82/100 · Critical
Manufactured by Boiron
Ferrous Sulfate Adverse Events: High Serious Reaction Rate
93,718 FDA adverse event reports analyzed
Last updated: 2026-05-12
FERROUS SULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Boiron. Based on analysis of 93,718 FDA adverse event reports, FERROUS SULFATE 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 FERROUS SULFATE include FATIGUE, DIARRHOEA, NAUSEA, DYSPNOEA, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FERROUS SULFATE.
Ferrous Sulfate 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 93,718 adverse event reports for this medication, which is primarily manufactured by Boiron.
The most commonly reported adverse events include Fatigue, Diarrhoea, Nausea. Of classified reports, 75.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Ferrous Sulfate reports include a high percentage of serious adverse events, particularly respiratory and renal issues.
The most common reactions are fatigue, diarrhea, and nausea, which are generally mild. A significant number of reports involve drug interactions and kidney-related issues. The majority of reports are from older adults, with the highest number of reports occurring in the 70-79 age range. Serious reactions such as death, acute kidney injury, and chronic kidney disease are notable.
Patients taking Ferrous Sulfate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ferrous Sulfate can interact with other medications, and its use in unapproved indications may lead to drug ineffectiveness or adverse reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ferrous Sulfate received a safety concern score of 82/100 (high concern). This is based on a 75.2% serious event ratio across 47,758 classified reports. The score accounts for 93,718 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: 27,654, Male: 16,612, Unknown: 36. The most frequently reported age groups are age 71 (862 reports), age 76 (857 reports), age 73 (838 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 47,758 classified reports for FERROUS SULFATE:
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.
Ferrous Sulfate can interact with other medications, and its use in unapproved indications may lead to drug ineffectiveness or adverse reactions.
If you are taking Ferrous Sulfate, here are important things to know. The most commonly reported side effects include fatigue, diarrhoea, nausea, dyspnoea, death. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always consult a healthcare provider before starting Ferrous Sulfate, especially if you have kidney issues or are taking other medications. Monitor for signs of kidney problems, such as changes in urination or swelling, and report any concerns to your healthcare provider. 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 closely monitors Ferrous Sulfate due to its high rate of serious adverse events, particularly in older adults.
The FDA has received approximately 93,718 adverse event reports associated with Ferrous Sulfate. 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 Ferrous Sulfate include Fatigue, Diarrhoea, Nausea, Dyspnoea, Death. By volume, the top reported reactions are: Fatigue (3,325 reports), Diarrhoea (3,101 reports), Nausea (2,746 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ferrous Sulfate.
Out of 47,758 classified reports, 35,924 (75.2%) were classified as serious and 11,834 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 Ferrous Sulfate break down by patient sex as follows: Female: 27,654, Male: 16,612, Unknown: 36. 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 Ferrous Sulfate adverse events are: age 71: 862 reports, age 76: 857 reports, age 73: 838 reports, age 72: 821 reports, age 74: 802 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 Ferrous Sulfate 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 Ferrous Sulfate include: Off Label Use, Acute Kidney Injury, Anaemia, Pneumonia, 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 Ferrous Sulfate 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.
Ferrous Sulfate 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. Ferrous Sulfate reports include a high percentage of serious adverse events, particularly respiratory and renal issues.
Key safety signals identified in Ferrous Sulfate's adverse event data include: Acute kidney injury and chronic kidney disease are key safety signals, especially in older adults.. Death is a significant safety signal, with 2345 reports.. Drug interactions and ineffective drug use are also important signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ferrous Sulfate can interact with other medications, and its use in unapproved indications may lead to drug ineffectiveness or adverse reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ferrous Sulfate.
Always consult a healthcare provider before starting Ferrous Sulfate, especially if you have kidney issues or are taking other medications. Monitor for signs of kidney problems, such as changes in urination or swelling, and report any concerns to your healthcare provider.
Ferrous Sulfate has 93,718 adverse event reports on file with the FDA. The most common reactions are fatigue, diarrhea, and nausea, which are generally mild. The volume of reports for Ferrous Sulfate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Ferrous Sulfate due to its high rate of serious adverse events, particularly in older adults. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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