Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Semaglutide
Drug ID BADD_D02518
Description Semaglutide is a glucagon-like peptide 1 (GLP-1) analog used to manage type 2 diabetes along with lifestyle changes, such as dietary restrictions and increased physical activity.[A31421,L8681] Other members of this drug class include [Exenatide] and [Liraglutide]. Semaglutide was developed by Novo Nordisk and approved by the FDA for subcutaneous injection in December 2017.[L8681] The tablet formulation was approved for oral administration in September 2019. Semaglutide works by binding to and activating the GLP-1 receptor, thereby stimulating insulin secretion and reducing blood glucose.[L8678] The subcutaneous injection is administered once weekly and the tablet is administered once a day. Semaglutide offers a competitive advantage over other drugs used to manage diabetes, which may require several daily doses. Clinical trials have determined that this drug reduces glycosylated hemoglobin (HbA1c) levels and reduces body weight, proving to be effective for patients with type 2 diabetes.[A186053] In June 2021, semaglutide was approved by the FDA for chronic weight management in adults with general obesity or overweight who have at least one weight-related condition: this marks semaglutide as the first approved drug for such use since 2014.[L34485] Health Canada also approved semaglutide in November 2021 for the treatment of adults with obesity.[L39347]
Indications and Usage Semaglutide is indicated to improve glycemic control in adults with type 2 diabetes mellitus as an adjunct of diet and exercise. The approved therapeutic doses are 0.5 mg and 1 mg.[L1068] Diabetes mellitus type 2 is a long-term metabolic disorder characterized by high blood sugar, insulin resistance and lack of insulin. Its onset is determined by the loss ability of beta cells to respond to an increased plasma glucose. This disease is predominantly caused by lifestyle factors like overweight and obesity. The key feature on type 2 diabetes is the presence of insulin resistance which reduced the capacity of insulin to exert its functions at normal at any given concentration. The secretion of insulin is stimulated by the action of incretins in the gut like glucagon-like peptide 1, which also delays gastric emptying and induces satiety, and glucose-dependent insulinotropic polypeptide.[T59]
Marketing Status Not Available
ATC Code A10BJ06
DrugBank ID DB13928
KEGG ID D10025
MeSH ID C000591245
PubChem ID 56843331
TTD Drug ID D02ULU
NDC Product Code 41524-0012; 71796-039; 0169-4136; 0169-4517; 43835-0028; 73569-024; 43835-0030; 0169-4501; 70518-2143; 43835-0029; 50090-5824; 0169-4525; 0169-4524; 73212-030; 50090-5138; 0420-9008; 0169-4130; 0169-4505; 50090-5139; 0169-4132
Synonyms semaglutide | rybelsus | Ozempic
Chemical Information
Molecular Formula C187H291N45O59
CAS Registry Number 910463-68-2
SMILES CCC(C)C(C(=O)NC(C)C(=O)NC(CC1=CNC2=CC=CC=C21)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)N C(CCCNC(=N)N)C(=O)NCC(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)O)NC(=O)C(CC3=CC=CC=C3)NC(=O) C(CCC(=O)O)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(C(=O)O)NC(=O)CCCCCCCC CCCCCCCCC(=O)O)NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(=O)N)NC(=O)CNC(=O)C(CCC(=O)O)NC(= O)C(CC(C)C)NC(=O)C(CC4=CC=C(C=C4)O)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(C(C)C)NC(=O)C(C C(=O)O)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CC5=CC=CC=C5)NC(=O)C(C(C)O)NC(=O)CNC(=O) C(CCC(=O)O)NC(=O)C(C)(C)NC(=O)C(CC6=CN=CN6)N
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Pain08.01.08.004--
Pain of skin23.03.03.0030.001017%
Palpitations02.01.02.0030.002543%
Pancreatic carcinoma16.13.10.001; 07.21.09.0020.000663%Not Available
Pancreatic disorder07.18.02.0010.001017%Not Available
Pancreatitis07.18.01.0010.055437%
Pancreatitis acute07.18.01.0020.003560%Not Available
Pancytopenia01.03.03.003--Not Available
Paraesthesia17.02.06.005--
Photophobia06.01.01.004; 17.17.02.0060.001017%
Pneumonia11.01.09.003; 22.07.01.003--Not Available
Pollakiuria20.02.02.0070.001017%
Pruritus23.03.12.001--
Rash23.03.13.0010.020344%Not Available
Rash generalised23.03.13.0020.004069%Not Available
Rash pruritic23.03.12.0020.003560%Not Available
Rectal haemorrhage07.12.03.001; 24.07.02.018--
Renal failure20.01.03.005--Not Available
Renal pain20.02.03.0030.001017%Not Available
Retching07.01.07.0020.001017%Not Available
Retinopathy24.03.07.003; 06.10.02.0010.011698%
Seizure17.12.03.001--
Sepsis11.01.11.003--
Skin exfoliation23.03.07.0030.002034%Not Available
Somnolence19.02.05.003; 17.02.04.006--
Suicidal ideation19.12.01.003--
Swelling face23.04.01.018; 10.01.05.0180.001526%Not Available
Swollen tongue07.14.02.003; 23.04.01.014; 10.01.05.0150.001526%Not Available
Syncope24.06.02.012; 17.02.04.008; 02.01.02.0080.003052%
Tachycardia02.03.02.007--Not Available
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