85/100 · Critical
Manufactured by APNAR PHARMA LP
Magnesium Oxide Adverse Events: High Serious Reaction Rate
82,440 FDA adverse event reports analyzed
Last updated: 2026-05-12
MAGNESIUM OXIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by APNAR PHARMA LP. Based on analysis of 82,440 FDA adverse event reports, MAGNESIUM OXIDE has a safety score of 85 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 MAGNESIUM OXIDE include NAUSEA, DIARRHOEA, FATIGUE, DYSPNOEA, PNEUMONIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MAGNESIUM OXIDE.
Magnesium Oxide has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 82,440 adverse event reports for this medication, which is primarily manufactured by Apnar Pharma Lp.
The most commonly reported adverse events include Nausea, Diarrhoea, Fatigue. Of classified reports, 80.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea and diarrhea are the most common adverse reactions.
Serious reactions, including pneumonia and renal failure, are frequent. Drug ineffectiveness and decreased appetite are also notable concerns.
Patients taking Magnesium Oxide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Caution is advised when using magnesium oxide with other medications, as drug interactions have been reported. Ensure proper dosing and monitor for adverse effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Magnesium Oxide received a safety concern score of 85/100 (high concern). This is based on a 80.5% serious event ratio across 39,818 classified reports. The score accounts for 82,440 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: 20,913, Male: 16,313, Unknown: 25. The most frequently reported age groups are age 71 (979 reports), age 65 (972 reports), age 70 (887 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 39,818 classified reports for MAGNESIUM OXIDE:
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.
Caution is advised when using magnesium oxide with other medications, as drug interactions have been reported. Ensure proper dosing and monitor for adverse effects.
If you are taking Magnesium Oxide, here are important things to know. The most commonly reported side effects include nausea, diarrhoea, fatigue, dyspnoea, pneumonia. 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 serious reactions such as pneumonia, renal failure, and hypotension. Inform healthcare providers of any existing medical conditions or medications to avoid potential drug interactions. 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 continues to monitor the safety of magnesium oxide. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 82,440 adverse event reports associated with Magnesium Oxide. 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 Magnesium Oxide include Nausea, Diarrhoea, Fatigue, Dyspnoea, Pneumonia. By volume, the top reported reactions are: Nausea (2,797 reports), Diarrhoea (2,579 reports), Fatigue (2,419 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Magnesium Oxide.
Out of 39,818 classified reports, 32,055 (80.5%) were classified as serious and 7,763 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 Magnesium Oxide break down by patient sex as follows: Female: 20,913, Male: 16,313, Unknown: 25. 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 Magnesium Oxide adverse events are: age 71: 979 reports, age 65: 972 reports, age 70: 887 reports, age 72: 881 reports, age 74: 873 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 Magnesium Oxide adverse event reports is Apnar Pharma Lp. 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 Magnesium Oxide include: Off Label Use, Pyrexia, Vomiting, Headache, Death. 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 Magnesium Oxide 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.
Magnesium Oxide has a safety concern score of 85 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. Nausea and diarrhea are the most common adverse reactions.
Key safety signals identified in Magnesium Oxide's adverse event data include: High incidence of serious reactions (80.5%). Multiple organ systems affected, including respiratory, renal, and hematological. Significant number of reports involving drug interactions and ineffective treatment. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Caution is advised when using magnesium oxide with other medications, as drug interactions have been reported. Ensure proper dosing and monitor for adverse effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Magnesium Oxide.
Monitor for signs of serious reactions such as pneumonia, renal failure, and hypotension. Inform healthcare providers of any existing medical conditions or medications to avoid potential drug interactions.
Magnesium Oxide has 82,440 adverse event reports on file with the FDA. Serious reactions, including pneumonia and renal failure, are frequent. The volume of reports for Magnesium Oxide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of magnesium oxide. Healthcare providers should report any adverse events to the FDA's MedWatch program. 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 MAGNESIUM OXIDE:
Drugs related to MAGNESIUM OXIDE based on therapeutic use, drug class, or shared indications: