Medical Editor: John P. Cunha, DO, FACOEP
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?
CaloMist Nasal Spray may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- easy bruising,
- unusual bleeding,
- purple or red spots under your skin,
- leg cramps,
- constipation,
- irregular heartbeats,
- fluttering in your chest,
- increased thirst or urination,
- numbness or tingling,
- muscle weakness, and
- limp feeling
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of CaloMist Nasal Spray (cyanocobalamin) includeL:
- headache
- dizziness
- weakness
- nausea
- upset stomach
- diarrhea
- numbness or tingling
- runny or stuffy nose
- postnasal drip
- sneezing
- sore throat
- swollen tongue
- fever
- joint pain
- itching
- rash
- asthma
- back pain
- cough
- nosebleed
- excessive sleepiness
- flu-like illness, and
- tooth abscess
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
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
Heart Healthy Diet: 25 Foods You Should Eat See SlideshowGet 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.
QUESTION
According to the USDA, there is no difference between a “portion” and a “serving.” See AnswerSIDE 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 Reaction | CaloMist (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 |
| treatment, peripheral 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 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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