Metformin is an (US) FDA-approved antidiabetic agent that manages high blood sugar levels in Type 2 Diabetes patients. It reduces glucose absorption from the intestines, lowers liver glucose production, and improves insulin sensitivity. Metformin is recommended with dietary changes and exercise for better results.[1]
Metformin (brand name: Glumetza) in the biguanide drug class, is usually the first drug used to help control blood sugar in people with Type 2 Diabetes. It helps to lower blood sugar throughout the day and after eating. Specifically, metformin, when used with diet and exercise, is approved by the FDA for blood sugar control in the treatment of Type 2 Diabetes in adults and children 10 years of age and older.
Side effects are not the same as complications but all are contra indications and should be communicated immediately to your doctor regardless of whether you are taking the medications for the first time or have been taking them for a while. Metformin’s side effects typically manifest shortly after the initial dose, and while they may improve for some individuals after a few weeks, others may experience their persistence. Other patients may not even begin to experience side effects until they have been taking the drug for months or a year.
[1] drugs.com, “Metformin,” (2026).
Off -label prescribing occurs when a drug is prescribed for an indication, a route of administration, or a patient group that is not included in the approved product information document for that drug.[1] Metformin has been “Repurposed “successfully in patients with PreDiabetes and Type 1 Diabetes to help lower blood sugars; however, this use is not approved by the FDA and is considered off-label. “Off-label” uses are those that are not approved by the FDA and are not found in the package labeling but it may be an accepted and well-researched use.
Prescribing off label is unavoidable and very common, especially if your practice includes children, pregnant women or palliative care. Off-label prescribing means that the Therapeutic Goods Administration (TGA) (Australia) has not approved the indication, route of administration or patient group. It does not mean that the TGA has rejected the indication. Commonly the TGA has not been asked to evaluate the indication. [2] Off label prescribing happens in most jurisdictions, but check yours – certainly it happens in Canada, UK, and the US.
Metformin has been prescribed off-label for certain Cancers, Li Fraumeni syndrome, renal protection, steatotic liver disease, Alzheimer’s, and Healthy Aging.
[1] Richard Day, “Off-Label Prescribing,” (2013).
[2] Richard Day, “Off-Label Prescribing.”
