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cyanocobalamin

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Brand names: Vitamin B12

Vitamin B12 Supplement OTC

PNV-DHA is a multivitamin and mineral supplement. It helps manage nutritional deficiencies or provides extra nutrients when you need them.

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.

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.

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.

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.

Storage

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

Side Effects (from patient reports)

Based on 21,668 FDA adverse event reports.

Tiredness
3,101
Feeling sick to your stomach
2,559
Using the medicine for something it's not approved for
2,270
Head pain
2,251
Loose stools
2,081
Discomfort
2,076
Medicine not working
2,034
Difficulty breathing
1,979
Throwing up
1,664
Weakness
1,653

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

Death-Related Reports

3,041

Hospitalization Reports

12,543

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 18,630 (65%)
Male 10,031 (35%)

Age Distribution

0–17 179
18–44 2,699
45–64 6,929
65–74 5,464
75+ 5,720

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 FATIGUE 3,101
2 NAUSEA 2,557
3 OFF LABEL USE 2,270
4 HEADACHE 2,250
5 DIARRHOEA 2,082
6 PAIN 2,075
7 DRUG INEFFECTIVE 2,034
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

Reactions in Death Reports

DEATH 1,103
FATIGUE 349
OFF LABEL USE 346
ASTHENIA 289
VOMITING 269
CONDITION AGGRAVATED 261
GENERAL PHYSICAL HEALTH DETERIORATION 259
DIARRHOEA 258
CONFUSIONAL STATE 256
HYPERTENSION 253

Reactions in Hospitalization Reports

FATIGUE 1,311
NAUSEA 1,256
DYSPNOEA 1,139
PNEUMONIA 1,078
VOMITING 1,065
HEADACHE 1,064
FALL 1,026
ASTHENIA 1,015
PAIN 979
DIARRHOEA 973

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.

Common Questions

What is PNV-DHA?
It is a multivitamin and mineral supplement.
Who should take PNV-DHA?
People with nutritional deficiencies or those needing extra nutrients.
How often should I take it?
Take one softgel daily.
Can I take it with other medications?
Talk to your doctor or pharmacist before taking it with other medications.
What should I do if I experience side effects?
Tell your doctor if you have any side effects.
Can children take this?
No, keep out of reach of children. Overdose can be dangerous.
What does the softgel look like?
It is blue and has "BP 321" printed on it.
What if I am allergic to one of the ingredients?
You should not take this product if you are allergic to any of its ingredients.
Does this replace a healthy diet?
No, it is a supplement and should be used with a balanced diet.
Where can I find the expiration date?
Check the product packaging for the expiration date.
What are the common side effects of cyanocobalamin?
The most commonly reported side effects of cyanocobalamin include Allergic reaction. Based on 21,668 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does cyanocobalamin interact with other medications?
Yes, cyanocobalamin has 1 known drug interactions. Notable interactions include drospirenone/ethinyl estradiol. Always inform your doctor about all medications you are taking.
What drug class is cyanocobalamin?
cyanocobalamin belongs to the Vitamin B12 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 cyanocobalamin safe during pregnancy?
This supplement is often used before, during, and after pregnancy. Talk to your doctor to see if it is right for you. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has cyanocobalamin been recalled?
There are 3 recalls associated with cyanocobalamin products. Lack of Assurance of Sterility. Check the recalls section below for full details and affected products.

Active Recalls

Class II May 21, 2025

Lack of Assurance of Sterility

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Class III June 18, 2024

Subpotent drug: out of specification results

Accord Healthcare, Inc.

Class II May 29, 2013

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.

Compare cyanocobalamin vs ascorbic acid side-by-side →

Medication Guides

Related Health & Safety Data

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 21,668 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 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). 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

All federal data sources used on this page