CaloMist Nasal Spray Side Effects Center

Last updated on RxList: 1/27/2020
CaloMist Nasal Spray Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 1/27/2020

What Is CaloMist?

CaloMist Nasal Spray (cyanocobalamin) is a synthetic form of vitamin B12 used to treat vitamin B12 deficiency in people with pernicious anemia and other conditions. The brand name CaloMist Nasal Spray is discontinued, but generic versions may be available.

What Are Side Effects of CaloMist?

Common side effects of CaloMist Nasal Spray (cyanocobalamin) includeL:

Dosage for CaloMist

The recommended initial dose of CaloMist Nasal Spray is one spray in each nostril once daily (25 mcg per nostril, total daily dose 50 mcg).

What Drugs, Substances, or Supplements Interact with CaloMist?

CaloMist Nasal Spray may interact with antibiotics, methotrexate, pyrimethamine, colchicine, or alcohol. Tell your doctor all medications and supplements you use.

CaloMist During Pregnancy and Breastfeeding

It is unknown if CaloMist Nasal Spray can harm a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This drug passes into breast milk, but it is unknown if it could harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our CaloMist Nasal Spray (cyanocobalamin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

SLIDESHOW

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CaloMist Nasal Spray Consumer Information

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

Call your doctor at once if you have :

  • easy bruising, unusual bleeding, purple or red spots under your skin; or
  • low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

  • runny nose;
  • cold or flu symptoms such as stuffy nose, sore throat, sinus pain;
  • headache;
  • tingling in your hands or feet;
  • weakness;
  • nausea; or
  • swelling in your tongue.

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.

Read the entire detailed patient monograph for CaloMist Nasal Spray (Cyanocobalamin)

QUESTION

According to the USDA, there is no difference between a “portion” and a “serving.” See Answer
CaloMist Nasal Spray Professional Information

SIDE EFFECTS

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 CaloMist 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 CaloMist 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 CaloMist in an uncontrolled clinical trial.

Adverse ReactionCaloMist
(N=25) n (%)
Arthralgia3 (12%)
Dizziness3 (12%)
Headache3 (12%)
Nasopharyngitis3 (12%)
Rhinorrhea3 (12%)
Bronchitis2 (8%)
Nasal Discomfort2 (8%)
Pain2 (8%)
Rash2 (8%)
Asthma1 (4%)
Back Pain1 (4%)
Cough1 (4%)
Epistaxis1 (4%)
Hypersomnia1 (4%)
Influenza Like Illness1 (4%)
Malaise1 (4%)
Pharyngolaryngeal Pain1 (4%)
Postnasal Drip1 (4%)
Procedural Pain1 (4%)
Pyrexia1 (4%)
Scab1 (4%)
Sinus Headache1 (4%)
Sinusitis1 (4%)
Tooth Abscess1 (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
treatment, peripheral vascular thrombosis
HematologicalPolycythemia vera
Gastrointestinal:Mild transient diarrhea
Dermatological:Itching; transitory exanthema

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of cyanocobalamin. 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 [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for CaloMist Nasal Spray (Cyanocobalamin)

© CaloMist Nasal Spray Patient Information is supplied by Cerner Multum, Inc. and CaloMist Nasal Spray Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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