| Epistaxis |
Death |
11/30/2005 |
40 |
Female |
154 lb |
2/2/2006 |
Physician |
Japan |
|
| Respiratory Failure |
Other Serious |
3/20/2006 |
52 |
Female |
|
4/20/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Respiratory Failure |
Other Serious |
3/20/2006 |
55 |
Female |
140 lb |
4/27/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Suicide Attempt |
Hospitalization |
5/24/2006 |
35 |
Female |
|
6/22/2006 |
Pharmacist |
Japan |
|
| Vomiting |
Hospitalization |
2/23/2005 |
76 |
Male |
104 lb |
10/10/2006 |
Physician |
Japan |
|
| Suicide Attempt |
Hospitalization |
8/9/2006 |
23 |
Female |
|
11/13/2006 |
Pharmacist |
Japan |
|
| Loss Of Consciousness |
Other Serious |
9/1/2006 |
27 |
Female |
|
11/13/2006 |
Physician |
Japan |
|
| Sedation |
Other Serious |
9/26/2006 |
53 |
Female |
146 lb |
11/17/2006 |
Physician |
Japan |
|
| Weight Increased |
Hospitalization |
8/9/2006 |
23 |
Female |
|
11/27/2006 |
Pharmacist |
Japan |
|
| Sleep Walking |
Other Serious |
9/29/2006 |
26 |
Female |
|
11/27/2006 |
Pharmacist |
Japan |
|
| Somnolence |
Other Serious |
8/17/2006 |
27 |
Female |
|
11/27/2006 |
Physician |
Japan |
|
| Weight Increased |
Hospitalization |
8/9/2006 |
23 |
Female |
|
12/1/2006 |
Pharmacist |
Japan |
|
| Somnolence |
Other Serious |
9/30/2006 |
53 |
Female |
146 lb |
12/13/2006 |
Physician |
Japan |
|
| Somnolence |
Other Serious |
8/17/2006 |
27 |
Female |
|
12/20/2006 |
Physician |
Japan |
|
| Vomiting |
Hospitalization |
7/27/2006 |
44 |
Female |
|
2/16/2007 |
Physician |
Japan |
|
| Self Injurious Behaviour |
Other Serious |
8/23/2006 |
23 |
Female |
|
3/30/2007 |
Physician |
Japan |
|
| Respiratory Disorder Neonatal |
Hospitalization |
|
|
Male |
8 lb |
4/10/2007 |
Physician |
Japan |
|
| Tachypnoea |
Other Serious |
2/28/2006 |
|
Male |
8 lb |
4/17/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Self Injurious Behaviour |
Other Serious |
8/23/2006 |
23 |
Female |
|
4/19/2007 |
Physician |
Japan |
|
| Tachypnoea |
Other Serious |
2/28/2006 |
|
Male |
8 lb |
4/19/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Suicide Attempt |
Other Serious |
4/6/2007 |
52 |
Male |
|
4/19/2007 |
Pharmacist |
Japan |
|
| Tachypnoea |
Other Serious |
2/28/2006 |
|
Male |
8 lb |
4/24/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Transient Tachypnoea Of The Newborn |
Other Serious |
1/1/2006 |
|
Male |
8 lb |
5/24/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Testicular Pain |
Other Serious |
1/1/2007 |
28 |
Male |
|
6/29/2007 |
Pharmacist |
Japan |
|
| Testicular Pain |
Other Serious |
1/1/2007 |
28 |
Male |
|
7/6/2007 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cardio-respiratory Arrest |
Death |
7/1/2007 |
54 |
Male |
|
8/14/2007 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hepatic Function Abnormal |
Other Serious |
7/14/2004 |
|
Male |
|
8/27/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Self Injurious Behaviour |
Other Serious |
12/13/2006 |
17 |
Male |
|
9/4/2007 |
Physician |
Japan |
|
| Nervous System Disorder |
Death |
7/1/2007 |
54 |
Male |
|
9/14/2007 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Personality Change |
Other Serious |
|
37 |
Male |
|
9/27/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Personality Change |
Other Serious |
6/1/2007 |
37 |
Male |
|
10/1/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Completed Suicide |
Death |
9/20/2007 |
16 |
Male |
|
10/1/2007 |
Physician |
Japan |
|
| Pyrexia |
Other Serious |
|
38 |
Female |
|
10/12/2007 |
Consumer |
Japan |
|
| Stevens-johnson Syndrome |
Life Threatening |
6/22/2007 |
69 |
Female |
104 lb |
11/26/2007 |
Physician |
Japan |
|
| Self Injurious Behaviour |
Disability |
11/5/2007 |
25 |
Female |
|
12/4/2007 |
Physician |
Japan |
|
| Self Injurious Behaviour |
Disability |
11/5/2007 |
25 |
Female |
|
12/17/2007 |
Physician |
Japan |
|
| Stevens-johnson Syndrome |
Other Serious |
3/14/2005 |
31 |
Female |
|
12/27/2007 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Joint Ankylosis |
Hospitalization |
12/11/2007 |
71 |
Male |
165 lb |
1/23/2008 |
Pharmacist |
Japan |
|
| Stevens-johnson Syndrome |
Other Serious |
6/22/2007 |
69 |
Female |
104 lb |
1/22/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Intracranial Venous Sinus Thrombosis |
Hospitalization |
1/22/2008 |
41 |
Male |
|
2/5/2008 |
Pharmacist |
Japan |
|
| Intracranial Venous Sinus Thrombosis |
Other Serious |
1/22/2008 |
41 |
Male |
|
2/8/2008 |
Other Health Professional |
Japan |
|
| Vomiting |
Hospitalization |
2/23/2005 |
76 |
Male |
104 lb |
2/27/2008 |
Physician |
Japan |
|
| Suicide Attempt |
Other Serious |
4/11/2007 |
|
|
|
5/23/2008 |
Pharmacist |
Japan |
|
| Loss Of Consciousness |
Other Serious |
9/11/2007 |
47 |
Male |
|
6/9/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Loss Of Consciousness |
Other Serious |
9/11/2007 |
47 |
Male |
|
6/13/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Platelet Count Decreased |
Hospitalization |
7/1/2007 |
|
Male |
|
8/19/2008 |
Physician |
Japan |
|
| Meige's Syndrome |
Other Serious |
|
62 |
Female |
|
8/27/2008 |
|
Japan |
|
| Blepharospasm |
Other Serious |
1/1/2001 |
|
Female |
|
10/13/2008 |
|
Japan |
|
| Dysacusis |
Other Serious |
10/1/2008 |
38 |
Male |
|
11/10/2008 |
Pharmacist |
Japan |
|
| Blepharospasm |
Other Serious |
1/1/2001 |
|
Female |
|
11/10/2008 |
|
Japan |
|
| Meige's Syndrome |
Other Serious |
3/1/2002 |
57 |
Female |
|
11/20/2008 |
Consumer |
Japan |
|
| Facial Palsy |
Other Serious |
1/1/2001 |
|
Female |
|
11/24/2008 |
|
Japan |
|
| Depression |
Other Serious |
10/20/2008 |
|
Female |
108 lb |
11/28/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Depression |
Other Serious |
10/21/2008 |
|
Female |
108 lb |
12/1/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Inappropriate Antidiuretic Hormone Secretion |
Hospitalization |
1/1/2009 |
65 |
Female |
|
2/11/2009 |
Physician |
Japan |
|
| Inappropriate Antidiuretic Hormone Secretion |
Hospitalization |
1/1/2009 |
65 |
Female |
|
2/16/2009 |
Physician |
Japan |
|
| Inappropriate Antidiuretic Hormone Secretion |
Hospitalization |
1/1/2009 |
65 |
Female |
|
2/23/2009 |
Physician |
Japan |
|
| Hyponatraemia |
Hospitalization |
1/1/2009 |
65 |
Female |
|
2/25/2009 |
Physician |
Japan |
|
| Hyponatraemia |
Hospitalization |
1/1/2009 |
65 |
Female |
|
3/5/2009 |
Physician |
Japan |
|
| Off Label Use |
Other Serious |
|
|
Male |
|
3/11/2009 |
Consumer |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Loss Of Consciousness |
Other Serious |
1/29/2009 |
19 |
Male |
|
3/12/2009 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Decreased |
Other Serious |
1/1/2001 |
62 |
Female |
105 lb |
4/3/2009 |
|
United States |
|
| Agitation |
Hospitalization |
10/29/2008 |
|
Male |
|
4/9/2009 |
Pharmacist |
Japan |
|
| Paralysis |
Other Serious |
|
21 |
Male |
|
4/21/2009 |
Pharmacist |
Japan |
|
| Paralysis |
Other Serious |
|
21 |
Male |
|
4/24/2009 |
Pharmacist |
Japan |
|
| Paralysis |
Other Serious |
4/8/2009 |
21 |
Male |
|
4/27/2009 |
Pharmacist |
Japan |
|
| Paralysis |
Other Serious |
4/8/2009 |
21 |
Male |
|
4/29/2009 |
Pharmacist |
Japan |
|
| Paralysis |
Other Serious |
4/8/2009 |
21 |
Male |
|
5/1/2009 |
Pharmacist |
Japan |
|
| Agitation |
Hospitalization |
10/29/2008 |
|
Male |
|
5/21/2009 |
Pharmacist |
Japan |
|
| Mood Altered |
Other Serious |
1/1/2007 |
|
Male |
|
6/22/2009 |
Physician |
Japan |
|
| Bone Marrow Failure |
Other Serious |
4/23/2009 |
45 |
|
|
6/30/2009 |
Physician |
Japan |
|
| Hyperglycaemia |
Other Serious |
4/20/2002 |
53 |
Female |
168 lb |
7/10/2009 |
|
United States |
|
| Bone Marrow Failure |
Other Serious |
4/23/2009 |
45 |
|
|
7/13/2009 |
Physician |
Japan |
|
| Mood Swings |
Other Serious |
11/9/2005 |
|
Male |
|
7/14/2009 |
Physician |
Japan |
|
| White Blood Cell Count Decreased |
Other Serious |
9/19/2006 |
9 |
Male |
51 lb |
7/10/2009 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Toxic Skin Eruption |
Hospitalization |
1/16/2009 |
|
Female |
|
8/4/2009 |
Physician |
Japan |
|
| Toxic Skin Eruption |
Hospitalization |
6/16/2009 |
|
Female |
|
8/5/2009 |
Physician |
Japan |
|
| Toxic Skin Eruption |
Hospitalization |
6/16/2009 |
|
Female |
|
8/6/2009 |
Physician |
Japan |
|
| Renal Cell Carcinoma |
Other Serious |
1/1/2009 |
45 |
|
|
9/22/2009 |
Physician |
Japan |
|
| Intracranial Haematoma |
Hospitalization |
9/1/2008 |
|
Male |
|
9/24/2009 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Subdural Haematoma |
Hospitalization |
1/1/2007 |
|
Male |
|
9/25/2009 |
Physician |
Japan |
|
| Intracranial Haematoma |
Hospitalization |
9/1/2008 |
|
Male |
|
10/5/2009 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Subdural Haematoma |
Hospitalization |
1/1/2007 |
|
Male |
|
11/25/2009 |
Physician |
Japan |
|
| Vomiting |
Other Serious |
11/11/2009 |
|
Male |
|
12/2/2009 |
Pharmacist |
Japan |
|
| Liver Disorder |
Other Serious |
|
37 |
Female |
|
12/23/2009 |
Other Health Professional |
Japan |
|
| Vomiting |
Other Serious |
11/21/2009 |
|
Male |
|
12/30/2009 |
Pharmacist |
Japan |
|
| Traumatic Fracture |
Hospitalization |
12/11/2007 |
41 |
Female |
|
12/30/2009 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Palpitations |
Other Serious |
12/1/2007 |
|
Male |
|
2/8/2010 |
Physician |
Japan |
|
| Ventricular Fibrillation |
Death |
12/17/2009 |
75 |
Female |
|
2/22/2010 |
Physician |
Japan |
|
| Liver Disorder |
Other Serious |
|
|
Female |
|
3/8/2010 |
Other Health Professional |
Japan |
|
| Renal Cell Carcinoma |
Other Serious |
4/23/2009 |
45 |
Female |
129 lb |
3/25/2010 |
Physician |
Japan |
|
| Ventricular Fibrillation |
Death |
12/17/2009 |
75 |
Female |
|
3/29/2010 |
Physician |
Japan |
|
| Leukocytosis |
Hospitalization |
12/11/2007 |
41 |
Female |
|
4/20/2010 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| White Blood Cell Count Decreased |
Other Serious |
5/13/2007 |
9 |
Male |
51 lb |
5/21/2010 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Decreased |
Other Serious |
1/1/2001 |
62 |
Female |
105 lb |
6/4/2010 |
|
United States |
|
| Overdose |
Disability |
1/1/2008 |
|
Male |
|
7/1/2010 |
Physician |
Japan |
|
| Dysgeusia |
|
1/1/2007 |
41 |
Female |
278 lb |
7/21/2010 |
Consumer |
United States |
|
| Leukocytosis |
Hospitalization |
12/11/2007 |
41 |
Female |
|
7/20/2010 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tremor |
Other Serious |
5/31/2010 |
30 |
Female |
110 lb |
7/27/2010 |
Physician |
Japan |
|
| Tremor |
Other Serious |
5/31/2010 |
30 |
Female |
110 lb |
8/6/2010 |
Physician |
Japan |
|
| Overdose |
Other Serious |
|
34 |
Female |
|
8/18/2010 |
Consumer |
Japan |
|
| Multiple Drug Overdose Intentional |
Other Serious |
11/1/2009 |
34 |
Female |
|
8/27/2010 |
Consumer |
Japan |
|
| Vomiting |
Hospitalization |
2/23/2005 |
76 |
Male |
104 lb |
8/30/2010 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Type 2 Diabetes Mellitus |
Other Serious |
2/1/2001 |
30 |
Male |
343 lb |
9/20/2010 |
|
United States |
|
| Hepatic Function Abnormal |
Hospitalization |
9/2/2010 |
41 |
Female |
183 lb |
9/26/2010 |
Physician |
Japan |
|
| Liver Disorder |
Hospitalization |
9/2/2010 |
41 |
Female |
183 lb |
10/6/2010 |
Physician |
Japan |
|
| Liver Disorder |
Hospitalization |
9/2/2010 |
41 |
Female |
183 lb |
10/18/2010 |
Physician |
Japan |
|
| White Blood Cell Count Increased |
Hospitalization |
9/27/2010 |
27 |
Female |
|
10/26/2010 |
Physician |
Japan |
|
| White Blood Cell Count Increased |
Hospitalization |
9/27/2010 |
27 |
Female |
|
11/18/2010 |
Physician |
Japan |
|
| Weight Decreased |
Other Serious |
1/1/2001 |
62 |
Female |
105 lb |
12/16/2010 |
|
United States |
|
| Pain |
Other Serious |
|
|
Female |
|
12/20/2010 |
Consumer |
Japan |
|
| Spinal Compression Fracture |
Hospitalization |
12/11/2007 |
41 |
Female |
|
12/14/2010 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Increased Appetite |
Other Serious |
10/1/2010 |
35 |
Female |
127 lb |
1/20/2011 |
Physician |
Japan |
|
| Oedema |
Other Serious |
10/1/2010 |
35 |
Female |
127 lb |
3/24/2011 |
Physician |
Japan |
|
| Blood Lactate Dehydrogenase Increased |
Hospitalization |
4/8/2011 |
25 |
Male |
|
4/28/2011 |
Physician |
Japan |
|
| No Adverse Event |
Other Serious |
4/11/2011 |
31 |
Female |
|
4/29/2011 |
Pharmacist |
Japan |
|
| White Blood Cell Count Increased |
Hospitalization |
8/10/2010 |
47 |
Female |
|
5/2/2011 |
Physician |
Japan |
|
| No Adverse Event |
Other Serious |
4/11/2011 |
31 |
Female |
|
5/24/2011 |
Pharmacist |
Japan |
|
| Face Oedema |
Other Serious |
4/13/2011 |
49 |
Female |
146 lb |
6/7/2011 |
Physician |
Japan |
|
| Off Label Use |
Hospitalization |
|
43 |
Female |
154 lb |
7/20/2011 |
Other Health Professional |
Japan |
|
| Hyperglycaemia |
Hospitalization |
|
43 |
Female |
154 lb |
7/21/2011 |
Other Health Professional |
Japan |
|
| Dizziness |
Other Serious |
4/13/2011 |
49 |
Female |
146 lb |
8/10/2011 |
Physician |
Japan |
|
| Rash |
Hospitalization |
7/19/2011 |
56 |
Male |
|
8/18/2011 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Overdose |
Hospitalization |
|
41 |
Female |
|
10/28/2011 |
Pharmacist |
Japan |
|
| Off Label Use |
Hospitalization |
10/18/2011 |
47 |
Female |
|
11/3/2011 |
Physician |
Japan |
|
| Eye Pain |
Other Serious |
|
|
Female |
|
11/9/2011 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Eye Pain |
Other Serious |
|
|
Female |
|
11/15/2011 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cataract |
Other Serious |
|
31 |
Female |
|
11/17/2011 |
Pharmacist |
Japan |
|
| Multiple Drug Overdose Intentional |
Other Serious |
10/18/2011 |
47 |
Female |
|
12/16/2011 |
Consumer |
Japan |
|
| Skin Disorder |
Hospitalization |
|
|
Female |
|
12/29/2011 |
Physician |
Japan |
|
| Drug Interaction |
Hospitalization |
10/25/2011 |
84 |
Female |
|
1/13/2012 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Skin Disorder |
Hospitalization |
12/5/2011 |
29 |
Female |
|
1/30/2012 |
Physician |
Japan |
|
| Hepatic Function Abnormal |
Other Serious |
|
74 |
Female |
|
2/6/2012 |
Pharmacist |
Japan |
|
| Completed Suicide |
Death |
12/24/2011 |
22 |
Female |
|
2/8/2012 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Completed Suicide |
Death |
12/24/2011 |
22 |
Female |
|
3/1/2012 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Blood Uric Acid Increased |
Hospitalization |
7/4/2007 |
42 |
Female |
194 lb |
3/9/2012 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Completed Suicide |
Death |
12/24/2011 |
22 |
Female |
|
3/22/2012 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Photophobia |
Other Serious |
|
|
Female |
|
3/26/2012 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Conjunctival Hyperaemia |
Hospitalization |
7/22/2011 |
56 |
Male |
|
3/28/2012 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hyperhidrosis |
Other Serious |
|
30 |
Male |
|
8/10/2010 |
Consumer |
United States |
|
| White Blood Cell Count Increased |
Hospitalization |
8/10/2010 |
47 |
Female |
|
4/13/2012 |
Physician |
Japan |
|
| Generalised Erythema |
Other Serious |
2/18/2012 |
37 |
Female |
|
4/17/2012 |
Physician |
Japan |
|
| Anxiety |
Other Serious |
11/9/2005 |
49 |
Male |
|
4/19/2012 |
Physician |
Japan |
|
| Hyperhidrosis |
Hospitalization |
2/25/2012 |
54 |
Male |
|
6/7/2012 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Completed Suicide |
Death |
12/24/2011 |
22 |
Female |
|
6/8/2012 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Contusion |
Other Serious |
|
36 |
Male |
|
6/12/2012 |
Physician |
Japan |
|
| Blood Sodium Decreased |
Hospitalization |
2/25/2011 |
53 |
Male |
|
6/20/2012 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Memory Impairment |
Other Serious |
5/22/2012 |
36 |
Male |
|
7/10/2012 |
Physician |
Japan |
|
| Enuresis |
|
8/26/2011 |
41 |
Male |
|
7/11/2012 |
Physician |
Japan |
|
| Anosognosia |
Other Serious |
3/1/2011 |
75 |
Male |
|
7/11/2012 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|