Biotin side effects: what 30,995 FDA adverse event reports show

Biotin · 1,190 reaction terms · 142,875 drug–reaction co-reports · data 2026-09-14

Drug class

Arteriolar Vasodilator

FDA label (Established Pharmacologic Class) · compare the class

Who reports

30,995 reports · 47% serious · 966 with death outcome · 90% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed

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 6Lab value / disease marker 4No label text to screen 30

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). 1,150 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Fractional exhaled nitric oxide increased	118	1,482.9 1,072.6–2,050.2ROR 1,488.6 · calibrated p 1e-18 ✓	428.2 EB05 367.2 · IC025 +7.0 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=118 · ♀ 0% (drug 90%)	no trial arm names this drug
Antacid therapy	49	466.2 323.7–671.6ROR 467.0 · calibrated p 6e-13 ✓	248.1 EB05 195.1 · IC025 +5.7 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	Reporting / coding artifact	serious n=49 · ♀ 0% (drug 90%) · 100% clinician	no trial arm names this drug
Sleep disorder therapy	69	399.6 296.6–538.5ROR 400.5 · calibrated p 2e-12 ✓	234.0 EB05 191.2 · IC025 +6.1 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	Reporting / coding artifact	serious n=69 · ♀ 0% (drug 90%) · 100% clinician	no trial arm names this drug
Appendicolith	94	222.8 176.5–281.3ROR 223.5 · calibrated p 2e-10 ✓	161.8 EB05 136.1 · IC025 +6.1 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=94 · ♀ 0% (drug 90%) · 100% clinician	no trial arm names this drug
Analgesic therapy	71	203.8 156.3–265.8ROR 204.3 · calibrated p 6e-10 ✓	150.1 EB05 123.0 · IC025 +5.8 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	Reporting / coding artifact	serious n=71 · ♀ 0% (drug 90%) · 100% clinician	no trial arm names this drug
Drug therapy	68	182.6 139.7–238.8ROR 183.0 · calibrated p 2e-9 ✓	138.1 EB05 112.6 · IC025 +5.7 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	Reporting / coding artifact	serious n=68 · ♀ 0% (drug 90%) · 100% clinician	no trial arm names this drug
Presbyacusis	64	175.4 133.2–231.0ROR 175.8 · calibrated p 2e-9 ✓	133.6 EB05 108.3 · IC025 +5.7 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=64 · 100% clinician	no trial arm names this drug
Congenital hiatus hernia	43	162.7 116.6–227.1ROR 163.0 · calibrated p 6e-9 ✓	123.9 EB05 95.8 · IC025 +5.2 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=43 · ♀ 0% (drug 90%) · 100% clinician	no trial arm names this drug
Anticoagulant therapy	50	148.7 109.4–202.0ROR 148.9 · calibrated p 1e-8 ✓	116.4 EB05 91.8 · IC025 +5.3 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	Reporting / coding artifact	serious n=50 · ♀ 0% (drug 90%) · 100% clinician	no trial arm names this drug
Malignant melanoma stage 0	32	145.0 98.9–212.5ROR 145.1 · calibrated p 2e-8 ✓	111.5 EB05 82.7 · IC025 +4.8 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=32 · ♀ 0% (drug 90%) · 100% clinician	no trial arm names this drug
Pleural thickening	66	72.4 56.2–93.3ROR 72.6 · calibrated p 2e-6 ✓	64.3 EB05 52.3 · IC025 +5.1 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=66	no trial arm names this drug
Bacteroides infection	24	68.9 45.3–104.9ROR 69.0 · calibrated p 4e-6 ✓	59.7 EB05 42.2 · IC025 +4.1 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=24 · ♀ 0% (drug 90%) · 100% clinician	no trial arm names this drug
Gait spastic	32	68.5 47.6–98.6ROR 68.6 · calibrated p 3e-6 ✓	60.1 EB05 44.6 · IC025 +4.4 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=31 · ♀ 0% (drug 90%) · 100% clinician	no trial arm names this drug
Obstructive sleep apnoea syndrome	118	62.4 51.7–75.3ROR 62.6 · calibrated p 4e-6 ✓	56.6 EB05 48.6 · IC025 +5.2 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=118 · ♀ 0% (drug 90%)	no trial arm names this drug
Myoglobin blood increased	119	56.8 47.1–68.5ROR 57.0 · calibrated p 7e-6 ✓	52.0 EB05 44.6 · IC025 +5.1 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	Lab value / disease marker	serious n=119 · ♀ 0% (drug 90%)	no trial arm names this drug
Blood magnesium increased	66	53.2 41.4–68.4ROR 53.3 · calibrated p 1e-5 ✓	48.7 EB05 39.6 · IC025 +4.8 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	Lab value / disease marker	serious n=65	no trial arm names this drug
Pleural fibrosis	66	46.2 36.0–59.3ROR 46.3 · calibrated p 3e-5 ✓	42.8 EB05 34.8 · IC025 +4.6 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=66	no trial arm names this drug
Needle fatigue	29	45.7 31.4–66.5ROR 45.7 · calibrated p 4e-5 ✓	41.7 EB05 30.5 · IC025 +4.0 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=28 · ♀ 0% (drug 90%) · 100% clinician	no trial arm names this drug
Relapsing-remitting multiple sclerosis	39	32.0 23.2–44.0ROR 32.0 · calibrated p 3e-4 ✓	30.1 EB05 23.0 · IC025 +3.9 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=39 · ♀ 0% (drug 90%) · 100% clinician	no trial arm names this drug
Hyperphosphataemia	92	30.6 24.9–37.7ROR 30.7 · calibrated p 3e-4 ✓	29.2 EB05 24.5 · IC025 +4.3 3/3 methods agree vs other Arteriolar Vasodilators: PRR 13.1 (7.5–23.1)	No label text to screen label has no adverse-reaction text	serious n=92 · ♀ 0% (drug 90%) · 100% clinician	no trial arm names this drug
Bronchopulmonary aspergillosis allergic	36	27.6 19.8–38.5ROR 27.6 · calibrated p 6e-4 ✓	26.2 EB05 19.8 · IC025 +3.7 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=36 · ♀ 0% (drug 90%) · 100% clinician	no trial arm names this drug
Brain natriuretic peptide increased	120	27.4 22.8–32.8ROR 27.5 · calibrated p 5e-4 ✓	26.2 EB05 22.5 · IC025 +4.3 3/3 methods agree vs other Arteriolar Vasodilators: PRR 20.0 (11.1–36.2)	Lab value / disease marker	serious n=120 · ♀ 0% (drug 90%)	no trial arm names this drug
Plantar fasciitis	128	26.7 22.4–31.8ROR 26.8 · calibrated p 5e-4 ✓	25.6 EB05 22.1 · IC025 +4.3 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=124 · ♀ 0% (drug 90%)	no trial arm names this drug
Bone cyst	33	24.6 17.4–34.8ROR 24.6 · calibrated p 0.001 ✓	23.4 EB05 17.5 · IC025 +3.6 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=33 · 100% clinician	no trial arm names this drug
Blood phosphorus increased	86	22.0 17.8–27.3ROR 22.1 · calibrated p 0.001 ✓	21.2 EB05 17.7 · IC025 +3.9 3/3 methods agree vs other Arteriolar Vasodilators: PRR 9.6 (5.8–15.9)	Lab value / disease marker	serious n=86 · ♀ 0% (drug 90%) · 100% clinician	no trial arm names this drug
Wrong patient received medication	84	21.1 17.0–26.2ROR 21.2 · calibrated p 0.002 ✓	20.4 EB05 17.0 · IC025 +3.8 3/3 methods agree vs other Arteriolar Vasodilators: PRR 15.3 (8.1–28.6)	Reporting / coding artifact	100% consumer	no trial arm names this drug
Total lung capacity decreased	45	19.5 14.5–26.2ROR 19.5 · calibrated p 0.003 ✓	18.8 EB05 14.6 · IC025 +3.5 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=44 · ♀ 0% (drug 90%) · 100% clinician	no trial arm names this drug
Periorbital pain	22	19.0 12.5–29.1ROR 19.0 · calibrated p 0.004 ✓	18.2 EB05 12.5 · IC025 +3.0 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Trichorrhexis	70	17.4 13.7–22.0ROR 17.4 · calibrated p 0.004 ✓	16.9 EB05 13.8 · IC025 +3.5 3/3 methods agree vs other Arteriolar Vasodilators: PRR 0.5 (0.4–0.7)	No label text to screen label has no adverse-reaction text	serious n=16 · 100% consumer	no trial arm names this drug
Deafness neurosensory	77	16.2 13.0–20.4ROR 16.3 · calibrated p 0.005 ✓	15.8 EB05 13.0 · IC025 +3.5 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=76	no trial arm names this drug
Osteosclerosis	37	16.2 11.7–22.5ROR 16.2 · calibrated p 0.006 ✓	15.6 EB05 11.7 · IC025 +3.2 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=37 · 100% clinician	no trial arm names this drug
Infusion site discharge	39	15.8 11.5–21.6ROR 15.8 · calibrated p 0.007 ✓	15.2 EB05 11.5 · IC025 +3.2 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=32 · 100% consumer	no trial arm names this drug
Eyelid pain	40	14.2 10.4–19.4ROR 14.2 · calibrated p 0.010 ✓	13.7 EB05 10.3 · IC025 +3.1 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	100% consumer	no trial arm names this drug
Hypertonic bladder	56	13.4 10.3–17.4ROR 13.4 · calibrated p 0.012 ✓	13.0 EB05 10.3 · IC025 +3.1 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=46 · ♀ 40% (drug 90%)	no trial arm names this drug
Exostosis	174	13.1 11.3–15.2ROR 13.2 · calibrated p 0.012 ✓	12.8 EB05 11.3 · IC025 +3.4 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious PRR 18.7 · ♀ 41% (drug 90%)	no trial arm names this drug
Onychoclasis	130	13.0 10.9–15.5ROR 13.1 · calibrated p 0.013 ✓	12.7 EB05 11.0 · IC025 +3.3 3/3 methods agree vs other Arteriolar Vasodilators: PRR 37.1 (17.4–79.4)	No label text to screen label has no adverse-reaction text	serious n=61	no trial arm names this drug
Epigastric discomfort	72	12.6 10.0–15.9ROR 12.7 · calibrated p 0.015 ✓	12.2 EB05 10.0 · IC025 +3.1 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=67	no trial arm names this drug
Hair growth abnormal	125	12.4 10.4–14.8ROR 12.5 · calibrated p 0.015 ✓	12.1 EB05 10.4 · IC025 +3.2 3/3 methods agree vs other Arteriolar Vasodilators: PRR 0.3 (0.3–0.4)	No label text to screen label has no adverse-reaction text	serious n=23 · 93% consumer	no trial arm names this drug
Iron deficiency	78	12.1 9.6–15.1ROR 12.1 · calibrated p 0.018 ✓	11.7 EB05 9.6 · IC025 +3.1 3/3 methods agree vs other Arteriolar Vasodilators: PRR 13.0 (7.1–23.9)	No label text to screen label has no adverse-reaction text	serious n=74 · ♀ 30% (drug 90%)	no trial arm names this drug
Infusion site haemorrhage	56	11.9 9.1–15.5ROR 11.9 · calibrated p 0.019 ✓	11.4 EB05 9.0 · IC025 +3.0 3/3 methods agree vs other Arteriolar Vasodilators: only this drug	No label text to screen label has no adverse-reaction text	serious n=39 · 71% consumer	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Biotin only as a background or rescue medication (NCT06605768, NCT00064753); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

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)	3,177	2.8 2.7–2.9ROR 3.0 · calibrated p 0.635	2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Arteriolar Vasodilators: PRR 8.5 (7.9–9.2)	No label text to screen label has no adverse-reaction text	serious PRR 3.4	no trial arm names this drug
Nausea	2,352	2.0 1.9–2.1ROR 2.1 · calibrated p 0.998	2.0 EB05 1.9 · IC025 +0.9 vs other Arteriolar Vasodilators: PRR 5.8 (5.4–6.3)	No label text to screen label has no adverse-reaction text	serious PRR 2.7	no trial arm names this drug
Headache	2,249	2.4 2.3–2.5ROR 2.5 · calibrated p 0.794	2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Arteriolar Vasodilators: PRR 1.9 (1.8–2.0)	No label text to screen label has no adverse-reaction text	serious PRR 3.0	no trial arm names this drug
Alopecia (hair loss)	2,245	7.8 7.5–8.1ROR 8.3 · calibrated p 0.059	7.7 EB05 7.4 · IC025 +2.9 3/3 methods agree vs other Arteriolar Vasodilators: PRR 1.0 (0.9–1.0)	No label text to screen label has no adverse-reaction text	serious PRR 7.1 · 78% consumer	no trial arm names this drug
Drug ineffective (drug did not work)	2,038	1.0 1.0–1.1ROR 1.0 · calibrated p 0.339	1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Arteriolar Vasodilators: PRR 0.3 (0.3–0.3)	Reporting / coding artifact	serious PRR 1.5	no trial arm names this drug
Diarrhoea (diarrhea)	1,983	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 Arteriolar Vasodilators: PRR 7.9 (7.2–8.8)	No label text to screen label has no adverse-reaction text	serious PRR 2.3	no trial arm names this drug
Pain	1,777	2.0 1.9–2.0ROR 2.0 · calibrated p 0.951	2.0 EB05 1.9 · IC025 +0.9 vs other Arteriolar Vasodilators: PRR 6.8 (6.2–7.5)	No label text to screen label has no adverse-reaction text	serious PRR 2.2	no trial arm names this drug
Dizziness	1,652	2.2 2.1–2.4ROR 2.3 · calibrated p 0.895	2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Arteriolar Vasodilators: PRR 2.3 (2.1–2.5)	No label text to screen label has no adverse-reaction text	serious PRR 2.7	no trial arm names this drug
Off label use (used outside approved label)	1,556	1.2 1.2–1.3ROR 1.2 · calibrated p 0.456	1.2 EB05 1.2 · IC025 +0.2 vs other Arteriolar Vasodilators: PRR 0.8 (0.8–0.9)	Reporting / coding artifact	serious PRR 1.3	no trial arm names this drug
Dyspnoea (shortness of breath)	1,483	1.8 1.7–1.9ROR 1.8 · calibrated p 0.838	1.8 EB05 1.7 · IC025 +0.7 vs other Arteriolar Vasodilators: PRR 3.8 (3.5–4.2)	No label text to screen label has no adverse-reaction text	serious PRR 2.2	no trial arm names this drug
Arthralgia (joint pain)	1,477	2.4 2.3–2.5ROR 2.5 · calibrated p 0.819	2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Arteriolar Vasodilators: PRR 7.8 (7.0–8.7)	No label text to screen label has no adverse-reaction text	serious PRR 3.2	no trial arm names this drug
Pruritus (itching)	1,348	2.4 2.3–2.5ROR 2.5 · calibrated p 0.822	2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Arteriolar Vasodilators: PRR 1.9 (1.8–2.0)	No label text to screen label has no adverse-reaction text	serious PRR 2.6	no trial arm names this drug
Fall	1,227	2.5 2.4–2.6ROR 2.6 · calibrated p 0.787	2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other Arteriolar Vasodilators: PRR 13.6 (11.6–15.8)	No label text to screen label has no adverse-reaction text	serious PRR 2.7	no trial arm names this drug
Asthenia (weakness)	1,124	2.0 1.9–2.1ROR 2.1 · calibrated p 0.978	2.0 EB05 1.9 · IC025 +0.9 vs other Arteriolar Vasodilators: PRR 6.3 (5.6–7.1)	No label text to screen label has no adverse-reaction text	serious PRR 2.3	no trial arm names this drug
Pain in extremity	1,103	2.5 2.4–2.7ROR 2.6 · calibrated p 0.776	2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other Arteriolar Vasodilators: PRR 10.6 (9.1–12.2)	No label text to screen label has no adverse-reaction text	serious PRR 3.3	no trial arm names this drug

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 Biotin?

In FDA FAERS, the most frequently co-reported reaction terms for Biotin are fatigue, nausea, headache, alopecia, diarrhoea, pain. 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 Biotin have an FDA boxed warning?

No. The FDA label retrieved for Biotin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Biotin 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 4c6ec616-a84e-6e1a-e063-6294a90a2aae, effective 20260307; matched on openfda.generic_name.exact:"BIOTIN")
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, field patient.drug.openfda.generic_name.exact, 1,190 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 BIOTIN, 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.