Drug · FAERS side-effect profile with label screen
Ergocalciferol side effects: what 382,305 FDA adverse event reports show
Drug class
Provitamin D2 Compound
FDA label (Established Pharmacologic Class)
Brand names
Vitamin D
openFDA label
Who reports
382,305 reports · 58% serious · 22,811 with death outcome · 71% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.
FDA label, Indications and Usage
What it is
Vitamin D2 is a vitamin D supplement and has been isolated from alfalfa. It has a role as a rodenticide, a bone density conservation agent, a nutraceutical and a plant metabolite.
PubChem CID 5280793 (ChEBI)
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
Lab value / disease marker 7No label text to screen 33
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,140 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 |
|---|---|---|---|---|---|---|
| Lupus vulgaris | 645 | 64.6 57.6–72.5ROR 64.7 · calibrated p 3e-6 ✓ | 29.7 EB05 27.8 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=645 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 1,046 | 62.4 57.1–68.2ROR 62.6 · calibrated p 3e-6 ✓ | 29.2 EB05 27.8 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1,046 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 315 | 48.6 41.7–56.6ROR 48.7 · calibrated p 2e-5 ✓ | 25.8 EB05 23.5 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=315 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| C-reactive protein | 421 | 47.1 41.3–53.6ROR 47.1 · calibrated p 2e-5 ✓ | 25.4 EB05 23.4 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=421 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Rheumatic fever | 1,815 | 38.6 36.3–41.0ROR 38.8 · calibrated p 6e-5 ✓ | 22.8 EB05 21.9 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1,815 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Mycotic allergy | 336 | 36.0 31.3–41.3ROR 36.0 · calibrated p 1e-4 ✓ | 21.8 EB05 19.9 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=327 · ♀ 0% (drug 71%) | not reported in cached trials |
| Swollen joint count increased | 1,204 | 34.1 31.7–36.6ROR 34.2 · calibrated p 1e-4 ✓ | 21.1 EB05 20.2 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=1,204 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 754 | 32.4 29.6–35.5ROR 32.4 · calibrated p 2e-4 ✓ | 20.5 EB05 19.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=739 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Facet joint syndrome | 1,123 | 30.0 27.9–32.2ROR 30.1 · calibrated p 3e-4 ✓ | 19.5 EB05 18.6 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1,122 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| X-ray abnormal | 595 | 27.1 24.5–29.9ROR 27.1 · calibrated p 5e-4 ✓ | 18.3 EB05 17.1 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=594 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Dislocation of vertebra | 738 | 26.9 24.6–29.4ROR 26.9 · calibrated p 5e-4 ✓ | 18.2 EB05 17.1 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=737 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Rheumatoid factor positive | 1,907 | 26.7 25.3–28.2ROR 26.9 · calibrated p 5e-4 ✓ | 18.1 EB05 17.4 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious n=1,905 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 2,152 | 23.5 22.3–24.7ROR 23.6 · calibrated p 9e-4 ✓ | 16.6 EB05 16.0 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious PRR 16.4 · ♀ 100% (drug 71%) · 94% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 2,217 | 23.4 22.3–24.6ROR 23.5 · calibrated p 9e-4 ✓ | 16.5 EB05 16.0 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.3 · ♀ 100% (drug 71%) · 94% clinician | not reported in cached trials |
| Retinitis | 504 | 23.4 21.1–26.0ROR 23.4 · calibrated p 1e-3 ✓ | 16.5 EB05 15.4 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=504 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Dust allergy | 283 | 22.5 19.5–25.8ROR 22.5 · calibrated p 0.001 ✓ | 16.1 EB05 14.5 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=276 · ♀ 0% (drug 71%) | not reported in cached trials |
| Peripheral venous disease | 1,089 | 20.3 18.9–21.7ROR 20.3 · calibrated p 0.002 ✓ | 14.9 EB05 14.2 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1,068 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 281 | 19.1 16.7–21.9ROR 19.1 · calibrated p 0.003 ✓ | 14.3 EB05 12.9 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=281 · ♀ 0% (drug 71%) | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 344 | 17.7 15.6–20.0ROR 17.7 · calibrated p 0.004 ✓ | 13.5 EB05 12.3 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=330 · ♀ 0% (drug 71%) | not reported in cached trials |
| Hyperparathyroidism secondary | 608 | 17.1 15.6–18.7ROR 17.1 · calibrated p 0.004 ✓ | 13.1 EB05 12.3 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=607 | not reported in cached trials |
| C-reactive protein abnormal | 1,524 | 16.9 15.9–17.9ROR 16.9 · calibrated p 0.004 ✓ | 13.0 EB05 12.5 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=1,521 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Muscle injury | 1,810 | 15.3 14.5–16.1ROR 15.3 · calibrated p 0.006 ✓ | 12.1 EB05 11.6 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.7 · ♀ 100% (drug 71%) · 91% clinician | not reported in cached trials |
| Helicobacter infection | 2,207 | 14.9 14.2–15.6ROR 15.0 · calibrated p 0.007 ✓ | 11.9 EB05 11.4 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.2 · ♀ 100% (drug 71%) · 91% clinician | not reported in cached trials |
| Pemphigus | 2,615 | 14.4 13.8–15.0ROR 14.5 · calibrated p 0.008 ✓ | 11.5 EB05 11.2 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.4 · ♀ 100% (drug 71%) · 93% clinician | not reported in cached trials |
| Conjunctivitis allergic | 305 | 14.2 12.5–16.1ROR 14.2 · calibrated p 0.009 ✓ | 11.4 EB05 10.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=293 · ♀ 0% (drug 71%) | not reported in cached trials |
| Nephrogenic anaemia | 957 | 13.9 12.9–14.9ROR 13.9 · calibrated p 0.009 ✓ | 11.2 EB05 10.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=957 | not reported in cached trials |
| Folliculitis | 2,042 | 13.3 12.7–14.0ROR 13.4 · calibrated p 0.011 ✓ | 10.8 EB05 10.4 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.4 · ♀ 100% (drug 71%) · 92% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 1,266 | 13.2 12.4–14.0ROR 13.2 · calibrated p 0.012 ✓ | 10.8 EB05 10.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1,239 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Hand deformity | 2,448 | 12.4 11.9–13.0ROR 12.5 · calibrated p 0.014 ✓ | 10.2 EB05 9.9 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.9 · ♀ 100% (drug 71%) · 91% clinician | not reported in cached trials |
| Bone erosion | 626 | 11.6 10.6–12.6ROR 11.6 · calibrated p 0.019 ✓ | 9.7 EB05 9.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=623 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Synovitis | 3,043 | 10.9 10.5–11.4ROR 11.0 · calibrated p 0.023 ✓ | 9.2 EB05 9.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.5 · ♀ 95% (drug 71%) · 90% clinician | not reported in cached trials |
| Nasal oedema | 288 | 10.3 9.1–11.7ROR 10.3 · calibrated p 0.029 ✓ | 8.7 EB05 7.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=270 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Infusion site discharge | 274 | 10.3 9.0–11.7ROR 10.3 · calibrated p 0.030 ✓ | 8.7 EB05 7.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | ♀ 100% (drug 71%) · 100% consumer | not reported in cached trials |
| Breast cancer stage iii | 1,026 | 10.2 9.6–10.9ROR 10.3 · calibrated p 0.030 ✓ | 8.7 EB05 8.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1,026 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Lip dry | 1,371 | 9.7 9.2–10.3ROR 9.8 · calibrated p 0.035 ✓ | 8.4 EB05 8.0 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1,250 · ♀ 100% (drug 71%) | not reported in cached trials |
| Drug tolerance decreased | 428 | 9.7 8.8–10.8ROR 9.7 · calibrated p 0.036 ✓ | 8.3 EB05 7.7 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=379 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Pericarditis | 2,538 | 9.7 9.3–10.1ROR 9.7 · calibrated p 0.035 ✓ | 8.3 EB05 8.1 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 · ♀ 100% (drug 71%) · 92% clinician | not reported in cached trials |
| Onychomadesis | 617 | 9.4 8.6–10.2ROR 9.4 · calibrated p 0.040 ✓ | 8.1 EB05 7.6 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=584 · ♀ 100% (drug 71%) · 100% clinician | not reported in cached trials |
| Bursitis | 1,772 | 9.3 8.8–9.8ROR 9.3 · calibrated p 0.041 ✓ | 8.0 EB05 7.7 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.9 · ♀ 95% (drug 71%) | not reported in cached trials |
| Respiratory symptom | 409 | 9.2 8.3–10.2ROR 9.2 · calibrated p 0.043 ✓ | 7.9 EB05 7.3 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=384 · ♀ 0% (drug 71%) | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Fall / fracture | 18,600 | 2.82.7–2.8 | signal |
| Tendon disorder | 1,649 | 2.42.3–2.6 | signal |
| Depression | 11,469 | 2.32.2–2.3 | signal |
| Serious infection | 30,053 | 2.22.2–2.2 | signal |
| Opportunistic infection | 4,203 | 1.71.7–1.8 | raised |
| Anaemia | 9,173 | 1.71.7–1.7 | raised |
| Interstitial lung disease | 2,932 | 1.71.6–1.8 | raised |
| Liver injury | 8,403 | 1.51.5–1.6 | raised |
| Venous thromboembolism | 5,969 | 1.51.5–1.6 | raised |
| Arrhythmia / qt | 5,165 | 1.51.4–1.5 | raised |
| Gi bleeding | 4,752 | 1.41.4–1.5 | raised |
| Kidney injury | 11,847 | 1.41.4–1.5 | raised |
| Hyperglycaemia / diabetes | 8,754 | 1.41.4–1.4 | raised |
| Hyponatraemia | 1,857 | 1.31.2–1.3 | raised |
| Thrombocytopenia | 4,879 | 1.21.2–1.3 | raised |
| Osteonecrosis | 1,145 | 1.11.0–1.2 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Ergocalciferol 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).
- NCT01395823 — Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients (N=470, PHASE4; 2 AE terms posted; arms: Ergocalciferol Supplementation; Placebo)
- NCT01320722 — Study of Vitamin D and Uric Acid Lowering on Kidney and Blood Vessel Function (N=242, PHASE3; 26 AE terms posted; arms: Vitamin D; Placebo- Vitamin D; Probenecid; Allopurinol)
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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 37,943 | 2.8 2.7–2.8ROR 3.0 · calibrated p 0.640 | 2.7 EB05 2.7 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.6 · serious PRR 3.0 | NCT01320722: 4/46 (8.7%) on Ergocalciferol; 2/51 (3.9%) control |
| Nausea | 28,191 | 2.0 2.0–2.0ROR 2.1 · calibrated p 0.984 | 2.0 EB05 1.9 · IC025 +1.0 | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.9 · serious PRR 2.3 | NCT01320722: 2/46 (4.3%) on Ergocalciferol; 3/51 (5.9%) control |
| Diarrhoea (diarrhea) | 27,096 | 2.4 2.3–2.4ROR 2.5 · calibrated p 0.825 | 2.3 EB05 2.3 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.1 · serious PRR 2.5 | NCT01320722: 2/46 (4.3%) on Ergocalciferol |
| Headache | 25,986 | 2.3 2.3–2.4ROR 2.4 · calibrated p 0.844 | 2.3 EB05 2.3 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.3 · serious PRR 2.8 | NCT01320722: 3/46 (6.5%) on Ergocalciferol; 2/51 (3.9%) control |
| Drug ineffective (drug did not work) | 25,677 | 1.1 1.1–1.1ROR 1.1 · calibrated p 0.356 | 1.1 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | age-adj. PRR 1.3 · serious PRR 1.7 | not reported in cached trials |
| Pain | 24,228 | 2.2 2.2–2.2ROR 2.3 · calibrated p 0.909 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.5 · serious PRR 2.4 | NCT01320722: 3/48 (6.2%) on Ergocalciferol; 2/51 (3.9%) control |
| Off label use (used outside approved label) | 23,142 | 1.5 1.5–1.5ROR 1.5 · calibrated p 0.645 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | age-adj. PRR 1.5 · serious PRR 1.7 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 20,511 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.989 | 2.0 EB05 2.0 · IC025 +1.0 | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.8 · serious PRR 2.1 | not reported in cached trials |
| Arthralgia (joint pain) | 20,179 | 2.8 2.7–2.8ROR 2.9 · calibrated p 0.676 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.6 · serious PRR 3.3 | not reported in cached trials |
| Dizziness | 19,628 | 2.2 2.2–2.2ROR 2.3 · calibrated p 0.915 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.1 · serious PRR 2.4 | NCT01320722: 1/46 (2.2%) on Ergocalciferol; 3/51 (5.9%) control |
| Asthenia (weakness) | 17,232 | 2.6 2.5–2.6ROR 2.7 · calibrated p 0.748 | 2.5 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.2 · serious PRR 2.6 | not reported in cached trials |
| Fall | 17,039 | 2.9 2.9–3.0ROR 3.0 · calibrated p 0.627 | 2.8 EB05 2.8 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.4 · serious PRR 2.7 | not reported in cached trials |
| Vomiting | 15,863 | 1.9 1.9–1.9ROR 1.9 · calibrated p 0.901 | 1.9 EB05 1.8 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.8 · serious PRR 2.1 | not reported in cached trials |
| Pain in extremity | 14,933 | 2.9 2.8–2.9ROR 2.9 · calibrated p 0.644 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.7 · serious PRR 3.3 | not reported in cached trials |
| Malaise (feeling unwell) | 14,767 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.892 | 1.8 EB05 1.8 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.9 · serious PRR 2.2 | not reported in cached trials |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Ergocalciferol?
In FDA FAERS, the most frequently co-reported reaction terms for Ergocalciferol are fatigue, nausea, diarrhoea, headache, pain, dyspnoea. 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 Ergocalciferol have an FDA boxed warning?
No. The FDA label retrieved for Ergocalciferol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ergocalciferol 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 26aba724-8990-def9-e063-6394a90a991d, effective 20250415; matched on
openfda.generic_name.exact:"ERGOCALCIFEROL" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 5280793 description (ChEBI)
- 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, 1,180 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
ERGOCALCIFEROL, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.