Drug · FAERS side-effect profile with label screen
Vitamin E side effects: what 31,255 FDA adverse event reports show
Who reports
31,255 reports · 58% serious · 1,699 with death outcome · 68% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Effectively relieves eye irritation,redness, swelling and itchingcaused by styes, chalazionsand blepharitis
FDA label, Indications and Usage
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
Reporting / coding artifact 5Lab value / disease marker 8No label text to screen 27
What the badges mean
- 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.
- 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). 1,153 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 |
|---|---|---|---|---|---|---|
| Fractional exhaled nitric oxide increased | 61 | 366.4 268.0–500.9ROR 367.1 · calibrated p 4e-12 ✓ | 219.9 EB05 177.3 · IC025 +5.9 3/3 methods agree vs other Vitamin Cs: only this drug | No label text to screen label has no adverse-reaction text | serious n=61 · ♀ 0% (drug 68%) | not reported in cached trials |
| Sleep disorder therapy | 49 | 239.8 173.0–332.5ROR 240.2 · calibrated p 2e-10 ✓ | 165.0 EB05 129.7 · IC025 +5.5 3/3 methods agree vs other Vitamin Cs: PRR 1.7 (1.2–2.3) | Reporting / coding artifact | serious n=48 · ♀ 0% (drug 68%) · 100% clinician | not reported in cached trials |
| Antacid therapy | 30 | 222.7 147.3–336.8ROR 222.9 · calibrated p 7e-10 ✓ | 151.0 EB05 110.8 · IC025 +4.9 3/3 methods agree vs other Vitamin Cs: PRR 5.7 (3.3–9.7) | Reporting / coding artifact | serious n=30 · ♀ 0% (drug 68%) · 100% clinician | not reported in cached trials |
| Appendicolith | 93 | 217.9 172.4–275.4ROR 218.6 · calibrated p 3e-10 ✓ | 158.8 EB05 133.5 · IC025 +6.1 3/3 methods agree vs other Vitamin Cs: PRR 1.6 (1.3–2.1) | No label text to screen label has no adverse-reaction text | serious n=93 · ♀ 0% (drug 68%) · 100% clinician | not reported in cached trials |
| Vaginal flatulence | 62 | 170.7 129.1–225.6ROR 171.0 · calibrated p 3e-9 ✓ | 130.5 EB05 105.4 · IC025 +5.6 3/3 methods agree vs other Vitamin Cs: PRR 10.9 (6.9–17.2) | No label text to screen label has no adverse-reaction text | serious n=62 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Analgesic therapy | 51 | 133.7 99.0–180.6ROR 133.9 · calibrated p 2e-8 ✓ | 107.0 EB05 84.6 · IC025 +5.3 3/3 methods agree vs other Vitamin Cs: PRR 1.8 (1.3–2.4) | Reporting / coding artifact | serious n=51 · ♀ 0% (drug 68%) · 100% clinician | not reported in cached trials |
| Drug therapy | 50 | 124.2 91.8–168.0ROR 124.4 · calibrated p 4e-8 ✓ | 100.8 EB05 79.4 · IC025 +5.2 3/3 methods agree vs other Vitamin Cs: PRR 1.9 (1.4–2.7) | Reporting / coding artifact | serious n=50 · ♀ 0% (drug 68%) · 100% clinician | not reported in cached trials |
| Post cholecystectomy syndrome | 40 | 111.1 79.5–155.2ROR 111.2 · calibrated p 1e-7 ✓ | 91.2 EB05 69.8 · IC025 +4.9 3/3 methods agree vs other Vitamin Cs: only this drug | No label text to screen label has no adverse-reaction text | serious n=40 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Anticoagulant therapy | 31 | 84.3 58.0–122.5ROR 84.4 · calibrated p 9e-7 ✓ | 71.7 EB05 52.9 · IC025 +4.5 3/3 methods agree vs other Vitamin Cs: PRR 5.6 (3.3–9.6) | Reporting / coding artifact | serious n=31 · ♀ 0% (drug 68%) · 100% clinician | not reported in cached trials |
| Granulocyte count increased | 40 | 73.4 53.0–101.8ROR 73.5 · calibrated p 2e-6 ✓ | 64.2 EB05 49.2 · IC025 +4.7 3/3 methods agree vs other Vitamin Cs: only this drug | Lab value / disease marker | serious n=40 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Electric shock | 68 | 58.4 45.6–74.9ROR 58.6 · calibrated p 7e-6 ✓ | 53.0 EB05 43.3 · IC025 +4.9 3/3 methods agree vs other Vitamin Cs: only this drug | No label text to screen label has no adverse-reaction text | serious n=67 · ♀ 100% (drug 68%) | not reported in cached trials |
| Blood immunoglobulin a increased | 41 | 55.5 40.4–76.3ROR 55.6 · calibrated p 1e-5 ✓ | 50.2 EB05 38.6 · IC025 +4.5 3/3 methods agree vs other Vitamin Cs: only this drug | Lab value / disease marker | serious n=40 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Vitamin b12 increased | 53 | 48.1 36.4–63.6ROR 48.2 · calibrated p 2e-5 ✓ | 44.2 EB05 35.1 · IC025 +4.5 3/3 methods agree vs other Vitamin Cs: only this drug | Lab value / disease marker | serious n=48 · ♀ 100% (drug 68%) | not reported in cached trials |
| Glomerular filtration rate increased | 43 | 37.4 27.5–50.9ROR 37.5 · calibrated p 1e-4 ✓ | 35.0 EB05 27.1 · IC025 +4.2 3/3 methods agree vs other Vitamin Cs: only this drug | Lab value / disease marker | serious n=42 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 59 | 29.6 22.8–38.4ROR 29.6 · calibrated p 4e-4 ✓ | 28.1 EB05 22.6 · IC025 +4.1 3/3 methods agree vs other Vitamin Cs: PRR 2.2 (1.6–3.0) | No label text to screen label has no adverse-reaction text | serious n=58 · ♀ 0% (drug 68%) | not reported in cached trials |
| Dactylitis | 41 | 29.2 21.4–39.9ROR 29.2 · calibrated p 4e-4 ✓ | 27.7 EB05 21.3 · IC025 +3.9 3/3 methods agree vs other Vitamin Cs: only this drug | No label text to screen label has no adverse-reaction text | serious n=40 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Myoglobin blood increased | 62 | 28.2 21.9–36.4ROR 28.3 · calibrated p 4e-4 ✓ | 26.9 EB05 21.7 · IC025 +4.1 3/3 methods agree vs other Vitamin Cs: only this drug | Lab value / disease marker | serious n=62 · ♀ 0% (drug 68%) | not reported in cached trials |
| Female genital tract fistula | 67 | 27.1 21.3–34.6ROR 27.2 · calibrated p 5e-4 ✓ | 25.9 EB05 21.1 · IC025 +4.1 3/3 methods agree vs other Vitamin Cs: PRR 10.5 (6.8–16.3) | No label text to screen label has no adverse-reaction text | serious n=67 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Intervertebral discitis | 73 | 26.9 21.3–33.9ROR 26.9 · calibrated p 5e-4 ✓ | 25.7 EB05 21.1 · IC025 +4.1 3/3 methods agree vs other Vitamin Cs: only this drug | No label text to screen label has no adverse-reaction text | serious n=72 · ♀ 100% (drug 68%) | not reported in cached trials |
| Blood phosphorus increased | 101 | 25.8 21.1–31.4ROR 25.9 · calibrated p 6e-4 ✓ | 24.7 EB05 21.0 · IC025 +4.1 3/3 methods agree vs other Vitamin Cs: PRR 2.1 (1.7–2.7) | Lab value / disease marker | serious n=99 · ♀ 0% (drug 68%) · 100% clinician | not reported in cached trials |
| Rheumatoid factor increased | 41 | 25.5 18.7–34.8ROR 25.5 · calibrated p 8e-4 ✓ | 24.3 EB05 18.7 · IC025 +3.7 3/3 methods agree vs other Vitamin Cs: only this drug | No label text to screen label has no adverse-reaction text | serious n=41 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Anaemia postoperative | 46 | 24.3 18.1–32.6ROR 24.3 · calibrated p 1e-3 ✓ | 23.3 EB05 18.2 · IC025 +3.8 3/3 methods agree vs other Vitamin Cs: PRR 4.1 (2.8–6.1) | No label text to screen label has no adverse-reaction text | serious n=46 · ♀ 100% (drug 68%) | not reported in cached trials |
| Hyperphosphataemia | 73 | 23.9 18.9–30.2ROR 23.9 · calibrated p 1e-3 ✓ | 23.0 EB05 18.9 · IC025 +3.9 3/3 methods agree vs other Vitamin Cs: PRR 1.9 (1.4–2.5) | No label text to screen label has no adverse-reaction text | serious n=73 · ♀ 0% (drug 68%) · 100% clinician | not reported in cached trials |
| Intramedullary rod insertion | 71 | 23.7 18.7–30.0ROR 23.7 · calibrated p 0.001 ✓ | 22.8 EB05 18.7 · IC025 +3.9 3/3 methods agree vs other Vitamin Cs: PRR 2.7 (2.0–3.6) | No label text to screen label has no adverse-reaction text | serious n=71 · ♀ 100% (drug 68%) | not reported in cached trials |
| Open reduction of fracture | 37 | 22.1 15.9–30.6ROR 22.1 · calibrated p 0.002 ✓ | 21.2 EB05 16.0 · IC025 +3.5 3/3 methods agree vs other Vitamin Cs: PRR 3.4 (2.2–5.2) | No label text to screen label has no adverse-reaction text | serious n=37 · ♀ 100% (drug 68%) | not reported in cached trials |
| Cystocele | 27 | 21.6 14.7–31.7ROR 21.6 · calibrated p 0.002 ✓ | 20.7 EB05 14.9 · IC025 +3.3 3/3 methods agree vs other Vitamin Cs: only this drug | No label text to screen label has no adverse-reaction text | serious n=27 · ♀ 100% (drug 68%) | not reported in cached trials |
| Radiculopathy | 82 | 21.5 17.3–26.8ROR 21.5 · calibrated p 0.002 ✓ | 20.8 EB05 17.3 · IC025 +3.9 3/3 methods agree vs other Vitamin Cs: PRR 8.5 (5.9–12.2) | No label text to screen label has no adverse-reaction text | serious n=82 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Muscle cramp | 52 | 19.9 15.1–26.2ROR 20.0 · calibrated p 0.002 ✓ | 19.2 EB05 15.2 · IC025 +3.6 3/3 methods agree vs other Vitamin Cs: only this drug | No label text to screen label has no adverse-reaction text | ♀ 100% (drug 68%) | not reported in cached trials |
| Chronic sinusitis | 103 | 18.9 15.6–23.0ROR 19.0 · calibrated p 0.003 ✓ | 18.4 EB05 15.6 · IC025 +3.8 3/3 methods agree vs other Vitamin Cs: PRR 3.0 (2.3–3.8) | No label text to screen label has no adverse-reaction text | serious n=102 · ♀ 100% (drug 68%) | not reported in cached trials |
| Blood uric acid increased | 144 | 17.1 14.5–20.2ROR 17.2 · calibrated p 0.004 ✓ | 16.7 EB05 14.5 · IC025 +3.7 3/3 methods agree vs other Vitamin Cs: PRR 2.8 (2.3–3.5) | Lab value / disease marker | serious n=140 · ♀ 44% (drug 68%) | not reported in cached trials |
| Proctitis | 70 | 17.1 13.5–21.7ROR 17.2 · calibrated p 0.004 ✓ | 16.6 EB05 13.6 · IC025 +3.5 3/3 methods agree vs other Vitamin Cs: PRR 9.7 (6.4–14.6) | No label text to screen label has no adverse-reaction text | serious n=70 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Joint noise | 48 | 17.0 12.8–22.6ROR 17.0 · calibrated p 0.005 ✓ | 16.5 EB05 12.9 · IC025 +3.4 3/3 methods agree vs other Vitamin Cs: only this drug | No label text to screen label has no adverse-reaction text | serious n=47 · ♀ 100% (drug 68%) | not reported in cached trials |
| Plantar fasciitis | 81 | 16.5 13.3–20.6ROR 16.6 · calibrated p 0.005 ✓ | 16.1 EB05 13.3 · IC025 +3.5 3/3 methods agree vs other Vitamin Cs: only this drug | No label text to screen label has no adverse-reaction text | serious n=80 · ♀ 0% (drug 68%) | not reported in cached trials |
| Brain natriuretic peptide increased | 74 | 16.5 13.1–20.7ROR 16.5 · calibrated p 0.005 ✓ | 16.0 EB05 13.1 · IC025 +3.5 3/3 methods agree vs other Vitamin Cs: only this drug | Lab value / disease marker | serious n=73 · ♀ 0% (drug 68%) | not reported in cached trials |
| Low turnover osteopathy | 97 | 16.4 13.4–20.1ROR 16.5 · calibrated p 0.005 ✓ | 16.0 EB05 13.5 · IC025 +3.6 3/3 methods agree vs other Vitamin Cs: PRR 4.0 (3.1–5.3) | No label text to screen label has no adverse-reaction text | serious n=97 · ♀ 100% (drug 68%) | not reported in cached trials |
| Spondylolisthesis | 40 | 15.7 11.5–21.5ROR 15.8 · calibrated p 0.007 ✓ | 15.2 EB05 11.5 · IC025 +3.2 3/3 methods agree vs other Vitamin Cs: PRR 4.3 (2.8–6.7) | No label text to screen label has no adverse-reaction text | serious n=40 · ♀ 100% (drug 68%) | not reported in cached trials |
| Fracture nonunion | 31 | 15.4 10.8–22.0ROR 15.5 · calibrated p 0.008 ✓ | 14.8 EB05 10.7 · IC025 +3.0 3/3 methods agree vs other Vitamin Cs: PRR 3.1 (1.9–4.8) | No label text to screen label has no adverse-reaction text | serious n=31 · ♀ 100% (drug 68%) | not reported in cached trials |
| Infective pulmonary exacerbation of cystic fibrosis | 115 | 14.3 11.9–17.2ROR 14.4 · calibrated p 0.009 ✓ | 14.0 EB05 11.9 · IC025 +3.4 3/3 methods agree vs other Vitamin Cs: PRR 6.5 (4.9–8.6) | No label text to screen label has no adverse-reaction text | serious n=101 · ♀ 42% (drug 68%) | not reported in cached trials |
| Total lung capacity decreased | 33 | 14.1 10.0–19.9ROR 14.1 · calibrated p 0.011 ✓ | 13.5 EB05 9.8 · IC025 +3.0 3/3 methods agree vs other Vitamin Cs: PRR 5.2 (3.1–8.5) | No label text to screen label has no adverse-reaction text | serious n=33 · 100% clinician | not reported in cached trials |
| Osteosclerosis | 32 | 13.9 9.8–19.7ROR 13.9 · calibrated p 0.012 ✓ | 13.2 EB05 9.6 · IC025 +2.9 3/3 methods agree vs other Vitamin Cs: PRR 4.3 (2.6–6.9) | No label text to screen label has no adverse-reaction text | serious n=32 | 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 Vitamin E 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).
- NCT00000479 — Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of (N=39876, PHASE3; 5 AE terms posted; arms: Aspirin Only; Vitamin E Only; Aspirin + Vitamin E; Both Placebos)
- NCT00006392 — S0000 Selenium and Vitamin E in Preventing Prostate Cancer (N=35533, PHASE3; 60 AE terms posted; arms: Selenium Alone; Combination; Placebo; Vitamin E Alone)
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) | 2,802 | 2.4 2.3–2.5ROR 2.6 · calibrated p 0.786 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Vitamin Cs: PRR 1.0 (0.9–1.0) | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | NCT00006392: 660/8,737 (7.6%) on Vitamin E; 632/8,696 (7.3%) control |
| Nausea | 2,460 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.958 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Vitamin Cs: PRR 1.2 (1.1–1.2) | No label text to screen label has no adverse-reaction text | serious PRR 2.5 | not reported in cached trials |
| Diarrhoea (diarrhea) | 2,265 | 2.4 2.3–2.5ROR 2.5 · calibrated p 0.825 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Vitamin Cs: PRR 1.1 (1.1–1.2) | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | not reported in cached trials |
| Drug ineffective (drug did not work) | 2,132 | 1.1 1.0–1.1ROR 1.1 · calibrated p 0.367 | 1.1 EB05 1.0 · IC025 +0.0 vs other Vitamin Cs: PRR 1.1 (1.0–1.1) | Reporting / coding artifact | serious PRR 1.5 | not reported in cached trials |
| Headache | 2,067 | 2.2 2.1–2.3ROR 2.3 · calibrated p 0.901 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree vs other Vitamin Cs: PRR 1.0 (0.9–1.0) | No label text to screen label has no adverse-reaction text | serious PRR 2.6 | NCT00006392: 1/8,737 (0.0%) on Vitamin E (serious AE) |
| Pain | 1,924 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.965 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Vitamin Cs: PRR 0.9 (0.9–0.9) | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | not reported in cached trials |
| Dizziness | 1,809 | 2.4 2.3–2.6ROR 2.5 · calibrated p 0.800 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Vitamin Cs: PRR 1.2 (1.1–1.2) | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,765 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.971 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Vitamin Cs: PRR 1.1 (1.0–1.1) | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | NCT00006392: 1/8,737 (0.0%) on Vitamin E; 1/8,696 (0.0%) control (serious AE) |
| Arthralgia (joint pain) | 1,667 | 2.7 2.6–2.8ROR 2.8 · calibrated p 0.695 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Vitamin Cs: PRR 1.1 (1.0–1.1) | No label text to screen label has no adverse-reaction text | serious PRR 3.4 | NCT00006392: 1/8,696 (0.0%) control (serious AE) |
| Asthenia (weakness) | 1,532 | 2.7 2.6–2.9ROR 2.8 · calibrated p 0.685 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Vitamin Cs: PRR 1.1 (1.0–1.1) | No label text to screen label has no adverse-reaction text | serious PRR 2.8 | not reported in cached trials |
| Fall | 1,480 | 3.0 2.8–3.1ROR 3.1 · calibrated p 0.597 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree vs other Vitamin Cs: PRR 1.4 (1.3–1.5) | No label text to screen label has no adverse-reaction text | serious PRR 3.0 | not reported in cached trials |
| Weight decreased (weight loss) | 1,416 | 3.4 3.2–3.6ROR 3.5 · calibrated p 0.477 | 3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree vs other Vitamin Cs: PRR 1.5 (1.5–1.6) | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | NCT00006392: 1/8,696 (0.0%) control (serious AE) |
| Pain in extremity | 1,243 | 2.8 2.7–3.0ROR 2.9 · calibrated p 0.657 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Vitamin Cs: PRR 1.2 (1.1–1.2) | No label text to screen label has no adverse-reaction text | serious PRR 3.3 | not reported in cached trials |
| Off label use (used outside approved label) | 1,235 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.276 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Vitamin Cs: PRR 0.6 (0.6–0.7) | Reporting / coding artifact | serious PRR 1.1 | not reported in cached trials |
| Vomiting | 1,222 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.818 | 1.7 EB05 1.7 · IC025 +0.7 vs other Vitamin Cs: PRR 0.9 (0.8–0.9) | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | 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 Vitamin E?
In FDA FAERS, the most frequently co-reported reaction terms for Vitamin E are fatigue, nausea, diarrhoea, headache, pain, dizziness. 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 Vitamin E have an FDA boxed warning?
No. The FDA label retrieved for Vitamin E has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Vitamin E 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 3f60193e-4b95-6759-e063-6394a90a991c, effective 20251217; matched on
openfda.generic_name.exact:"VITAMIN E") - 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, 1,193 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
VITAMIN E, 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.