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Over-the-counter medication · Vitamin B6 Supplement

pyridoxine

Also sold as Vitamin B6. PNV-DHA is used to help people who don't get enough vitamins and minerals from their diet.

Data updated 2026-05-15

2,439
FDA reportsLightly reported
1
InteractionFew interactions
3
Recall records

What the data shows

pyridoxine (Vitamin B6) is an over-the-counter Vitamin B6 Supplement, among the least-reported drugs the FDA tracks (2,439 FDA reports), with 1 documented drug interaction.

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

pyridoxine (Vitamin B6) is an over-the-counter Vitamin B6 Supplement. PNV-DHA is used to help people who don't get enough vitamins and minerals from their diet.

PNV-DHA is a multivitamin and mineral supplement. It helps manage nutritional deficiencies and provides extra nutrients.

View Alternatives → Compare with Another Drug → Full Side Effects Report →

What it does

PNV-DHA is used to help people who don't get enough vitamins and minerals from their diet.

Common side effects

No common side effects listed.

Key warnings

Accidental overdose of iron-containing products can cause fatal poisoning in children under 6.

The sections below are summarized in plain English from pyridoxine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

This medicine provides vitamins and minerals that your body needs. It helps to fill in any gaps in your diet. It ensures you get the right amount of nutrients.

How to Take It

Take one softgel each day. You can take it before, during, or after pregnancy. Follow your doctor's instructions on how to take it. Take it with a full glass of water.

This is a plain-language summary of pyridoxine's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.

Pregnancy & Breastfeeding

This medicine can be taken before, during, and after pregnancy. It provides important nutrients for both you and your baby. Talk to your doctor to see if it is right for you.

This is a plain-language summary of pyridoxine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

This is a plain-language summary of pyridoxine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.

Storage

Store at room temperature between 68° and 77°F.

Side Effects (from patient reports)

Based on 2,439 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for pyridoxine, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS) As of 2025

Reports over time

Adverse-event reports filed for pyridoxine each year to the FDA Adverse Event Reporting System (FAERS).

-1000100200300400 20042007201020132016201920222025 283

Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.

Where pyridoxine sits

pyridoxine has more FDA adverse-event reports than 16% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.

fewest reports most reports

Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is pyridoxine; the line is the median (50th percentile).

FDA Adverse Event Report Analysis

Detailed analysis of 2,439 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

2,439

Reports Mentioning Death

501

20.5% of reports — not proof of cause

Hospitalization Reports

1,129

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 1,274 (57%)
Male 942 (42%)

Age Distribution

0–17 76
18–44 394
45–64 501
65–74 311
75+ 533

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
2 NAUSEA 389
3 VOMITING 357
4 PAIN 306
5 GENERAL PHYSICAL HEALTH DETERIORATION 286
6 ABDOMINAL PAIN 276
7 ABDOMINAL DISTENSION 269
8 CONDITION AGGRAVATED 262
10 CONSTIPATION 255
11 HEADACHE 255
12 FATIGUE 253
13 SOMNOLENCE 253
14 SEPSIS 223
15 ASCITES 221
16 DIARRHOEA 220
17 HYPONATRAEMIA 216

Reactions in Death 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

Reactions in Hospitalization Reports

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
ABDOMINAL PAIN 161

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Accidental overdose of iron-containing products can cause fatal poisoning in children under 6. Keep this medicine out of the reach of children. If a child swallows too much, call a doctor or poison control center right away.

Known Drug Interactions

Decrease exposure Selective 5-HT3 Receptor Antagonists Ondansetron Decrease exposure Statins Metabolized by CYP3A4 Simvastatin Decrease exposure Thiazolidinediones Rosiglitazone Decrease AUC by 66% Tricyclic Antidepressants Nortriptyline A tuberculosis treatment regimen including rifampin (600 mg/day), isoniazid (300 mg/day), pyrazinamide (500 mg 3× per day), and pyridoxine (25 mg) was associated with higher than expected doses of nortriptyline were required to obtain a therapeutic drug level.

Mechanism: When these medications are taken together as part of a treatment plan, they can cause the body to process other drugs much faster, leading to lower levels in the blood.

What to do: Your doctor may need to increase the dose of your other medicines, such as antidepressants, to ensure they remain effective.

This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.

Common Questions

What is PNV-DHA used for?
It is used to supplement your diet with vitamins and minerals.
How often should I take PNV-DHA?
Take one softgel daily.
Can I take this if I am allergic to any of the ingredients?
No, you should not take this if you are allergic to any of the ingredients.
What should I do if I miss a dose?
Take it as soon as you remember. If it is almost time for your next dose, skip the missed dose.
How should I store PNV-DHA?
Store it at room temperature.
Is PNV-DHA safe to take during pregnancy?
Yes, it can be taken before, during, and after pregnancy.
What do I do if a child swallows too much?
Call a doctor or poison control center immediately.
Does this medication have iron?
Yes, it contains iron.
What form does this medication come in?
It comes as a softgel.
Can I get an allergic reaction from this medicine?
Yes, allergic reactions have been reported with similar medications.
Does pyridoxine interact with other medications?
Yes, pyridoxine has 1 known drug interactions. Notable interactions include rifampin. Always inform your doctor about all medications you are taking.
What drug class is pyridoxine?
pyridoxine belongs to the Vitamin B6 Supplement drug class. It is available over the counter (OTC). PNV-DHA is used to help people who don't get enough vitamins and minerals from their diet.
Is pyridoxine safe during pregnancy?
This medicine can be taken before, during, and after pregnancy. It provides important nutrients for both you and your baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has pyridoxine been recalled?
There are 3 recalls associated with pyridoxine products. Lack of Assurance of Sterility. Check the recalls section below for full details and affected products.

Active Recalls

Class II November 17, 2016

Lack of Assurance of Sterility

Tri-Coast Pharmacy

Class II November 17, 2016

Lack of Assurance of Sterility

Tri-Coast Pharmacy

Class II November 17, 2016

Lack of Assurance of Sterility

Tri-Coast Pharmacy

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Other drugs grouped near pyridoxine - same-class peers and common alternatives.

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Medication Guides

What the FDA Data Shows for pyridoxine

The FDA label for pyridoxine (sold under brand names such as Vitamin B6) classifies it as an over-the-counter product in the Vitamin B6 Supplement class. PNV-DHA is used to help people who don't get enough vitamins and minerals from their diet. Labeling covers dosing, contraindications, and monitoring requirements derived from clinical trials.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 2,439 voluntary reports. The database also lists 1 documented drug interaction derived from FDA labeling, with the top-flagged interaction rated minor severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 3 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: January 15, 2024

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.

All federal data sources used on this page