Lanreotide (Somatuline Depot)

Safety Summary

Most common adverse reactions in acromegaly (>5%): diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), injection site reactions (9%), and dysglycemia (14%) (FDA label). In label-based cardiac safety pooling, sinus bradycardia occurred in 5.5% and bradycardia in 2.8% of acromegaly patients (FDA label). In GEP-NET trials (>10%): abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis (FDA label). In the CLARINET trial, treatment-related diarrhea occurred in 26% of lanreotide vs 9% of placebo patients PMID 25014687. In the carcinoid syndrome ELECT trial, headache, dizziness, and muscle spasm occurred at ≥5% and at least 5% greater than placebo (FDA label, PMID 27214300). In the DIPAK-1 ADPKD trial, injection site discomfort (32%), loose stools (91%), and abdominal discomfort (79%) were notably frequent PMID 30422235. A gallstone analysis from DIPAK-1 found incident gallstones in 15% of lanreotide-treated patients versus 1% of controls (OR 25.9, 95% CI 3.37-198.8), with 9 of 19 patients developing complications, usually after treatment discontinuation PMID 33779943. Hepatic cyst infection was observed exclusively in lanreotide-treated ADPKD patients at a rate of 0.23/10 patient-years, particularly in those with prior cyst infection history PMID 27995519. Switching from lanreotide 30 mg IM to Autogel formulation showed similar or improved GI tolerability PMID 11788630.