73/100 · Elevated
Manufactured by AiPing Pharmaceutical, Inc.
Metformin Extended-Release Tablets: High Serious Reaction Rate, Primarily Affecting Elderly
106,995 FDA adverse event reports analyzed
Last updated: 2026-05-12
METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AiPing Pharmaceutical, Inc.. Based on analysis of 106,995 FDA adverse event reports, METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS has a safety score of 73 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 EXTENDED RELEASE 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 EXTENDED RELEASE TABLETS.
Metformin Hydrochloride Extended-Release Tablets has a safety concern score of 73 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 106,995 adverse event reports for this medication, which is primarily manufactured by Aiping Pharmaceutical, Inc..
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, with high report volumes.
Diarrhea, nausea, and fatigue are common gastrointestinal side effects. Drug interactions and hypoglycemia are significant safety concerns, especially in elderly patients.
Patients taking Metformin Hydrochloride Extended-Release 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, especially in patients with renal impairment. It is contraindicated in patients with severe renal impairment or acute kidney injury. Close monitoring is required when used with other drugs that may cause lactic ac This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Metformin Hydrochloride Extended-Release Tablets received a safety concern score of 73/100 (elevated concern). This is based on a 73.3% serious event ratio across 53,370 classified reports. The score accounts for 106,995 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: 26,608, 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 53,370 classified reports for METFORMIN HYDROCHLORIDE EXTENDED RELEASE 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, especially in patients with renal impairment. It is contraindicated in patients with severe renal impairment or acute kidney injury. Close monitoring is required when used with other drugs that may cause lactic ac
If you are taking Metformin Hydrochloride Extended-Release 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 blood glucose levels regularly, especially in elderly patients and those with renal impairment. Be cautious when metformin is used in combination with other drugs that may cause lactic acidosis or renal impairment. 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 continues to monitor the safety of metformin extended-release tablets. Healthcare providers should be vigilant about monitoring for serious adverse reactions, particularly in elderly patients and those with renal impairment.
The FDA has received approximately 106,995 adverse event reports associated with Metformin Hydrochloride Extended-Release 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 Extended-Release Tablets include Lactic Acidosis, Diarrhoea, Nausea, Acute Kidney Injury, Fatigue. By volume, the top reported reactions are: Lactic Acidosis (4,135 reports), Diarrhoea (3,973 reports), Nausea (3,243 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 Extended-Release Tablets.
Out of 53,370 classified reports, 39,139 (73.3%) were classified as serious and 14,231 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 Extended-Release Tablets break down by patient sex as follows: Female: 26,608, 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 Extended-Release 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 Extended-Release Tablets adverse event reports is Aiping Pharmaceutical, Inc.. 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 Extended-Release 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 Extended-Release 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 Extended-Release Tablets has a safety concern score of 73 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. Lactic acidosis and acute kidney injury are the most serious adverse reactions, with high report volumes.
Key safety signals identified in Metformin Hydrochloride Extended-Release Tablets's adverse event data include: Lactic acidosis. Acute kidney injury. Drug interactions. Hypoglycemia. 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, especially in patients with renal impairment. It is contraindicated in patients with severe renal impairment or acute kidney injury. Close monitoring is required when used with other drugs that may cause lactic ac Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Metformin Hydrochloride Extended-Release Tablets.
Monitor blood glucose levels regularly, especially in elderly patients and those with renal impairment. Be cautious when metformin is used in combination with other drugs that may cause lactic acidosis or renal impairment.
Metformin Hydrochloride Extended-Release Tablets has 106,995 adverse event reports on file with the FDA. Diarrhea, nausea, and fatigue are common gastrointestinal side effects. The volume of reports for Metformin Hydrochloride Extended-Release Tablets reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of metformin extended-release tablets. Healthcare providers should be vigilant about monitoring for serious adverse reactions, particularly in elderly patients and those with renal impairment. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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