| Respiratory Failure |
Death |
10/16/2006 |
86 |
Male |
|
11/15/2006 |
Physician |
United States |
|
| Hepatic Neoplasm Malignant |
Hospitalization |
5/1/2007 |
|
Male |
110 lb |
8/30/2007 |
|
Japan |
|
| Hepatic Neoplasm Malignant |
Hospitalization |
5/1/2007 |
|
Male |
110 lb |
8/31/2007 |
|
Japan |
|
| Hepatic Neoplasm Malignant |
Hospitalization |
5/10/2007 |
|
Male |
110 lb |
9/12/2007 |
|
Japan |
|
| Chest Discomfort |
Other Serious |
6/11/2007 |
91 |
Female |
110 lb |
10/10/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Muscle Rigidity |
Life Threatening |
9/10/2007 |
82 |
Female |
|
10/11/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hyponatraemia |
Life Threatening |
9/3/2007 |
82 |
Female |
88 lb |
10/22/2007 |
Physician |
Japan |
|
| Respiratory Failure |
Life Threatening |
10/2/2007 |
|
Male |
122 lb |
10/19/2007 |
Physician |
Japan |
|
| Cardiac Failure |
Hospitalization |
6/11/2007 |
91 |
Female |
110 lb |
10/24/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Candidiasis |
|
1/1/2006 |
53 |
Female |
|
10/24/2007 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Respiratory Failure |
Life Threatening |
10/2/2007 |
|
Male |
122 lb |
10/31/2007 |
Physician |
Japan |
|
| White Blood Cell Count Increased |
Hospitalization |
7/13/2006 |
|
Male |
|
11/5/2007 |
Physician |
Japan |
|
| Cardiac Failure |
Hospitalization |
6/11/2007 |
91 |
Female |
110 lb |
11/12/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vision Blurred |
Other Serious |
6/1/2004 |
|
Female |
|
12/3/2007 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vision Blurred |
Other Serious |
6/1/2004 |
|
Female |
|
12/17/2007 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Urticaria |
Required Intervention |
2/1/2008 |
62 |
Male |
262 lb |
2/29/2008 |
Pharmacist |
United States |
|
| Drug Effect Decreased |
|
|
44 |
Female |
141 lb |
3/13/2008 |
Physician |
United States |
|
| Troponin Increased |
Hospitalization |
3/1/2008 |
62 |
Male |
180 lb |
4/3/2008 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Troponin Increased |
Hospitalization |
3/1/2008 |
62 |
Male |
180 lb |
4/4/2008 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Visual Disturbance |
|
|
|
Male |
|
6/6/2008 |
Pharmacist |
Japan |
|
| Visual Disturbance |
|
2/1/2008 |
|
Male |
|
6/20/2008 |
Pharmacist |
Japan |
|
| Ventricular Tachycardia |
Other Serious |
1/1/2008 |
|
Male |
|
7/14/2008 |
Pharmacist |
Australia |
|
| Ventricular Tachycardia |
Other Serious |
1/1/2008 |
|
Male |
|
7/21/2008 |
Pharmacist |
Australia |
|
| Pulmonary Oedema |
Other Serious |
6/4/2008 |
|
Male |
|
9/2/2008 |
Consumer |
United States |
|
| Alopecia |
Other Serious |
6/1/2008 |
|
Male |
220 lb |
8/29/2008 |
Consumer |
United States |
|
| Death |
Death |
|
|
Female |
|
9/30/2008 |
Consumer |
United States |
|
| Pulmonary Oedema |
Other Serious |
6/4/2008 |
|
Male |
|
10/10/2008 |
Consumer |
|
|
| Obstructive Airways Disorder |
|
9/30/2008 |
42 |
Female |
|
10/27/2008 |
Consumer |
|
|
| Urinary Retention |
Hospitalization |
9/30/2008 |
|
Male |
|
11/12/2008 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Respiratory Disorder |
Other Serious |
9/23/2008 |
|
Male |
111 lb |
11/21/2008 |
Physician |
|
|
| Respiratory Disorder |
Other Serious |
9/23/2008 |
|
Male |
111 lb |
11/24/2008 |
Physician |
|
|
| Urinary Retention |
Hospitalization |
9/30/2008 |
|
Male |
|
12/1/2008 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Other Serious |
8/1/2008 |
|
Female |
172 lb |
12/24/2008 |
Consumer |
United States |
|
| Respiratory Distress |
Other Serious |
12/10/2007 |
67 |
Male |
|
12/22/2008 |
Other Health Professional |
United States |
|
| Sinus Disorder |
Life Threatening |
2/1/2008 |
|
Female |
|
3/6/2009 |
Consumer |
|
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Sinus Disorder |
Life Threatening |
2/1/2008 |
|
Female |
|
3/30/2009 |
Physician |
|
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vision Blurred |
Other Serious |
3/28/2001 |
58 |
Female |
189 lb |
4/14/2009 |
|
United States |
|
| Obstructive Airways Disorder |
|
9/30/2008 |
42 |
Female |
|
4/23/2009 |
Consumer |
|
|
| Osteoporosis |
Hospitalization |
|
66 |
Female |
|
4/24/2009 |
Consumer |
United States |
|
| Heart Rate Irregular |
Hospitalization |
1/1/2009 |
66 |
Female |
|
4/24/2009 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Suicide Attempt |
Other Serious |
8/2/1999 |
33 |
Female |
125 lb |
5/15/2009 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Dyspnoea |
Hospitalization |
4/9/2009 |
70 |
Female |
|
6/9/2009 |
Consumer |
United States |
|
| Sinus Disorder |
Life Threatening |
2/1/2008 |
|
Female |
|
6/12/2009 |
Physician |
|
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Urinary Retention |
Other Serious |
6/8/2009 |
74 |
Female |
150 lb |
6/16/2009 |
Consumer |
United States |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Type 2 Diabetes Mellitus |
Other Serious |
1/1/2003 |
42 |
Female |
160 lb |
7/14/2009 |
|
United States |
|
| Sinus Disorder |
Life Threatening |
2/1/2008 |
|
Female |
|
7/29/2009 |
Physician |
|
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Decreased |
Hospitalization |
10/13/2006 |
65 |
Female |
167 lb |
8/13/2009 |
Lawyer |
United States |
|
| Muscle Spasms |
|
|
|
Male |
250 lb |
8/29/2009 |
|
United States |
|
| Incorrect Dose Administered |
|
5/7/2007 |
|
Female |
154 lb |
9/11/2009 |
Consumer |
United States |
|
| White Blood Cell Count Decreased |
Other Serious |
3/31/2007 |
60 |
Male |
152 lb |
9/4/2009 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| White Blood Cell Count Decreased |
Other Serious |
3/31/2007 |
60 |
Male |
152 lb |
10/5/2009 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Multiple Myeloma |
Other Serious |
3/31/2007 |
60 |
Male |
152 lb |
11/17/2009 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pulmonary Function Test Decreased |
|
1/1/2009 |
80 |
Female |
122 lb |
12/17/2009 |
Physician |
|
|
| Pneumonia |
Other Serious |
12/1/2009 |
|
Female |
|
12/21/2009 |
Consumer |
United States |
|
| Throat Irritation |
Other Serious |
1/1/2005 |
|
Female |
153 lb |
1/11/2010 |
Pharmacist |
United States |
|
| Throat Irritation |
Other Serious |
1/1/2005 |
|
Female |
153 lb |
1/21/2010 |
Pharmacist |
United States |
|
| Neuropathy Peripheral |
Other Serious |
1/5/2009 |
|
Male |
143 lb |
1/28/2010 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vision Blurred |
Other Serious |
1/1/2005 |
|
Female |
153 lb |
1/30/2010 |
Pharmacist |
United States |
|
| Vision Blurred |
Other Serious |
1/1/2005 |
|
Female |
153 lb |
2/8/2010 |
Pharmacist |
United States |
|
| Neuropathy Peripheral |
Other Serious |
1/5/2009 |
|
Male |
143 lb |
2/18/2010 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pseudomembranous Colitis |
Hospitalization |
|
74 |
Female |
106 lb |
3/2/2010 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Rash |
|
2/24/2010 |
|
Female |
|
3/18/2010 |
Consumer |
|
|
| Staphylococcal Sepsis |
Death |
11/1/2007 |
50 |
Female |
282 lb |
3/24/2010 |
Other Health Professional |
United States |
|
| Pyrexia |
Hospitalization |
12/11/2009 |
74 |
Female |
106 lb |
3/23/2010 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| T-cell Lymphoma |
Hospitalization |
9/13/2007 |
74 |
Male |
|
4/9/2010 |
|
Japan |
|
| Cholecystitis |
Hospitalization |
2/24/2010 |
64 |
Male |
148 lb |
4/21/2010 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| White Blood Cell Count Increased |
Hospitalization |
10/15/2009 |
78 |
Male |
159 lb |
4/28/2010 |
Other Health Professional |
Switzerland |
|
| Vomiting |
Hospitalization |
3/14/2008 |
60 |
Female |
|
4/19/2010 |
|
United States |
|
| Wheezing |
Hospitalization |
3/14/2008 |
60 |
Female |
|
6/2/2010 |
|
United States |
|
| White Blood Cell Count Decreased |
Hospitalization |
10/19/2009 |
79 |
Male |
141 lb |
6/2/2010 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vision Blurred |
Other Serious |
1/1/2005 |
64 |
Female |
153 lb |
6/11/2010 |
|
United States |
|
| Cholecystitis |
Hospitalization |
2/24/2010 |
64 |
Male |
148 lb |
6/24/2010 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Wheezing |
Hospitalization |
3/14/2008 |
60 |
Female |
|
7/1/2010 |
|
United States |
|
| Weight Increased |
Other Serious |
1/1/2007 |
56 |
Male |
125 lb |
7/14/2010 |
Other Health Professional |
United States |
|
| Ventricular Extrasystoles |
Hospitalization |
3/14/2008 |
60 |
Female |
|
7/12/2010 |
|
United States |
|
| Vision Blurred |
Other Serious |
1/1/2005 |
64 |
Female |
153 lb |
7/27/2010 |
|
United States |
|
| Vision Blurred |
Other Serious |
1/1/2005 |
64 |
Female |
153 lb |
8/20/2010 |
|
United States |
|
| Weight Decreased |
Other Serious |
6/1/2004 |
75 |
Male |
184 lb |
8/27/2010 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Unevaluable Event |
Hospitalization |
|
81 |
Male |
|
8/16/2010 |
|
United States |
|
| Haemoptysis |
|
|
|
Male |
|
8/29/2010 |
Consumer |
United States |
|
| Interstitial Lung Disease |
Hospitalization |
6/18/2010 |
80 |
Female |
|
9/14/2010 |
Physician |
|
|
| Weight Decreased |
Hospitalization |
10/13/2006 |
65 |
Female |
167 lb |
9/3/2010 |
|
United States |
|
| Weight Decreased |
Other Serious |
6/1/2004 |
75 |
Male |
184 lb |
9/20/2010 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| White Blood Cell Count Increased |
Hospitalization |
10/15/2009 |
78 |
Male |
159 lb |
9/24/2010 |
Other Health Professional |
Switzerland |
|
| Vision Blurred |
Other Serious |
1/1/2005 |
64 |
Female |
153 lb |
10/1/2010 |
|
United States |
|
| Weight Decreased |
Other Serious |
6/1/2004 |
75 |
Male |
184 lb |
10/1/2010 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Product Quality Issue |
Other Serious |
|
67 |
Female |
|
10/11/2010 |
Consumer |
United States |
|
| Pneumonia |
Hospitalization |
|
60 |
Female |
|
10/13/2010 |
Consumer |
United States |
|
| Aphonia |
|
|
74 |
Male |
|
10/13/2010 |
Consumer |
United States |
|
| Tinnitus |
Other Serious |
|
67 |
Female |
|
10/21/2010 |
|
United States |
|
| Product Quality Issue |
Other Serious |
|
67 |
Female |
|
11/29/2010 |
Consumer |
United States |
|
| Vision Blurred |
Other Serious |
1/1/2005 |
64 |
Female |
153 lb |
12/2/2010 |
|
United States |
|
| International Normalised Ratio Increased |
Hospitalization |
11/25/2010 |
72 |
Male |
148 lb |
2/4/2011 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Fluctuation |
Other Serious |
10/1/2010 |
79 |
Female |
97 lb |
2/24/2011 |
Consumer |
United States |
|
| Myocardial Infarction |
Hospitalization |
|
41 |
Male |
224 lb |
3/3/2011 |
Consumer |
United States |
|
| Ballismus |
Other Serious |
2/15/2011 |
55 |
Male |
224 lb |
2/25/2011 |
Pharmacist |
United States |
|
| Dry Mouth |
|
2/1/2011 |
78 |
Female |
|
3/7/2011 |
Consumer |
United States |
|
| Blood Creatinine Increased |
Hospitalization |
4/4/2011 |
85 |
Male |
172 lb |
4/6/2011 |
Other Health Professional |
United States |
|
| Weight Fluctuation |
Hospitalization |
10/1/2010 |
79 |
Female |
97 lb |
4/15/2011 |
Consumer |
United States |
|
| Pyrexia |
Death |
1/10/2010 |
63 |
Male |
|
4/27/2011 |
Physician |
Japan |
|
| Myelodysplastic Syndrome |
Other Serious |
1/26/2011 |
74 |
Female |
206 lb |
5/11/2011 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Myelodysplastic Syndrome |
Other Serious |
1/26/2011 |
74 |
Female |
206 lb |
5/11/2011 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pneumonia Aspiration |
Hospitalization |
1/10/2010 |
63 |
Male |
|
6/2/2011 |
Physician |
Japan |
|
| Syncope |
Hospitalization |
11/1/2010 |
79 |
Male |
88 lb |
7/27/2011 |
Physician |
Japan |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Interstitial Lung Disease |
Other Serious |
3/18/2011 |
64 |
Male |
132 lb |
7/29/2011 |
Consumer |
Japan |
|
| Dysphonia |
Other Serious |
|
66 |
Male |
|
8/2/2011 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Syncope |
Other Serious |
11/1/2010 |
79 |
Male |
88 lb |
8/10/2011 |
Physician |
Japan |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Visual Impairment |
|
6/1/2011 |
79 |
Male |
|
9/22/2011 |
Pharmacist |
United States |
|
| Speech Disorder |
Other Serious |
8/4/2011 |
88 |
Female |
|
10/12/2011 |
Other Health Professional |
Japan |
|
| Rash |
Other Serious |
9/27/2010 |
72 |
Male |
|
10/12/2011 |
Physician |
|
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Urinary Retention |
Hospitalization |
7/8/2011 |
71 |
Female |
|
10/13/2011 |
Physician |
United States |
|
| Hyponatraemia |
Hospitalization |
9/3/2007 |
82 |
Female |
88 lb |
10/20/2011 |
Physician |
Japan |
|
| Delirium |
Other Serious |
8/4/2011 |
88 |
Female |
|
10/24/2011 |
Other Health Professional |
Japan |
|
| Abdominal Pain |
Life Threatening |
|
|
Female |
|
10/31/2011 |
Physician |
United States |
|
| Diverticulum Intestinal |
Hospitalization |
5/6/2011 |
74 |
Male |
|
10/27/2011 |
|
Japan |
|
| Cardiac Death |
Death |
2/13/2009 |
81 |
Male |
121 lb |
11/3/2011 |
Physician |
Japan |
|
| Death |
Death |
10/19/2011 |
86 |
Female |
102 lb |
11/8/2011 |
Physician |
United States |
|
| Myelodysplastic Syndrome |
Death |
10/15/2011 |
77 |
Female |
|
11/10/2011 |
Physician |
United States |
|
| Tonsil Cancer |
Hospitalization |
4/1/2010 |
62 |
Male |
155 lb |
11/17/2011 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Confusional State |
Other Serious |
10/24/2011 |
83 |
Male |
|
12/2/2011 |
Physician |
Netherlands |
|
| Stevens-johnson Syndrome |
Life Threatening |
11/12/2011 |
72 |
Male |
|
12/2/2011 |
Physician |
Japan |
|
| Cough |
Life Threatening |
10/6/2011 |
66 |
Female |
|
12/6/2011 |
|
United States |
|
| Erythema |
|
10/7/2011 |
|
Female |
|
12/9/2011 |
Pharmacist |
United States |
|
| Drug Hypersensitivity |
|
|
|
Female |
|
12/9/2011 |
Pharmacist |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cardiac Arrest |
Death |
10/19/2011 |
86 |
Female |
102 lb |
12/9/2011 |
Physician |
United States |
|
| Stevens-johnson Syndrome |
Life Threatening |
11/12/2011 |
72 |
Male |
|
12/13/2011 |
Physician |
Japan |
|
| Drug Eruption |
Other Serious |
11/12/2011 |
72 |
Male |
|
12/15/2011 |
Physician |
Japan |
|
| Drug Eruption |
Other Serious |
11/12/2011 |
72 |
Male |
132 lb |
12/29/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Eruption |
Other Serious |
11/12/2011 |
72 |
Male |
132 lb |
1/3/2012 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cardiac Arrest |
Hospitalization |
10/19/2011 |
86 |
Female |
102 lb |
1/3/2012 |
Physician |
United States |
|
| Ileus |
Hospitalization |
11/15/2011 |
63 |
Male |
128 lb |
1/9/2012 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cholangitis |
Hospitalization |
1/8/2012 |
55 |
Female |
229 lb |
1/17/2012 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Small Intestinal Obstruction |
Hospitalization |
10/19/2011 |
86 |
Female |
102 lb |
1/19/2012 |
Physician |
United States |
|
| Ileus |
Hospitalization |
11/15/2011 |
63 |
Male |
128 lb |
1/25/2012 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Joint Stiffness |
|
7/1/2010 |
65 |
Female |
110 lb |
1/28/2012 |
Consumer |
United States |
|
| Scar |
Hospitalization |
11/1/2011 |
78 |
Female |
154 lb |
1/30/2012 |
Physician |
United States |
|
| Lung Disorder |
Hospitalization |
12/4/2010 |
71 |
Male |
106 lb |
2/12/2012 |
Physician |
Japan |
|
| Type 2 Diabetes Mellitus |
|
|
60 |
Female |
|
2/22/2012 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Fracture Nonunion |
Hospitalization |
7/8/2011 |
71 |
Female |
144 lb |
2/29/2012 |
Physician |
United States |
|
| Melaena |
Other Serious |
2/1/2012 |
80 |
Male |
|
3/5/2012 |
Consumer |
United States |
|
| Asthma |
Hospitalization |
12/4/2010 |
71 |
Male |
106 lb |
3/9/2012 |
Physician |
Japan |
|
| Nervousness |
|
2/24/2012 |
69 |
Female |
|
3/10/2012 |
Consumer |
United States |
|
| Arthropathy |
Hospitalization |
1/1/2002 |
65 |
Female |
|
3/15/2012 |
Lawyer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pyloric Stenosis |
Required Intervention |
1/1/2002 |
62 |
Female |
142 lb |
3/26/2012 |
Lawyer |
United States |
|
| Nausea |
Other Serious |
2/1/2012 |
80 |
Male |
|
4/4/2012 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cardiac Failure |
Hospitalization |
12/4/2010 |
71 |
Male |
106 lb |
4/5/2012 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Intervertebral Disc Space Narrowing |
Other Serious |
|
|
Female |
240 lb |
4/2/2012 |
Lawyer |
United States |
|
| Upper Respiratory Tract Inflammation |
Other Serious |
12/3/2010 |
72 |
Male |
|
4/9/2012 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Rash |
|
1/1/2010 |
62 |
Female |
|
4/13/2012 |
Consumer |
United States |
|
| Dysuria |
Hospitalization |
8/8/2011 |
67 |
Female |
180 lb |
8/24/2011 |
Pharmacist |
United States |
|