Where Metformin is approved
All regulators →Of the three regulators tracked here, the first to approve Metformin was the US, on 3 Mar 1995. It is approved in 2 of the 3 regulators tracked here.
- 2 EU orphan designations, most recently for treatment of Duchenne muscular dystrophy (17 Jan 2018, positive)
- 1 EU safety letter (DHPC), latest: quality defect for Jentadueto, 20 Aug 2026
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Metformin
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Metformin works
All drug targets →- Mitochondrial complex I (NADH dehydrogenase) inhibitor InhibitorTarget: Mitochondrial complex I (NADH dehydrogenase)ChEMBL only
- Mitochondrial glycerol-3-phosphate dehydrogenase inhibitor InhibitorTarget: GPD2 glycerol-3-phosphate dehydrogenase 2ChEMBL only
- COVID-19Phase 3
- Duchenne muscular dystrophyPhase 3
- FatiguePhase 3
- Huntington diseasePhase 3
- HyperglycemiaPhase 3
- Impaired glucose tolerancePhase 3
- Increased body weightPhase 3
- InfertilityPhase 3
- Insulin resistancePhase 3
- MiscarriagePhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1431, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 4503, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Metformin
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 22 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Metformin
- ATC code
- A10BA02
- ChEMBL
- CHEMBL1431
- DrugBank
- DB00331
- PubChem CID
- 155906370
- CAS number
- 657-24-9
- FDA UNII
- 9100L32L2N
- Wikidata
- Q19484
- Wikipedia
- Metformin
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Glucophage is used for
Metformin (Glucophage) is the first-line oral medicine for type-2 diabetes. It belongs to the Biguanide class.
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 10 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.