65/100 · Elevated
Manufactured by Boiron
Iron Supplements: Common Mild Reactions with Some Serious Concerns
149,621 FDA adverse event reports analyzed
Last updated: 2026-05-12
IRON is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Boiron. Based on analysis of 149,621 FDA adverse event reports, IRON has a safety score of 65 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 IRON include FATIGUE, OFF LABEL USE, DIARRHOEA, NAUSEA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for IRON.
Iron has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 149,621 adverse event reports for this medication, which is primarily manufactured by Boiron.
The most commonly reported adverse events include Fatigue, Off Label Use, Diarrhoea. Of classified reports, 65.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Most reactions are mild, but serious adverse events like pneumonia and death are reported.
Diarrhoea, nausea, and fatigue are the most common reactions. Drug ineffectiveness and anaemia are also frequently reported.
Patients taking Iron should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Iron supplements can interact with other medications, potentially affecting their absorption. Warnings include avoiding iron with antacids and certain antibiotics. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Iron received a safety concern score of 65/100 (elevated concern). This is based on a 65.0% serious event ratio across 63,819 classified reports. The score accounts for 149,621 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: 41,440, Male: 17,615, Unknown: 75. The most frequently reported age groups are age 67 (910 reports), age 70 (876 reports), age 63 (848 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 63,819 classified reports for IRON:
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.
Iron supplements can interact with other medications, potentially affecting their absorption. Warnings include avoiding iron with antacids and certain antibiotics.
If you are taking Iron, here are important things to know. The most commonly reported side effects include fatigue, off label use, diarrhoea, nausea, drug ineffective. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult a healthcare provider before starting iron supplements, especially if you have existing health conditions or are taking other medications. Monitor for any unusual symptoms and report them to your healthcare provider promptly. 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 the FDA monitoring these reports to ensure public safety.
The FDA has received approximately 149,621 adverse event reports associated with Iron. 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 Iron include Fatigue, Off Label Use, Diarrhoea, Nausea, Drug Ineffective. By volume, the top reported reactions are: Fatigue (5,818 reports), Off Label Use (5,086 reports), Diarrhoea (4,728 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Iron.
Out of 63,819 classified reports, 41,476 (65.0%) were classified as serious and 22,343 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 Iron break down by patient sex as follows: Female: 41,440, Male: 17,615, Unknown: 75. 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 Iron adverse events are: age 67: 910 reports, age 70: 876 reports, age 63: 848 reports, age 65: 846 reports, age 66: 841 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 Iron 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 Iron include: Headache, Pain, Dyspnoea, Dizziness, Arthralgia. 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 Iron 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.
Iron has a safety concern score of 65 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. Most reactions are mild, but serious adverse events like pneumonia and death are reported.
Key safety signals identified in Iron's adverse event data include: High number of reports of pneumonia and death indicate potential serious risks.. Multiple reports of haemoglobin and blood iron decreased suggest possible haematological effects.. A significant number of reports involve drug hyper-sensitivity and allergic reactions.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Iron supplements can interact with other medications, potentially affecting their absorption. Warnings include avoiding iron with antacids and certain antibiotics. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Iron.
Consult a healthcare provider before starting iron supplements, especially if you have existing health conditions or are taking other medications. Monitor for any unusual symptoms and report them to your healthcare provider promptly.
Iron has 149,621 adverse event reports on file with the FDA. Diarrhoea, nausea, and fatigue are the most common reactions. The volume of reports for Iron reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with the FDA monitoring these reports to ensure public safety. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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