This page presents data from the FDA Adverse Event Reporting System (FAERS) and the FDA-approved drug label. A report submitted to FAERS does not prove a drug caused the reported event. Always consult a healthcare provider about medications.
Metformin is the brand name for metformin er 750 mg. According to the FDA-approved label, Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. FAERS contains 294,221 submissions naming this drug from 2001 through 2026; the top three reactions cited are nausea, diarrhoea, and blood glucose increased.
Most-Reported Reactions
Counts of the reactions most often cited in FAERS submissions that named Metformin. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.
Patient Demographics
Patient sex and age across the FAERS submissions that named Metformin. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.
By Sex
By Age Group
Severity Outcomes
Severity flags recorded across the 294,221 FAERS submissions that named Metformin. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.
Submissions Per Quarter
Quarterly count of FAERS submissions that named Metformin. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.
From the FDA-Approved Label
Excerpts from the official FDA-approved prescribing information for Metformin. This is the authoritative source on indications, warnings, and known adverse reactions.
Indications
1 INDICATIONS AND USAGE Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets are biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1 )
Adverse Reactions (from label)
6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: • Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1) ] • Vitamin B 12 Deficiency [see Warnings and Precautions (5.2) ] • Hypoglycemia [see Warnings and Precautions (5.3) ] For metformin hydrochloride extended-release tablets, the most common adverse reactions (>5%) are diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc. at 1-877-770-3183 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Metformin Hydrochloride Extended-Release Tablets In placebo-controlled trials, in adults with type 2 diabetes mellitus, 781 patients were administered metformin hydrochloride extended-release tablets. (continues in label)
AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.
