CaloMist Nasal Spray
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CaloMist Nasal Spray
CaloMist Nasal Spray Side Effects Center
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- chest pain;
- feeling short of breath, even with mild exertion;
- swelling, rapid weight gain; or
- unusual warmth, redness, or pain in an arm or leg.
Less serious side effects may include:
- headache, dizziness, weakness;
- nausea, upset stomach, diarrhea;
- numbness or tingling;
- runny nose, sneezing, sore throat, swollen tongue;
- joint pain; or
- itching or rash.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for CaloMist Nasal Spray (Cyanocobalamin) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
CaloMist Nasal Spray FDA Prescribing 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 Nasal Spray 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 BI2 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 Nasal Spray 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 Nasal Spray in an uncontrolled clinical trial.
|Preferred Term||CaloMist Nasal Spray (cyanocobalamin) |
|Nasal Discomfort||2 (8%)|
|Back Pain||1 (4%)|
|Influenza Like Illness||1 (4%)|
|Pharyngolaryngeal Pain||1 (4%)|
|Postnasal Drip||1 (4%)|
|Procedural Pain||1 (4%)|
|Sinus Headache||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
Hematological : Polycythemia vera
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) »
Additional CaloMist Nasal Spray Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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