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Review Sandostatin Safety Reports submitted to FDA

Total Sandostatin reports: 229.
Sandostatin FDA safety alerts: No.
Reported deaths: 33    Reported hospitalizations: 84.
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FDA Reported Sandostatin Side Effects: diarrhoea, dizziness, dehydration, normal newborn, malignant neoplasm progression, abdominal pain upper, abdominal pain, fatigue, back pain, injection site reaction, asthenia.
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Sandostatin Side Effects Report #5371669-2
Physician from AUSTRALIA reported SANDOSTATIN problem on June 19, 2007. Female patient was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: dizziness, hypotension, vomiting. SANDOSTATIN dosage: unknown. Patient recovered.

Sandostatin Side Effects Report #5374357-1
SANDOSTATIN problem was reported by a Physician from JAPAN on June 26, 2007. Male patient was diagnosed with gastrinoma and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: hepatic failure, malignant neoplasm progression, metastases to liver. SANDOSTATIN dosage: 30MG MONTHLY. During the same period patient was treated with TAKEPRON, SUCRALFATE, ZYRTEC, MEXITIL. Patient died on 04/04/2007.

Sandostatin Side Effects Report #5317579-8
Physician from JAPAN reported SANDOSTATIN problem on Apr 24, 2007. Male patient, 50 years of age, was diagnosed with carcinoid tumour and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, hypotension. SANDOSTATIN dosage: unknown. During the same period patient was treated with RISUMIC, PREDONINE, CALCICOL, ADRENAL CORTICAL, INSULIN. Patient recovered.

Sandostatin Side Effects Report #5333217-2
SANDOSTATIN problem was reported by a Consumer or non-health professional from UNITED STATES on May 15, 2007. Female patient, 35 years of age, was diagnosed with acromegaly and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous, arthralgia, back pain, injection site pain. SANDOSTATIN dosage: 30 MG, QMO. Patient recovered.


Sandostatin Side Effects Report #5338007-2
Consumer or non-health professional from UNITED STATES reported SANDOSTATIN problem on May 20, 2007. Male patient was diagnosed with acromegaly and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: disease progression, insulin-like growth factor increased, ventricular hypertrophy. SANDOSTATIN dosage: 30 MG Q28DAYS. Patient recovered.

Sandostatin Side Effects Report #5338057-6
SANDOSTATIN problem was reported by a Physician from UNITED STATES on May 21, 2007. Male patient, 76 years of age, was diagnosed with carcinoid syndrome, atrial fibrillation, hypertension, hyperlipidaemia and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: condition aggravated, dehydration, diarrhoea, discomfort, dizziness, flushing, malignant neoplasm progression, surgery. SANDOSTATIN dosage: 0.3 ML, BID. During the same period patient was treated with SANDOSTATIN LAR, SANDOSTATIN LAR, COUMADIN, TOPROL, DIGITEK, LIPITOR. Patient was hospitalized. Patient recovered.

Sandostatin Side Effects Report #5339739-2
Physician from JAPAN reported SANDOSTATIN problem on May 25, 2007. Male patient was diagnosed with gastrinoma and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: hepatic failure, malignant neoplasm progression, metastases to liver. SANDOSTATIN dosage: 30MG MONTHLY. During the same period patient was treated with TAKEPRON, SUCRALFATE, ZYRTEC, MEXITIL. Patient died on 04/04/2007.

Sandostatin Side Effects Report #5285940-6
SANDOSTATIN problem was reported by a Physician from ARGENTINA on Mar 22, 2007. Male patient, 43 years of age, was diagnosed with acromegaly and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: biliary dilatation. SANDOSTATIN dosage: 20 MG, QD. During the same period patient was treated with SANDOSTATIN LAR. Patient recovered.

Sandostatin Side Effects Report #5286226-6
Physician from JAPAN reported SANDOSTATIN problem on Mar 23, 2007. Female patient was diagnosed with chylothorax and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: bone marrow failure. SANDOSTATIN dosage: unknown. Patient recovered.


Sandostatin Side Effects Report #5288137-9
SANDOSTATIN problem was reported by a Health Professional from UNITED KINGDOM on Mar 26, 2007. Female patient was diagnosed with carcinoid syndrome and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: decubitus ulcer, lymphoedema. SANDOSTATIN dosage: 30MG. Patient recovered.

Sandostatin Side Effects Report #5289627-5
Consumer or non-health professional from UNITED STATES reported SANDOSTATIN problem on Mar 26, 2007. Male patient, 70 years of age, was diagnosed with carcinoid syndrome and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: diarrhoea, flushing, loss of consciousness. SANDOSTATIN dosage: unknown. Patient recovered.

Sandostatin Side Effects Report #5298924-9
SANDOSTATIN problem was reported by a Physician from ISRAEL on Apr 15, 2007. Male patient, 82 years of age, was diagnosed with carcinoid syndrome and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: myocardial infarction. SANDOSTATIN dosage: 10 MG DAILY. Patient was hospitalized. Patient died.

Sandostatin Side Effects Report #5300296-8
Physician from JAPAN reported SANDOSTATIN problem on Apr 05, 2007. Female patient was diagnosed with insulinoma and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: pancytopenia, platelet count decreased, red blood cell count decreased, white blood cell count decreased. SANDOSTATIN dosage: unknown. During the same period patient was treated with CORTRIL. Patient recovered.

Sandostatin Side Effects Report #5304134-9
SANDOSTATIN problem was reported by a Consumer or non-health professional from CANADA on Apr 11, 2007. Female patient, 67 years of age, was diagnosed with ovarian cancer and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: blister, erythema, pain in extremity. SANDOSTATIN dosage: 20 MG EVERY 4 WEEKS. Patient recovered.


Sandostatin Side Effects Report #5304285-9
Health Professional from CANADA reported SANDOSTATIN problem on Apr 10, 2007. Male patient, 78 years of age, was diagnosed with carcinoid syndrome and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, diarrhoea, disease progression, fatigue, flushing, hepatic neoplasm, hormone level abnormal, malaise, therapeutic embolisation. SANDOSTATIN dosage: 40 MG, QMO. During the same period patient was treated with SANDOSTATIN LAR. Patient was hospitalized. Patient recovered.

Sandostatin Side Effects Report #5304320-8
SANDOSTATIN problem was reported by a Physician from ISRAEL on Apr 16, 2007. Female patient, 84 years of age, was diagnosed with carcinoid syndrome and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: fall, hip fracture, hip surgery. SANDOSTATIN dosage: 20 MG, UNK. Patient was hospitalized. Patient died on 04/01/2007.

Sandostatin Side Effects Report #5311366-2
Physician from JAPAN reported SANDOSTATIN problem on Apr 17, 2007. Female patient was diagnosed with insulinoma and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: pancytopenia, platelet count decreased, red blood cell count decreased, white blood cell count decreased. SANDOSTATIN dosage: unknown. During the same period patient was treated with CORTRIL. Patient recovered.

Sandostatin Side Effects Report #5254102-0
SANDOSTATIN problem was reported by a Physician from UNITED STATES on Feb 20, 2007. Female patient, 67 years of age, was diagnosed with carcinoid syndrome and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: biopsy breast abnormal, breast cancer, diarrhoea, malignant breast lump removal. SANDOSTATIN dosage: 40 MG Q3WEEKS. Patient recovered.

Sandostatin Side Effects Report #5262422-9
Consumer or non-health professional from UNITED STATES reported SANDOSTATIN problem on June 09, 2006. Female patient, 43 years of age, was diagnosed with pancreatitis chronic and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, arthralgia, dyspnoea, nausea, pancreatitis. SANDOSTATIN dosage: unknown. During the same period patient was treated with SANDOSTATIN LAR. Patient recovered.


Sandostatin Side Effects Report #5262426-6
SANDOSTATIN problem was reported by a Pharmacist from UNITED STATES on June 28, 2006. Female patient, 28 years of age, was diagnosed with pancreatic carcinoma and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: nausea. SANDOSTATIN dosage: unknown. During the same period patient was treated with ENOXAPARIN, REGLAN, PREVACID, HYDROMORPHONE. Patient was hospitalized. Patient recovered.

Sandostatin Side Effects Report #5262457-6
Pharmacist from UNITED STATES reported SANDOSTATIN problem on Aug 22, 2006. Male patient was diagnosed with carcinoid syndrome and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: depression, paranoia. SANDOSTATIN dosage: unknown. Patient recovered.

Sandostatin Side Effects Report #5265994-3
SANDOSTATIN problem was reported by a Physician from UNITED STATES on Mar 02, 2007. Female patient, 67 years of age, was diagnosed with carcinoid syndrome and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: biopsy breast abnormal, breast cancer, diarrhoea, malignant breast lump removal. SANDOSTATIN dosage: 40 MG Q3WEEKS. During the same period patient was treated with VITAMIN D, VITAMIN D, VITAMIN A, VITAMIN B CAP, ASCORBIC ACID, VITAMIN E. Patient recovered.

Sandostatin Side Effects Report #5271287-0
Consumer or non-health professional from JAPAN reported SANDOSTATIN problem on Mar 09, 2007. Male patient, 82 years of age, was diagnosed with acromegaly and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: bone lesion, diarrhoea, papillary thyroid cancer. SANDOSTATIN dosage: unknown. Patient recovered.

Sandostatin Side Effects Report #5273807-9
SANDOSTATIN problem was reported by a Physician from GERMANY on Mar 12, 2007. Female patient, 56 years of age, weighting 218.3 lb, was diagnosed with acromegaly and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: adhesion, epistaxis. SANDOSTATIN dosage: 30MG MONTHLY. During the same period patient was treated with DOSTINEX. Patient was hospitalized. Patient recovered.

Sandostatin Side Effects Report #5273810-9
Consumer or non-health professional from UNITED STATES reported SANDOSTATIN problem on Mar 12, 2007. Female patient, 66 years of age, was diagnosed with carcinoid syndrome and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, autoimmune disorder, back pain, cataract operation, condition aggravated, immunology test, injection site reaction. SANDOSTATIN dosage: 60 MG, QMO. During the same period patient was treated with SANDOSTATIN LAR. Patient was hospitalized and became disabled. Patient recovered.

Sandostatin Side Effects Report #5276891-1
SANDOSTATIN problem was reported by a Physician from GERMANY on Mar 16, 2007. Male patient, 73 years of age, weighting 216.1 lb, was diagnosed with diabetic retinopathy and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: concomitant disease progression, coronary angioplasty, silent myocardial infarction. SANDOSTATIN dosage: unknown. Patient was hospitalized. Patient recovered.

Sandostatin Side Effects Report #5276901-1
Physician from GERMANY reported SANDOSTATIN problem on Mar 16, 2007. Male patient, 73 years of age, weighting 218.3 lb, was diagnosed with diabetic retinopathy and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: concomitant disease progression, diabetic foot. SANDOSTATIN dosage: unknown. During the same period patient was treated with LORZAAR, PENTOXIFYLLINE. Patient was hospitalized. Patient recovered.

Sandostatin Side Effects Report #5276902-3
SANDOSTATIN problem was reported by a Health Professional from UNITED KINGDOM on Mar 16, 2007. Female patient was diagnosed with acromegaly and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, diarrhoea, dysgeusia, paraesthesia. SANDOSTATIN dosage: unknown. Patient recovered.

Sandostatin Side Effects Report #5278219-X
Consumer or non-health professional from UNITED STATES reported SANDOSTATIN problem on Mar 15, 2007. Female patient, 35 years of age, was diagnosed with acromegaly and was treated with SANDOSTATIN. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous. SANDOSTATIN dosage: 30 MG, QMO. Patient recovered.

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