pyridoxine Side Effects
Also known as: Vitamin B6
Analysis of 2,439 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
2,439
Death-Related
501
20.5% of reports
Hospitalizations
1,129
46.3% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 501 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| VOMITING | 240 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 239 |
| ABDOMINAL DISTENSION | 223 |
| ABDOMINAL PAIN | 216 |
| ASCITES | 212 |
| APPENDICITIS | 211 |
| APPENDICOLITH | 210 |
| CONSTIPATION | 207 |
| NAUSEA | 207 |
| SEPSIS | 206 |
| HYPONATRAEMIA | 204 |
| OFF LABEL USE | 203 |
| CARDIOGENIC SHOCK | 202 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 198 |
| STRESS | 189 |
| CONDITION AGGRAVATED | 182 |
| VENTRICULAR FIBRILLATION | 171 |
| DRY MOUTH | 164 |
| SWELLING | 145 |
| BLOOD CHOLESTEROL INCREASED | 144 |
Reactions in Hospitalization Reports
Top reactions in 1,129 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| OFF LABEL USE | 237 |
| NAUSEA | 216 |
| VOMITING | 215 |
| SOMNOLENCE | 200 |
| CONDITION AGGRAVATED | 196 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 177 |
| DRUG HYPERSENSITIVITY | 169 |
| FATIGUE | 166 |
| GASTROOESOPHAGEAL REFLUX DISEASE | 166 |
| SWELLING | 165 |
| DRUG INEFFECTIVE | 163 |
| ABDOMINAL PAIN | 161 |
| DIARRHOEA | 157 |
| BLOOD CHOLESTEROL INCREASED | 156 |
| DYSPNOEA | 156 |
| DRY MOUTH | 153 |
| PAIN | 152 |
| DRUG INTOLERANCE | 151 |
| ABDOMINAL DISTENSION | 142 |
| SLEEP DISORDER | 138 |
Nearby — Related Medications
What the FAERS Data Reveals About pyridoxine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 2,439 voluntary reports linked to pyridoxine and its brand equivalents (Vitamin B6), spanning 2004 through 2025. Of those, 501 (20.5%) listed death as an outcome and 1,129 (46.3%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 57% were female and 42% male; age distribution skews toward 75+, with 533 reports in that bracket. The single most reported reaction is off label use with 403 submissions, followed by nausea and vomiting.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.