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 For use as an adjunct to diet and exercise in adult patients (18 years and older) with NIDDM. May also be used for the management of metabolic and reproductive abnormalities associated with polycystic ovary syndrome (PCOS). Jentadueto is for the treatment of patients when both linagliptin and metformin is appropriate.
Marketing Status Prescription; Discontinued
ATC Code A10BA02
DrugBank ID DB00331
KEGG ID D04966
MeSH ID D008687
PubChem ID 4091
TTD Drug ID D0D7LA
NDC Product Code 0615-8105; 52493-334; 50742-633; 0378-6001; 50742-634; 0378-6002; 60155-001
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
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.0010.001512%Not Available
Abdominal distension07.01.04.0010.000508%
Abdominal pain07.01.05.0020.003101%
Abdominal pain upper07.01.05.0030.001251%
Abdominal rigidity07.01.05.0110.000065%Not Available
Abdominal tenderness07.01.05.0040.000300%Not Available
Abnormal faeces07.01.03.0010.000039%Not Available
Abortion18.01.01.0010.000130%Not Available
Abortion missed18.01.01.0020.000104%Not Available
Abortion spontaneous18.01.04.001--Not Available
Acetonaemia14.01.01.0120.000091%Not Available
Acidosis14.01.03.0020.000177%
Acne23.02.01.001--Not Available
Actinic keratosis23.01.06.0010.000065%Not Available
Acute abdomen07.01.06.0150.000117%Not Available
Acute hepatic failure09.01.03.0010.000031%Not Available
Acute myeloid leukaemia01.10.05.001; 16.01.05.001--Not Available
Acute myocardial infarction02.02.02.001; 24.04.04.0010.000573%Not Available
Acute prerenal failure20.01.03.001; 24.06.02.0030.000065%Not Available
Acute pulmonary oedema02.05.02.004; 22.01.03.0050.000065%Not Available
Acute respiratory distress syndrome22.01.03.0010.000180%
Acute respiratory failure14.01.04.004; 22.02.06.001--Not Available
Ageusia07.14.03.003; 17.02.07.001--Not Available
Aggression19.05.01.001--Not Available
Agitation17.02.05.012; 19.06.02.0010.000873%
Alanine aminotransferase abnormal13.03.01.0010.000039%Not Available
Alanine aminotransferase increased13.03.01.0030.000443%
Alcohol abuse19.07.02.0070.000010%Not Available
Alcoholism19.07.02.0010.000039%Not Available
Alopecia23.02.02.001--
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ADReCS-Target
Drug Name ADR Term Target
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