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Somatuline Depot (Lanreotide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Somatuline Depot (Lanreotide) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (94)
Death (11)
Life Threatening Events (2)
Disability (2)

Reports by Reaction Type

Vomiting (9)Nausea (9)Condition Aggravated (9)Diarrhoea (9)Pneumonia (8)Blood Glucose Decreased (8)Weight Decreased (7)Dehydration (7)Off Label Use (6)Death (6)Injection Site Haemorrhage (5)Flatulence (5)

Below are a few examples of reports where side effects / adverse reactions may be related to Somatuline Depot (Lanreotide). For a complete list or a specific selection of reports, please use the links above.

Possible Somatuline Depot side effects in 77 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-03

Patient: 77 year old female

Reactions: Inappropriate Schedule of Drug Administration, Fatigue, Oedema Peripheral

Adverse event resulted in: death

Drug(s) suspected as cause:
Somatuline Depot



Possible Somatuline Depot side effects in 38 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-25

Patient: 38 year old female

Reactions: Blood Iron Decreased, Abdominal Pain, Fall, Hepatic Enzyme Increased, Cholelithiasis, Uterine Cyst, Blood Potassium Decreased, Amenorrhoea, Uterine Leiomyoma, Insulin-Like Growth Factor Increased, White Blood Cell Count Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Somatuline Depot

Other drugs received by patient: Levoxyl



Possible Somatuline Depot side effects in female

Reported by a pharmacist from United States on 2012-07-19

Patient: female

Reactions: Sciatica

Drug(s) suspected as cause:
Somatuline Depot
    Dosage: 120mg/0.5ml pfs q289 days sq
    Indication: Acromegaly
    Start date: 2012-02-06

Somatuline Depot
    Dosage: 120mg/0.5ml pfs q289 days sq
    Indication: Gigantism
    Start date: 2012-02-06



Possible Somatuline Depot side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-19

Patient: male

Reactions: Injection Site Mass, Renal Failure, Atrioventricular Block

Drug(s) suspected as cause:
Somatuline Depot



Possible Somatuline Depot side effects in 73 year old male

Reported by a individual with unspecified qualification from Colombia on 2012-07-19

Patient: 73 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Somatuline Depot



Possible Somatuline Depot side effects in 27 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-17

Patient: 27 year old female

Reactions: Pituitary Tumour Removal, Drug Ineffective

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Somatuline Depot



Possible Somatuline Depot side effects in 75 year old male

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-07-17

Patient: 75 year old male

Reactions: Haemoglobin Decreased, Dyspnoea, Neoplasm Progression, Carcinoid Tumour, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Somatuline Depot



Possible Somatuline Depot side effects in 43 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-17

Patient: 43 year old female

Reactions: Off Label Use, Blood Glucose Decreased, Convulsion

Drug(s) suspected as cause:
Somatuline Depot

Other drugs received by patient: Maxalt -MCT (Rizatriptan Benzoate); Glucagon IM (Glucagon); Nitrofurantoin; Prednisone; Advil PM (Diphenhydramine, Combinations); Amitriptline Hydrochloride TAB; Glucose



Possible Somatuline Depot side effects in 59 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-17

Patient: 59 year old female, weighing 99.8 kg (219.6 pounds)

Reactions: Blood Glucose Decreased, Hot Flush, Nausea, Renal Cancer, Alopecia, Dizziness, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Somatuline Depot

Somatuline Depot
    Dosage: 60 mg, once every 28 days (60 mg, 1 in 28 d), subcutaneous
    Indication: Acromegaly
    Start date: 2011-05-01

Other drugs received by patient: Furosemide; Unspecified Beta Blocker (Beta Blocking Agents); Uloric



Possible Somatuline Depot side effects in 62 year old female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-07-05

Patient: 62 year old female

Reactions: Off Label Use, Diarrhoea, Dehydration, Condition Aggravated

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Somatuline Depot

Somatuline Depot
    Dosage: 120 mg (120 mg, 1 in 28 d) subcutaneous
    Indication: Diarrhoea
    Start date: 2007-09-26



Possible Somatuline Depot side effects in 62 year old female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-07-05

Patient: 62 year old female

Reactions: Diarrhoea, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Somatuline Depot

Somatuline Depot
    Dosage: 120 mg (120 mg, 1 in 28 d),subcutaneous
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-09-26



Possible Somatuline Depot side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-29

Patient: female

Reactions: Neoplasm Progression, Pituitary Tumour

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Somatuline Depot



Possible Somatuline Depot side effects in 54 year old female

Reported by a individual with unspecified qualification from United States on 2012-06-15

Patient: 54 year old female

Reactions: Endocrine Neoplasm, Pituitary Tumour

Drug(s) suspected as cause:
Somatuline Depot



Possible Somatuline Depot side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-06

Patient: female

Reactions: Heart Rate Increased

Drug(s) suspected as cause:
Somatuline Depot



Possible Somatuline Depot side effects in 55 year old male

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-06-06

Patient: 55 year old male

Reactions: Emotional Distress, Off Label Use, Chest Pain, Arteriospasm Coronary

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Somatuline Depot
    Dosage: 120 mg (120 mg, 1 in 28 d), intramuscular
    Indication: Post Gastric Surgery Syndrome

Somatuline Depot



Possible Somatuline Depot side effects in 23 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-06

Patient: 23 year old male, weighing 57.0 kg (125.4 pounds)

Reactions: Confusional State, Flat Affect, Injection Site Haemorrhage, Haemorrhage, Abnormal Behaviour, Dysphemia, Convulsion, Blood Glucose Decreased, Off Label Use, Disturbance in Attention

Drug(s) suspected as cause:
Somatuline Depot
    Dosage: 120 mg, once every 30 to 35 days (120 mg, once every 30 to 35 days), subcutaneous
    Indication: Hypoglycaemia
    Start date: 2010-02-01

Somatuline Depot
    Dosage: 120 mg, once every 30 to 35 days (120 mg, once every 30 to 35 days), subcutaneous
    Indication: Off Label Use
    Start date: 2010-02-01

Other drugs received by patient: Carbatrol; Ergocalciferol



Possible Somatuline Depot side effects in 19 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-31

Patient: 19 year old female

Reactions: Drug Dose Omission, Fatigue, Pain, Suicidal Ideation

Drug(s) suspected as cause:
Somatuline Depot



Possible Somatuline Depot side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-05-29

Patient: 60 year old female

Reactions: Spinal Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Somatuline Depot

Somatuline Depot
    Dosage: 60 mg (60 mg, 1 in 28 d), subcutaneous
    Indication: Pancreatic Neuroendocrine Tumour

Somatuline Depot

Somatuline Depot

Other drugs received by patient: Novolog; Pancrease (Pancreatin); Sutent (SU 11248); Lisinopril; Omeprazole; Nitrofurantoin



Possible Somatuline Depot side effects in 55 year old male

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-05-24

Patient: 55 year old male

Reactions: Duodenitis, Accidental Overdose

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Somatuline Depot



Possible Somatuline Depot side effects in 21 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-23

Patient: 21 year old male, weighing 113.3 kg (249.3 pounds)

Reactions: Vomiting, Nausea, Diarrhoea, Flatulence, JAW Disorder

Drug(s) suspected as cause:
Somatuline Depot

Other drugs received by patient: Levothyroxine Sodium; Ddvap (Desmopressin)



Possible Somatuline Depot side effects in 72 year old female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-05-14

Patient: 72 year old female

Reactions: Weight Decreased, Pneumonia, Vomiting, Hepatic Neoplasm Malignant, Nausea, Neoplasm Progression, Constipation, Malaise

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Somatuline Depot

Somatuline Depot
    Dosage: 120 mg (120 mg, 1 in 21 d), subcutaneous
    Indication: Carcinoid Syndrome
    Start date: 2010-08-31

Somatuline Depot

Somatuline Depot

Other drugs received by patient: Octreotide Acetate; Propranolol; Nose Spray FOR Allergy (Cetirizine Hydrochloride); Symbicort



Possible Somatuline Depot side effects in 77 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-10

Patient: 77 year old female

Reactions: Intestinal Obstruction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Somatuline Depot



Possible Somatuline Depot side effects in 47 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-10

Patient: 47 year old male, weighing 136.0 kg (299.2 pounds)

Reactions: Pneumonia, Blood Growth Hormone Increased

Drug(s) suspected as cause:
Somatuline Depot

Other drugs received by patient: Zocor; LOW Dose Aspirin (Acetylsalicylic Acid); Celexa; Morphine; Zestril; Dostinex; Robaxin; Mirapex



Possible Somatuline Depot side effects in 72 year old female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-05-10

Patient: 72 year old female

Reactions: Weight Decreased, Hepatic Function Abnormal, Pneumonia, Vomiting, Nausea, Hepatic Neoplasm Malignant, Neoplasm Progression, Constipation, Malaise

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Somatuline Depot

Somatuline Depot

Somatuline Depot
    Dosage: 120 mg (120 mg, 1 in 21 d), subcutaneous
    Indication: Carcinoid Syndrome
    Start date: 2010-08-31

Somatuline Depot

Other drugs received by patient: Propranolol; Octreotide Acetate; Nose Spray FOR Allergy (Cetirizine Hydrochloride); Symbicort



Possible Somatuline Depot side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-07

Patient: 68 year old female

Reactions: Malaise, Laryngitis, Suture Removal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Somatuline Depot

Other drugs received by patient: Celebrex; Estraderm; Diovan; Medroxyprogesterone; Hydrocortone; Hydrochlorothiazide; Toprol-XL; Nexium; Vitamins (Vitamins Nos)



Possible Somatuline Depot side effects in 57 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-07

Patient: 57 year old male

Reactions: Hot Flush, Blood Testosterone Decreased, Condition Aggravated, Pituitary Tumour, Hypertension

Drug(s) suspected as cause:
Somatuline Depot

Other drugs received by patient: Labetalol HCL; Benicar



Possible Somatuline Depot side effects in 21 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-07

Patient: 21 year old male, weighing 113.3 kg (249.3 pounds)

Reactions: Vomiting, Nausea, Diarrhoea, Flatulence, JAW Disorder

Drug(s) suspected as cause:
Somatuline Depot



Possible Somatuline Depot side effects in 38 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-07

Patient: 38 year old female, weighing 78.0 kg (171.6 pounds)

Reactions: Amenorrhoea, Uterine Leiomyoma

Drug(s) suspected as cause:
Somatuline Depot

Other drugs received by patient: Levoxyl; LO-Ogesterol (Eugynon / 00022701 / )



Possible Somatuline Depot side effects in 66 year old female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-05-07

Patient: 66 year old female

Reactions: Neoplasm Progression, Neuroendocrine Tumour

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Somatuline Depot

Somatuline Depot
    Dosage: 120 (120 mg, 1 in 28 d), subcutaneous
    Indication: Neuroendocrine Tumour
    Start date: 2011-06-24

Somatuline Depot

Somatuline Depot



Possible Somatuline Depot side effects in 62 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-03

Patient: 62 year old male

Reactions: Neutropenia

Drug(s) suspected as cause:
Somatuline Depot

Other drugs received by patient: Potassium Chloride; Xatral LP (Alfuzosin)

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