Octreotide (Sandostatin, Sandostatin LAR, Mycapssa, Bynfezia Pen)
Octreotide acetate (SMS 201-995); synonyms: L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl)propyl]-, cyclic (2->7)-disulfide; [R-(R*,R*)] acetate salt
Approved status applies to specific products, routes, and indications, not every use context discussed online.
An FDA-approved injection (Sandostatin) that helps control the overproduction of certain hormones in the body. It is used to treat acromegaly (excess growth hormone), certain hormone-producing tumors of the digestive system, and the severe diarrhea and flushing that can accompany these conditions.
Safety Summary
Gastrointestinal side effects (diarrhea, nausea, abdominal discomfort) are the most common, occurring in 34-61% of acromegalic patients, though they tend to resolve with continued treatment and are less frequent with lower doses. Only 2.6% of patients discontinued due to GI symptoms (FDA label 2024. Gallbladder abnormalities are the most clinically significant long-term concern, with 63% developing biliary tract abnormalities (27% gallstones, 24% sludge, 12% duct dilatation) and 52% incidence with treatment >12 months (FDA label 2024. Cardiac effects include sinus bradycardia in 25% of acromegalic patients, with conduction abnormalities in 10% and arrhythmias in 9%; QT prolongation and other ECG changes have been observed (FDA label 2024. A new warning for steatorrhea and malabsorption of dietary fats was added to the label in July 2024, recommending evaluation for pancreatic exocrine insufficiency (FDA label 2024. Postmarketing reports include complete AV block (primarily with IV use at higher doses during surgical procedures), hypoxia, necrotizing enterocolitis, and death in pediatric patients under 2 years (FDA label 2024. Antibodies develop in up to 25% of SC-treated patients (77-81% nasal, 27% SC) but usually without clinical effect. No potential for abuse or dependence has been identified. Long-term safety monitoring should include thyroid function (TSH, free T4), glucose levels, gallbladder ultrasound, and vitamin B12 levels (FDA label 2024.
Clinical check-in
If real-world use or exposure is being considered, review potential interactions, contraindications, and monitoring needs with a licensed clinician rather than relying on summary copy alone.
Sources: [1-9]