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)
Pregnancy18.08.02.004--Not Available
Proctalgia07.03.02.001--
Prostatic disorder21.04.01.001--Not Available
Prostatitis21.09.01.001--Not Available
Pruritus23.03.12.001--
Psychomotor hyperactivity17.01.02.011; 19.11.02.003--Not Available
Rash23.03.13.001--Not Available
Raynaud's phenomenon24.04.03.003--Not Available
Rectal haemorrhage24.07.02.018; 07.12.03.001--
Renal pain20.02.03.003--Not Available
Rhinitis11.01.13.004; 22.07.03.006--
Seborrhoea23.02.07.001--Not Available
Seborrhoeic dermatitis23.03.04.018--Not Available
Seizure17.12.03.001--
Sensory loss17.02.07.007--Not Available
Shock24.06.02.002--Not Available
Sinus bradycardia02.03.03.009--
Sinusitis11.01.13.005; 22.07.03.007--
Skin disorder23.03.03.007--Not Available
Sleep disorder19.02.04.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Steatorrhoea07.17.01.002--Not Available
Syncope24.06.02.012; 17.02.04.008; 02.11.04.015--
Tachycardia02.03.02.007--Not Available
Tenderness08.01.08.005--Not Available
Tension19.06.02.005--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombophlebitis24.01.02.001--Not Available
Thyroid disorder05.02.01.002--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
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