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
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)
Hypoventilation22.02.01.0070.000008%-
Hypovitaminosis14.12.01.0010.000038%-
Hypovolaemia14.05.05.0020.000246%-
Hypovolaemic shock24.06.02.0170.000054%-
Hypoxia22.02.02.0030.000073%
Idiopathic pulmonary fibrosis10.02.01.034; 22.01.02.0140.000049%-
Ileus paralytic07.02.05.0010.000011%-
Immune system disorder10.02.01.001---
Impaired gastric emptying07.02.02.0040.000014%
Indifference19.05.01.0040.000014%-
Infection11.01.08.002---
Influenza11.05.03.001; 22.07.02.001---
Injection site bruising08.02.03.042; 12.07.03.042; 23.03.11.015; 24.07.06.0170.000040%-
Injection site erythema08.02.03.001; 12.07.03.001; 23.03.06.0150.000071%-
Injection site haemorrhage08.02.03.005; 12.07.03.005; 24.07.01.0100.000055%-
Injection site induration08.02.03.007; 12.07.03.0070.000016%-
Injection site inflammation08.02.03.008; 12.07.03.0090.000015%-
Injection site mass08.02.03.009; 12.07.03.0100.000094%-
Injection site necrosis08.02.03.020; 12.07.03.0200.000005%-
Injection site pain08.02.03.010; 12.07.03.011---
Injection site pruritus08.02.03.013; 12.07.03.014; 23.03.12.0070.000107%-
Injection site rash08.02.03.032; 12.07.03.032; 23.03.13.0100.000030%-
Injection site reaction08.02.03.014; 12.07.03.015--
Injection site urticaria08.02.03.029; 10.01.06.003; 12.07.03.029; 23.04.02.0030.000018%-
Injection site vesicles08.02.03.051; 12.07.03.051; 23.03.01.0240.000015%-
Injection site warmth08.02.03.036; 12.07.03.0360.000005%-
Injury12.01.08.004---
Insulin resistance05.06.02.003; 14.06.02.0030.000051%-
Insulinoma05.08.01.004; 07.21.09.001; 16.24.02.0030.000011%-
Intestinal ischaemia07.15.02.001; 24.04.08.0010.000030%-
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ADReCS-Target
Drug Name ADR Term Target
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