 1e-10 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.4 | 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 2,814.4
- Recalled product — n=473, PRR 394.5
- Malignant melanoma stage 0 — n=49, PRR 391.0
- Congenital hiatus hernia — n=59, PRR 382.6
- Heart failure with preserved ejection fraction — n=68, PRR 371.3
- Milk-alkali syndrome — n=135, PRR 362.8
- Central nervous system lupus — n=42, PRR 253.3
- Vaginal flatulence — n=50, PRR 205.8
- Hungry bone syndrome — n=25, PRR 167.3
- Bacteroides infection — n=32, PRR 148.2
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 Calcitriol 0.25?
In FDA FAERS, the most frequently co-reported reaction terms for Calcitriol 0.25 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 0.25 have an FDA boxed warning?
No. The FDA label retrieved for Calcitriol 0.25 has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Calcitriol 0.25 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 261398eb-80b8-4c3d-9d2b-3a8004347a75, effective 20251113; matched on
openfda.generic_name.exact:"CALCITRIOL CAPSULES 0.25 MCG") - 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, 1,201 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 0.25, 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.