Adverse Drug Reaction Classification System

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
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
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)
Abdominal discomfort07.01.06.0010.000794%Not Available
Abdominal distension07.01.04.0010.000206%
Abdominal pain07.01.05.0020.001023%
Abdominal pain upper07.01.05.003--
Abdominal rigidity07.01.05.0110.000014%Not Available
Abdominal tenderness07.01.05.0040.000062%Not Available
Abnormal dreams19.02.03.001; Available
Abnormal faeces07.01.03.0010.000015%Not Available
Abortion18.01.01.0010.000027%Not Available
Abortion missed18.01.01.0020.000022%Not Available
Acetonaemia14.01.01.0120.000022%Not Available
Actinic keratosis23.01.06.0010.000016%Not Available
Acute abdomen07.01.06.0150.000024%Not Available
Acute hepatic failure09.01.03.0010.000062%Not Available
Acute myocardial infarction24.04.04.001; Available
Acute promyelocytic leukaemia01.10.05.003; Available
Acute pulmonary oedema22.01.03.005; Available
Acute respiratory distress syndrome24.03.02.034;;
Acute respiratory failure22.02.06.001; Available
Adenoma benign16.02.02.0010.000005%Not Available
Akinesia17.01.02.0030.000005%Not Available
Alcohol abuse19.07.06.0010.000008%Not Available
Alcoholism19.07.06.0060.000008%Not Available
Altered state of consciousness19.07.01.003; Available
Anaemia macrocytic14.12.01.002; Available
Anaemia megaloblastic14.12.01.003; Available
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