56/100 · Moderate
Manufactured by Boiron
ZINC Safety Profile: Moderate Concern with Common Mild Reactions
63,326 FDA adverse event reports analyzed
Last updated: 2026-05-12
ZINC is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Boiron. Based on analysis of 63,326 FDA adverse event reports, ZINC has a safety score of 56 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 ZINC include FATIGUE, PAIN, NAUSEA, DIARRHOEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ZINC.
Zinc has a safety concern score of 56 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 63,326 adverse event reports for this medication, which is primarily manufactured by Boiron.
The most commonly reported adverse events include Fatigue, Pain, Nausea. Of classified reports, 56.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions are fatigue, pain, and nausea, indicating a general mild to moderate safety profile.
A significant portion of reports (56.8%) involve serious adverse events, highlighting the need for careful monitoring. The reaction diversity is high, with over 100 distinct reactions reported, suggesting a complex safety profile. Off-label use and drug ineffectiveness are notable concerns, indicating potential misuse or efficacy issues.
Patients taking Zinc should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. ZINC has warnings for off-label use and drug ineffectiveness, and interactions with other drugs should be monitored, especially in elderly patients. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Zinc received a safety concern score of 56/100 (elevated concern). This is based on a 56.8% serious event ratio across 23,167 classified reports. The score accounts for 63,326 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: 14,207, Male: 7,302, Unknown: 24. The most frequently reported age groups are age 77 (573 reports), age 68 (488 reports), age 65 (439 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 23,167 classified reports for ZINC:
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.
ZINC has warnings for off-label use and drug ineffectiveness, and interactions with other drugs should be monitored, especially in elderly patients.
If you are taking Zinc, here are important things to know. The most commonly reported side effects include fatigue, pain, nausea, diarrhoea, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for any signs of serious adverse events, especially in elderly patients. Report any off-label use or drug ineffectiveness to your healthcare provider. 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 is closely monitoring ZINC due to a high number of serious adverse events, and patients should report any unusual symptoms to their healthcare provider.
The FDA has received approximately 63,326 adverse event reports associated with Zinc. 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 Zinc include Fatigue, Pain, Nausea, Diarrhoea, Headache. By volume, the top reported reactions are: Fatigue (2,485 reports), Pain (1,848 reports), Nausea (1,795 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Zinc.
Out of 23,167 classified reports, 13,156 (56.8%) were classified as serious and 10,011 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 Zinc break down by patient sex as follows: Female: 14,207, Male: 7,302, Unknown: 24. 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 Zinc adverse events are: age 77: 573 reports, age 68: 488 reports, age 65: 439 reports, age 70: 420 reports, age 63: 415 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 Zinc adverse event reports is Boiron. 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 Zinc include: Off Label Use, Drug Ineffective, Dyspnoea, Arthralgia, Dizziness. 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 Zinc 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.
Zinc has a safety concern score of 56 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. The most common reactions are fatigue, pain, and nausea, indicating a general mild to moderate safety profile.
Key safety signals identified in Zinc's adverse event data include: Serious adverse events account for 56.8% of all reports, indicating a notable safety concern.. A wide range of reactions, including neurological and gastrointestinal symptoms, are reported.. Off-label use and drug ineffectiveness are key signals, suggesting potential misuse or efficacy issues.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
ZINC has warnings for off-label use and drug ineffectiveness, and interactions with other drugs should be monitored, especially in elderly patients. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Zinc.
Monitor for any signs of serious adverse events, especially in elderly patients. Report any off-label use or drug ineffectiveness to your healthcare provider.
Zinc has 63,326 adverse event reports on file with the FDA. A significant portion of reports (56.8%) involve serious adverse events, highlighting the need for careful monitoring. The volume of reports for Zinc reflects both the drug's usage level and the vigilance of the reporting community.
The FDA is closely monitoring ZINC due to a high number of serious adverse events, and patients should report any unusual symptoms 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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