SOMATULINE DEPOT

Somatuline Depot Adverse Events Reported to the FDA Over Time

How are Somatuline Depot adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Somatuline Depot, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Somatuline Depot is flagged as the suspect drug causing the adverse event.

Most Common Somatuline Depot Adverse Events Reported to the FDA

What are the most common Somatuline Depot adverse events reported to the FDA?

Diarrhoea	62 (4.66%)
Nausea	34 (2.55%)
Condition Aggravated	25 (1.88%)
Headache	25 (1.88%)
Abdominal Pain	24 (1.8%)
Vomiting	23 (1.73%)
Malaise	22 (1.65%)
Weight Decreased	22 (1.65%)
Cholelithiasis	21 (1.58%)
Off Label Use	21 (1.58%)
Injection Site Pain	19 (1.43%)
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Dehydration	18 (1.35%)
Death	13 (.98%)
Fatigue	13 (.98%)
Injection Site Nodule	13 (.98%)
Muscle Spasms	13 (.98%)
Pneumonia	13 (.98%)
Asthenia	12 (.9%)
Flatulence	12 (.9%)
Neoplasm Progression	12 (.9%)
Constipation	11 (.83%)
Abdominal Pain Upper	10 (.75%)
Blood Glucose Decreased	10 (.75%)
Cytolytic Hepatitis	10 (.75%)
Dizziness	9 (.68%)
Drug Ineffective	9 (.68%)
General Physical Health Deteriorati...	9 (.68%)
Hypoglycaemia	9 (.68%)
Loss Of Consciousness	9 (.68%)
Hot Flush	8 (.6%)
Injection Site Haemorrhage	8 (.6%)
Injection Site Pruritus	8 (.6%)
Pancreatitis	8 (.6%)
Blood Glucose Increased	7 (.53%)
Cholestasis	7 (.53%)
Depression	7 (.53%)
Dyspnoea	7 (.53%)
Fall	7 (.53%)
Hypertension	7 (.53%)
Palpitations	7 (.53%)
Pruritus	7 (.53%)
Alopecia	6 (.45%)
Blood Sodium Decreased	6 (.45%)
Disease Progression	6 (.45%)
Flushing	6 (.45%)
Haemorrhage	6 (.45%)
Insomnia	6 (.45%)
Pain	6 (.45%)
Suicidal Ideation	6 (.45%)
Tremor	6 (.45%)
Vertigo	6 (.45%)
Weight Increased	6 (.45%)
Abdominal Distension	5 (.38%)
Chills	5 (.38%)
Gastrointestinal Disorder	5 (.38%)
Hypotension	5 (.38%)
Inappropriate Schedule Of Drug Admi...	5 (.38%)
Incorrect Route Of Drug Administrat...	5 (.38%)
Influenza Like Illness	5 (.38%)
Injection Site Abscess	5 (.38%)
Injection Site Extravasation	5 (.38%)
Injection Site Induration	5 (.38%)
Mass	5 (.38%)
Neuroendocrine Tumour	5 (.38%)
Pituitary Tumour	5 (.38%)
Pyrexia	5 (.38%)
Acromegaly	4 (.3%)
Arthralgia	4 (.3%)
Balance Disorder	4 (.3%)
Blood Potassium Increased	4 (.3%)
Erythema	4 (.3%)
Gallbladder Disorder	4 (.3%)
Haemoglobin Decreased	4 (.3%)
Hepatic Function Abnormal	4 (.3%)
Hepatic Neoplasm Malignant	4 (.3%)
Hepatic Steatosis	4 (.3%)
Incorrect Dose Administered	4 (.3%)
Injection Site Mass	4 (.3%)
Lethargy	4 (.3%)
Malignant Neoplasm Progression	4 (.3%)
Metastases To Lung	4 (.3%)
Neck Pain	4 (.3%)
Pericarditis	4 (.3%)
Regurgitation	4 (.3%)
Renal Impairment	4 (.3%)
Urticaria	4 (.3%)
Abasia	3 (.23%)
Abnormal Behaviour	3 (.23%)
Amenorrhoea	3 (.23%)
Anaemia	3 (.23%)
Blood Creatinine Increased	3 (.23%)
Blood Pressure Decreased	3 (.23%)
Blood Pressure Increased	3 (.23%)
Blood Sodium Increased	3 (.23%)
Carcinoid Tumour	3 (.23%)
Cholecystitis Infective	3 (.23%)
Concussion	3 (.23%)
Convulsion	3 (.23%)
Dyskinesia	3 (.23%)
Haemangioma Of Liver	3 (.23%)
Heart Rate Increased	3 (.23%)

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This graph shows the top adverse events submitted to the FDA for Somatuline Depot, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Somatuline Depot is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Somatuline Depot

What are the most common Somatuline Depot adverse events reported to the FDA?

Gastrointestinal Signs	126 (9.47%)
Administration Site Reactions	80 (6.01%)
Gastrointestinal Motility And Defec...	80 (6.01%)
Neurological	40 (3.01%)
Infections - Pathogen Unspecified	36 (2.7%)
Physical Examination Topics	33 (2.48%)
Hepatic And Hepatobiliary	31 (2.33%)
Epidermal And Dermal Conditions	29 (2.18%)
Gallbladder	27 (2.03%)
Headaches	27 (2.03%)
Medication Errors	24 (1.8%)
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Therapeutic Procedures And Supporti...	24 (1.8%)
Metabolic, Nutritional And Blood Ga...	20 (1.5%)
Muscle	20 (1.5%)
Electrolyte And Fluid Balance Condi...	19 (1.43%)
Endocrine Neoplasms Malignant And U...	19 (1.43%)
Miscellaneous And Site Unspecified ...	19 (1.43%)
Glucose Metabolism Disorders	17 (1.28%)
Water, Electrolyte And Mineral	16 (1.2%)
Hematology Investigations	15 (1.13%)
Vascular	15 (1.13%)
Skin Appendage Conditions	14 (1.05%)
Fatal Outcomes	13 (.98%)
Cardiac Arrhythmias	12 (.9%)
Tissue	12 (.9%)
Cardiac And Vascular Investigations	11 (.83%)
Endocrine Investigations	11 (.83%)
Exocrine Pancreas Conditions	11 (.83%)
Injuries	11 (.83%)
Respiratory	11 (.83%)
Musculoskeletal And Connective Tiss...	10 (.75%)
Joint	9 (.68%)
Movement Disorders	9 (.68%)
Therapeutic And Nontherapeutic Effe...	9 (.68%)
Metastases	8 (.6%)
Procedural And Device Related Injur...	8 (.6%)
Renal Disorders	8 (.6%)
Vascular Hypertensive	8 (.6%)
Bone, Calcium, Magnesium And Phosph...	7 (.53%)
Cardiac Disorder Signs	7 (.53%)
Central Nervous System Vascular	7 (.53%)
Depressed Mood Disorders	7 (.53%)
Gastrointestinal Conditions	7 (.53%)
Hepatobiliary	7 (.53%)
Sleep Disorders	7 (.53%)
Appetite And General Nutritional	6 (.45%)
Decreased And Nonspecific Blood Pre...	6 (.45%)
Gastrointestinal Stenosis And Obstr...	6 (.45%)
Hepatobiliary Neoplasms Malignant A...	6 (.45%)
Inner Ear And Viiith Cranial Nerve	6 (.45%)
Suicidal And Self-injurious Behavio...	6 (.45%)
Vascular Hemorrhagic	6 (.45%)
Anemias Nonhemolytic And Marrow Dep...	5 (.38%)
Bile Duct	5 (.38%)
Body Temperature Conditions	5 (.38%)
Bone Disorders	5 (.38%)
Coronary Artery	5 (.38%)
Gastrointestinal Hemorrhages	5 (.38%)
Hypothalamus And Pituitary Gland	5 (.38%)
Lifestyle Issues	5 (.38%)
Nervous System Neoplasms Malignant ...	5 (.38%)
Renal And Urinary Tract Investigati...	5 (.38%)
Vision	5 (.38%)
Angiedema And Urticaria	4 (.3%)
Hepatobiliary Therapeutic Procedure...	4 (.3%)
Lower Respiratory Tract Disorders	4 (.3%)
Mood Disorders	4 (.3%)
Oral Soft Tissue Conditions	4 (.3%)
Pericardial	4 (.3%)
Product Quality Issues	4 (.3%)
Protein And Chemistry Analyses	4 (.3%)
Renal And Urinary Tract Neoplasms M...	4 (.3%)
Uterine, Pelvic And Broad Ligament	4 (.3%)
Deliria	3 (.23%)
Embolism And Thrombosis	3 (.23%)
Endocrine Gland Therapeutic Procedu...	3 (.23%)
Gastrointestinal Vascular Condition...	3 (.23%)
Hepatic And Biliary Neoplasms Benig...	3 (.23%)
Lipid Metabolism	3 (.23%)
Menstrual Cycle And Uterine Bleedin...	3 (.23%)
Mental Impairment	3 (.23%)
Parathyroid Gland	3 (.23%)
Psychiatric And Behavioural Symptom...	3 (.23%)
Reproductive Neoplasms Female Benig...	3 (.23%)
Seizures	3 (.23%)
Sexual Function And Fertility	3 (.23%)
Viral Infectious	3 (.23%)
Allergic Conditions	2 (.15%)
Anal And Rectal Conditions	2 (.15%)
Bacterial Infectious	2 (.15%)
Bone And Joint Injuries	2 (.15%)
Breast Neoplasms Malignant And Unsp...	2 (.15%)
Bronchial Disorders	2 (.15%)
Changes In Physical Activity	2 (.15%)
Communication Disorders	2 (.15%)
Disturbances In Thinking	2 (.15%)
Endocrine Neoplasms Benign	2 (.15%)
Eye	2 (.15%)
Gastrointestinal Inflammatory Condi...	2 (.15%)
Heart Failures	2 (.15%)
Immunology And Allergy	2 (.15%)

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This graph shows the top categories of adverse events submitted to the FDA for Somatuline Depot, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Somatuline Depot is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.