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.
Verify with FDA → · CMS NADAC pricing →
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.
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
- Nausea
Nausea
389 reports
- Vomiting
Vomiting
357 reports
- Pain
Pain
306 reports
- General Physical Health Deterioration
General Physical Health Deterioration
286 reports
- Abdominal Pain
Abdominal Pain
276 reports
- Abdominal Distension
Abdominal Distension
269 reports
- Condition Aggravated
Condition Aggravated
262 reports
- Constipation
Constipation
255 reports
- Headache
Headache
255 reports
- Fatigue
Fatigue
253 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.
Reports over time
Adverse-event reports filed for pyridoxine each year to the FDA Adverse Event Reporting System (FAERS).
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.
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
Age Distribution
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
Reactions in Hospitalization Reports
Source: 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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What is PNV-DHA used for?
How often should I take PNV-DHA?
Can I take this if I am allergic to any of the ingredients?
What should I do if I miss a dose?
How should I store PNV-DHA?
Is PNV-DHA safe to take during pregnancy?
What do I do if a child swallows too much?
Does this medication have iron?
What form does this medication come in?
Can I get an allergic reaction from this medicine?
Does pyridoxine interact with other medications?
What drug class is pyridoxine?
What pregnancy or breastfeeding source fields are listed for pyridoxine?
Has pyridoxine been recalled?
Active Recalls
Lack of Assurance of Sterility
Tri-Coast Pharmacy
Lack of Assurance of Sterility
Tri-Coast Pharmacy
Lack of Assurance of Sterility
Tri-Coast Pharmacy
Related Medications in Vitamin B6 Supplement
Other drugs grouped near pyridoxine - same-class peers and common alternatives.
ascorbic acid
Vitamin C
This medicine is a Vitamin C supplement.
Compare with pyridoxine →
biotin
Vitamin B7
Dialyvite with Zinc is a prescription vitamin supplement.
Compare with pyridoxine →
calcitriol
Rocaltrol
Calcitriol is a form of vitamin D that helps your body absorb and use calcium.
Compare with pyridoxine →
calcium carbonate
Tums, Caltrate
Calcium carbonate is a medicine that can relieve heartburn and upset stomach.
Compare with pyridoxine →
cholecalciferol
Vitamin D3
PNV-DHA is a multivitamin with minerals and essential fatty acids.
Compare with pyridoxine →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for pyridoxine: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 2,439.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 20.54%.
- bupropion Δ 0.18 pts · 41,778 reports · Norepinephrine-Dopamine Reuptake Inhibitor (NDRI) 20.36%death share
- atropine Δ 0.32 pts · 7,881 reports · Anticholinergic 20.23%death share
- amikacin Δ 0.32 pts · 16,238 reports · Aminoglycoside Antibiotic 20.22%death share
- isavuconazonium Δ 0.40 pts · 3,219 reports · Azole Antifungal 20.94%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Pain Relievers Compared
NSAIDs vs acetaminophen, which OTC pain reliever to use
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: January 15, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages