82/100 · Critical
Manufactured by EPIC PHARMA, LLC
Metformin Hydrochloride Tablets: High Serious Reaction Rate and Diverse Safety Concerns
106,986 FDA adverse event reports analyzed
Last updated: 2026-05-12
METFORMIN HYDROCHLORIDE TABLETS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by EPIC PHARMA, LLC. Based on analysis of 106,986 FDA adverse event reports, METFORMIN HYDROCHLORIDE TABLETS 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 METFORMIN HYDROCHLORIDE TABLETS include LACTIC ACIDOSIS, DIARRHOEA, NAUSEA, ACUTE KIDNEY INJURY, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for METFORMIN HYDROCHLORIDE TABLETS.
Metformin Hydrochloride Tablets 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 106,986 adverse event reports for this medication, which is primarily manufactured by Epic Pharma, Llc.
The most commonly reported adverse events include Lactic Acidosis, Diarrhoea, Nausea. Of classified reports, 73.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Lactic acidosis and acute kidney injury are the most serious and frequent adverse reactions.
Diarrhea, nausea, and fatigue are common gastrointestinal side effects. Drug interactions and hypoglycemia are significant safety concerns.
Patients taking Metformin Hydrochloride Tablets should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Metformin can cause lactic acidosis, and it is contraindicated in patients with renal impairment. Drug interactions, particularly with sulfonylureas, can lead to hypoglycemia. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Metformin Hydrochloride Tablets received a safety concern score of 82/100 (high concern). This is based on a 73.3% serious event ratio across 53,364 classified reports. The score accounts for 106,986 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: 26,602, Male: 21,882, Unknown: 117. The most frequently reported age groups are age 65 (1,215 reports), age 70 (1,109 reports), age 73 (1,077 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 53,364 classified reports for METFORMIN HYDROCHLORIDE TABLETS:
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.
Metformin can cause lactic acidosis, and it is contraindicated in patients with renal impairment. Drug interactions, particularly with sulfonylureas, can lead to hypoglycemia.
If you are taking Metformin Hydrochloride Tablets, here are important things to know. The most commonly reported side effects include lactic acidosis, diarrhoea, nausea, acute kidney injury, fatigue. 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 lactic acidosis, such as dyspnea, malaise, and abdominal pain, especially in elderly patients. Be cautious with drug interactions, particularly with sulfonylureas, to prevent hypoglycemia. 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 lactic acidosis and hypoglycemia. Patients should be regularly monitored, especially those with renal impairment or on concomitant medications.
The FDA has received approximately 106,986 adverse event reports associated with Metformin Hydrochloride Tablets. 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 Metformin Hydrochloride Tablets include Lactic Acidosis, Diarrhoea, Nausea, Acute Kidney Injury, Fatigue. By volume, the top reported reactions are: Lactic Acidosis (4,135 reports), Diarrhoea (3,972 reports), Nausea (3,242 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Metformin Hydrochloride Tablets.
Out of 53,364 classified reports, 39,139 (73.3%) were classified as serious and 14,225 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 Metformin Hydrochloride Tablets break down by patient sex as follows: Female: 26,602, Male: 21,882, Unknown: 117. 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 Metformin Hydrochloride Tablets adverse events are: age 65: 1,215 reports, age 70: 1,109 reports, age 73: 1,077 reports, age 72: 1,066 reports, age 66: 1,056 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 Metformin Hydrochloride Tablets adverse event reports is Epic Pharma, 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 Metformin Hydrochloride Tablets include: Drug Ineffective, Dyspnoea, Vomiting, Headache, Off Label Use. 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 Metformin Hydrochloride Tablets 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.
Metformin Hydrochloride Tablets 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. Lactic acidosis and acute kidney injury are the most serious and frequent adverse reactions.
Key safety signals identified in Metformin Hydrochloride Tablets's adverse event data include: Lactic acidosis and acute kidney injury are the most serious adverse reactions.. A high number of reports involve drug interactions and hypoglycemia.. Serious reactions account for 73.3% of all outcomes.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Metformin can cause lactic acidosis, and it is contraindicated in patients with renal impairment. Drug interactions, particularly with sulfonylureas, can lead to hypoglycemia. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Metformin Hydrochloride Tablets.
Monitor for signs of lactic acidosis, such as dyspnea, malaise, and abdominal pain, especially in elderly patients. Be cautious with drug interactions, particularly with sulfonylureas, to prevent hypoglycemia.
Metformin Hydrochloride Tablets has 106,986 adverse event reports on file with the FDA. Diarrhea, nausea, and fatigue are common gastrointestinal side effects. The volume of reports for Metformin Hydrochloride Tablets reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring for lactic acidosis and hypoglycemia. Patients should be regularly monitored, especially those with renal impairment or on concomitant medications. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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