Sandostatin LAR Depot Side Effects

Generic Name: octreotide

Note: This document contains side effect information about octreotide. Some of the dosage forms listed on this page may not apply to the brand name Sandostatin LAR Depot.

Some side effects of Sandostatin LAR Depot 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: powder for solution, powder for suspension, solution

Along with its needed effects, octreotide (the active ingredient contained in Sandostatin LAR Depot) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking octreotide:

More common
  • Abdominal or stomach pain
  • blurred vision
  • constipation
  • depressed mood
  • dizziness
  • dry mouth
  • dry skin and hair
  • fainting
  • fast, slow, or irregular heartbeat
  • feeling cold
  • flushed, dry skin
  • fruit-like breath odor
  • hair loss
  • hoarseness or husky voice
  • increased hunger
  • increased thirst
  • increased urination
  • muscle cramps and stiffness
  • nausea
  • severe stomach pain with nausea and vomiting
  • sweating
  • troubled breathing
  • unexplained weight loss
  • unusual tiredness or weakness
  • vomiting
  • weight gain
Less common or rare
  • Abdominal or stomach bloating
  • anxious feeling
  • behavior change similar to drunkenness
  • changes in menstrual periods
  • cold sweats
  • confusion
  • convulsions (seizures)
  • cool, pale skin
  • decreased sexual ability in males
  • difficulty with concentrating
  • drowsiness
  • headache
  • loss of appetite
  • muscle cramps and stiffness
  • nightmares
  • restless sleep
  • shakiness
  • slurred speech
  • swelling of the front part of the neck
  • tiredness
  • troubled breathing (rapid and deep)
  • unconsciousness
  • unusual thirst
Incidence not known
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • chills
  • darkened urine
  • fever
  • indigestion
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pinpoint red spots on the skin
  • severe constipation
  • unusual bleeding or bruising
  • yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking octreotide:

Symptoms of overdose
  • Abdominal or stomach discomfort
  • decreased appetite
  • diarrhea
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, shallow breathing
  • feeling of warmth
  • general feeling of discomfort
  • light-colored stools
  • muscle pain or cramping
  • no blood pressure or pulse
  • redness of the face, neck, arms, and occasionally, upper chest
  • shortness of breath
  • sleepiness
  • stopping of heart
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • upper right abdominal or stomach pain
  • weakness
  • weight loss

Some side effects of octreotide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Pain, redness, stinging, swelling, tingling, or burning sensation at the injection site
  • passing of gas
Less common or rare
  • Backache
  • bladder pain
  • cloudy urine
  • cough
  • difficult, burning, or painful urination
  • disturbed color perception
  • double vision
  • frequent urge to urinate
  • frequent urination usually with very small amounts of urine
  • general feeling of discomfort or illness
  • halos around lights
  • itching skin
  • joint pain
  • lack of appetite
  • loss of vision
  • lower back or side pain
  • muscle aches and pains
  • night blindness
  • overbright appearance of lights
  • runny nose
  • shivering
  • sore throat
  • stools that float, are foul smelling, and fatty in appearance
  • trouble concentrating
  • trouble sleeping
  • tunnel vision

For Healthcare Professionals

Applies to octreotide: injectable solution, intramuscular powder for injection

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 (the active ingredient contained in Sandostatin LAR Depot) 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 (the active ingredient contained in Sandostatin LAR Depot) 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 (the active ingredient contained in Sandostatin LAR Depot) 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 (the active ingredient contained in Sandostatin LAR Depot) 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 (the active ingredient contained in Sandostatin LAR Depot) 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 (the active ingredient contained in Sandostatin LAR Depot) 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

Psychiatric side effects including chemical or physical dependence in patients with acromegaly who become tolerant to the analgesic effect of octreotide (the active ingredient contained in Sandostatin LAR Depot) 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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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