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 →
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.
How to Take It
Take one softgel each day. You can take it before, during, or after pregnancy. Follow your doctor's directions on how to take this medicine. You can take it with or without food.
This is a plain-language summary of cyanocobalamin's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
This supplement is often used before, during, and after pregnancy. Talk to your doctor to see if it is right for you. It can help make sure you and your baby get the nutrients you need.
This is a plain-language summary of cyanocobalamin'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 close to your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of cyanocobalamin'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 31,083 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for cyanocobalamin, by number of reports
- Tiredness
Tiredness
3,101 reports
- Feeling sick to your stomach
Feeling sick to your stomach
2,559 reports
- Head pain
Head pain
2,251 reports
- Loose stools
Loose stools
2,081 reports
- Discomfort
Discomfort
2,076 reports
- Difficulty breathing
Difficulty breathing
1,979 reports
- Throwing up
Throwing up
1,664 reports
- Weakness
Weakness
1,653 reports
- Joint pain
Joint pain
1,642 reports
- Accidental fall
Accidental 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) 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.
What to do: Your doctor should monitor your vitamin B12 levels carefully to ensure a deficiency is not being missed.
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?
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?
Is cyanocobalamin safe during pregnancy?
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 →
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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 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). 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. Always consult a healthcare professional before making medication decisions.
Last updated: January 15, 2024
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 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
- 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