Drug · FAERS side-effect profile with label screen
Pyridoxine side effects: what 2,646 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Pyridoxine Hydrochloride (Pyridoxine Hydrochloride)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
2,646 reports · 83% serious · 590 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Pyridoxine Hydrochloride Injection is effective for the treatment of pyridoxine deficiency as seen in the following: Inadequate dietary intake. Drug-induced deficiency, as from isoniazid (INH) or oral contraceptives. Inborn errors of metabolism, e.g., vitamin B 6 dependent convulsions or vitamin B 6 responsive anemia.
FDA label, Indications and Usage
What it is
DESCRIPTION: Pyridoxine Hydrochloride Injection, USP is a sterile solution of pyridoxine hydrochloride in Water for Injection.
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
Reporting / coding artifact 2Lab value / disease marker 2No label text to screen 36
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 252 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 |
|---|---|---|---|---|---|---|
| Appendicitis | 234 | 204.4 180.6–231.4ROR 224.1 · χ² 45,985 / p <1e-300 | 196.1 EB05 175.9 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 140.4 · ♀ 8% (drug 58%) · 96% clinician | no trial data cached |
| Ventricular fibrillation | 190 | 137.4 119.6–157.8ROR 147.9 · χ² 25,159 / p <1e-300 | 133.2 EB05 118.1 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 94.0 · ♀ 4% (drug 58%) · 95% clinician | no trial data cached |
| Cardiogenic shock | 225 | 126.8 111.8–143.9ROR 138.5 · χ² 27,531 / p <1e-300 | 123.5 EB05 110.6 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 86.6 · ♀ 8% (drug 58%) · 96% clinician | no trial data cached |
| Folliculitis | 104 | 80.5 66.6–97.3ROR 83.7 · χ² 8,007 / p <1e-300 | 78.6 EB05 66.7 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 65.1 · ♀ 99% (drug 58%) · 94% clinician | no trial data cached |
| Bursitis | 111 | 73.5 61.2–88.2ROR 76.7 · χ² 7,796 / p <1e-300 | 71.9 EB05 61.4 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 59.6 · ♀ 100% (drug 58%) · 95% clinician | no trial data cached |
| Incorrect route of product administration | 143 | 67.9 57.9–79.7ROR 71.7 · χ² 9,290 / p <1e-300 | 66.8 EB05 58.1 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 93.5 · ♀ 26% (drug 58%) · 95% clinician | no trial data cached |
| Helicobacter infection | 84 | 65.8 53.2–81.2ROR 67.9 · χ² 5,250 / p <1e-300 | 64.3 EB05 53.6 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.9 · ♀ 100% (drug 58%) · 96% clinician | no trial data cached |
| Ascites | 242 | 65.7 58.2–74.1ROR 72.2 · χ² 15,238 / p <1e-300 | 64.8 EB05 58.2 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.9 · ♀ 11% (drug 58%) · 95% clinician | no trial data cached |
| Pemphigus | 101 | 64.8 53.5–78.6ROR 67.4 · χ² 6,235 / p <1e-300 | 63.6 EB05 53.8 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.8 · ♀ 100% (drug 58%) · 97% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 217 | 62.0 54.6–70.5ROR 67.5 · χ² 12,885 / p <1e-300 | 61.2 EB05 54.7 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.7 · ♀ 3% (drug 58%) · 95% clinician | no trial data cached |
| Pericarditis | 126 | 60.3 50.8–71.5ROR 63.3 · χ² 7,238 / p <1e-300 | 59.3 EB05 51.1 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.9 · ♀ 99% (drug 58%) · 97% clinician | no trial data cached |
| Wound infection | 80 | 58.7 47.3–72.9ROR 60.5 · χ² 4,448 / p <1e-300 | 57.5 EB05 47.7 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.4 · ♀ 100% (drug 58%) · 96% clinician | no trial data cached |
| Bacterial infection | 121 | 51.9 43.6–61.8ROR 54.3 · χ² 5,956 / p <1e-300 | 51.2 EB05 44.0 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.4 · ♀ 16% (drug 58%) · 96% clinician | no trial data cached |
| Joint range of motion decreased | 87 | 51.9 42.1–63.8ROR 53.6 · χ² 4,262 / p <1e-300 | 51.0 EB05 42.6 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.6 · ♀ 100% (drug 58%) · 98% clinician | no trial data cached |
| Hand deformity | 81 | 49.3 39.8–61.1ROR 50.8 · χ² 3,764 / p <1e-300 | 48.5 EB05 40.2 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.0 · ♀ 100% (drug 58%) · 99% clinician | no trial data cached |
| Obesity | 88 | 43.9 35.7–53.9ROR 45.4 · χ² 3,628 / p <1e-300 | 43.3 EB05 36.2 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.2 · ♀ 99% (drug 58%) · 100% clinician | no trial data cached |
| Synovitis | 99 | 43.7 36.0–53.0ROR 45.3 · χ² 4,064 / p <1e-300 | 43.1 EB05 36.4 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.6 · ♀ 100% (drug 58%) · 98% clinician | no trial data cached |
| Hyperlipidaemia | 65 | 43.2 33.9–54.9ROR 44.2 · χ² 2,622 / p <1e-300 | 42.4 EB05 34.5 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.8 · ♀ 29% (drug 58%) · 95% clinician | no trial data cached |
| Taste disorder | 107 | 42.5 35.3–51.2ROR 44.2 · χ² 4,274 / p <1e-300 | 42.0 EB05 35.7 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 57.3 · ♀ 98% (drug 58%) | no trial data cached |
| Blood cholesterol increased | 233 | 39.7 35.1–44.9ROR 43.5 · χ² 8,736 / p <1e-300 | 39.4 EB05 35.4 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious PRR 41.3 · 96% clinician | no trial data cached |
| Neuralgia | 113 | 37.0 30.9–44.4ROR 38.7 · χ² 3,914 / p <1e-300 | 36.7 EB05 31.3 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.0 · ♀ 6% (drug 58%) · 95% clinician | no trial data cached |
| Irritable bowel syndrome | 93 | 34.6 28.3–42.3ROR 35.8 · χ² 2,991 / p <1e-300 | 34.2 EB05 28.8 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.4 · ♀ 99% (drug 58%) · 96% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 238 | 33.7 29.8–38.0ROR 36.9 · χ² 7,497 / p <1e-300 | 33.4 EB05 30.0 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.9 · ♀ 4% (drug 58%) · 95% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 87 | 30.9 25.1–38.0ROR 31.9 · χ² 2,482 / p <1e-300 | 30.6 EB05 25.6 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.3 · ♀ 99% (drug 58%) · 97% clinician | no trial data cached |
| Pneumonia aspiration | 96 | 30.6 25.1–37.3ROR 31.7 · χ² 2,712 / p <1e-300 | 30.3 EB05 25.6 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.2 · ♀ 97% (drug 58%) | no trial data cached |
| Red blood cell sedimentation rate increased | 42 | 30.1 22.3–40.6ROR 30.6 · χ² 1,148 / p 5e-252 | 29.6 EB05 22.8 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious PRR 23.6 · ♀ 100% (drug 58%) · 93% clinician | no trial data cached |
| Back injury | 41 | 30.1 22.2–40.8ROR 30.5 · χ² 1,120 / p 7e-246 | 29.6 EB05 22.8 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.6 · ♀ 100% (drug 58%) · 95% clinician | no trial data cached |
| End stage renal disease | 68 | 29.3 23.2–37.1ROR 30.1 · χ² 1,827 / p <1e-300 | 29.0 EB05 23.7 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.3 · ♀ 26% (drug 58%) · 96% clinician | no trial data cached |
| Liver injury | 89 | 29.2 23.8–35.9ROR 30.2 · χ² 2,393 / p <1e-300 | 29.0 EB05 24.3 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.0 · ♀ 99% (drug 58%) · 97% clinician | no trial data cached |
| Gout | 66 | 29.2 23.0–37.1ROR 29.9 · χ² 1,763 / p <1e-300 | 28.9 EB05 23.5 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.5 · ♀ 27% (drug 58%) · 98% clinician | no trial data cached |
| Epilepsy | 112 | 29.2 24.3–35.0ROR 30.4 · χ² 3,010 / p <1e-300 | 28.9 EB05 24.7 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.3 · ♀ 91% (drug 58%) · 92% clinician | no trial data cached |
| Fibromyalgia | 89 | 29.1 23.7–35.7ROR 30.1 · χ² 2,382 / p <1e-300 | 28.8 EB05 24.2 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.5 · ♀ 100% (drug 58%) · 98% clinician | no trial data cached |
| Micturition urgency | 41 | 28.7 21.2–38.9ROR 29.2 · χ² 1,066 / p 4e-234 | 28.3 EB05 21.7 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.9 · ♀ 6% (drug 58%) | no trial data cached |
| Ulcer | 56 | 27.9 21.5–36.2ROR 28.5 · χ² 1,423 / p <1e-300 | 27.6 EB05 22.0 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.4 · ♀ 12% (drug 58%) · 95% clinician | no trial data cached |
| Wound | 97 | 27.7 22.8–33.7ROR 28.7 · χ² 2,465 / p <1e-300 | 27.5 EB05 23.2 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.6 · ♀ 98% (drug 58%) · 94% clinician | no trial data cached |
| Blood test abnormal | 48 | 27.2 20.5–36.0ROR 27.6 · χ² 1,180 / p 8e-259 | 26.8 EB05 21.0 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 28.8 · ♀ 36% (drug 58%) · 96% clinician | no trial data cached |
| Head discomfort | 59 | 26.6 20.7–34.2ROR 27.2 · χ² 1,424 / p <1e-300 | 26.3 EB05 21.1 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.2 · ♀ 4% (drug 58%) · 95% clinician | no trial data cached |
| Osteoarthritis | 142 | 26.5 22.6–31.2ROR 28.0 · χ² 3,461 / p <1e-300 | 26.4 EB05 22.9 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.6 · ♀ 99% (drug 58%) · 92% clinician | no trial data cached |
| Hypercholesterolaemia | 31 | 25.7 18.1–36.5ROR 26.0 · χ² 710 / p 9e-157 | 25.3 EB05 18.7 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.9 · ♀ 83% (drug 58%) · 97% clinician | no trial data cached |
| Lower respiratory tract infection | 146 | 25.6 21.8–30.0ROR 27.0 · χ² 3,420 / p <1e-300 | 25.4 EB05 22.2 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.7 · 96% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 446 | 4.1 3.7–4.4ROR 4.7 · χ² 1,074 / p 9e-236 | 4.1 EB05 3.7 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 | no trial data cached |
| Nausea | 418 | 4.2 3.8–4.6ROR 4.8 · χ² 1,053 / p 2e-231 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 | no trial data cached |
| Vomiting | 408 | 6.9 6.3–7.5ROR 8.0 · χ² 2,095 / p <1e-300 | 6.8 EB05 6.3 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.0 | no trial data cached |
| General physical health deterioration | 360 | 24.9 22.6–27.4ROR 28.6 · χ² 8,247 / p <1e-300 | 24.8 EB05 22.7 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 20.2 · 92% clinician | no trial data cached |
| Pain | 351 | 4.5 4.1–5.0ROR 5.1 · χ² 986 / p 8e-217 | 4.5 EB05 4.1 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.6 | no trial data cached |
| Abdominal pain | 314 | 10.7 9.6–11.9ROR 12.0 · χ² 2,780 / p <1e-300 | 10.6 EB05 9.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.8 · ♀ 26% (drug 58%) · 94% clinician | no trial data cached |
| Condition aggravated | 310 | 8.1 7.3–9.0ROR 9.1 · χ² 1,959 / p <1e-300 | 8.1 EB05 7.3 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 · 91% clinician | no trial data cached |
| Headache | 300 | 3.8 3.4–4.2ROR 4.2 · χ² 633 / p 5e-140 | 3.8 EB05 3.4 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.9 | no trial data cached |
| Abdominal distension (bloating) | 290 | 22.1 19.9–24.7ROR 24.7 · χ² 5,845 / p <1e-300 | 22.1 EB05 20.0 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.7 · ♀ 16% (drug 58%) · 91% clinician | no trial data cached |
| Constipation | 284 | 10.4 9.3–11.6ROR 11.5 · χ² 2,426 / p <1e-300 | 10.3 EB05 9.3 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.3 · ♀ 20% (drug 58%) | no trial data cached |
| Somnolence (drowsiness) | 272 | 10.7 9.6–12.0ROR 11.8 · χ² 2,408 / p <1e-300 | 10.7 EB05 9.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.5 | no trial data cached |
| Dry mouth | 260 | 25.5 22.7–28.6ROR 28.2 · χ² 6,097 / p <1e-300 | 25.4 EB05 22.9 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.8 · 96% clinician | no trial data cached |
| Sepsis (blood infection) | 242 | 17.2 15.3–19.4ROR 18.8 · χ² 3,688 / p <1e-300 | 17.1 EB05 15.4 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.0 · ♀ 9% (drug 58%) · 94% clinician | no trial data cached |
| Ascites | 242 | 65.7 58.2–74.1ROR 72.2 · χ² 15,238 / p <1e-300 | 64.8 EB05 58.2 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.9 · ♀ 11% (drug 58%) · 95% clinician | no trial data cached |
| Swelling | 239 | 20.3 18.0–22.9ROR 22.2 · χ² 4,376 / p <1e-300 | 20.2 EB05 18.2 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.2 · 92% clinician | no trial data cached |
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 Pyridoxine?
In FDA FAERS, the most frequently co-reported reaction terms for Pyridoxine are nausea, vomiting, pain, abdominal pain, headache, abdominal distension. 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 Pyridoxine have an FDA boxed warning?
No. The FDA label retrieved for Pyridoxine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pyridoxine 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 a56d11c0-b033-4201-85ff-fc710506481a, effective 20241015; matched on
openfda.generic_name.exact:"PYRIDOXINE HYDROCHLORIDE") - 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, 292 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
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.