Sandostatin Side Effects

Generic Name: octreotide,octreotide acetate

Please note - some side effects for Sandostatin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Sandostatin - for the Consumer

Sandostatin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sandostatin:

Constipation; diarrhea; dizziness; gas; headache; mild to moderate pain at the injection site; nausea; stomach pain or discomfort; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Sandostatin:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe or persistent stomach pain or tenderness; severe or persistent vomiting or diarrhea; slow or irregular heartbeat; stomach bloating or swelling; swollen or enlarged glands; trouble swallowing; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Sandostatin LAR Depot Kit

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sandostatin LAR Depot Kit:

Constipation; diarrhea; dizziness; gas; headache; mild to moderate pain at the injection site; nausea; stomach pain or discomfort; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Sandostatin LAR Depot Kit:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe or persistent stomach pain or tenderness; severe or persistent vomiting or diarrhea; slow or irregular heartbeat; stomach bloating or swelling; swollen or enlarged glands; trouble swallowing; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Sandostatin Side Effects - for the Professional

Sandostatin

Gallbladder Abnormalities

Gallbladder abnormalities, especially stones and/or biliary sludge, frequently develop in patients on chronic Sandostatin® (octreotide acetate) therapy.

Cardiac

In acromegalics, sinus bradycardia (<50 bpm) developed in 25%; conduction abnormalities occurred in 10% and arrhythmias developed in 9% of patients during Sandostatin therapy.

Gastrointestinal

Diarrhea, loose stools, nausea and abdominal discomfort were each seen in 34%-61% of acromegalic patients in U.S. studies although only 2.6% of the patients discontinued therapy due to these symptoms. These symptoms were seen in 5%-10% of patients with other disorders.

The frequency of these symptoms was not dose-related, but diarrhea and abdominal discomfort generally resolved more quickly in patients treated with 300 mcg/day than in those treated with 750 mcg/day. Vomiting, flatulence, abnormal stools, abdominal distention, and constipation were each seen in less than 10% of patients.

In rare instances, gastrointestinal side effects may resemble acute intestinal obstruction, with progressive abdominal distension, severe epigastric pain, abdominal tenderness and guarding.

Hypo/Hyperglycemia

Hypoglycemia and hyperglycemia occurred in 3% and 16% of acromegalic patients, respectively, but only in about 1.5% of other patients. Symptoms of hypoglycemia were noted in approximately 2% of patients.

Hypothyroidism

In acromegalics, biochemical hypothyroidism alone occurred in 12% while goiter occurred in 6% during Sandostatin therapy. In patients without acromegaly, hypothyroidism has only been reported in several isolated patients and goiter has not been reported.

Other Adverse Events

Pain on injection was reported in 7.7%, headache in 6% and dizziness in 5%. Pancreatitis was also observed.

Other Adverse Events 1%-4%

Other events (relationship to drug not established), each observed in 1%-4% of patients, included fatigue, weakness, pruritus, joint pain, backache, urinary tract infection, cold symptoms, flu symptoms, injection site hematoma, bruise, edema, flushing, blurred vision, pollakiuria, fat malabsorption, hair loss, visual disturbance and depression.

Other Adverse Events <1%

Events reported in less than 1% of patients and for which relationship to drug is not established are listed: Gastrointestinal: hepatitis, jaundice, increase in liver enzymes, GI bleeding, hemorrhoids, appendicitis, gastric/peptic ulcer, gallbladder polyp; Integumentary: rash, cellulitis, petechiae, urticaria, basal cell carcinoma; Musculoskeletal: arthritis, joint effusion, muscle pain, Raynaud’s phenomenon; Cardiovascular: chest pain, shortness of breath, thrombophlebitis, ischemia, congestive heart failure, hypertension, hypertensive reaction, palpitations, orthostatic BP decrease, tachycardia; CNS: anxiety, libido decrease, syncope, tremor, seizure, vertigo, Bell’s Palsy, paranoia, pituitary apoplexy, increased intraocular pressure, amnesia, hearing loss, neuritis; Respiratory: pneumonia, pulmonary nodule, status asthmaticus; Endocrine: galactorrhea, hypoadrenalism, diabetes insipidus, gynecomastia, amenorrhea, polymenorrhea, oligomenorrhea, vaginitis; Urogenital: nephrolithiasis, hematuria; Hematologic: anemia, iron deficiency, epistaxis; Miscellaneous: otitis, allergic reaction, increased CK, weight loss.

Evaluation of 20 patients treated for at least 6 months has failed to demonstrate titers of antibodies exceeding background levels. However, antibody titers to Sandostatin were subsequently reported in three patients and resulted in prolonged duration of drug action in two patients. Anaphylactoid reactions, including anaphylactic shock, have been reported in several patients receiving Sandostatin.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

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

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

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

Nervous system side effects have included dizziness, fatigue, headache, anxiety, anorexia, depression, drowsiness, or tremor in less than 1% of patients.

Cardiovascular

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

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

Musculoskeletal side effects have included pain and cramping in less than 1% of patients.

Hepatic

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.

Immunologic

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

Hematologic side effects have included rare cases of thrombocytopenia.

Metabolic

Metabolic side effects have included a decrease in the secretion of thyrotropin (TSH).

Other

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 opiates, 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.

Psychiatric

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 opiates, 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 opiate receptors, and has been used as an intrathecal analgesic in rare cases.

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