Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Octreotide acetate
Drug ID BADD_D01595
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 D02250; D06495
MeSH ID D015282
PubChem ID 6917964
TTD Drug ID D02XIY
NDC Product Code 0078-0182; 25021-463; 25021-467; 63323-376; 32861-0005; 55463-0035; 65015-840; 0078-0818; 25021-464; 63323-378; 0078-0825; 23155-685; 68083-517; 68083-515; 0641-6176; 76177-119; 67457-239; 66558-0192; 0078-0181; 68083-516; 68083-560; 0641-6175; 0641-6177; 0641-6178; 59149-007; 59651-004; 25021-466; 63323-377; 63323-379; 65129-1049; 0078-0180; 23155-687; 25021-465; 67457-245; 67457-246; 63415-0065; 23155-688; 63629-8831; 0641-6174; 52416-123; 0078-0811; 23155-686; 23155-689
UNII 75R0U2568I
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 C51H70N10O12S2
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.CC(=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)
Tremor17.01.06.002--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Vaginal infection21.14.02.002; 11.01.10.002--
Varicose vein24.10.04.001--Not Available
Vertigo17.02.12.002; 04.04.01.003--
Viral infection11.05.04.001--Not Available
Vision blurred17.17.01.010; 06.02.06.007--
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Wheezing22.03.01.009--
Hypoacusis04.02.01.006--
Gallbladder polyp16.06.02.002; 09.03.02.003--Not Available
Pituitary haemorrhage24.07.04.009; 17.08.01.019; 05.03.04.005--Not Available
Contusion15.03.05.007; 24.07.06.001; 23.03.11.002; 12.01.06.001--
Musculoskeletal discomfort15.03.04.001--Not Available
Blood pressure orthostatic decreased13.14.03.011--Not Available
Transaminases increased13.03.04.036--Not Available
Thyroxine free decreased13.10.06.009--Not Available
Pulmonary mass22.02.07.004--Not Available
Vulvovaginal pruritus23.03.12.009; 21.08.02.004--Not Available
Rectal tenesmus15.05.03.011; 07.03.03.001--Not Available
Hypogonadism21.03.02.010; 05.05.04.002--Not Available
Blood alkaline phosphatase increased13.04.02.004--
Urine output increased13.13.03.002--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.027--
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