Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Octreotide
Drug ID BADD_D02412
Description Acromegaly is a disorder caused by excess growth hormone (GH), increasing the growth of body tissues and causing metabolic dysfunction.[L14501] In most cases, it results from an anterior pituitary growth hormone-releasing tumor. Typically, the feet, hands, and face grow abnormally large; organomegaly and insulin resistance may also occur. Acromegaly is a life-threatening disease requiring life-long management.[L14501] Octreotide is a long-acting drug with pharmacologic activities that mimic those of the natural hormone, somatostatin, which inhibits the secretion of growth hormone.[L14513] Additionally, it is used for the treatment of acromegaly and symptoms arising from various tumors, including carcinoid tumors and vasoactive intestinal tumors (VIPomas).[L14513] In the past, octreotide has been administered solely by injection. On June 26, 2020, the first approved delayed-release oral somatostatin analog, Mycapssa, received FDA approval for the long term maintenance treatment of acromegaly. This drug was developed by Chiasma Inc.[L14495,L14507,L14528]
Indications and Usage Octreotide by injection is used for the treatment of acromegaly and the reduction of flushing and diarrhea symptoms related to carcinoid tumors and/or vasoactive intestinal peptide (VIPoma) tumors.[L14513] The delayed-release oral formulation is used for the long-term treatment of acromegaly in patients who tolerate and respond adequately to injectable octreotide and [lanreotide].[L14507]
Marketing Status approved; investigational
ATC Code H01CB02
DrugBank ID DB00104
KEGG ID D00442
MeSH ID D015282
PubChem ID 448601
TTD Drug ID D02XIY
NDC Product Code 73301-004; 35207-0002; 69880-120; 52416-118; 52416-109; 62147-0206; 41524-0007
UNII RWM8CCW8GP
Synonyms Octreotide | SMS 201-995 | SMS 201 995 | SMS 201995 | SM 201-995 | SM 201 995 | SM 201995 | Sandoz 201-995 | Sandoz 201 995 | Sandoz 201995 | Compound 201-995 | Compound 201 995 | Compound 201995 | SAN 201-995 | SAN 201 995 | SAN 201995 | Octreotide Acetate | Octreotide Acetate Salt | Sandostatine | Sandostatin
Chemical Information
Molecular Formula C49H66N10O10S2
CAS Registry Number 79517-01-4
SMILES CC(C1C(=O)NC(CSSCC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)N1)CCCCN)CC2=CNC3=CC=CC=C32)CC4= CC=CC=C4)NC(=O)C(CC5=CC=CC=C5)N)C(=O)NC(CO)C(C)O)O
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)
Injection site haematoma24.07.01.009; 12.07.03.004; 08.02.03.004--Not Available
Injection site haemorrhage24.07.01.010; 12.07.03.005; 08.02.03.0050.001062%Not Available
Injection site hypersensitivity12.07.03.006; 10.01.03.017; 08.02.03.0060.000279%Not Available
Injection site induration08.02.03.007; 12.07.03.0070.000876%Not Available
Injection site inflammation12.07.03.009; 08.02.03.008--Not Available
Injection site irritation12.07.03.027; 08.02.03.0270.000633%Not Available
Injection site mass12.07.03.010; 08.02.03.0090.002068%Not Available
Injection site oedema12.07.03.024; 08.02.03.0240.000186%Not Available
Injection site pain12.07.03.011; 08.02.03.0100.008681%Not Available
Injection site pruritus12.07.03.014; 08.02.03.013; 23.03.12.0070.000689%Not Available
Injection site rash23.03.13.010; 12.07.03.032; 08.02.03.0320.000410%Not Available
Injection site reaction12.07.03.015; 08.02.03.0140.000689%
Injection site urticaria23.04.02.003; 12.07.03.029; 10.01.06.003; 08.02.03.0290.000410%Not Available
Injection site warmth12.07.03.036; 08.02.03.0360.000596%Not Available
Insomnia19.02.01.002; 17.15.03.0020.001770%
Intestinal infarction24.04.08.008; 07.15.02.0060.000186%Not Available
Intestinal ischaemia07.15.02.001; 24.04.08.0010.000186%Not Available
Intestinal obstruction07.13.01.0020.002608%Not Available
Intestinal perforation07.04.06.002--Not Available
Intracranial aneurysm24.02.04.001; 17.08.06.001--Not Available
Intussusception07.13.01.008--Not Available
Irritable bowel syndrome19.24.01.003; 07.02.04.003--Not Available
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.0040.000279%Not Available
Joint stiffness15.01.02.003--Not Available
Joint swelling15.01.02.0040.000876%Not Available
Lacrimation increased06.08.02.004--
Lethargy17.02.04.003; 08.01.01.008; 19.04.04.0040.000466%
Leukaemia16.01.03.001; 01.10.03.001--
Lip pain07.05.05.029--
Lipoma15.09.01.001; 16.18.01.001--Not Available
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