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Argatroban Side Effects Report #5671399-3
Health Professional from JAPAN reported ARGATROBAN problem on Feb 28, 2008. Male patient, 57 years of age, was diagnosed with lateral medullary syndrome, cerebral infarction and was treated with ARGATROBAN. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, coma, subarachnoid haemorrhage, . ARGATROBAN dosage: 10 MG, INTRAVENOUS. During the same period patient was treated with RADICUT. Patient was hospitalized. Patient died.

Nexavar Side Effects Report #5635125-6
NEXAVAR problem was reported by a Health Professional from CANADA on Feb 15, 2008. Male patient, 76 years of age, weighting 222.7 lb, was diagnosed with metastatic renal cell carcinoma and was treated with NEXAVAR. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, gait disturbance, nausea, . NEXAVAR dosage: TOTAL DAILY DOSE: 800 MG UNIT DOSE: 200 MG. During the same period patient was treated with ALLOPURINOL, ALTACE, ASPIRIN, CRESTOR, HYDROCHLOROTHIAZIDE. Patient was hospitalized. Patient recovered.

Precedex Side Effects Report #5639754-5
Health Professional from UNITED STATES reported PRECEDEX problem on Feb 12, 2008. Female patient, 39 years of age, weighting 250.0 lb, was diagnosed with sedation and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, cardiac arrest, cerebrovascular accident, depressed level of consciousness, dysarthria, . PRECEDEX dosage: unknown. During the same period patient was treated with BENADRYL, MIDAZOLAM, PROPOFOL, SUCCINYLCHOLINE CHLORIDE, KETAMINE, ZEMURON, SEVOFLUORANE, ENLON PLUS. Patient was hospitalized. Patient died on 01/31/2007.

Velcade Side Effects Report #5613486-1
VELCADE problem was reported by a Physician from JAPAN on Jan 17, 2008. Male patient, 52 years of age, weighting 149.9 lb, was diagnosed with multiple myeloma and was treated with VELCADE. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, nephrotic syndrome, . VELCADE dosage: 1.30 MG/M2, INTRAVENOUS. During the same period patient was treated with DEXAMETHASONE. Patient died on 01/15/2008.


Nexavar Side Effects Report #5531712-4
Health Professional from CANADA reported NEXAVAR problem on Nov 22, 2007. Male patient, 76 years of age, weighting 222.7 lb, was diagnosed with metastatic renal cell carcinoma and was treated with NEXAVAR. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, cerebellar artery thrombosis, cerebrovascular accident, gait disturbance, nausea, . NEXAVAR dosage: TOTAL DAILY DOSE: 800 MG UNIT DOSE: 200 MG. During the same period patient was treated with ALLOPURINOL, ALTACE, ASPIRIN, CRESTOR, HYDROCHLOROTHIAZIDE. Patient was hospitalized. Patient recovered.

Premarin Side Effects Report #5519414-1
PREMARIN problem was reported by a Health Professional from JAPAN on Nov 06, 2007. Female patient, 47 years of age, was treated with PREMARIN. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, . PREMARIN dosage: unknown. Patient recovered.

Aggrenox Side Effects Report #5493801-2
Consumer or non-health professional from reported AGGRENOX problem on Oct 15, 2007. Male patient, weighting 183.0 lb, was diagnosed with haemodilution, hypertension, blood cholesterol increased, platelet aggregation inhibition and was treated with AGGRENOX. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, dizziness, dysarthria, dysphagia, encephalopathy, facial paresis, headache, hypercholesterolaemia, . AGGRENOX dosage: 200MG DIPYRIDAMOL + 25 MG ASS. During the same period patient was treated with ENALALPRIL, NITRENDIPIN, LOCOL, BAYOTENSIN, ASPIRIN, PANTOPRAZOLE. Patient was hospitalized. Patient recovered.

Nexavar Side Effects Report #5444499-0
NEXAVAR problem was reported by a Health Professional from CANADA on Aug 28, 2007. Male patient, 76 years of age, was treated with NEXAVAR. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, gait disturbance, nausea, . NEXAVAR dosage: TOTAL DAILY DOSE: 800 MG. During the same period patient was treated with ALLOPURINOL, ALTACE, ASPIRIN, CRESTOR, HYDROCHLOROTHIAZIDE. Patient recovered.

Aggrenox Side Effects Report #5460773-6
Consumer or non-health professional from reported AGGRENOX problem on Sept 13, 2007. Male patient, 82 years of age, weighting 183.0 lb, was diagnosed with hypertension, hydraemia, blood cholesterol increased and was treated with AGGRENOX. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, headache, lacrimation increased, monoplegia, paralysis, speech disorder, . AGGRENOX dosage: 200MG DIPYRIDAMOL + 25 MG ASS. During the same period patient was treated with ENALAPRIL MALEATE, NITRENDIPIN, ASPIRIN, ANTICHOLESTEREMIC, HEPARIN. Patient was hospitalized. Patient recovered.


Aggrenox Side Effects Report #5464556-2
AGGRENOX problem was reported by a Consumer or non-health professional from on Sept 13, 2007. Male patient, 82 years of age, weighting 183.0 lb, was diagnosed with hypertension, hydraemia, blood cholesterol increased and was treated with AGGRENOX. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, headache, lacrimation increased, monoplegia, paralysis, speech disorder, . AGGRENOX dosage: 200MG DIPYRIDAMOL + 25 MG ASS. During the same period patient was treated with ENALAPRIL MALEATE, NITRENDIPIN, ASPIRIN, ANTICHOLESTEREMIC, HEPARIN. Patient was hospitalized. Patient recovered.

Fabrazyme Side Effects Report #5420219-0
Physician from JAPAN reported FABRAZYME problem on Aug 07, 2007. Male patient, 29 years of age, weighting 154.3 lb, was diagnosed with fabry's disease and was treated with FABRAZYME. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, . FABRAZYME dosage: 70 MG Q2WKS IV. Patient was hospitalized. Patient recovered.

Rebif Side Effects Report #5380025-2
REBIF problem was reported by a Consumer or non-health professional from GERMANY on June 21, 2007. Female patient, 39 years of age, weighting 198.4 lb, was diagnosed with multiple sclerosis and was treated with REBIF. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, cerebral disorder, haemolytic uraemic syndrome, leukocytosis, nephrotic syndrome, scotoma, thrombocythaemia, . REBIF dosage: unknown. During the same period patient was treated with MITOXANTRONE HYDROCHLORIDE. Patient recovered.

Angiomax Side Effects Report #5392988-X
Physician from NORWAY reported ANGIOMAX problem on May 04, 2007. Male patient, 50 years of age, weighting 220.5 lb, was diagnosed with percutaneous coronary intervention, thrombosis and was treated with ANGIOMAX. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, cerebellar infarction, . ANGIOMAX dosage: 75 MG, BOLUS, IV BOLUS, 175 MG, HR, INTRAVENOUS. During the same period patient was treated with EPTIFIBA. Patient was hospitalized. Patient recovered.

Methylprednisolo Side Effects Report #5393122-2
METHYLPREDNISOLONE ACETATE problem was reported by a Physician from UNITED STATES on July 09, 2007. Male patient, 41 years of age, was diagnosed with spondylitis and was treated with METHYLPREDNISOLONE ACETATE. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, post procedural complication, . METHYLPREDNISOLONE ACETATE dosage: 40 MG Q WEEK X 3 DOSES, EPIDURAL. Patient died.


Rebif Side Effects Report #5380025-2
Consumer or non-health professional from GERMANY reported REBIF problem on June 21, 2007. Female patient, 39 years of age, weighting 198.4 lb, was diagnosed with multiple sclerosis and was treated with REBIF. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, cerebral disorder, haemolytic uraemic syndrome, leukocytosis, nephrotic syndrome, scotoma, thrombocythaemia, . REBIF dosage: unknown. During the same period patient was treated with MITOXANTRONE HYDROCHLORIDE. Patient recovered.

Angiomax Side Effects Report #5392988-X
ANGIOMAX problem was reported by a Physician from NORWAY on May 04, 2007. Male patient, 50 years of age, weighting 220.5 lb, was diagnosed with percutaneous coronary intervention, thrombosis and was treated with ANGIOMAX. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, cerebellar infarction, . ANGIOMAX dosage: 75 MG, BOLUS, IV BOLUS, 175 MG, HR, INTRAVENOUS. During the same period patient was treated with EPTIFIBA. Patient was hospitalized. Patient recovered.

Methylprednisolo Side Effects Report #5393122-2
Physician from UNITED STATES reported METHYLPREDNISOLONE ACETATE problem on July 09, 2007. Male patient, 41 years of age, was diagnosed with spondylitis and was treated with METHYLPREDNISOLONE ACETATE. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, post procedural complication, . METHYLPREDNISOLONE ACETATE dosage: 40 MG Q WEEK X 3 DOSES, EPIDURAL. Patient died.

Maxalt Side Effects Report #5729588-5
MAXALT problem was reported by a Physician from UNITED STATES on Apr 30, 2008. Female patient, 50 years of age, was treated with MAXALT. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, cerebral vasoconstriction, . MAXALT dosage: unknown. Patient recovered.

Maxalt Side Effects Report #5749645-7
Physician from UNITED STATES reported MAXALT problem on May 13, 2008. Female patient, 50 years of age, was treated with MAXALT. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, cerebral vasoconstriction, . MAXALT dosage: unknown. Patient recovered.


Lispro Side Effects Report #5694561-2
LISPRO problem was reported by a Consumer or non-health professional from KOREA, REPUBLIC OF on Mar 21, 2008. Male patient, weighting 179.7 lb, was diagnosed with hyperlipidaemia, hypertension, diabetes mellitus and was treated with LISPRO. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, . LISPRO dosage: unknown. During the same period patient was treated with FENOFIBRATE, CILAZAPRIL, HYDROCHLOROTHIAZIDE W, ATORVASTATIN CALCIUM, EFONIDIPINE HYDROCHLORIDE, GLIMEPIRIDE, METFORMIN. Patient was hospitalized. Patient recovered.

Januvia Side Effects Report #5356414-9
Health Professional from UNITED STATES reported JANUVIA problem on June 07, 2007. Female patient, 55 years of age, was diagnosed with diabetes mellitus, depression and was treated with JANUVIA. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, coronary artery disease, peripheral vascular disorder, transient ischaemic attack, . JANUVIA dosage: unknown. During the same period patient was treated with PLAVIX, LISINOPRIL, LANTUS, GLUCOPHAGE, SYNTHROID, KLONOPIN. Patient was hospitalized and became disabled. Patient recovered.

Angiomax Side Effects Report #5332842-2
ANGIOMAX problem was reported by a Physician from NORWAY on May 04, 2007. Male patient, 50 years of age, weighting 220.5 lb, was diagnosed with percutaneous coronary intervention and was treated with ANGIOMAX. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, cerebellar infarction, coagulation time shortened, facial palsy, thalamic infarction, . ANGIOMAX dosage: 75 MG, BOLUS, IV BOLUS, 175 MG, HR, INTRAVENOUS. During the same period patient was treated with EPTIFIBATIDE. Patient was hospitalized. Patient recovered.

Myozyme Side Effects Report #5644648-5
Physician from UNITED STATES reported MYOZYME problem on Feb 13, 2008. Male patient, 19 years of age, was diagnosed with glycogen storage disease type ii and was treated with MYOZYME. After drug was administered, patient experienced the following problems/side effects: basilar artery thrombosis, brain stem infarction, cerebellar infarction, cerebrovascular accident, intracranial aneurysm, . MYOZYME dosage: 20 MG/KG, Q2W, INTRAVENOUS. Patient was hospitalized. Patient died on 09/16/2006.

Minirin Side Effects Report #5563011-9
MINIRIN problem was reported by a Physician from GERMANY on Dec 07, 2007. Female patient, 72 years of age, was treated with MINIRIN. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, brain stem infarction, pulmonary embolism, thrombosis, . MINIRIN dosage: unknown. During the same period patient was treated with CYCLOCAPRON, FIBROGAMMIN, PLASMA, WHOLE BLOOD. Patient died on 10/11/2007.

Avonex Side Effects Report #5455832-8
Consumer or non-health professional from UNITED STATES reported AVONEX problem on Sept 06, 2007. Female patient, 50 years of age, weighting 149.0 lb, was diagnosed with multiple sclerosis and was treated with AVONEX. After drug was administered, patient experienced the following problems/side effects: blood potassium decreased, brain stem infarction, cerebrovascular accident, . AVONEX dosage: unknown. Patient was hospitalized. Patient recovered.

Januvia Side Effects Report #5437389-0
JANUVIA problem was reported by a Physician from UNITED STATES on Aug 28, 2007. Female patient, 55 years of age, weighting 191.8 lb, was diagnosed with type 2 diabetes mellitus, depression and was treated with JANUVIA. After drug was administered, patient experienced the following problems/side effects: acute coronary syndrome, brain stem infarction, cerebrovascular accident, coronary artery disease, nausea, peripheral vascular disorder, transient ischaemic attack, . JANUVIA dosage: unknown. During the same period patient was treated with PLAVIX, LISINOPRIL, LANTUS, GLUCOPHAGE, SYNTHROID, KLONOPIN, HUMALOG. Patient was hospitalized and became disabled. Patient recovered.

Aggrastat Side Effects Report #5388699-7
Physician from UNITED KINGDOM reported AGGRASTAT problem on July 09, 2007. Male patient, 85 years of age, was diagnosed with acute coronary syndrome and was treated with AGGRASTAT. After drug was administered, patient experienced the following problems/side effects: acute coronary syndrome, brain stem infarction, cerebral haemorrhage, glomerular filtration rate decreased, subdural haematoma, troponin i increased, . AGGRASTAT dosage: (50 MCG/ML FOR 1 DAY INTRAVENOUS (NOT OTHERWISE SPECIFIED)). During the same period patient was treated with ASPIRIN, ENOXAPARIN, CLOPIDOGREL BISULPHATE. Patient was hospitalized. Patient died on 03/01/2007.

Ortho Side Effects Report #5408930-9
ORTHO EVRA problem was reported by a Health Professional from UNITED STATES on Mar 30, 2007. Female patient, 31 years of age, weighting 118.0 lb, was diagnosed with contraception and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: artery dissection, brain stem infarction, migraine, . ORTHO EVRA dosage: unknown. During the same period patient was treated with ANTIVERT. Patient was hospitalized. Patient recovered.

Aggrastat Side Effects Report #5388699-7
Physician from UNITED KINGDOM reported AGGRASTAT problem on July 09, 2007. Male patient, 85 years of age, was diagnosed with acute coronary syndrome and was treated with AGGRASTAT. After drug was administered, patient experienced the following problems/side effects: acute coronary syndrome, brain stem infarction, cerebral haemorrhage, glomerular filtration rate decreased, subdural haematoma, troponin i increased, . AGGRASTAT dosage: (50 MCG/ML FOR 1 DAY INTRAVENOUS (NOT OTHERWISE SPECIFIED)). During the same period patient was treated with ASPIRIN, ENOXAPARIN, CLOPIDOGREL BISULPHATE. Patient was hospitalized. Patient died on 03/01/2007.

Ortho Side Effects Report #5408930-9
ORTHO EVRA problem was reported by a Health Professional from UNITED STATES on Mar 30, 2007. Female patient, 31 years of age, weighting 118.0 lb, was diagnosed with contraception and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: artery dissection, brain stem infarction, migraine, . ORTHO EVRA dosage: unknown. During the same period patient was treated with ANTIVERT. Patient was hospitalized. Patient recovered.

Leuplinforection Side Effects Report #5773809-X
Consumer or non-health professional from JAPAN reported LEUPLINFORECTION problem on June 06, 2008. Male patient, 86 years of age, was diagnosed with prostate cancer stage iv and was treated with LEUPLINFORECTION. After drug was administered, patient experienced the following problems/side effects: anaemia, brain stem infarction, eosinophil count increased, . LEUPLINFORECTION dosage: 11.25 MG, 1 IN 12 WK. Patient was hospitalized. Patient recovered.

Trisenox Side Effects Report #5354590-5
TRISENOX problem was reported by a Physician from JAPAN on June 04, 2007. Male patient, 73 years of age, was diagnosed with acute promyelocytic leukaemia and was treated with TRISENOX. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, brain stem infarction, dysphagia, electrocardiogram qt corrected interval prolonged, electrocardiogram qt prolonged, haemodialysis, . TRISENOX dosage: 10.05 MG QD, INTRAVENOUS DRIP. During the same period patient was treated with TRETINOIN, GABEXATE MESILATE, DALTEPARIN, CALCIUM GLUCONATE. Patient recovered.

Triamcinolone Side Effects Report #5368268-5
Physician from UNITED KINGDOM reported TRIAMCINOLONE problem on June 07, 2007. Male patient, 60 years of age, was diagnosed with neck pain, radicular pain and was treated with TRIAMCINOLONE. After drug was administered, patient experienced the following problems/side effects: balance disorder, brain stem infarction, cerebellar infarction, convulsion, diplopia, disorientation, dysphasia, hypertension, . TRIAMCINOLONE dosage: 40 MG ONCE. During the same period patient was treated with OMNIPAQUE CONTRAST. Patient was hospitalized and became disabled. Patient recovered.

Lochol Side Effects Report #5291764-6
LOCHOL problem was reported by a Physician from JAPAN on Mar 29, 2007. Female patient, 76 years of age, weighting 321.9 lb, was diagnosed with hypercholesterolaemia and was treated with LOCHOL. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, brain stem infarction, dizziness, dyslalia, hemiparesis, quadriplegia, thrombotic stroke, . LOCHOL dosage: 40 MG, QD. During the same period patient was treated with NORVASC, BLOPRESS, ACINON. Patient was hospitalized. Patient recovered.

Lochol Side Effects Report #5305287-9
Physician from JAPAN reported LOCHOL problem on Apr 12, 2007. Female patient, 76 years of age, weighting 321.9 lb, was diagnosed with hypercholesterolaemia and was treated with LOCHOL. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, brain stem infarction, dizziness, dyslalia, hemiparesis, quadriplegia, thrombotic stroke, . LOCHOL dosage: 40 MG, QD. During the same period patient was treated with NORVASC, BLOPRESS, ACINON. Patient was hospitalized. Patient recovered.

Lochol Side Effects Report #5305849-9
LOCHOL problem was reported by a Physician from JAPAN on Apr 12, 2007. Female patient, 76 years of age, weighting 321.9 lb, was diagnosed with hypercholesterolaemia and was treated with LOCHOL. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, brain stem infarction, dizziness, dyslalia, hemiparesis, quadriplegia, thrombotic stroke, . LOCHOL dosage: 40 MG, QD. During the same period patient was treated with NORVASC, BLOPRESS, ACINON. Patient was hospitalized. Patient recovered.

Natalizumab Side Effects Report #5565885-4
Physician from GERMANY reported NATALIZUMAB problem on Nov 29, 2007. Male patient, 62 years of age, weighting 160.9 lb, was diagnosed with relapsing-remitting multiple sclerosis and was treated with NATALIZUMAB. After drug was administered, patient experienced the following problems/side effects: arteriosclerosis, basilar artery thrombosis, brain stem infarction, cerebellar infarction, . NATALIZUMAB dosage: 300 MG; QM; IV. During the same period patient was treated with EFEROX, LIORESAL. Patient was hospitalized and became disabled. Patient recovered.

Betamethasone Side Effects Report #5466258-5
BETAMETHASONE problem was reported by a Physician from JAPAN on Sept 05, 2007. Female patient, 60 years of age, was diagnosed with asthma and was treated with BETAMETHASONE. After drug was administered, patient experienced the following problems/side effects: asthma, atelectasis, brain stem infarction, cellulitis, diabetes mellitus, diabetes mellitus inadequate control, diabetic ketoacidosis, pulmonary embolism, septic shock, . BETAMETHASONE dosage: 2 MG; QD; PO. Patient was hospitalized. Patient died on 07/30/2006.

Lispro Side Effects Report #5713285-6
Consumer or non-health professional from KOREA, REPUBLIC OF reported LISPRO problem on Apr 08, 2008. Male patient, weighting 179.7 lb, was diagnosed with type 2 diabetes mellitus, hyperlipidaemia, hypertension and was treated with LISPRO. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, blood triglycerides increased, brain stem infarction, glycosylated haemoglobin increased, haematocrit decreased, haemoglobin decreased, red blood cell sedimentation rate increased, . LISPRO dosage: unknown. During the same period patient was treated with FENOFIBRATE, CILAZAPRIL, HYDROCHLOROTHIAZIDE W, ATORVASTATIN CALCIUM, EFONIDIPINE HYDROCHLORIDE, GLIMEPIRIDE, METFORMIN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5373486-6
MYLOTARG problem was reported by a Consumer or non-health professional from UNITED STATES on June 26, 2007. Female patient, weighting 85.76 lb, was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: aspergillosis, blood culture positive, brain stem infarction, cerebral haemorrhage, facial palsy, fungal infection, meningitis, nerve compression, neutropenia, . MYLOTARG dosage: unknown. During the same period patient was treated with MITOXANTRONE, CYTARABINE. Patient was hospitalized. Patient recovered.

Grtpa Side Effects Report #5291105-4
Health Professional from JAPAN reported GRTPA problem on Mar 28, 2007. Female patient, 57 years of age, was diagnosed with cerebral infarction and was treated with GRTPA. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, blood pressure decreased, brain stem infarction, depressed level of consciousness, haematocrit decreased, hemiplegia, international normalised ratio decreased, platelet count decreased, pneumonia, . GRTPA dosage: 29 ML SINGLE INTRAVENOUS. During the same period patient was treated with LACTATED RINGER, ARGATROBAN, DOPAMINE HYDROCHLORIDE, PIPERACILLIN, RADICUT, ISOTONIC SOLUTION. Patient died on 09/26/2006.