ADReCS

Pharmaceutical Information

Drug Name	Metformin
Drug ID	BADD_D01401
Description	Metformin is an antihyperglycemic agent of the _biguanide_ class, used for the management of type II diabetes) [FDA label]. Currently, metformin is the first drug of choice for the management of type II diabetes and is prescribed to at least 120 million people worldwide [A176173]. Metformin is considered an antihyperglycemic drug because it lowers blood glucose concentrations in type II diabetes without causing hypoglycemia. Metformin is commonly described as an _insulin sensitizer_ leading to a decrease in insulin resistance and a clinically significant reduction of plasma fasting insulin levels [A176173]. Another well-known benefit of this drug is modest weight loss. Metformin is the drug of choice for obese type II diabetes patients [A36559]. Metformin was first approved in Canada in 1972 [A36552], followed by 1995 in the USA [FDA label]. This drug is available in regular and extended-release forms [FDA label].
Indications and Usage	Metformin tablet Metformin is indicated as an adjunct to diet and exercise to increase glycemic control in _adults and pediatric patients_ 10 years of age and older diagnosed with type 2 diabetes mellitus.[FDA label] Metformin extended-release tablet (XR) The extended-release form is indicated as an adjunct to diet and exercise to improve glycemic control in only _adults_ with type 2 diabetes mellitus. Safety in children has not been determined to this date.[FDA label] An extended-release combination product containing empagliflozin, linagliptin, and metformin was approved by the FDA in January 2020 for the improvement of glycemic control in adults with type 2 diabetes mellitus when used adjunctively with diet and exercise.[L11479]
Marketing Status	approved
ATC Code	A10BA02
DrugBank ID	DB00331
KEGG ID	D04966
MeSH ID	D008687
PubChem ID	4091
TTD Drug ID	D0D7LA
NDC Product Code	0378-6002; 0615-8105; 52493-334; 50742-634; 0378-6001; 50742-633
UNII	9100L32L2N
Synonyms	Metformin \| Dimethylbiguanidine \| Dimethylguanylguanidine \| Glucophage \| Metformin Hydrochloride \| Hydrochloride, Metformin \| Metformin HCl \| HCl, Metformin

Chemical Information

Molecular Formula	C4H11N5
CAS Registry Number	657-24-9
SMILES	CN(C)C(=N)N=C(N)N
Chemical Structure

ADRs Induced by Drug

*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..

ADR Term	ADReCS ID	ADR Frequency (FAERS)	ADR Severity Grade (FAERS)	ADR Severity Grade (CTCAE)
Adnexal torsion	21.11.02.012	0.000005%		Not Available
Hepatic cancer	16.07.02.004; 09.04.02.008	-	-	Not Available
Autoimmune haemolytic anaemia	10.04.01.005; 01.06.01.004	0.000049%		Not Available
Faeces soft	07.01.03.008	0.000016%		Not Available
Peripheral venous disease	24.04.02.022	0.000005%		Not Available
Respiratory symptom	22.12.02.013	0.000005%		Not Available
Multiple organ dysfunction syndrome	08.01.03.057	0.000785%
Anal incontinence	07.01.06.029; 17.05.01.021	0.000083%
Ureterolithiasis	20.04.03.003	0.000008%		Not Available
Abdominal mass	07.01.01.003	0.000028%		Not Available
Abnormal loss of weight	14.03.02.019	0.000019%		Not Available
Adenocarcinoma gastric	16.13.03.002; 07.21.02.002	0.000005%		Not Available
Agitated depression	19.15.01.007; 17.02.05.050	0.000008%		Not Available
Alcohol interaction	08.06.03.003	0.000014%		Not Available
Anaemia folate deficiency	01.03.01.005; 14.12.02.009	0.000016%		Not Available
Anorexia nervosa	19.09.01.007; 14.03.03.002	0.000005%		Not Available
Antiphospholipid syndrome	24.01.01.029; 18.02.04.002; 10.04.01.009; 01.01.02.016	0.000005%		Not Available
Aortitis	24.12.01.001	0.000024%		Not Available
Bladder transitional cell carcinoma	20.03.04.003; 16.08.01.002	0.000008%		Not Available
Bone cancer	16.29.02.002; 15.09.03.012	0.000005%		Not Available
Chronic gastritis	10.04.04.011; 07.08.02.005; 11.07.01.016	0.000011%		Not Available
Coeliac disease	14.02.01.007; 10.04.04.012; 07.17.01.008	0.000020%		Not Available
Concomitant disease aggravated	08.01.03.063	-	-	Not Available
Coombs negative haemolytic anaemia	01.06.03.001	0.000005%		Not Available
Delusion of reference	19.10.01.005	0.000005%		Not Available
Dermatitis exfoliative generalised	23.03.07.002; 10.01.01.029	0.000057%		Not Available
Diabetic eye disease	14.07.01.005; 06.08.03.024; 05.07.01.005	0.000005%		Not Available
Dumping syndrome	12.02.03.017; 07.01.06.031	0.000012%		Not Available
Faeces pale	07.01.03.005	0.000014%		Not Available
Foetal malnutrition	18.03.01.004	0.000014%		Not Available

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