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Sandostatin

Last reviewed on RxList: 1/26/2017
Sandostatin Side Effects Center

Last reviewed on RxList 11/22/2016

Sandostatin (octreotide acetate) is an octapeptide used to treat acromegaly and bleeding variceal veins. Sandostatin is also used to reduce flushing episodes and watery diarrhea caused by cancerous tumors (carcinoid syndrome) or tumors called vasoactive intestinal peptide tumors (VIP adenomas). Sandostatin may be available in generic form. Common side effects of Sandostatin include:

  • nausea,
  • vomiting,
  • loose/oily stools,
  • diarrhea,
  • constipation,
  • stomach pain or upset,
  • gas,
  • bloating,
  • dizziness, or
  • headache.

Tell your doctor if you have unlikely but serious side effects of Sandostatin including:

  • signs of gallbladder or liver problems (e.g., fever, stomach or abdominal pain, severe nausea or vomiting, yellowing eyes/skin, unexplained pain in the back or right shoulder),
  • signs of underactive thyroid (e.g., unexplained weight gain, cold intolerance, slow heartbeat, severe constipation, unusual or extreme tiredness, growth/lump/swelling on the front of the neck),
  • worsening heart condition symptoms (e.g., trouble breathing, slow/fast/irregular heartbeat), or
  • numbness or tingling of the arms or legs.

Dosing of Sandostatin depends on the condition being treated and the response of the patient. Sandostatin may interact with bromocriptine, cyclosporine, diuretics (water pills), diabetes medication, or medicine for heart disease or high blood pressure. Sandostatin may restore the normal ability to become pregnant in females with acromegaly who have infertility. Females of childbearing age should discuss reliable forms of birth control with the doctor. During pregnancy, this medication should be used only when prescribed. It is not known whether this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Sandostatin (octreotide acetate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sandostatin Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: 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 may include:

  • diarrhea, constipation;
  • stomach pain or discomfort, gas, bloating;
  • nausea or vomiting; or
  • headache, dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Sandostatin (Octreotide Acetate)

Sandostatin Professional Information

SIDE EFFECTS

Gallbladder Abnormalities

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

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 (see PRECAUTIONS - General).

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 (see PRECAUTIONS - General). 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 (see WARNINGS and PRECAUTIONS).

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 (octreotide acetate) 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 (octreotide acetate) .

Read the entire FDA prescribing information for Sandostatin (Octreotide Acetate)

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© Sandostatin Patient Information is supplied by Cerner Multum, Inc. and Sandostatin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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