| Suicide Attempt |
Other Serious |
1/8/2006 |
24 |
Female |
117 lb |
1/24/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Inappropriate Antidiuretic Hormone Secretion |
Other Serious |
8/1/2005 |
81 |
Male |
|
2/1/2006 |
Physician |
Japan |
|
| Suicide Attempt |
Other Serious |
1/8/2006 |
24 |
Female |
117 lb |
2/3/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Incorrect Dose Administered |
Other Serious |
1/1/2005 |
36 |
Female |
276 lb |
2/8/2006 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Suicide Attempt |
Other Serious |
1/8/2006 |
24 |
Female |
117 lb |
2/13/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Ulcer |
Hospitalization |
1/1/2001 |
58 |
Male |
240 lb |
2/21/2006 |
Lawyer |
United States |
|
| Platelet Count Decreased |
Other Serious |
2/25/2005 |
41 |
Male |
146 lb |
3/3/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Rhabdomyolysis |
Other Serious |
|
65 |
Male |
|
3/27/2006 |
Pharmacist |
Japan |
|
| Rhabdomyolysis |
Other Serious |
|
65 |
|
|
3/31/2006 |
Pharmacist |
Japan |
|
| Rhabdomyolysis |
Other Serious |
|
65 |
Male |
|
4/4/2006 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Exposure During Pregnancy |
|
|
0 |
Female |
|
4/10/2006 |
Physician |
Japan |
|
| Tremor |
Hospitalization |
4/1/2006 |
68 |
Female |
|
4/13/2006 |
Physician |
Japan |
|
| Ventricular Septal Defect |
Other Serious |
|
0 |
Female |
|
4/18/2006 |
Physician |
Japan |
|
| Treatment Noncompliance |
Other Serious |
|
|
Male |
|
4/17/2006 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| White Blood Cell Count Increased |
Hospitalization |
3/23/2006 |
68 |
Female |
79 lb |
4/26/2006 |
Physician |
Japan |
|
| Restlessness |
Hospitalization |
3/1/2006 |
59 |
Female |
|
4/27/2006 |
Physician |
Japan |
|
| Tremor |
Hospitalization |
3/23/2006 |
68 |
Female |
79 lb |
5/1/2006 |
Physician |
Japan |
|
| Hepatic Function Abnormal |
Hospitalization |
3/16/2006 |
60 |
Female |
|
5/3/2006 |
Physician |
Japan |
|
| Road Traffic Accident |
Hospitalization |
1/1/2001 |
58 |
Male |
240 lb |
5/17/2006 |
Lawyer |
United States |
|
| Completed Suicide |
Death |
5/7/2006 |
72 |
Male |
|
5/25/2006 |
Physician |
Japan |
|
| Loss Of Consciousness |
Death |
5/15/2006 |
76 |
Male |
|
5/25/2006 |
Other Health Professional |
Japan |
|
| Depressed Mood |
Death |
5/7/2006 |
72 |
Male |
|
6/5/2006 |
Physician |
Japan |
|
| Suicide Attempt |
Other Serious |
4/21/2006 |
54 |
Female |
|
5/30/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Depressed Mood |
Death |
5/7/2006 |
72 |
Male |
|
6/23/2006 |
Physician |
Japan |
|
| Suicide Attempt |
Other Serious |
1/8/2006 |
24 |
Female |
117 lb |
7/13/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Loss Of Consciousness |
Death |
5/16/2006 |
77 |
Male |
|
7/26/2006 |
Other Health Professional |
Japan |
|
| Completed Suicide |
Death |
4/10/2006 |
73 |
Male |
|
8/2/2006 |
Physician |
Japan |
|
| Respiratory Arrest |
Death |
5/16/2006 |
77 |
Male |
|
8/4/2006 |
Other Health Professional |
Japan |
|
| Completed Suicide |
Life Threatening |
7/27/2006 |
59 |
Male |
|
8/18/2006 |
Physician |
Japan |
|
| Completed Suicide |
Life Threatening |
7/27/2006 |
59 |
Male |
|
8/22/2006 |
Physician |
Japan |
|
| Completed Suicide |
Life Threatening |
7/27/2006 |
59 |
Male |
|
8/24/2006 |
Physician |
Japan |
|
| Loss Of Consciousness |
Other Serious |
1/1/2006 |
30 |
Male |
|
9/19/2006 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Multiple Drug Overdose |
Death |
|
37 |
Male |
|
9/22/2006 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Loss Of Consciousness |
Other Serious |
4/1/2006 |
30 |
Male |
|
10/9/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Multiple Drug Overdose |
Death |
|
37 |
Male |
|
10/23/2006 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Somnolence |
Hospitalization |
8/5/2006 |
40 |
Male |
157 lb |
11/1/2006 |
Physician |
Japan |
|
| Somnolence |
Hospitalization |
8/5/2006 |
40 |
Male |
157 lb |
11/27/2006 |
Physician |
Japan |
|
| Somnolence |
Hospitalization |
8/5/2006 |
40 |
Male |
157 lb |
11/30/2006 |
Physician |
Japan |
|
| Wheezing |
Death |
11/17/2006 |
57 |
Male |
143 lb |
12/22/2006 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tachycardia |
Hospitalization |
12/6/2006 |
31 |
Female |
205 lb |
12/27/2006 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Systemic Inflammatory Response Syndrome |
Hospitalization |
11/3/2006 |
57 |
Male |
143 lb |
1/2/2007 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Personality Disorder |
Other Serious |
|
83 |
Female |
|
1/18/2007 |
Pharmacist |
Japan |
|
| Aspartate Aminotransferase Increased |
Other Serious |
1/15/2007 |
31 |
Male |
|
1/29/2007 |
Physician |
Japan |
|
| Somnolence |
Disability |
1/1/2006 |
40 |
Male |
|
1/31/2007 |
Physician |
Japan |
|
| Suicide Attempt |
Other Serious |
11/11/2006 |
|
Female |
|
2/6/2007 |
Physician |
Japan |
|
| Somnolence |
Disability |
1/1/2006 |
40 |
Male |
|
2/14/2007 |
Physician |
Japan |
|
| Aspartate Aminotransferase Increased |
Other Serious |
1/15/2007 |
31 |
Male |
|
2/23/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Somnolence |
Other Serious |
1/16/2007 |
81 |
Female |
|
3/6/2007 |
Physician |
Japan |
|
| Personality Disorder |
Other Serious |
|
83 |
Female |
|
3/12/2007 |
Pharmacist |
Japan |
|
| Aspartate Aminotransferase Increased |
Other Serious |
1/15/2007 |
31 |
Male |
|
3/12/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Depressed Level Of Consciousness |
Other Serious |
11/20/2006 |
|
Female |
95 lb |
3/29/2007 |
Physician |
Japan |
|
| Urinary Tract Infection |
Other Serious |
11/20/2006 |
|
Female |
95 lb |
4/24/2007 |
Physician |
Japan |
|
| Syncope |
Other Serious |
1/1/1999 |
43 |
Female |
200 lb |
4/24/2007 |
Consumer |
United States |
|
| Weight Increased |
Hospitalization |
1/1/2006 |
|
Female |
|
4/30/2007 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Restlessness |
Other Serious |
1/4/2003 |
79 |
Female |
104 lb |
5/4/2007 |
Physician |
Japan |
|
| Pyrexia |
Other Serious |
5/10/2007 |
32 |
Male |
|
5/31/2007 |
Physician |
Japan |
|
| Suicide Attempt |
Other Serious |
6/1/2007 |
59 |
Male |
|
6/14/2007 |
Physician |
Japan |
|
| Pyrexia |
Other Serious |
5/10/2007 |
32 |
Male |
|
6/21/2007 |
Physician |
Japan |
|
| Restlessness |
Other Serious |
1/4/2003 |
79 |
Female |
104 lb |
5/4/2007 |
Physician |
Japan |
|
| Testicular Pain |
Other Serious |
1/1/2007 |
28 |
Male |
|
6/29/2007 |
Pharmacist |
Japan |
|
| Speech Disorder |
Hospitalization |
6/17/2007 |
75 |
Male |
141 lb |
7/2/2007 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Self Mutilation |
Hospitalization |
6/18/2007 |
43 |
Female |
|
7/5/2007 |
Physician |
Japan |
|
| Testicular Pain |
Other Serious |
1/1/2007 |
28 |
Male |
|
7/6/2007 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Suicide Attempt |
Other Serious |
6/1/2007 |
59 |
Male |
|
7/9/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Overdose |
Death |
2/1/2007 |
21 |
Male |
|
7/10/2007 |
Physician |
Japan |
|
| Completed Suicide |
Death |
5/8/2007 |
84 |
Female |
|
7/10/2007 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Completed Suicide |
Death |
5/8/2007 |
84 |
Female |
95 lb |
7/13/2007 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cellulitis |
Hospitalization |
7/6/2007 |
59 |
Female |
|
7/20/2007 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Sputum Abnormal |
Hospitalization |
5/7/2007 |
|
Female |
116 lb |
7/23/2007 |
Physician |
Japan |
|
| Completed Suicide |
Death |
5/8/2007 |
84 |
Female |
95 lb |
7/27/2007 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| White Blood Cell Count Increased |
Hospitalization |
6/18/2007 |
43 |
Female |
104 lb |
7/30/2007 |
Physician |
Japan |
|
| Completed Suicide |
Death |
5/8/2007 |
84 |
Female |
95 lb |
7/30/2007 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Suicidal Ideation |
Other Serious |
7/6/2007 |
39 |
Male |
|
7/30/2007 |
Pharmacist |
Japan |
|
| Weight Increased |
Other Serious |
3/1/2006 |
40 |
Female |
|
8/2/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Speech Disorder |
Hospitalization |
6/17/2007 |
75 |
Male |
141 lb |
8/7/2007 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Disinhibition |
Hospitalization |
7/31/2007 |
27 |
Male |
|
8/9/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cardio-respiratory Arrest |
Death |
7/1/2007 |
54 |
Male |
|
8/14/2007 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Serotonin Syndrome |
Hospitalization |
8/4/2007 |
57 |
Female |
|
8/20/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Serotonin Syndrome |
Hospitalization |
8/4/2007 |
57 |
Female |
|
8/27/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Self Injurious Behaviour |
Other Serious |
12/13/2006 |
17 |
Male |
|
9/4/2007 |
Physician |
Japan |
|
| Intentional Overdose |
Death |
3/23/2007 |
21 |
Male |
353 lb |
9/7/2007 |
Physician |
Japan |
|
| Somnolence |
|
11/1/2001 |
|
Male |
213 lb |
9/7/2007 |
Consumer |
United States |
|
| Nervous System Disorder |
Death |
7/1/2007 |
54 |
Male |
|
9/14/2007 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Syncope |
Other Serious |
1/1/1999 |
43 |
Female |
200 lb |
9/17/2007 |
Consumer |
United States |
|
| White Blood Cell Count Increased |
Hospitalization |
6/18/2007 |
43 |
Female |
104 lb |
9/28/2007 |
Physician |
Japan |
|
| Intentional Overdose |
Death |
3/23/2007 |
21 |
Male |
353 lb |
10/2/2007 |
Physician |
Japan |
|
| Anger |
Other Serious |
1/1/2007 |
|
Male |
|
10/12/2007 |
Physician |
Japan |
|
| Self Mutilation |
Hospitalization |
7/31/2007 |
27 |
Male |
196 lb |
10/18/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Self Mutilation |
Hospitalization |
7/31/2007 |
27 |
Male |
196 lb |
10/26/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Self Mutilation |
Hospitalization |
7/31/2007 |
27 |
Male |
|
10/26/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Ventricular Septal Defect |
Hospitalization |
2/25/2006 |
|
Female |
7 lb |
10/30/2007 |
Physician |
Japan |
|
| Tremor |
Life Threatening |
4/1/2004 |
36 |
Female |
143 lb |
10/31/2007 |
Physician |
Japan |
|
| Tremor |
Life Threatening |
4/1/2004 |
36 |
Female |
143 lb |
11/5/2007 |
Physician |
Japan |
|
| White Blood Cell Count Increased |
Hospitalization |
3/22/2007 |
44 |
Male |
190 lb |
11/14/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Eyelid Ptosis |
Other Serious |
1/1/2007 |
74 |
Female |
|
11/19/2007 |
Pharmacist |
Japan |
|
| Cardiac Failure |
Other Serious |
|
85 |
Male |
|
11/29/2007 |
Pharmacist |
Japan |
|
| Eyelid Ptosis |
Other Serious |
11/7/2007 |
74 |
Female |
|
11/30/2007 |
Pharmacist |
Japan |
|
| Anger |
Other Serious |
12/1/2006 |
29 |
Male |
|
12/17/2007 |
Physician |
Japan |
|
| Gamma-glutamyltransferase Increased |
Other Serious |
12/3/2007 |
|
Male |
159 lb |
12/28/2007 |
Physician |
Japan |
|
| Physical Assault |
Other Serious |
8/27/2007 |
40 |
Male |
|
1/2/2008 |
Physician |
Japan |
|
| Visual Acuity Reduced |
Other Serious |
|
38 |
Male |
|
1/2/2008 |
Pharmacist |
Japan |
|
| Anger |
Other Serious |
12/1/2006 |
29 |
Male |
|
1/3/2008 |
Physician |
Japan |
|
| Urine Output Decreased |
Other Serious |
1/30/2007 |
|
Female |
148 lb |
1/17/2008 |
Physician |
Japan |
|
| Visual Acuity Reduced |
Other Serious |
|
38 |
Male |
|
1/25/2008 |
Pharmacist |
Japan |
|
| Blepharospasm |
Other Serious |
|
45 |
Female |
|
2/5/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vomiting |
Hospitalization |
8/1/1994 |
|
Male |
5 lb |
2/5/2008 |
Consumer |
United States |
|
| Cardiac Failure |
Other Serious |
11/11/2007 |
85 |
Male |
|
2/12/2008 |
Pharmacist |
Japan |
|
| Speech Disorder |
Other Serious |
6/14/2005 |
61 |
Female |
132 lb |
3/5/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hypercholesterolaemia |
Other Serious |
|
43 |
Female |
|
3/26/2008 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Ventricular Septal Defect |
Hospitalization |
8/1/1994 |
|
Male |
5 lb |
4/1/2008 |
Other Health Professional |
United States |
|
| Hypercholesterolaemia |
|
3/11/2008 |
43 |
Female |
|
4/4/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Ventricular Septal Defect |
Hospitalization |
8/1/1994 |
|
Male |
5 lb |
4/11/2008 |
Other Health Professional |
United States |
|
| Ventricular Septal Defect |
Hospitalization |
8/1/1994 |
|
Male |
5 lb |
5/6/2008 |
Other Health Professional |
United States |
|
| Vomiting |
Hospitalization |
8/1/1994 |
|
Male |
5 lb |
5/7/2008 |
Other Health Professional |
United States |
|
| Ventricular Septal Defect |
Hospitalization |
8/1/1994 |
|
Male |
5 lb |
5/28/2008 |
Other Health Professional |
United States |
|
| Tremor |
Other Serious |
7/1/2008 |
57 |
Male |
123 lb |
7/14/2008 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Syncope |
Other Serious |
5/10/2008 |
40 |
Female |
|
7/18/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Liver Function Test Abnormal |
Other Serious |
|
|
Female |
|
7/18/2008 |
Physician |
Japan |
|
| Syncope |
Other Serious |
5/10/2008 |
41 |
Female |
|
7/28/2008 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tremor |
Other Serious |
7/1/2008 |
57 |
Male |
123 lb |
8/12/2008 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Prurigo |
Other Serious |
7/1/2008 |
33 |
Male |
|
8/20/2008 |
Physician |
Japan |
|
| Prurigo |
Other Serious |
7/1/2008 |
33 |
Male |
|
8/26/2008 |
Physician |
Japan |
|
| Logorrhoea |
Other Serious |
|
|
Male |
|
9/2/2008 |
Other Health Professional |
Japan |
|
| Prurigo |
Other Serious |
7/1/2008 |
33 |
Male |
|
9/3/2008 |
Physician |
Japan |
|
| Weight Increased |
Other Serious |
|
43 |
Female |
|
10/2/2008 |
Pharmacist |
Japan |
|
| Weight Increased |
Other Serious |
|
43 |
Female |
|
10/8/2008 |
Pharmacist |
Japan |
|
| Pyrexia |
Hospitalization |
10/14/2008 |
|
Female |
|
10/29/2008 |
Physician |
Japan |
|
| Renal Failure |
Life Threatening |
11/15/2007 |
86 |
Male |
123 lb |
11/5/2008 |
Other Health Professional |
Japan |
|
| Hepatic Function Abnormal |
Other Serious |
1/1/2008 |
61 |
Male |
132 lb |
11/7/2008 |
Physician |
Japan |
|
| Urinary Tract Inflammation |
Hospitalization |
10/14/2008 |
77 |
Female |
|
11/14/2008 |
Physician |
Japan |
|
| Renal Failure |
Life Threatening |
1/22/2008 |
86 |
Male |
123 lb |
12/1/2008 |
Other Health Professional |
Japan |
|
| Urinary Tract Inflammation |
Hospitalization |
10/14/2008 |
77 |
Female |
|
12/5/2008 |
Physician |
Japan |
|
| Urinary Tract Inflammation |
Hospitalization |
10/14/2008 |
77 |
Female |
|
12/18/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hepatic Function Abnormal |
Other Serious |
1/1/2008 |
61 |
Male |
132 lb |
2/16/2009 |
Physician |
Japan |
|
| Loss Of Consciousness |
Life Threatening |
1/30/2009 |
|
Female |
|
2/23/2009 |
Pharmacist |
Japan |
|
| Memory Impairment |
Life Threatening |
1/31/2009 |
27 |
Female |
|
2/24/2009 |
Pharmacist |
Japan |
|
| Stomatitis |
Other Serious |
6/1/2008 |
66 |
Female |
104 lb |
2/24/2009 |
Physician |
Japan |
|
| Off Label Use |
Other Serious |
|
|
Male |
|
3/11/2009 |
Consumer |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Ventricular Septal Defect |
Hospitalization |
8/1/1994 |
|
Male |
5 lb |
3/16/2009 |
Other Health Professional |
United States |
|
| Pneumonia |
Hospitalization |
10/10/2002 |
69 |
Female |
|
3/27/2009 |
Other Health Professional |
Japan |
|
| Suicidal Ideation |
Life Threatening |
2/18/2009 |
69 |
Male |
|
3/31/2009 |
Pharmacist |
Japan |
|
| Memory Impairment |
Life Threatening |
1/31/2009 |
|
Female |
|
4/1/2009 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Stomatitis |
Other Serious |
6/1/2008 |
66 |
Female |
104 lb |
3/27/2009 |
Physician |
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 |
|
| Renal Failure |
Other Serious |
7/3/2008 |
|
|
|
4/29/2009 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Suicidal Ideation |
Life Threatening |
2/18/2009 |
|
Male |
|
4/30/2009 |
Pharmacist |
Japan |
|
| Paralysis |
Other Serious |
4/8/2009 |
21 |
Male |
|
5/1/2009 |
Pharmacist |
Japan |
|