72/100 · Elevated
Manufactured by APEXEL CO., LTD.
Calcium Supplements: High Serious Event Rate and Diverse Reactions
374,933 FDA adverse event reports analyzed
Last updated: 2026-05-12
CALCIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by APEXEL CO., LTD.. Based on analysis of 374,933 FDA adverse event reports, CALCIUM has a safety score of 72 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for CALCIUM include FATIGUE, OFF LABEL USE, NAUSEA, DRUG INEFFECTIVE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CALCIUM.
Calcium has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 374,933 adverse event reports for this medication, which is primarily manufactured by Apexel Co., Ltd..
The most commonly reported adverse events include Fatigue, Off Label Use, Nausea. Of classified reports, 61.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are non-serious, but the serious event rate is high at 61.5%.
A wide variety of reactions are reported, indicating a complex safety profile. The most common reactions include fatigue, nausea, and pain, which are frequently reported.
Patients taking Calcium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Calcium supplements may interact with other medications, potentially affecting absorption or causing adverse effects. Warnings include potential for hypercalcemia and kidney stones, especially in high doses. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Calcium received a safety concern score of 72/100 (elevated concern). This is based on a 61.5% serious event ratio across 143,524 classified reports. The score accounts for 374,933 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: 104,535, Male: 29,546, Unknown: 126. The most frequently reported age groups are age 65 (3,032 reports), age 70 (2,741 reports), age 69 (2,712 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 143,524 classified reports for CALCIUM:
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.
Calcium supplements may interact with other medications, potentially affecting absorption or causing adverse effects. Warnings include potential for hypercalcemia and kidney stones, especially in high doses.
If you are taking Calcium, here are important things to know. The most commonly reported side effects include fatigue, off label use, nausea, drug ineffective, pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of hypercalcemia, such as constipation, nausea, and confusion, especially in elderly patients. Consult a healthcare provider before starting calcium supplements, especially if taking other medications. 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.
Regulatory oversight is ongoing, with a focus on monitoring serious events and ensuring appropriate labeling for potential interactions and side effects.
The FDA has received approximately 374,933 adverse event reports associated with Calcium. 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 Calcium include Fatigue, Off Label Use, Nausea, Drug Ineffective, Pain. By volume, the top reported reactions are: Fatigue (14,115 reports), Off Label Use (12,110 reports), Nausea (10,624 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Calcium.
Out of 143,524 classified reports, 88,260 (61.5%) were classified as serious and 55,264 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 Calcium break down by patient sex as follows: Female: 104,535, Male: 29,546, Unknown: 126. 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 Calcium adverse events are: age 65: 3,032 reports, age 70: 2,741 reports, age 69: 2,712 reports, age 67: 2,710 reports, age 64: 2,703 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 Calcium adverse event reports is Apexel Co., Ltd.. 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 Calcium include: Diarrhoea, Arthralgia, Headache, Dizziness, Dyspnoea. 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 Calcium 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.
Calcium has a safety concern score of 72 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 majority of adverse events are non-serious, but the serious event rate is high at 61.5%.
Key safety signals identified in Calcium's adverse event data include: High number of serious events (88,260 out of 143,524 total outcomes, 61.5%). Diverse range of reactions, including cardiovascular, respiratory, and gastrointestinal issues. Significant number of falls and respiratory infections reported. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Calcium supplements may interact with other medications, potentially affecting absorption or causing adverse effects. Warnings include potential for hypercalcemia and kidney stones, especially in high doses. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Calcium.
Monitor for signs of hypercalcemia, such as constipation, nausea, and confusion, especially in elderly patients. Consult a healthcare provider before starting calcium supplements, especially if taking other medications.
Calcium has 374,933 adverse event reports on file with the FDA. A wide variety of reactions are reported, indicating a complex safety profile. The volume of reports for Calcium reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious events and ensuring appropriate labeling for potential interactions and side effects. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with CALCIUM:
Drugs related to CALCIUM based on therapeutic use, drug class, or shared indications: