82/100 · Critical
Manufactured by Haleon US Holdings LLC
Calcium Carbonate Adverse Events: High Seriousness and Diverse Reactions
242,064 FDA adverse event reports analyzed
Last updated: 2026-05-12
CALCIUM CARBONATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Haleon US Holdings LLC. Based on analysis of 242,064 FDA adverse event reports, CALCIUM CARBONATE has a safety score of 82 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 CARBONATE include FATIGUE, NAUSEA, DIARRHOEA, CHRONIC KIDNEY DISEASE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CALCIUM CARBONATE.
Calcium Carbonate has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 242,064 adverse event reports for this medication, which is primarily manufactured by Haleon Us Holdings Llc.
The most commonly reported adverse events include Fatigue, Nausea, Diarrhoea. Of classified reports, 79.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are serious, with chronic kidney disease and acute kidney injury being among the top reactions.
A wide variety of reactions are reported, indicating a diverse safety profile. Report volume is substantial, with over 240,000 total reports.
Patients taking Calcium Carbonate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Calcium Carbonate may interact with diuretics, potentially increasing the risk of hypokalemia and nephrotoxicity. Warnings are also present for patients with pre-existing kidney conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Calcium Carbonate received a safety concern score of 82/100 (high concern). This is based on a 79.8% serious event ratio across 64,374 classified reports. The score accounts for 242,064 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 39,880, Male: 19,389, Unknown: 63. The most frequently reported age groups are age 65 (1,450 reports), age 43 (1,252 reports), age 64 (1,129 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 64,374 classified reports for CALCIUM CARBONATE:
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 Carbonate may interact with diuretics, potentially increasing the risk of hypokalemia and nephrotoxicity. Warnings are also present for patients with pre-existing kidney conditions.
If you are taking Calcium Carbonate, here are important things to know. The most commonly reported side effects include fatigue, nausea, diarrhoea, chronic kidney disease, pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should monitor for signs of kidney issues, such as changes in urine output or swelling, and report any concerns to their healthcare provider. Follow prescribed dosing instructions and do not exceed recommended doses. 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 for renal toxicity and ensuring appropriate use, especially in patients with pre-existing kidney conditions.
The FDA has received approximately 242,064 adverse event reports associated with Calcium Carbonate. 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 Carbonate include Fatigue, Nausea, Diarrhoea, Chronic Kidney Disease, Pain. By volume, the top reported reactions are: Fatigue (6,167 reports), Nausea (5,630 reports), Diarrhoea (4,986 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 Carbonate.
Out of 64,374 classified reports, 51,346 (79.8%) were classified as serious and 13,028 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 Carbonate break down by patient sex as follows: Female: 39,880, Male: 19,389, Unknown: 63. 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 Carbonate adverse events are: age 65: 1,450 reports, age 43: 1,252 reports, age 64: 1,129 reports, age 44: 1,047 reports, age 69: 1,023 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 Carbonate adverse event reports is Haleon Us Holdings Llc. 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 Carbonate include: Off Label Use, Drug Ineffective, Dyspnoea, Vomiting, Headache. 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 Carbonate 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 Carbonate has a safety concern score of 82 out of 100 (high 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 serious, with chronic kidney disease and acute kidney injury being among the top reactions.
Key safety signals identified in Calcium Carbonate's adverse event data include: Chronic kidney disease and acute kidney injury are key safety signals, indicating potential renal toxicity.. Pain and drug ineffectiveness are also significant signals, suggesting issues with efficacy and patient satisfaction.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Calcium Carbonate may interact with diuretics, potentially increasing the risk of hypokalemia and nephrotoxicity. Warnings are also present for patients with pre-existing kidney conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Calcium Carbonate.
Patients should monitor for signs of kidney issues, such as changes in urine output or swelling, and report any concerns to their healthcare provider. Follow prescribed dosing instructions and do not exceed recommended doses.
Calcium Carbonate has 242,064 adverse event reports on file with the FDA. A wide variety of reactions are reported, indicating a diverse safety profile. The volume of reports for Calcium Carbonate reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring for renal toxicity and ensuring appropriate use, especially in patients with pre-existing kidney conditions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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