Summary of the safety profile: The most frequent adverse reactions reported during octreotide therapy include gastrointestinal disorders, nervous system disorders, hepatobiliary disorders, and metabolism and nutritional disorders.
The most commonly reported adverse reactions in clinical trials with octreotide administration were diarrhea, abdominal pain, nausea, flatulence, headache, cholelithiasis, hyperglycemia and constipation. Other commonly reported adverse reactions were dizziness, localized pain, biliary sludge, thyroid dysfunction (e.g., decreased thyroid stimulating hormone [TSH], decreased Total T4, and decreased Free T4), loose stools, impaired glucose tolerance, vomiting, asthenia, and hypoglycemia.
Tabulated summary of adverse drug reactions from clinical trials: The following adverse drug reactions (ADRs), listed in Table 1, have been accumulated from clinical studies with octreotide: Adverse drug reactions (Table 1) are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), including isolated reports. Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness. (See Table 1.)
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Adverse drug reactions from spontaneous reports and literature cases (frequency not known): The following adverse drug reactions have been derived from post-marketing experience with octreotide via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorized as not known. ADRs are listed according to system organ classes in MedDRA. Within each system organ class, ADRs are presented in order of decreasing seriousness. (See Table 2.)
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Description of selected adverse drug reactions: Gastrointestinal disorders and nutrition: In rare instances, gastrointestinal side effects may resemble acute intestinal obstruction, with progressive abdominal distension, severe epigastric pain, abdominal tenderness and guarding.
Although measured fecal fat excretion may increase, there is no evidence to date that long-term treatment with octreotide has led to nutritional deficiency due to malabsorption.
Occurrence of gastrointestinal side effects may be reduced by avoiding meals around the time of Sandostatin s.c. administration, that is, by injecting between meals or on retiring to bed.
Gallbladder and related reactions: Somatostatin analogues have been shown to inhibit gallbladder contractility and decrease bile secretion, which may lead to gallbladder abnormalities or sludge. The incidence of gallstone formation with Sandostatin treatment is estimated to be between 15 to 30%. The incidence in the general population is 5 to 20%. The presence of gallstones or biliary sludge in Sandostatin-treated patients is largely asymptomatic. Symptomatic stones should be treated either by dissolution therapy with bile acids or by surgery. (See "Recommendation for the management of patients during Sandostatin treatment with respect to the development of gallstones" under Patient Counselling Information).
Injection site reactions: Pain or a sensation of stinging, tingling or burning at the site of s.c. injection can occur, with redness and swelling, rarely lasting more than 15 minutes. Local discomfort may be reduced by allowing the solution to reach room temperature before injection, or by injecting a smaller volume using a more concentrated solution.
Cardiac disorders: Bradycardia is a common adverse reaction with somatostatin analogues. In both acromegalic and carcinoid syndrome patients, ECG changes were observed such as QT prolongation, axis shifts, early repolarization, low voltage, R/S transition, early R wave progression, and non-specific ST-T wave changes. The relationship of these events to octreotide acetate is not established because many of these patients have underlying cardiac diseases (see PRECAUTIONS).
Pancreatitis: Cholelithiasis-induced pancreatitis has been reported for patients on long-term Sandostatin s.c. treatment. In very rare instances, acute pancreatitis has been reported within the first hours or days of Sandostatin s.c. treatment and resolved on withdrawal of the drug.
Hypersensitivity and anaphylactic reactions: Hypersensitivity and allergic reactions have been reported during post-marketing experience. When these occur, they mostly affect the skin, rarely the mouth and airways. Isolated cases of anaphylactic shock have been reported.
Thrombocytopenia: Thrombocytopenia has been reported during post-marketing experience, particularly during treatment with Sandostatin (i.v.) in patients with cirrhosis of the liver. This is reversible after discontinuation of treatment.