What the label lists and what reports show
Pyridoxine side effects
Pyridoxine's FDA label lists its adverse reactions in its own words. FAERS holds 2,648 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is general physical health deterioration (360 reports).
- Generic listed
Check it at the source: the pyridoxine FDA label on DailyMed (effective October 15, 2024, Fresenius Kabi USA, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsTo report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Paresthesia, somnolence, and low serum folic acid levels have been reported.
Source: FDA drug label, Fresenius Kabi USA, LLC, effective October 15, 2024 (SPL set a56d11c0-b033-4201-85ff-fc710506481a), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,648 reports list pyridoxine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 590 are coded as a death and 1,250 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 1 is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Pyridoxine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions