Nascobal Side Effects
Generic Name: Cyanocobalamin
Please note - some side effects for Nascobal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Nascobal - for the consumer
Nascobal Spray
All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Nascobal Spray. Seek medical attention right away if any of these SEVERE side effects occur when using Nascobal Spray:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf swelling or tenderness; chest pain; irregular heartbeat; muscle weakness or cramping; shortness of breath; swelling of the hands, ankles, or feet; unusual bruising.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .
TopFor the professional
Nascobal
The incidence of adverse experiences described in the Table below are based on data from a short-term clinical trial in vitamin B12 deficient patients in hematologic remission receiving Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration (N=24) and intramuscular vitamin B12 (N=25). In the pharmacokinetic study comparing Nascobal Nasal Spray and Nascobal Nasal Gel, the incidence of adverse events was similar.
Body System |
Adverse Experience |
Number of Patients (Occurrences) |
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Vitamin B12 Nasal Gel, 500 mcg N=24 |
Intramuscular Vitamin B12, 100 mcg N=25 |
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Body as a Whole |
Asthenia |
1 (1) |
4 (4) |
Back Pain |
0 (0) |
1 (1) |
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Generalized Pain |
0 (0) |
2 (3) |
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Headache |
1 (2)* |
5 (11) |
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Infection† |
3 (4) |
3 (3) |
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Cardiovascular System |
Peripheral Vascular Disorder |
0 (0) |
1 (1) |
Digestive System |
Dyspepsia |
0 (0) |
1 (2) |
Glossitis |
1 (1) |
0 (0) |
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Nausea |
1 (1)* |
1 (1) |
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Nausea & Vomiting |
0 (0) |
1 (1) |
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Vomiting |
0 (0) |
1 (1) |
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Musculoskeletal System |
Arthritis |
0 (0) |
2 (2) |
Myalgia |
0 (0) |
1 (1) |
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Nervous System |
Abnormal Gait |
0 (0) |
1 (1) |
Anxiety |
0 (0) |
1 (1)* |
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Dizziness |
0 (0) |
3 (3) |
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Hypoesthesia |
0 (0) |
1 (1) |
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Incoordination |
0 (0) |
1 (2)* |
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Nervousness |
0 (0) |
1 (3)* |
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Paresthesia |
1 (1) |
1 (1) |
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Respiratory System |
Dyspnea |
0 (0) |
1 (1) |
Rhinitis |
1 (1)* |
2 (2) |
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The intensity of the reported adverse experiences following the administration of Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration and intramuscular vitamin B12 were generally mild. One patient reported severe headache following intramuscular dosing. Similarly, a few adverse experiences of moderate intensity were reported following intramuscular dosing (two headaches and rhinitis; one dyspepsia, arthritis, and dizziness), and dosing with Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration (one headache, infection, and paresthesia).
The majority of the reported adverse experiences following dosing with Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration and intramuscular vitamin B12 were judged to be intercurrent events. For the other reported adverse experiences, the relationship to study drug was judged as "possible" or "remote". Of the adverse experiences judged to be of "possible" relationship to the study drug, anxiety, incoordination, and nervousness were reported following intramuscular vitamin B12 and headache, nausea, and rhinitis were reported following dosing with Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration.
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.
Miscellaneous: Feeling of swelling of the entire body.
TopMore resources:
Nascobal - Includes detailed dosage instructions.
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