82/100 · Critical
Manufactured by EPIC PHARMA, LLC
Metformin Hydrochloride Tablet Adverse Events: High Seriousness and Diverse Reactions
107,050 FDA adverse event reports analyzed
Last updated: 2026-05-12
METFORMIN HYDROCHLORIDE TABLET is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by EPIC PHARMA, LLC. Based on analysis of 107,050 FDA adverse event reports, METFORMIN HYDROCHLORIDE TABLET 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 TABLET 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 TABLET.
Metformin Hydrochloride Tablet 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 107,050 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 adverse reactions, each reported over 2,900 times.
Diarrhoea, nausea, and dyspnoea are common gastrointestinal and respiratory issues. The drug is associated with a range of neurological and cardiovascular issues, including confusion and chest pain.
Patients taking Metformin Hydrochloride Tablet should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Metformin can interact with other medications, potentially leading to lactic acidosis. It is contraindicated in patients with renal impairment or liver disease. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Metformin Hydrochloride Tablet received a safety concern score of 82/100 (high concern). This is based on a 73.3% serious event ratio across 53,380 classified reports. The score accounts for 107,050 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: 26,605, 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 53,380 classified reports for METFORMIN HYDROCHLORIDE TABLET:
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 interact with other medications, potentially leading to lactic acidosis. It is contraindicated in patients with renal impairment or liver disease.
If you are taking Metformin Hydrochloride Tablet, 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 muscle pain, weakness, and shortness of breath, especially in elderly patients. Be cautious with concurrent use of metformin and other medications that may affect kidney function. 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 metformin for safety, and any unusual symptoms should be reported to healthcare providers immediately.
The FDA has received approximately 107,050 adverse event reports associated with Metformin Hydrochloride Tablet. 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 Tablet include Lactic Acidosis, Diarrhoea, Nausea, Acute Kidney Injury, Fatigue. By volume, the top reported reactions are: Lactic Acidosis (4,143 reports), Diarrhoea (3,972 reports), Nausea (3,244 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 Tablet.
Out of 53,380 classified reports, 39,151 (73.3%) were classified as serious and 14,229 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 Tablet break down by patient sex as follows: Female: 26,605, 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 Tablet 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 Tablet 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 Tablet 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 Tablet 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 Tablet 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 adverse reactions, each reported over 2,900 times.
Key safety signals identified in Metformin Hydrochloride Tablet's adverse event data include: Lactic acidosis and acute kidney injury are key safety signals, with high report counts.. There are numerous reports of serious conditions like death, renal failure, and pneumonia.. Drug interactions and overuse are also significant safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Metformin can interact with other medications, potentially leading to lactic acidosis. It is contraindicated in patients with renal impairment or liver disease. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Metformin Hydrochloride Tablet.
Monitor for signs of lactic acidosis, such as muscle pain, weakness, and shortness of breath, especially in elderly patients. Be cautious with concurrent use of metformin and other medications that may affect kidney function.
Metformin Hydrochloride Tablet has 107,050 adverse event reports on file with the FDA. Diarrhoea, nausea, and dyspnoea are common gastrointestinal and respiratory issues. The volume of reports for Metformin Hydrochloride Tablet reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors metformin for safety, and any unusual symptoms should be reported to healthcare providers immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by EPIC PHARMA, LLC and compare their safety profiles:
The following drugs share commonly reported adverse reactions with METFORMIN HYDROCHLORIDE TABLET:
Drugs related to METFORMIN HYDROCHLORIDE TABLET based on therapeutic use, drug class, or shared indications: