72/100 · Elevated
Manufactured by Granules Pharmaceuticals Inc.
Metformin ER 750 MG: Common Gastrointestinal Issues and Rare but Serious Adverse Events
532,492 FDA adverse event reports analyzed
Last updated: 2026-05-12
METFORMIN ER 750 MG is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Granules Pharmaceuticals Inc.. Based on analysis of 532,492 FDA adverse event reports, METFORMIN ER 750 MG has a safety score of 72 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 ER 750 MG include NAUSEA, DIARRHOEA, BLOOD GLUCOSE INCREASED, DRUG INEFFECTIVE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for METFORMIN ER 750 MG.
Metformin Er 750 Mg has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 532,492 adverse event reports for this medication, which is primarily manufactured by Granules Pharmaceuticals Inc..
The most commonly reported adverse events include Nausea, Diarrhoea, Blood Glucose Increased. Of classified reports, 67.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Gastrointestinal issues like nausea and diarrhea are the most common adverse events.
Serious adverse events such as acute kidney injury and lactic acidosis are reported but less frequently. Weight changes, both increase and decrease, are notable side effects. Drug interactions and incorrect dose administration are significant safety concerns. Serious adverse events account for a substantial portion of reports, indicating potential risks.
Patients taking Metformin Er 750 Mg should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Metformin ER 750 MG can cause gastrointestinal issues and may interact with other drugs, leading to hypoglycemia. Incorrect dose administration can also lead to serious adverse events. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Metformin Er 750 Mg received a safety concern score of 72/100 (elevated concern). This is based on a 67.8% serious event ratio across 289,695 classified reports. The score accounts for 532,492 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: 142,977, Male: 123,403, Unknown: 942. The most frequently reported age groups are age 65 (6,619 reports), age 70 (6,364 reports), age 68 (6,185 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 289,695 classified reports for METFORMIN ER 750 MG:
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 ER 750 MG can cause gastrointestinal issues and may interact with other drugs, leading to hypoglycemia. Incorrect dose administration can also lead to serious adverse events.
If you are taking Metformin Er 750 Mg, here are important things to know. The most commonly reported side effects include nausea, diarrhoea, blood glucose increased, drug ineffective, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always follow the prescribed dose and schedule to avoid hypoglycemia and other adverse events. Inform your healthcare provider about any other medications you are taking to prevent drug interactions. 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 ER 750 MG for safety, and regulatory actions may be taken based on emerging safety signals.
The FDA has received approximately 532,492 adverse event reports associated with Metformin Er 750 Mg. 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 Er 750 Mg include Nausea, Diarrhoea, Blood Glucose Increased, Drug Ineffective, Fatigue. By volume, the top reported reactions are: Nausea (18,881 reports), Diarrhoea (18,086 reports), Blood Glucose Increased (16,755 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 Er 750 Mg.
Out of 289,695 classified reports, 196,413 (67.8%) were classified as serious and 93,282 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 Er 750 Mg break down by patient sex as follows: Female: 142,977, Male: 123,403, Unknown: 942. 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 Er 750 Mg adverse events are: age 65: 6,619 reports, age 70: 6,364 reports, age 68: 6,185 reports, age 66: 6,120 reports, age 63: 6,105 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 Er 750 Mg adverse event reports is Granules Pharmaceuticals 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 Er 750 Mg include: Acute Kidney Injury, Vomiting, Lactic Acidosis, Off Label Use, Dyspnoea. 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 Er 750 Mg 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 Er 750 Mg has a safety concern score of 72 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. Gastrointestinal issues like nausea and diarrhea are the most common adverse events.
Key safety signals identified in Metformin Er 750 Mg's adverse event data include: Acute kidney injury and lactic acidosis are key safety signals, though less common.. Weight changes, both gain and loss, are significant.. Drug interactions and incorrect dose administration are critical safety signals.. Serious adverse events like death and renal failure are reported.. Gastrointestinal issues are the most frequent adverse events.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Metformin ER 750 MG can cause gastrointestinal issues and may interact with other drugs, leading to hypoglycemia. Incorrect dose administration can also lead to serious adverse events. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Metformin Er 750 Mg.
Always follow the prescribed dose and schedule to avoid hypoglycemia and other adverse events. Inform your healthcare provider about any other medications you are taking to prevent drug interactions.
Metformin Er 750 Mg has 532,492 adverse event reports on file with the FDA. Serious adverse events such as acute kidney injury and lactic acidosis are reported but less frequently. The volume of reports for Metformin Er 750 Mg reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Metformin ER 750 MG for safety, and regulatory actions may be taken based on emerging safety signals. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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