Over-the-counter medication · Vitamin B12 Supplement
cyanocobalamin
Also sold as Vitamin B12. PNV-DHA is used to help people who don't get enough vitamins and minerals from their diet.
Data updated 2026-05-15
- 31,083
- FDA reportsModerately reported
- 1
- InteractionFew interactions
- 4
- Recall records
What the data shows
cyanocobalamin (Vitamin B12) is an over-the-counter Vitamin B12 Supplement, reported at a middle-of-the-pack volume (31,083 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.
cyanocobalamin (Vitamin B12) is an over-the-counter Vitamin B12 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 or provides extra nutrients when you need them.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$1.66/unit
Generic Available
Yes (15 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
NADAC price trail: CYANOCOBALAMIN 1,000 MCG/ML VL
Same CMS presentation as the headline generic unit price above (3 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: +13.7% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| June 19, 2024 | $2.10/ML | - | 1 |
| July 17, 2024 | $1.56/ML | -26% | 1 |
| December 18, 2024 | $1.77/ML | +13.7% | 14 |
What it does
PNV-DHA is used to help people who don't get enough vitamins and minerals from their diet.
Common side effects
Allergic reaction
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 cyanocobalamin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
PNV-DHA provides essential vitamins, minerals, and omega-3 fatty acids. These nutrients support overall health and well-being. They help fill in nutritional gaps in your diet.
Side Effects (from patient reports)
Based on 31,083 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for cyanocobalamin, by number of reports
- Fatigue
Fatigue
3,101 reports
- Nausea
Nausea
2,557 reports
- Headache
Headache
2,250 reports
- Diarrhoea
Diarrhoea
2,082 reports
- Pain
Pain
2,075 reports
- Dyspnoea
Dyspnoea
1,979 reports
- Vomiting
Vomiting
1,664 reports
- Asthenia
Asthenia
1,653 reports
- Arthralgia
Arthralgia
1,642 reports
- Fall
Fall
1,623 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 cyanocobalamin 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 cyanocobalamin sits
cyanocobalamin has more FDA adverse-event reports than 65% 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 cyanocobalamin; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 31,083 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
31,083
Reports Mentioning Death
3,041
9.8% of reports — not proof of cause
Hospitalization Reports
12,543
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 3,101 |
| 2 | NAUSEA | 2,557 |
| 4 | HEADACHE | 2,250 |
| 5 | DIARRHOEA | 2,082 |
| 6 | PAIN | 2,075 |
| 8 | DYSPNOEA | 1,979 |
| 9 | VOMITING | 1,664 |
| 10 | ASTHENIA | 1,653 |
| 11 | ARTHRALGIA | 1,642 |
| 12 | FALL | 1,623 |
| 13 | DIZZINESS | 1,534 |
| 14 | PNEUMONIA | 1,389 |
| 15 | PYREXIA | 1,387 |
| 16 | HYPERTENSION | 1,359 |
| 17 | MALAISE | 1,336 |
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 product out of the reach of children. If a child swallows too much, call a doctor or poison control center right away.
Known Drug Interactions
Folates may mask vitamin B12 deficiency.
Mechanism: Folate can make blood tests for vitamin B12 deficiency look normal even when they are not. This can delay the discovery of a B12 problem.
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?
Who should take PNV-DHA?
How often should I take it?
Can I take it with other medications?
What should I do if I experience side effects?
Can children take this?
What does the softgel look like?
What if I am allergic to one of the ingredients?
Does this replace a healthy diet?
Where can I find the expiration date?
What are the common side effects of cyanocobalamin?
Does cyanocobalamin interact with other medications?
What drug class is cyanocobalamin?
What pregnancy or breastfeeding source fields are listed for cyanocobalamin?
Has cyanocobalamin been recalled?
Active Recalls
Lack of Assurance of Sterility
PAYLESS COMPOUNDERS, LLC
Lack of Assurance of Sterility
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Subpotent drug: out of specification results
Accord Healthcare, Inc.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Related Medications in Vitamin B12 Supplement
Other drugs grouped near cyanocobalamin - same-class peers and common alternatives.
ascorbic acid
Vitamin C
This medicine is a Vitamin C supplement.
Compare with cyanocobalamin →
biotin
Vitamin B7
Dialyvite with Zinc is a prescription vitamin supplement.
Compare with cyanocobalamin →
calcitriol
Rocaltrol
Calcitriol is a form of vitamin D that helps your body absorb and use calcium.
Compare with cyanocobalamin →
calcium carbonate
Tums, Caltrate
Calcium carbonate is a medicine that can relieve heartburn and upset stomach.
Compare with cyanocobalamin →
cholecalciferol
Vitamin D3
PNV-DHA is a multivitamin with minerals and essential fatty acids.
Compare with cyanocobalamin →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for cyanocobalamin: 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: 31,083.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 9.78%.
- sarilumab Δ 0.02 pts · 23,683 reports · IL-6 Receptor Antagonist 9.77%death share
- doxycycline Δ 0.02 pts · 64,488 reports · Tetracycline Antibiotic 9.76%death share
- nebivolol Δ 0.02 pts · 14,997 reports · Beta-1 Selective Blocker 9.76%death share
- promethazine Δ 0.02 pts · 17,969 reports · Phenothiazine Antiemetic / Antihistamine 9.76%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
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FDA requirements, cost savings, and when the difference matters
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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 cyanocobalamin
The FDA label for cyanocobalamin (sold under brand names such as Vitamin B12) classifies it as an over-the-counter product in the Vitamin B12 Supplement class. PNV-DHA is used to help people who don't get enough vitamins and minerals from their diet. Official labeling lists 1 commonly reported side effect, including Allergic reaction.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 31,083 voluntary reports. The database also lists 1 documented drug interaction derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $1.66.
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 4 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). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
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