Somatuline Depot Side Effects

Please note - some side effects for Somatuline Depot may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Somatuline Depot - for the Consumer

Somatuline Depot

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 Somatuline Depot:

Constipation; diarrhea; gas; headache; joint pain; minor redness, pain, or swelling at the injection site; nausea; stomach pain or discomfort; vomiting; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; dizziness; severe or persistent headache; severe or persistent nausea, stomach pain, or vomiting; slow or irregular heartbeat; unusual tiredness or weakness.

Somatuline Depot Side Effects - for the Professional

Somatuline Depot

Most common adverse reactions are diarrhea, cholelithiasis, abdominal pain, nausea and injection site reactions (6)

Side Effects by Body System

Gastrointestinal

One percent of acromegalic patients treated with lanreotide in the pooled clinical studies discontinued treatment because of gastrointestinal reactions.

New cholelithiasis was reported in 12.0% of patients. Cholelithiasis may be related to dose or duration of exposure.

Gastrointestinal side effects including diarrhea (37%), cholelithiasis and gallbladder sludge (20%), abdominal pain (19%), nausea (11%), constipation (8%), flatulence (7%), vomiting (7%), and loose stools (6%) have been reported (percentages are from overall pooled data). A lethal case of acute necrotizing pancreatitis has also been reported.

Hepatic

Hepatic side effects including cholelithiasis (20%) have been reported. (Percentage is from overall pooled data.)

Local

Local side effects injection site pain (4.1%), injection site mass (1.7%), induration, nodule, and pruritus have been reported. (Percentage is from overall pooled data.)

Injection site adverse reactions were more commonly reported soon after the start of treatment and were less commonly reported as treatment continued. Such adverse reactions were usually mild or moderate but lead to withdrawal from clinical studies in two subjects.

Musculoskeletal

Musculoskeletal side effects including arthralgia (7%) have been reported. (Percentage is from overall pooled data.)

Nervous system

Nervous system side effects including headache (7%) have been reported. (Percentage is from overall pooled data.)

Cardiovascular

In patients without underlying cardiac disease, lanreotide may lead to a decrease in heart rate without necessarily reaching the threshold of bradycardia. In patients suffering from cardiac disorders prior to lanreotide treatment, sinus bradycardia may occur. Care should be taken when initiating treatment with lanreotide in patients with bradycardia.

Cardiovascular side effects including hypertension (5%) and sinus bradycardia (3%) have been reported. (Percentage is from overall pooled data.)

Hematologic

Hematologic side effects including anemia (3%) have been reported. (Percentage is from overall pooled data.)

Metabolic

Metabolic side effects including dysglycemia have been reported. In clinical studies of acromegalic patients treated with lanreotide, adverse reactions of dysglycemia (hypoglycemia, hyperglycemia, diabetes) were reported by 14% of patients and were considered related to study drug in 7% of patients.

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