Octreotide Side Effects
Some side effects of octreotide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to octreotide: injectable solution, intramuscular powder for injection
Get emergency medical help if you have any of these signs of an allergic reaction while taking octreotide: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
slow or uneven heartbeats;
severe stomach pain or tenderness, severe constipation;
severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
unusual weakness, loss of energy, weight gain, joint or muscle pain, swelling in your neck or throat (enlarged thyroid);
low blood sugar (headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery); or
high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).
Less serious side effects of octreotide may include:
stomach pain or discomfort, gas, bloating;
nausea or vomiting; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to octreotide: injectable solution, intramuscular powder for injection
Gastrointestinal side effects have been the most common, usually having occurred during the first days to weeks of therapy, and have generally been self-limited. Octreotide inhibits gallbladder contractility and may alter bile composition. An average of 29% of patients have developed new gallstones during octreotide therapy, and up to 20% of patients developed biliary sludge. Associated pancreatitis has been reported in rare cases. Gallbladder hypercontractility, sometimes resulting in biliary colic, has been reported upon withdrawal of octreotide.
Diarrhea, loose stools, nausea, and abdominal discomfort were each reported in 34% to 61% of acromegalic patients in U.S. studies. Only 2.65% of these patients discontinued therapy due to these symptoms.
In patients with other disorders, gastritis or nausea in 10%, diarrhea in 8%, abdominal pain in 3% to 10%, vomiting in 2% to 5%, and steatorrhea in 2% of patients. Constipation, flatulence, hepatitis, jaundice, elevated liver enzymes, rectal spasm, gastrointestinal hemorrhaging, and dyspepsia have been reported in less than 1% of patients.
Despite fat malabsorption during octreotide therapy, fat soluble vitamin deficiencies have not been reported. Rare reports of vitamin B12 deficiency have been associated with use of octreotide.
A case of intestinal perforation associated with octreotide therapy has also been reported.
Because octreotide impairs gallbladder contractility in response to a fatty meal (inhibits the release of cholecystokinin) and increases residual volume of the gallbladder, some experts suggest a 24 to 96-hour drug-free interval to allow gallbladder function to resume. Animal data have shown that octreotide increases gallbladder bile calcium, bilirubin, protein, lipid, and hydrogen ion concentrations. These bile composition changes increase the likelihood of cholesterol and calcium bilirubinate precipitation.
In rare instances, gastrointestinal side effects may resemble acute intestinal obstruction, with progressive abdominal distention, severe epigastric pain, abdominal tenderness, and guarding.
Endocrine side effects have been associated with the inhibition of insulin, glucagon, gastrin, vasoactive intestinal peptide, and growth hormone by octreotide. Both increased and decreased glucose tolerance have been reported, depending on the patient's condition. Careful monitoring of the blood glucose is recommended in patients with diabetes or insulinoma, particularly since the incidence of hypoglycemia may actually increase due to inhibition of glucagon and growth hormone. Both hyper- and hypoglycemia have been associated with the use of octreotide in nondiabetic patients with acromegaly.
Rarely, hypothyroidism requiring thyroid hormone replacement may occur during chronic therapy. More commonly, a statistically significant, but usually clinically insignificant, increase in TSH may be observed, possibly caused by slight inhibition of peripheral deiodination of thyroxine.
Normalization of hypertriglyceridemia has been observed in patients with acromegaly who were treated for up to six months. Limited data have shown significant reductions in LDL cholesterol and apoprotein B after 15 days of therapy, but these potentially beneficial effects disappeared after 30 days of therapy.
Low total and free T4 (without elevated TSH) levels during chronic octreotide therapy have been reported, indicative of hypothalamic-pituitary dysfunction. Octreotide appears to slightly inhibit iodothyronine deiodination and induces a transient reduction in serum T3, which is normally accompanied by elevated TSH levels. Octreotide also appears to reduce the response of TSH to TRH.
A single case in which octreotide was associated with a paradoxical increase in plasma and urinary cortisol, corticotropin, and beta-lipotropic pituitary hormone has been reported.
Local side effects including pain, stinging, or hematoma at the site of injection has occurred in approximately 7% of patients. (This can be reduced by administering the drug slowly and warming it prior to injection.) It rarely has lasted more than 15 minutes and has often resolved over time.
Nervous system side effects have included dizziness, fatigue, headache, anxiety, anorexia, depression, drowsiness, or tremor in less than 1% of patients.
Octreotide may benefit nonobstructive cardiomyopathy associated with acromegaly if there is no coexisting coronary artery disease, but may be deleterious in patients with ischemic cardiomyopathy, uncompensated congestive heart failure, or a left ventricular ejection fraction less than 20%.
Cardiovascular side effects have included rare case reports of congestive heart failure (octreotide inhibits growth hormone, which is a positive inotropic agent), dyspnea, bradycardia, heart block, blood pressure changes, and chest pain.
Dermatologic reactions have been rare, and included skin rash and hair loss.
Alopecia has been reported in four euthyroid women with acromegaly who had previous external irradiation therapy. Octreotide was withheld in three of the four, and hair loss diminished in all three cases.
Musculoskeletal side effects have included pain and cramping in less than 1% of patients.
In one case, the patient had underlying cryptogenic cirrhosis, portal hypertension, and active esophageal varices. While there was a well documented temporal relationship between what appeared to be new onset hepatorenal syndrome and the use of octreotide, some confounding variables, such as viral serology, were not reported. In another case, seronegative hepatitis with a negative ultrasound was temporally associated with the use of octreotide and confirmed by rechallenge.
Hepatic side effects have included several cases of acute hepatic injury.
In one study of 25 patients with acromegaly, 2 developed IgG antibodies against octreotide after approximately 2.5 years of treatment. The antibodies did not cross-react with somatostatin, and were associated with a prolonged half-life of octreotide and increased growth hormone suppression.
Immunologic side effects have been limited to extremely rare reports of antibody formation to octreotide.
Hematologic side effects have included rare cases of thrombocytopenia.
Metabolic side effects have included a decrease in the secretion of thyrotropin (TSH).
Other side effects have rarely included cases of chemical, or physical dependence in patients with acromegaly who become tolerant to the analgesic effect of octreotide. Since many conventional analgesics, including opioids, typically fail to relieve headaches associated with acromegaly, physical dependency to octreotide may not necessarily indicate psychiatric pathology, and may simply indicate the unique analgesic effect of the drug.
Psychiatric side effects including chemical or physical dependence in patients with acromegaly who become tolerant to the analgesic effect of octreotide have been reported in rare cases. A case of octreotide manic episodes has been reported in a patient with acromegaly.
Since many conventional analgesics, including opioids, typically fail to relieve headaches associated with acromegaly, physical dependency on octreotide may not necessarily indicate psychiatric pathology, and may simply indicate the unique analgesic effect of the drug.
One patient with acromegaly and severe headaches gained relief after octreotide therapy, although there was no significant growth hormone response to therapy. The patient apparently required doses up to 1,500 mcg every 2 hours. Gradual reduction in the dose of octreotide resulted in classical withdrawal symptoms including aggressiveness, craving and restlessness. A psychiatrist diagnosed physical dependence. Octreotide was discontinued and, two years later, after surgery and normalization of growth hormone levels, the headaches abated.
Octreotide may interact with opioid receptors, and has been used as an intrathecal analgesic in rare cases.
More octreotide resources
- octreotide MedFacts Consumer Leaflet (Wolters Kluwer)
- octreotide Injection, Intramuscular Advanced Consumer (Micromedex) - Includes Dosage Information
- Octreotide Prescribing Information (FDA)
- Octreotide Acetate Monograph (AHFS DI)
- Sandostatin Prescribing Information (FDA)
- Sandostatin Consumer Overview
- Sandostatin LAR Depot kit MedFacts Consumer Leaflet (Wolters Kluwer)
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