MAGNESIUM

78/100 · Elevated

Manufactured by Korea Life Science

Magnesium Adverse Events: High Serious Reaction Rate

219,679 FDA adverse event reports analyzed

Last updated: 2026-05-12

About MAGNESIUM

MAGNESIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Korea Life Science. Based on analysis of 219,679 FDA adverse event reports, MAGNESIUM has a safety score of 78 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 include FATIGUE, NAUSEA, DIARRHOEA, HEADACHE, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MAGNESIUM.

AI Safety Analysis

Magnesium has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 219,679 adverse event reports for this medication, which is primarily manufactured by Korea Life Science.

The most commonly reported adverse events include Fatigue, Nausea, Diarrhoea. Of classified reports, 62.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and nausea are the most common adverse reactions.

Serious reactions, such as death and pneumonia, are reported frequently. A wide range of reactions, including neurological and gastrointestinal issues, are observed.

Patients taking Magnesium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Magnesium can cause various side effects, including fatigue, nausea, and dizziness. It is important to follow prescribed dosages and consult a healthcare provider if any adverse reactions occur. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.

Safety Score: 78/100

Magnesium received a safety concern score of 78/100 (high concern). This is based on a 62.7% serious event ratio across 77,339 classified reports. The score accounts for 219,679 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.

Top Adverse Reactions

FATIGUE8,477 reports
NAUSEA6,658 reports
DIARRHOEA6,465 reports
HEADACHE5,805 reports
DRUG INEFFECTIVE5,485 reports
PAIN5,226 reports
OFF LABEL USE4,930 reports
DIZZINESS4,855 reports
DYSPNOEA4,723 reports
ARTHRALGIA4,504 reports
ASTHENIA4,205 reports
VOMITING3,680 reports
MALAISE3,278 reports
PAIN IN EXTREMITY3,265 reports
RASH3,133 reports
INSOMNIA3,064 reports
FALL3,018 reports
MUSCLE SPASMS3,002 reports
WEIGHT DECREASED2,983 reports
PRURITUS2,900 reports
PNEUMONIA2,880 reports
ANXIETY2,687 reports
PYREXIA2,664 reports
DECREASED APPETITE2,634 reports
WEIGHT INCREASED2,600 reports
CONSTIPATION2,551 reports
COUGH2,519 reports
ABDOMINAL PAIN UPPER2,489 reports
GAIT DISTURBANCE2,413 reports
CONDITION AGGRAVATED2,379 reports
BACK PAIN2,355 reports
DEATH2,249 reports
NASOPHARYNGITIS2,240 reports
PERIPHERAL SWELLING2,223 reports
ALOPECIA2,170 reports
DEPRESSION2,165 reports
HYPERTENSION2,141 reports
HYPOAESTHESIA2,112 reports
FEELING ABNORMAL2,055 reports
ABDOMINAL DISCOMFORT2,046 reports
PARAESTHESIA2,024 reports
CHEST PAIN2,012 reports
ABDOMINAL PAIN1,992 reports
PRODUCT DOSE OMISSION ISSUE1,920 reports
URINARY TRACT INFECTION1,850 reports
SINUSITIS1,823 reports
JOINT SWELLING1,780 reports
MEMORY IMPAIRMENT1,756 reports
CONFUSIONAL STATE1,698 reports
MYALGIA1,685 reports
COVID 191,645 reports
DRUG HYPERSENSITIVITY1,636 reports
MIGRAINE1,621 reports
CONTUSION1,603 reports
MUSCULAR WEAKNESS1,588 reports
BLOOD PRESSURE INCREASED1,565 reports
PRODUCT USE IN UNAPPROVED INDICATION1,552 reports
HYPERSENSITIVITY1,486 reports
ANAEMIA1,479 reports
INFECTION1,477 reports
URTICARIA1,437 reports
GENERAL PHYSICAL HEALTH DETERIORATION1,407 reports
DRY MOUTH1,402 reports
MUSCULOSKELETAL STIFFNESS1,390 reports
HYPOTENSION1,382 reports
RHEUMATOID ARTHRITIS1,379 reports
DYSPEPSIA1,372 reports
MOBILITY DECREASED1,355 reports
SWELLING1,333 reports
PRODUCT USE ISSUE1,331 reports
TREMOR1,313 reports
DEHYDRATION1,278 reports
SLEEP DISORDER1,273 reports
SOMNOLENCE1,270 reports
INFUSION RELATED REACTION1,269 reports
OEDEMA PERIPHERAL1,267 reports
DRUG INTOLERANCE1,242 reports
STOMATITIS1,231 reports
ARTHROPATHY1,206 reports
GASTROINTESTINAL DISORDER1,175 reports
MATERNAL EXPOSURE DURING PREGNANCY1,160 reports
PALPITATIONS1,155 reports
ASTHMA1,151 reports
INJECTION SITE PAIN1,146 reports
NEUROPATHY PERIPHERAL1,142 reports
ABDOMINAL DISTENSION1,125 reports
PSORIATIC ARTHROPATHY1,120 reports
BLOOD CHOLESTEROL INCREASED1,119 reports
HEPATIC ENZYME INCREASED1,119 reports
OEDEMA1,111 reports
MUSCULOSKELETAL PAIN1,093 reports
ERYTHEMA1,086 reports
BLISTER1,082 reports
VISION BLURRED1,065 reports
WHEEZING1,061 reports
DISCOMFORT1,050 reports
HEART RATE INCREASED1,046 reports
BALANCE DISORDER1,045 reports
INTENTIONAL PRODUCT USE ISSUE1,038 reports
OSTEOARTHRITIS1,033 reports

Key Safety Signals

  • High number of serious reactions (48,502 out of 77,339, 62.7%)
  • Multiple serious conditions like pneumonia and death are reported
  • A diverse range of reactions, including neurological and gastrointestinal issues

Patient Demographics

Adverse event reports by sex: Female: 50,710, Male: 21,325, Unknown: 45. The most frequently reported age groups are age 69 (1,481 reports), age 65 (1,433 reports), age 70 (1,433 reports). These demographics reflect reporting patterns and may not represent the full patient population.

Report Outcomes

Out of 77,339 classified reports for MAGNESIUM:

  • Serious: 48,502 reports (62.7%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 28,837 reports (37.3%)
Serious 62.7%Non-Serious 37.3%

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 Breakdown

Reports by Sex

Female50,710 (70.4%)
Male21,325 (29.6%)
Unknown45 (0.1%)

Reports by Age

Age 691,481 reports
Age 651,433 reports
Age 701,433 reports
Age 711,401 reports
Age 671,368 reports
Age 661,362 reports
Age 741,358 reports
Age 681,356 reports
Age 721,300 reports
Age 621,287 reports
Age 731,281 reports
Age 631,277 reports
Age 641,252 reports
Age 611,250 reports
Age 751,209 reports
Age 601,176 reports
Age 761,136 reports
Age 431,069 reports
Age 591,069 reports
Age 771,064 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Drug Interactions & Warnings

Magnesium can cause various side effects, including fatigue, nausea, and dizziness. It is important to follow prescribed dosages and consult a healthcare provider if any adverse reactions occur.

What You Should Know

If you are taking Magnesium, here are important things to know. The most commonly reported side effects include fatigue, nausea, diarrhoea, headache, drug ineffective. 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 difficulty breathing, chest pain, or severe allergic reactions. Follow prescribed dosages and consult a healthcare provider if any adverse reactions occur. 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 Context

The FDA continues to monitor magnesium safety and has not issued any specific warnings or changes to labeling. However, patients should report any serious adverse events to their healthcare provider.

Frequently Asked Questions

How many adverse event reports has the FDA received for Magnesium?

The FDA has received approximately 219,679 adverse event reports associated with Magnesium. 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.

What are the most commonly reported side effects of Magnesium?

The most frequently reported adverse events for Magnesium include Fatigue, Nausea, Diarrhoea, Headache, Drug Ineffective. By volume, the top reported reactions are: Fatigue (8,477 reports), Nausea (6,658 reports), Diarrhoea (6,465 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.

What percentage of Magnesium adverse event reports are serious?

Out of 77,339 classified reports, 48,502 (62.7%) were classified as serious and 28,837 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.

Who reports adverse events for Magnesium (by sex)?

Adverse event reports for Magnesium break down by patient sex as follows: Female: 50,710, Male: 21,325, Unknown: 45. 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.

What age groups report the most side effects for Magnesium?

The most frequently reported age groups for Magnesium adverse events are: age 69: 1,481 reports, age 65: 1,433 reports, age 70: 1,433 reports, age 71: 1,401 reports, age 67: 1,368 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.

Who manufactures Magnesium?

The primary manufacturer associated with Magnesium adverse event reports is Korea Life Science. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.

What other side effects have been reported for Magnesium?

Beyond the most common reactions, other reported adverse events for Magnesium include: Pain, Off Label Use, Dizziness, Dyspnoea, Arthralgia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.

How do I report a side effect from Magnesium?

You can report adverse events from Magnesium 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.

What is Magnesium's safety score and what does it mean?

Magnesium has a safety concern score of 78 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. Fatigue and nausea are the most common adverse reactions.

What are the key safety signals for Magnesium?

Key safety signals identified in Magnesium's adverse event data include: High number of serious reactions (48,502 out of 77,339, 62.7%). Multiple serious conditions like pneumonia and death are reported. A diverse range of reactions, including neurological and gastrointestinal issues. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.

Does Magnesium interact with other drugs?

Magnesium can cause various side effects, including fatigue, nausea, and dizziness. It is important to follow prescribed dosages and consult a healthcare provider if any adverse reactions occur. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Magnesium.

What should patients know before taking Magnesium?

Monitor for signs of serious reactions such as difficulty breathing, chest pain, or severe allergic reactions. Follow prescribed dosages and consult a healthcare provider if any adverse reactions occur.

Are Magnesium side effects well-documented?

Magnesium has 219,679 adverse event reports on file with the FDA. Serious reactions, such as death and pneumonia, are reported frequently. The volume of reports for Magnesium reflects both the drug's usage level and the vigilance of the reporting community.

What is the FDA's position on Magnesium?

The FDA continues to monitor magnesium safety and has not issued any specific warnings or changes to labeling. However, patients should report any serious adverse events 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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Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.