| Urine Output Decreased |
Hospitalization |
11/7/2005 |
|
Female |
143 lb |
1/3/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pneumonia |
Hospitalization |
10/25/2005 |
75 |
Male |
132 lb |
12/30/2005 |
|
Japan |
|
| Depressed Level Of Consciousness |
Disability |
7/12/2004 |
39 |
Male |
168 lb |
1/5/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Myocardial Infarction |
Other Serious |
11/1/2003 |
68 |
Female |
251 lb |
1/19/2006 |
Lawyer |
United States |
|
| Renal Disorder |
Other Serious |
11/7/2005 |
|
Female |
143 lb |
1/19/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Urine Output Decreased |
Hospitalization |
11/7/2005 |
|
Female |
143 lb |
2/1/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Ineffective |
|
9/14/2005 |
42 |
Female |
|
2/8/2006 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Ineffective |
|
|
|
Male |
|
2/8/2006 |
Consumer |
United States |
|
| Hyperkalaemia |
Hospitalization |
1/13/2004 |
81 |
Female |
|
2/10/2005 |
Pharmacist |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Thyroid Disorder |
Hospitalization |
11/1/2002 |
63 |
Female |
190 lb |
2/21/2006 |
Lawyer |
United States |
|
| Myocardial Infarction |
Hospitalization |
10/13/2003 |
48 |
Female |
236 lb |
2/21/2006 |
Physician |
United States |
|
| Myocardial Infarction |
Other Serious |
10/29/2004 |
49 |
Female |
|
2/28/2006 |
Lawyer |
United States |
|
| Syncope Vasovagal |
Other Serious |
11/30/2002 |
52 |
Female |
|
3/9/2006 |
Physician |
United States |
|
| Sleep Apnoea Syndrome |
Hospitalization |
9/3/2002 |
50 |
Male |
209 lb |
3/20/2006 |
Lawyer |
Puerto Rico |
|
| Myocardial Infarction |
Other Serious |
1/31/2003 |
68 |
Female |
251 lb |
3/24/2006 |
Lawyer |
United States |
|
| Transient Ischaemic Attack |
Hospitalization |
10/30/2003 |
42 |
Female |
|
3/27/2006 |
Physician |
United States |
|
| Upper Respiratory Tract Infection |
Hospitalization |
9/1/2005 |
49 |
Female |
214 lb |
3/27/2006 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pulmonary Embolism |
Required Intervention |
2/15/2006 |
63 |
Male |
262 lb |
3/30/2006 |
Other Health Professional |
United States |
|
| Spinal Osteoarthritis |
Hospitalization |
12/13/1999 |
59 |
Male |
176 lb |
4/7/2006 |
Physician |
United States |
|
| Transient Ischaemic Attack |
Hospitalization |
1/1/2003 |
42 |
Female |
236 lb |
4/10/2006 |
Physician |
United States |
|
| Ventricular Hypertrophy |
Required Intervention |
2/15/2006 |
63 |
Male |
262 lb |
4/10/2006 |
Other Health Professional |
United States |
|
| Pulmonary Embolism |
Required Intervention |
2/15/2006 |
63 |
Male |
262 lb |
4/13/2006 |
Other Health Professional |
United States |
|
| Plantar Fasciitis |
Other Serious |
3/1/2004 |
49 |
Female |
|
4/24/2006 |
Physician |
United States |
|
| Ulcer Haemorrhage |
Hospitalization |
8/21/2000 |
53 |
Male |
333 lb |
4/24/2006 |
Lawyer |
United States |
|
| Weight Decreased |
Hospitalization |
6/21/2000 |
53 |
Male |
333 lb |
5/3/2006 |
Physician |
United States |
|
| Thrombosis |
Hospitalization |
10/1/2000 |
61 |
Male |
278 lb |
5/12/2006 |
Lawyer |
United States |
|
| Silent Myocardial Infarction |
Other Serious |
1/1/2001 |
57 |
Female |
181 lb |
5/16/2006 |
Lawyer |
United States |
|
| Tremor |
Hospitalization |
6/19/2006 |
73 |
Male |
230 lb |
6/27/2006 |
Pharmacist |
United States |
|
| Drug Ineffective |
|
12/12/2005 |
59 |
Male |
|
8/10/2006 |
Consumer |
United States |
|
| Sleep Apnoea Syndrome |
Other Serious |
|
|
Female |
|
8/18/2006 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Urinary Retention |
Hospitalization |
7/20/2006 |
77 |
Female |
|
8/30/2006 |
Pharmacist |
Japan |
|
| Urinary Retention |
Hospitalization |
7/20/2006 |
77 |
Female |
|
9/6/2006 |
Pharmacist |
Japan |
|
| Nausea |
|
2/1/2006 |
61 |
Male |
260 lb |
7/19/2006 |
Consumer |
United States |
|
| Nausea |
|
6/18/2006 |
38 |
Female |
158 lb |
7/19/2006 |
Consumer |
United States |
|
| Upper Respiratory Tract Infection |
Hospitalization |
9/1/2005 |
49 |
Female |
214 lb |
9/21/2006 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Haematochezia |
Other Serious |
|
|
Male |
225 lb |
|
Physician |
United States |
|
| Somnolence |
|
9/22/2006 |
40 |
Female |
210 lb |
10/19/2006 |
|
United States |
|
| Visual Acuity Reduced |
Other Serious |
2/2/2001 |
|
Male |
261 lb |
10/27/2006 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Somnolence |
|
9/22/2006 |
40 |
Female |
210 lb |
10/31/2006 |
Consumer |
United States |
|
| Haematochezia |
Other Serious |
|
|
Male |
225 lb |
|
Physician |
United States |
|
| Somnolence |
|
9/22/2006 |
40 |
Female |
210 lb |
11/10/2006 |
Consumer |
United States |
|
| Pharmaceutical Product Complaint |
|
9/22/2006 |
40 |
Female |
210 lb |
12/1/2006 |
Consumer |
United States |
|
| Somnolence |
|
9/22/2006 |
40 |
Female |
224 lb |
1/5/2007 |
Physician |
United States |
|
| Incorrect Dose Administered |
|
|
61 |
Male |
269 lb |
1/9/2007 |
Physician |
United States |
|
| Urinary Incontinence |
|
|
|
Female |
290 lb |
1/18/2007 |
Pharmacist |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Squamous Cell Carcinoma |
|
6/17/2006 |
75 |
Female |
180 lb |
10/16/2006 |
Physician |
United States |
|
| Nausea |
|
6/18/2006 |
38 |
Female |
158 lb |
10/16/2006 |
Consumer |
United States |
|
| Nervousness |
|
1/1/2004 |
|
Male |
|
2/6/2007 |
Consumer |
United States |
|
| Drug Ineffective |
|
|
|
Female |
|
2/6/2007 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Syncope |
Other Serious |
12/27/2006 |
|
Female |
|
2/9/2007 |
Physician |
United States |
|
| Hypotension |
Other Serious |
12/1/2006 |
|
Female |
|
3/6/2007 |
Consumer |
Canada |
|
| Nausea |
Other Serious |
1/1/2006 |
66 |
Male |
|
3/29/2007 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pleural Fibrosis |
Other Serious |
2/21/2007 |
70 |
Male |
|
3/30/2007 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hypotension |
Other Serious |
12/1/2006 |
|
Female |
|
4/17/2007 |
Consumer |
Canada |
|
| Road Traffic Accident |
|
9/10/2006 |
63 |
Female |
280 lb |
1/12/2007 |
Consumer |
United States |
|
| Hyperhidrosis |
Hospitalization |
|
61 |
Female |
|
4/26/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Nausea |
|
|
64 |
Female |
170 lb |
4/30/2007 |
Consumer |
United States |
|
| Hyperhidrosis |
Hospitalization |
3/28/2007 |
62 |
Female |
64 lb |
5/1/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tuberculous Pleurisy |
Other Serious |
2/21/2007 |
70 |
Male |
|
4/26/2007 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hypotension |
Other Serious |
12/1/2006 |
|
Female |
227 lb |
5/18/2007 |
Consumer |
Canada |
|
| Shock |
Required Intervention |
2/15/2007 |
48 |
Male |
|
5/16/2007 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hypotension |
Other Serious |
12/1/2006 |
|
Female |
227 lb |
5/23/2007 |
Consumer |
Canada |
|
| Grand Mal Convulsion |
Other Serious |
9/13/2006 |
45 |
Female |
299 lb |
1/22/2007 |
|
United States |
|
| Vomiting |
Hospitalization |
6/1/2005 |
68 |
Male |
253 lb |
5/25/2007 |
Physician |
United States |
|
| Blood Glucose Increased |
Other Serious |
1/1/2007 |
62 |
Male |
210 lb |
5/21/2007 |
Other Health Professional |
United States |
|
| Weight Increased |
|
2/1/2006 |
61 |
Male |
260 lb |
4/10/2007 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pyrexia |
Other Serious |
1/24/2007 |
56 |
Female |
242 lb |
4/10/2007 |
Other Health Professional |
United States |
|
| Cardiac Flutter |
Other Serious |
3/1/2003 |
68 |
Female |
|
6/21/2007 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Liver Disorder |
Other Serious |
7/17/2007 |
56 |
Male |
|
7/23/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Somnolence |
Hospitalization |
12/12/2006 |
76 |
Female |
108 lb |
7/27/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Somnolence |
Hospitalization |
12/12/2006 |
76 |
Female |
108 lb |
7/30/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hepatic Function Abnormal |
Hospitalization |
7/3/2007 |
57 |
Male |
|
8/3/2007 |
|
Japan |
|
| Liver Disorder |
Other Serious |
7/17/2007 |
57 |
Male |
|
8/6/2007 |
Physician |
Japan |
|
| Weight Increased |
|
1/1/2006 |
80 |
Female |
|
7/11/2007 |
Physician |
United States |
|
| Drug Ineffective |
Other Serious |
3/1/2003 |
68 |
Female |
|
8/31/2007 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Stomach Discomfort |
Other Serious |
7/1/2007 |
|
Female |
200 lb |
8/31/2007 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Liver Disorder |
Hospitalization |
7/17/2007 |
57 |
Male |
|
9/6/2007 |
Physician |
Japan |
|
| Liver Disorder |
Hospitalization |
7/17/2007 |
57 |
Male |
|
9/11/2007 |
Physician |
Japan |
|
| Nipple Exudate Bloody |
Other Serious |
1/1/2004 |
|
Female |
180 lb |
9/17/2007 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Somnolence |
|
3/1/2007 |
50 |
Male |
330 lb |
9/17/2007 |
Consumer |
United States |
|
| Liver Disorder |
Hospitalization |
7/17/2007 |
|
Male |
|
9/17/2007 |
|
Japan |
|
| Glycosylated Haemoglobin Increased |
Other Serious |
1/1/2007 |
|
Female |
|
9/28/2007 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Liver Disorder |
Hospitalization |
7/17/2007 |
57 |
Male |
|
10/4/2007 |
Physician |
Japan |
|
| Metabolic Acidosis |
Hospitalization |
7/19/2007 |
60 |
Male |
131 lb |
10/9/2007 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cardiac Failure Congestive |
Required Intervention |
|
|
Male |
|
9/18/2007 |
Physician |
United States |
|
| Hepatic Enzyme Increased |
Other Serious |
1/1/2007 |
|
Female |
|
10/31/2007 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Liver Disorder |
Hospitalization |
7/17/2007 |
57 |
Male |
|
11/7/2007 |
Physician |
Japan |
|
| Weight Decreased |
Hospitalization |
1/1/2007 |
|
Female |
280 lb |
11/8/2007 |
Consumer |
United States |
|
| Syncope |
Hospitalization |
11/13/2007 |
79 |
Male |
|
12/7/2007 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Proctalgia |
Hospitalization |
11/28/2007 |
|
Male |
165 lb |
12/26/2007 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Osteonecrosis |
Other Serious |
3/1/2007 |
53 |
Female |
250 lb |
11/28/2007 |
Other Health Professional |
United States |
|
| Rhabdomyolysis |
Life Threatening |
1/6/2008 |
80 |
Male |
|
1/22/2008 |
|
Japan |
|
| Vomiting |
Hospitalization |
1/17/2008 |
|
Male |
|
1/29/2008 |
Consumer |
United States |
|
| Vomiting |
Hospitalization |
12/1/2007 |
|
Male |
220 lb |
2/6/2008 |
Consumer |
United States |
|
| Rhabdomyolysis |
Life Threatening |
1/6/2008 |
80 |
Male |
|
1/31/2008 |
|
Japan |
|
| Coronary Artery Disease |
Life Threatening |
1/16/2008 |
|
Female |
231 lb |
1/31/2008 |
Physician |
United States |
|
| Viral Load Increased |
Other Serious |
10/1/2007 |
41 |
Male |
|
2/13/2008 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Restlessness |
Other Serious |
12/10/2007 |
|
Female |
|
2/11/2008 |
Consumer |
United States |
|
| Vomiting |
Hospitalization |
12/1/2007 |
|
Male |
220 lb |
2/15/2008 |
Consumer |
United States |
|
| Vomiting |
Other Serious |
12/10/2007 |
|
Female |
|
2/19/2008 |
Consumer |
United States |
|
| Vomiting |
Other Serious |
12/10/2007 |
|
Female |
|
3/4/2008 |
Consumer |
United States |
|
| Nerve Compression |
|
5/1/2006 |
56 |
Female |
238 lb |
11/1/2007 |
Consumer |
United States |
|
| Viral Load Increased |
Other Serious |
10/1/2007 |
41 |
Male |
|
3/24/2008 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Nausea |
Hospitalization |
7/31/2007 |
60 |
Male |
131 lb |
3/25/2008 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Verbal Abuse |
Other Serious |
3/20/2008 |
|
Female |
200 lb |
4/2/2008 |
|
United States |
|
| Proctalgia |
Hospitalization |
11/28/2007 |
|
Male |
165 lb |
4/2/2008 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| White Blood Cell Count Increased |
Other Serious |
2/1/2008 |
81 |
Female |
82 lb |
4/4/2008 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Viral Load Increased |
Other Serious |
10/1/2007 |
|
Male |
220 lb |
4/7/2008 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Decreased |
Hospitalization |
7/31/2007 |
|
Male |
131 lb |
4/7/2008 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Rectal Cancer |
Hospitalization |
3/31/2008 |
76 |
Female |
|
4/9/2008 |
Physician |
Japan |
|
| Diarrhoea |
Hospitalization |
4/1/2008 |
|
Female |
|
4/25/2008 |
Consumer |
United States |
|
| Weight Increased |
|
|
68 |
Male |
270 lb |
4/29/2008 |
Consumer |
United States |
|
| Drug Ineffective |
Hospitalization |
7/1/2006 |
|
Female |
|
5/14/2008 |
Pharmacist |
United States |
|
| Vomiting |
Other Serious |
12/10/2007 |
|
Female |
|
5/23/2008 |
Physician |
United States |
|
| Respiratory Failure |
Congenital Anomaly |
12/27/2006 |
|
Female |
|
5/30/2008 |
Lawyer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Ineffective |
|
7/1/2006 |
|
Female |
|
6/3/2008 |
Pharmacist |
United States |
|
| Drug Ineffective |
|
7/1/2006 |
|
Female |
|
6/6/2008 |
Pharmacist |
United States |
|
| Respiratory Failure |
Hospitalization |
12/27/2006 |
|
Female |
|
7/11/2008 |
Lawyer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vomiting |
|
1/9/2008 |
44 |
Female |
375 lb |
7/7/2008 |
Consumer |
United States |
|
| Respiratory Failure |
Hospitalization |
12/27/2006 |
|
Female |
|
8/25/2008 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Myocardial Infarction |
Hospitalization |
1/1/2005 |
34 |
Female |
180 lb |
9/10/2008 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Respiratory Failure |
Hospitalization |
12/27/2006 |
|
Female |
|
9/15/2008 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vomiting |
Other Serious |
12/10/2007 |
|
Female |
|
9/16/2008 |
Physician |
United States |
|
| Aspiration |
Death |
9/1/2008 |
77 |
Male |
|
10/9/2008 |
Other Health Professional |
United States |
|
| Syncope |
Other Serious |
6/26/2008 |
72 |
Female |
143 lb |
10/31/2008 |
Physician |
Japan |
|
| Respiratory Failure |
Hospitalization |
12/27/2006 |
|
Female |
|
11/13/2008 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Type 2 Diabetes Mellitus |
Hospitalization |
10/1/2002 |
36 |
Female |
276 lb |
12/5/2008 |
Other Health Professional |
United States |
|
| Thrombosis |
Hospitalization |
7/1/2006 |
55 |
Female |
266 lb |
12/10/2008 |
Consumer |
United States |
|
| Hypoglycaemia |
Hospitalization |
11/29/2008 |
71 |
Female |
|
12/15/2008 |
Pharmacist |
United States |
|
| Injection Site Pain |
|
|
|
Male |
|
12/17/2008 |
Consumer |
United States |
|
| Syncope |
Other Serious |
6/26/2008 |
72 |
Female |
143 lb |
12/29/2008 |
Physician |
Japan |
|
| Treatment Noncompliance |
Hospitalization |
1/1/2007 |
58 |
Female |
280 lb |
1/9/2009 |
Consumer |
United States |
|
| Vomiting |
Other Serious |
12/10/2007 |
|
Female |
|
1/21/2009 |
Physician |
United States |
|
| Pancreatitis Acute |
Other Serious |
8/4/2007 |
|
Male |
|
1/20/2009 |
Physician |
United States |
|
| Myocardial Infarction |
Other Serious |
10/29/2004 |
43 |
Female |
211 lb |
1/26/2009 |
Pharmacist |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pancreatitis Acute |
Other Serious |
8/4/2007 |
|
Male |
283 lb |
2/25/2009 |
Physician |
United States |
|
| Myocardial Infarction |
Other Serious |
10/29/2004 |
43 |
Female |
211 lb |
2/26/2009 |
Pharmacist |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tuberculin Test Positive |
Hospitalization |
1/26/2008 |
|
Female |
175 lb |
2/27/2009 |
|
|
|
| Pancreatitis Acute |
Other Serious |
8/4/2007 |
|
Male |
283 lb |
2/27/2009 |
Physician |
United States |
|
| Respiratory Failure |
Hospitalization |
12/27/2006 |
|
Female |
|
3/3/2009 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cardiac Operation |
Hospitalization |
|
|
Female |
200 lb |
3/11/2009 |
Consumer |
United States |
|
| Coronary Artery Disease |
Hospitalization |
|
|
Female |
200 lb |
3/17/2009 |
Physician |
United States |
|
| Pancreatitis Acute |
Other Serious |
8/4/2007 |
|
Male |
283 lb |
3/19/2009 |
Physician |
United States |
|
| Pancreatitis Acute |
Other Serious |
8/4/2007 |
|
Male |
283 lb |
3/30/2009 |
Physician |
United States |
|
| Urinary Tract Infection |
Other Serious |
6/21/2001 |
45 |
Female |
240 lb |
4/3/2009 |
|
United States |
|
| Wrist Fracture |
Other Serious |
1/9/2004 |
39 |
Male |
346 lb |
4/14/2009 |
|
United States |
|
| Vomiting |
Other Serious |
1/1/1997 |
37 |
Female |
342 lb |
4/15/2009 |
|
United States |
|
| Weight Increased |
Other Serious |
5/1/2000 |
43 |
Female |
239 lb |
4/17/2009 |
|
United States |
|
| Myocardial Infarction |
Other Serious |
10/29/2004 |
43 |
Female |
211 lb |
4/27/2009 |
Pharmacist |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Myocardial Infarction |
Hospitalization |
10/29/2004 |
43 |
Female |
211 lb |
5/6/2009 |
Pharmacist |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|