Important Safety Information: Methylcobalamin (Vitamin B12) | Compounded Injectable

What is this?

This Important Safety Information summarizes key warnings and precautions for Methylcobalamin, a biologically active, methylated form of Vitamin B12. Methylcobalamin plays a role in neurological function, red blood cell formation, DNA synthesis, and methylation pathways. It is commonly used in patients with Vitamin B12 deficiency and in clinical settings requiring neurological or metabolic support.

This compounded injectable formulation is not reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy. It should only be used exactly as prescribed and under the supervision of a licensed healthcare provider. This summary does not include all available information. Always read your medication label and follow your provider’s instructions. 

Most Serious Warnings

Product can cause:

• Severe allergic reactions, including anaphylaxis (rash, swelling of the face or throat, difficulty breathing)

• Hypersensitivity reactions in patients with known Vitamin B12 or cobalt allergy

• Electrolyte imbalances related to rapid red blood cell production in severely deficient patients

• Worsening symptoms in patients with underlying methylation pathway disorders if not properly monitored

• Compounded injectable formulations may carry sterility, dosing, or formulation risks due to limited FDA oversight.

Who Should NOT Take Methylcobalamin

Do not take this medication if you:

• Have a known allergy to methylcobalamin, Vitamin B12, cobalt, or any component of the formulation

• Have a history of hypersensitivity reactions to injectable B12 products

• Have Leber’s disease (hereditary optic neuropathy), as Vitamin B12 may worsen optic nerve damage

Before Taking Methylcobalamin, Tell Your Healthcare Provider if You:

• Have a history of anemia, blood disorders, or rapid red blood cell turnover

• Have kidney disease or liver dysfunction

• Have known methylation pathway disorders or genetic variants affecting methylation

• Are pregnant, breastfeeding, or planning pregnancy

• Take prescription, over-the-counter, or herbal medications or supplements

• Have neurological conditions requiring ongoing monitoring

Possible Side Effects

Common (mild to moderate):

• Mild pain, redness, or swelling at the injection site

• Headache

• Dizziness or lightheadedness

• Nausea or gastrointestinal discomfort

• Fatigue or weakness

Serious (seek medical care immediately):

• Rash, hives, swelling of the face, lips, or throat

• Difficulty breathing or swallowing

• Severe dizziness or fainting

• Signs of allergic reaction or anaphylaxis

While Taking Methylcobalamin

Tell your healthcare provider immediately if you:

• Experience symptoms of an allergic reaction

• Develop worsening neurological symptoms

• Notice unusual fatigue, weakness, or changes in sensation

• Experience persistent injection site reactions

• Have new or worsening symptoms that concern you

Pregnancy and Breastfeeding

Methylcobalamin may be used during pregnancy or breastfeeding only when clinically indicated and prescribed by a licensed provider. Dosing and monitoring should be individualized based on lab values and clinical need.

Overdose

Symptoms of overdose may include:

• Severe dizziness or headache

• Nausea or vomiting

• Rapid heartbeat

• Allergic or hypersensitivity reactions

If overdose is suspected, seek emergency medical attention or contact Poison Control immediately.

Missed Dosage

If you miss a scheduled dose:

• Do not double your next dose

• Follow your provider’s instructions for resuming therapy

• Contact your provider or pharmacy if you are unsure how to proceed

Storage

• Store according to pharmacy label instructions

• Refrigerate if indicated by the dispensing pharmacy

• Protect from light

• Do not freeze

• Keep out of reach of children

• Do not use beyond the pharmacy-provided beyond-use date

Medication Disposal

Dispose of unused or expired medication according to local medication disposal guidelines. Do not flush injectable medications or dispose of them in household drains. Contact your pharmacy for proper disposal instructions or medication take-back programs.

Provider Oversight and Order Review

This compounded medication requires review and oversight by licensed Superior Health & Wellness providers. Dosing, frequency, and duration of therapy are determined based on individual lab results, clinical presentation, and provider discretion. Orders may be adjusted as needed to ensure safety and effectiveness.

Telemedicine Disclosure

This prescription was issued via telemedicine. If you experience concerning or severe symptoms, contact your prescribing provider immediately or seek emergency medical care.

Disclaimer

This summary does not include all information about Methylcobalamin and should not replace medical advice. Always consult your healthcare provider or pharmacist for complete safety information, potential interactions, and individualized treatment recommendations. This compounded medication has not been evaluated or approved by the FDA for safety or efficacy.

Superior Health & Wellness

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.