ADVERSE REACTIONS
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 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.
Postmarketing Experience
The following adverse reactions have been identified during the postapproval use of Sandostatin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal: intestinal obstruction
Hematologic: thrombocytopenia
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REPORTS OF SUSPECTED SANDOSTATIN SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Sandostatin. The information is not vetted and should not be considered as verified clinical evidence.
Possible Sandostatin side effects / adverse reactions in 57 year old female
Reported by a health professional (non-physician/pharmacist) from China on 2011-10-10
Patient: 57 year old female
Reactions: Liver Injury, Nausea, Abdominal Pain Upper
Adverse event resulted in: hospitalization
Suspect drug(s):
Sandostatin
Dosage: 0.1 mg, unk
Sandostatin
Dosage: 0.1 mg, unk
Indication: Pancreatitis Acute
Possible Sandostatin side effects / adverse reactions in 62 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-27
Patient: 62 year old male
Reactions: Septic Shock, Hepatic Cirrhosis, Post Procedural Infection
Adverse event resulted in: death
Suspect drug(s):
Sandostatin
Other drugs received by patient: Antibiotics
Possible Sandostatin side effects / adverse reactions in 33 year old female
Reported by a health professional (non-physician/pharmacist) from Israel on 2011-10-31
Patient: 33 year old female weighing 62.0 kg (136.4 pounds)
Reactions: Vomiting, Pain, Maternal Exposure During Pregnancy, Vaginal Haemorrhage
Adverse event resulted in: hospitalization
Suspect drug(s):
Sandostatin
Sandostatin LAR
Dosage: 30 mg, every 28 days
Start date: 2011-10-17
Other drugs received by patient: Vitamin B-12; Cabergoline; Cortisone Acetate
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