Vitamin B12 Side effects

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What are the possible side effects of Vitamin B12?

Get emergency medical help if you have any of these signs of an allergic reaction to Vitamin B12: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have signs of low potassium--confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling.

Common Vitamin B12 side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Vitamin B12 in details

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Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below and in Table 1 reflect exposure in 25 subjects (age range 27-82 years; 17 women; 21 Caucasians) with vitamin B12 deficiency (12 with pernicious anemia, 4 secondary to gastrointestinal surgery, 9 with unknown cause) who received Vitamin B12 50 mcg daily for 8 weeks in an uncontrolled clinical trial. Prior to enrollment, all subjects were required to have normal vitamin B12 levels with intramuscular vitamin B12 injections. One patient who completed the study developed epistaxis on Day 12 of dosing and was noted to have irritation of the right nasal septum at study end. This patient had pre-existing allergic rhinitis and required a doubling of the Vitamin B12 dose during the last week of the study because of declining vitamin B12 concentrations.

Table 1. Potentially related adverse reactions reported during 8 weeks of treatment with Vitamin B12 in an uncontrolled clinical trial.
Preferred Term Vitamin B12

(N=25)n (%)

Arthralgia 3 (12%)
Dizziness 3 (12%)
Headache 3 (12%)
Nasopharyngitis 3 (12%)
Rhinorrhea 3 (12%)
Bronchitis 2 (8%)
Nasal Discomfort 2 (8%)
Pain 2 (8%)
Rash 2 (8%)
Asthma 1 (4%)
Back Pain 1 (4%)
Cough 1 (4%)
Epistaxis 1 (4%)
Hypersomnia 1 (4%)
Influenza Like Illness 1 (4%)
Malaise 1 (4%)
Pharyngolaryngeal Pain 1 (4%)
Postnasal Drip 1 (4%)
Procedural Pain 1 (4%)
Pyrexia 1 (4%)
Scab 1 (4%)
Sinus Headache 1 (4%)
Sinusitis 1 (4%)
Tooth Abscess 1 (4%)

Experience with

Parenteral Vitamin B12

The following adverse reactions have been reported with parenteral vitamin B12:

Generalized: Anaphylactic shock and death
Cardiovascular: Pulmonary edema and congestive heart failure early in treatmentPeripheral vascular thrombosis
Hematological Polycythemia vera
Gastrointestinal: Mild transient diarrhea
Dermatological: Itching; transitory exanthema

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Vitamin B12. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Angioedema and angioedema-like reactions.

What is the most important information I should know about Vitamin B12?

Vitamin B12 contraindications

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You should not use this medication if you are allergic to cobalt, or if you have Leber's disease. Vitamin B12 can lead to optic nerve damage (and possibly blindness) in people with Leber's disease.

To treat pernicious anemia, you will have to use this medication on a regular basis for the rest of your life. Not using the medication can lead to irreversible nerve damage in your spinal cord.

Pernicious anemia is also treated with folic acid to help maintain red blood cells. However, folic acid will not treat Vitamin B12 deficiency and will not prevent possible damage to the spinal cord. Take all of your medications as directed.

Your dose needs may change if you become pregnant, if you breast-feed, or if you eat a vegetarian diet. Tell your doctor about any changes in your diet or medical condition.

Reviews

The results of a survey conducted on ndrugs.com for Vitamin B12 are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Vitamin B12. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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