65/100 · Elevated
Manufactured by ENDO USA, Inc.
Moderate Safety Concerns with Cyanocobalamin Use
90,076 FDA adverse event reports analyzed
Last updated: 2026-05-12
CYANOCOBALAMIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ENDO USA, Inc.. Based on analysis of 90,076 FDA adverse event reports, CYANOCOBALAMIN has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for CYANOCOBALAMIN include FATIGUE, NAUSEA, OFF LABEL USE, HEADACHE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CYANOCOBALAMIN.
Cyanocobalamin has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 90,076 adverse event reports for this medication, which is primarily manufactured by Endo Usa, Inc..
The most commonly reported adverse events include Fatigue, Nausea, Off Label Use. Of classified reports, 74.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue, nausea, and headache are the most common adverse reactions reported.
Serious adverse events, such as pneumonia and death, are reported but less frequently. Drug ineffectiveness and fall are also notable common reactions. The majority of reactions are non-serious, but the diversity of reactions is significant.
Patients taking Cyanocobalamin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Cyanocobalamin may cause dizziness and fatigue, which can increase the risk of falls, especially in elderly patients. Warnings should be given to patients about the potential for dizziness and the need for caution when engaging in activities that req This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Cyanocobalamin received a safety concern score of 65/100 (elevated concern). This is based on a 74.3% serious event ratio across 31,058 classified reports. The score accounts for 90,076 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 18,626, Male: 10,029, Unknown: 15. The most frequently reported age groups are age 71 (640 reports), age 72 (614 reports), age 64 (580 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 31,058 classified reports for CYANOCOBALAMIN:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Cyanocobalamin may cause dizziness and fatigue, which can increase the risk of falls, especially in elderly patients. Warnings should be given to patients about the potential for dizziness and the need for caution when engaging in activities that req
If you are taking Cyanocobalamin, here are important things to know. The most commonly reported side effects include fatigue, nausea, off label use, headache, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should be advised to report any unusual symptoms to their healthcare provider immediately. Elderly patients should be particularly cautious due to the increased risk of falls and respiratory issues. Patients should follow the prescribed dosage and not exceed the recommended amount. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA has not issued specific guidelines for cyanocobalamin, but given the reported adverse events, it is recommended that patients closely monitor any new or worsening symptoms and report them to their healthcare provider.
The FDA has received approximately 90,076 adverse event reports associated with Cyanocobalamin. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Cyanocobalamin include Fatigue, Nausea, Off Label Use, Headache, Diarrhoea. By volume, the top reported reactions are: Fatigue (3,101 reports), Nausea (2,558 reports), Off Label Use (2,270 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Cyanocobalamin.
Out of 31,058 classified reports, 23,075 (74.3%) were classified as serious and 7,983 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Cyanocobalamin break down by patient sex as follows: Female: 18,626, Male: 10,029, Unknown: 15. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Cyanocobalamin adverse events are: age 71: 640 reports, age 72: 614 reports, age 64: 580 reports, age 65: 576 reports, age 73: 570 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Cyanocobalamin adverse event reports is Endo Usa, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Cyanocobalamin include: Pain, Drug Ineffective, Dyspnoea, Vomiting, Asthenia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Cyanocobalamin to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Cyanocobalamin has a safety concern score of 65 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Fatigue, nausea, and headache are the most common adverse reactions reported.
Key safety signals identified in Cyanocobalamin's adverse event data include: Frequent reports of fall and dizziness suggest potential risk of falls in elderly patients.. Multiple reports of respiratory issues (pneumonia, asthma, respiratory tract infections) indicate possible respiratory side effects.. Serious adverse events like death and pneumonia highlight the need for careful monitoring.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Cyanocobalamin may cause dizziness and fatigue, which can increase the risk of falls, especially in elderly patients. Warnings should be given to patients about the potential for dizziness and the need for caution when engaging in activities that req Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Cyanocobalamin.
Patients should be advised to report any unusual symptoms to their healthcare provider immediately. Elderly patients should be particularly cautious due to the increased risk of falls and respiratory issues. Patients should follow the prescribed dosage and not exceed the recommended amount.
Cyanocobalamin has 90,076 adverse event reports on file with the FDA. Serious adverse events, such as pneumonia and death, are reported but less frequently. The volume of reports for Cyanocobalamin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has not issued specific guidelines for cyanocobalamin, but given the reported adverse events, it is recommended that patients closely monitor any new or worsening symptoms and report them to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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