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)
Grief reaction	19.23.01.003	0.000008%		Not Available
Hepatic infarction	24.04.07.007; 09.01.06.017	0.000005%		Not Available
Hepatosplenomegaly neonatal	18.04.08.002; 09.01.05.010; 01.09.03.002	0.000016%		Not Available
Hypoglycaemic encephalopathy	14.06.03.011; 05.06.03.011; 17.13.01.010	0.000060%		Not Available
Induced labour	18.07.01.007	0.000005%		Not Available
Kussmaul respiration	22.02.01.008; 14.01.01.004	0.000030%		Not Available
Large for dates baby	18.04.02.004	0.000016%		Not Available
Myocardial fibrosis	02.04.02.016	0.000005%		Not Available
Neonatal respiratory distress syndrome	18.04.10.003; 22.11.02.010	0.000022%		Not Available
Non-alcoholic fatty liver	14.08.04.023; 09.01.07.034	0.000011%		Not Available
Normal newborn	18.08.06.001	0.000066%		Not Available
Overweight	14.03.02.021	0.000014%		Not Available
Pernicious anaemia	10.04.01.007; 07.17.01.004; 01.03.01.003	0.000030%		Not Available
Persecutory delusion	19.10.01.007	0.000008%		Not Available
Rheumatic fever	15.01.01.010; 11.07.01.011; 10.02.01.018; 02.09.03.002	0.000022%		Not Available
Slow response to stimuli	17.02.05.063	0.000011%		Not Available
Small for dates baby	18.04.02.002	0.000060%		Not Available
Tachycardia paroxysmal	02.03.02.028	0.000005%		Not Available
Vitamin B1 deficiency	14.12.02.012	0.000022%		Not Available
Vocal cord polyp	22.04.01.009; 16.38.02.001	0.000005%		Not Available
Ruptured ectopic pregnancy	18.02.02.005	0.000008%		Not Available
Ovarian adenoma	21.11.01.012; 16.04.03.005	0.000016%		Not Available
Coma acidotic	17.02.09.007; 14.01.03.003	0.000032%		Not Available
Pancreatic mass	07.18.02.007	0.000005%		Not Available
Weight loss poor	14.03.02.027	-	-	Not Available
Pulmonary vein stenosis	24.04.09.013; 22.06.03.008	0.000016%		Not Available
Short-bowel syndrome	12.02.03.024; 07.17.01.010	0.000005%		Not Available
Peripartum cardiomyopathy	18.02.04.004; 02.04.01.011	0.000005%		Not Available
Live birth	18.08.02.007	0.000073%		Not Available
Renal oncocytoma	20.01.04.019; 16.27.01.008	0.000016%		Not Available

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