CaloMist Side Effects
Generic Name: cyanocobalamin,vitamin b12
Please note - some side effects for CaloMist may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
CaloMist Side Effects - for the Professional
Calomist
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.
| Preferred Term | 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 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 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 (5.4)].
TopSide Effects by Body System - for Healthcare Professionals
Cardiovascular
Cardiovascular side effects associated with parenteral cyanocobalamin have included congestive heart failure, pulmonary edema, and peripheral vascular thrombosis. These effects were usually reported early in treatment.
Dermatologic
Dermatologic side effects associated with both intranasal and parenteral cyanocobalamin have included itching and transitory exanthema.
Dermatologic side effects have rarely included exacerbation or onset of inflammatory acne and folliculitis related to B12.
Exacerbation or onset of inflammatory acne and folliculitis have been seen with high doses of B12 (5 to 10 mg/week). The etiology and pathogenic mechanisms of vitamin B12-induced acne are unknown. When present, acneiform eruptions usually occur on the facial area after the first or second injection, and typically disappear within 8 to 10 days after stopping therapy.
A single case of a severe skin eruption resembling acne rosacea that was temporally associated with daily ingestion of 100 mcg of B12 (with 100 mg of B6) has been reported. The rash resolved upon discontinuation of both drugs and recurred upon rechallenge with half the doses.
Some have suspected sorbitol or iodine that is present in some ampules of B12 may be the cause of at least some cases of skin eruptions associated with this drug.
Gastrointestinal
A single case of cecal vitamin B12 bezoar has been reported in an elderly man with a history of multiple gastrointestinal surgeries.
Gastrointestinal side effects associated with parenteral cyanocobalamin have included dyspepsia, nausea, vomiting, and mild transient diarrhea.
Gastrointestinal side effects associated with intranasal cyanocobalamin have included glossitis and nausea.
Hypersensitivity
Anaphylactic reactions have been reported primarily with parenteral administration of B12 and are thought to be the result of impurities of B12 preparations that are no longer manufactured. They may occur soon after a sensitizing dose, within a few weeks or months, or rarely after a latency of several years.
Hypersensitivity side effects associated with parenteral cyanocobalamin have rarely included anaphylactic reactions and death.
Nervous system
Nervous system side effects associated with parenteral cyanocobalamin have included abnormal gait, asthenia, anxiety, dizziness, hypoesthesia, incoordination, nervousness, and incoordination.
Nervous system side effects associated with both parenteral and intranasal cyanocobalamin have included paresthesia and headache.
Hematologic
Hematologic side effects have included polycythemia vera.
Musculoskeletal
Musculoskeletal side effects associated with parenteral cyanocobalamin have included arthritis, back pain, and myalgia.
Respiratory
Respiratory side effects associated with parenteral cyanocobalamin have included dyspnea.
Respiratory side effects associated with both parenteral and intranasal cyanocobalamin have included rhinitis.
Immunologic
Immunologic side effects associated with both parenteral and intranasal cyanocobalamin have included infection.
Other
Other side effects associated with parenteral administration of cyanocobalamin have included feeling of swelling of entire body, back pain, and generalized pain.
TopMore CaloMist resources
- Cyanocobalamin Prescribing Information (FDA)
- Calomist Consumer Overview
- Calomist Prescribing Information (FDA)
- Nascobal Monograph (AHFS DI)
- Nascobal Prescribing Information (FDA)
- Nascobal Spray MedFacts Consumer Leaflet (Wolters Kluwer)
- Vitamin b12
- vitamin b12 Nasal, Oral, Parenteral Advanced Consumer (Micromedex) - Includes Dosage Information
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