Sandostatin LAR Adverse Reactions

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 [eg, decreased thyroid stimulating hormone (TSH), decreased total T₄, and decreased Free T₄], loose stools, impaired glucose tolerance, vomiting, asthenia, and hypoglycemia.
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.
In very rare instances, acute pancreatitis has been reported within the 1st hours or days of Sandostatin SC treatment and resolved on withdrawal of the drug. In addition, cholelithiasis-induced pancreatitis has been reported for patients on long-term Sandostatin SC treatment.
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).
The following adverse drug reactions, have been accumulated from clinical studies with octreotide:
Adverse drug reactions are ranked under heading of frequency, 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.
Gastrointestinal Disorders: Very common: Diarrhea, abdominal pain, nausea, constipation, flatulence. Common: Dyspepsia, vomiting, abdominal bloating, steatorrhoea, loose stools, discoloration of faeces.
Nervous System Disorders: Very Common: Headache. Common: Dizziness.
Endocrine Disorders: Common: Hypothyroidism, thyroid dysfunction (eg, decreased TSH, decreased total T₄, and decreased free T₄).
Hepatobiliary Disorders: Very common: Cholelithiasis. Common: Cholecystitis, biliary sludge, hyperbilirubinemia.
Metabolism and Nutrition Disorders: Very Common: Hyperglycemia. Common: Hypoglycemia, impaired glucose tolerance, anorexia. Uncommon: Dehydration.
General Disorders and Administration Site: Very common: Injection site localized pain.
Investigations: Common: Elevated transaminase levels.
Skin and Subcutaneous Tissue Disorders: Common: Pruritus, rash, alopecia.
Respiratory Disorders: Common: Dyspnea.
Cardiac Disorders: Common: Bradycardia. Uncommon: Tachycardia.
Post-marketing: Spontaneously reported adverse reactions are reported voluntarily and it is not always possible to reliably establish frequency or a causal relationship to drug exposure.
Adverse Drug Reactions Derived from Spontaneous Reports: Immune Disorders: Anaphylaxis, allergy/hypersensitivity reactions.
Skin and Subcutaneous Tissue Disorders: Urticaria.
Hepatobiliary Disorders: Acute pancreatitis, acute hepatitis without cholestasis, cholestatic hepatitis, cholestasis, jaundice, cholestatic jaundice.
Cardiac Disorders: Arrhythmias.
Investigations: Increased alkaline phosphatase levels, increased gamma glutamyl transferase levels.