| Vanishing Bile Duct Syndrome |
Other Serious |
|
35 |
Male |
|
1/23/2007 |
|
|
|
| Vanishing Bile Duct Syndrome |
Other Serious |
|
35 |
Male |
|
5/15/2007 |
Physician |
United States |
|
| Restless Legs Syndrome |
Other Serious |
|
50 |
Female |
|
8/20/2007 |
|
|
|
| Weight Decreased |
Life Threatening |
6/1/2002 |
49 |
Female |
127 lb |
1/14/2008 |
Consumer |
United Kingdom |
|
| Weight Decreased |
Life Threatening |
6/1/2002 |
49 |
Female |
127 lb |
2/25/2008 |
Consumer |
United Kingdom |
|
| Self Injurious Behaviour |
Other Serious |
|
|
Female |
|
3/5/2008 |
Physician |
Japan |
|
| Pco2 Decreased |
Required Intervention |
2/1/2008 |
47 |
Female |
120 lb |
10/7/2008 |
|
United States |
|
| Intra-uterine Death |
Other Serious |
3/1/2008 |
40 |
Female |
|
3/10/2009 |
Other Health Professional |
Netherlands |
|
| Epilepsy |
Other Serious |
6/2/2005 |
1 |
Male |
22 lb |
3/6/2009 |
|
Italy |
|
| Respiratory Arrest |
Required Intervention |
2/1/2008 |
47 |
Female |
120 lb |
4/15/2009 |
|
United States |
|
| Muscle Spasms |
Other Serious |
7/16/2007 |
31 |
Female |
|
5/12/2009 |
Consumer |
United States |
|
| Death |
Death |
6/10/2009 |
59 |
Female |
157 lb |
6/24/2009 |
Physician |
United States |
|
| Weight Decreased |
Life Threatening |
6/1/2002 |
49 |
Female |
127 lb |
10/19/2009 |
|
United Kingdom |
|
| Weight Decreased |
Life Threatening |
6/1/2002 |
49 |
Female |
127 lb |
10/27/2009 |
Consumer |
United Kingdom |
|
| Stomatitis |
Hospitalization |
8/7/2009 |
35 |
Female |
|
11/25/2009 |
Physician |
Japan |
|
| Weight Decreased |
Other Serious |
6/1/2002 |
|
Female |
127 lb |
1/18/2010 |
Consumer |
United Kingdom |
|
| White Blood Cell Count Increased |
Life Threatening |
1/16/2006 |
|
Female |
172 lb |
3/11/2010 |
|
Germany |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vomiting |
Other Serious |
4/1/2006 |
27 |
Female |
172 lb |
3/18/2010 |
Physician |
|
|
| Toxic Epidermal Necrolysis |
Life Threatening |
5/1/2009 |
48 |
Male |
|
4/5/2010 |
Physician |
Japan |
|
| Hallucination, Visual |
Hospitalization |
9/26/2009 |
10 |
Male |
|
4/16/2010 |
Other Health Professional |
Japan |
|
| Drug Exposure During Pregnancy |
Other Serious |
|
|
Female |
|
4/23/2010 |
Other Health Professional |
United Kingdom |
|
| Intra-uterine Death |
Other Serious |
3/1/2008 |
35 |
Female |
|
4/26/2010 |
Other Health Professional |
United Kingdom |
|
| Maternal Drugs Affecting Foetus |
Death |
|
35 |
|
|
4/26/2010 |
Other Health Professional |
United Kingdom |
|
| Vertigo |
Other Serious |
|
39 |
Female |
|
4/27/2010 |
|
Austria |
|
| Myocardial Infarction |
Death |
|
64 |
Male |
|
6/11/2010 |
|
Germany |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Thrombophlebitis |
Hospitalization |
6/7/2010 |
21 |
Female |
|
7/23/2010 |
Pharmacist |
Ireland |
|
| Vomiting |
Hospitalization |
|
27 |
Female |
|
8/2/2010 |
Other Health Professional |
Germany |
|
| Vomiting |
Hospitalization |
|
27 |
Female |
|
8/2/2010 |
Other Health Professional |
Germany |
|
| Vomiting |
Hospitalization |
|
27 |
Female |
|
8/2/2010 |
Other Health Professional |
Germany |
|
| Vomiting |
Hospitalization |
|
27 |
Female |
|
8/2/2010 |
Other Health Professional |
Germany |
|
| Overdose |
Hospitalization |
4/1/2006 |
27 |
Female |
|
8/3/2010 |
Other Health Professional |
Germany |
|
| Vomiting |
Hospitalization |
4/1/2006 |
27 |
Female |
|
7/30/2010 |
Other Health Professional |
Germany |
|
| Vomiting |
Hospitalization |
4/1/2006 |
27 |
Female |
172 lb |
8/25/2010 |
Other Health Professional |
Germany |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| White Blood Cell Count Decreased |
Hospitalization |
4/16/2010 |
43 |
Male |
|
9/1/2010 |
Other Health Professional |
Japan |
|
| Nephrolithiasis |
Other Serious |
|
6 |
Male |
|
9/1/2010 |
|
|
|
| Calculus Urinary |
Other Serious |
|
6 |
Male |
|
9/8/2010 |
Other Health Professional |
United States |
|
| Calculus Urinary |
Other Serious |
|
6 |
Male |
|
9/8/2010 |
Other Health Professional |
United States |
|
| Calculus Urinary |
Other Serious |
|
6 |
Male |
|
9/8/2010 |
Other Health Professional |
United States |
|
| Hyperammonaemic Encephalopathy |
Other Serious |
|
5 |
Male |
|
9/9/2010 |
|
|
|
| Myocardial Infarction |
|
|
64 |
Male |
|
9/7/2010 |
Physician |
Germany |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| White Blood Cell Count Decreased |
Hospitalization |
4/16/2010 |
43 |
Male |
|
9/22/2010 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Respiratory Disorder |
Other Serious |
|
14 |
Male |
|
10/1/2010 |
Other Health Professional |
Japan |
|
| Paranoia |
Other Serious |
|
22 |
Female |
|
10/21/2010 |
Other Health Professional |
Japan |
|
| Paranoia |
Other Serious |
|
22 |
Female |
|
11/8/2010 |
Other Health Professional |
Japan |
|
| Status Epilepticus |
Other Serious |
|
38 |
Female |
|
11/4/2010 |
|
Italy |
|
| Lennox-gastaut Syndrome |
Other Serious |
|
38 |
Female |
|
11/4/2010 |
|
Italy |
|
| Encephalopathy |
Hospitalization |
8/21/2007 |
37 |
Female |
154 lb |
1/14/2011 |
Other Health Professional |
Korea, Republic Of |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Blood Urine Present |
Hospitalization |
4/16/2010 |
43 |
Male |
|
1/28/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hyperammonaemic Encephalopathy |
Hospitalization |
7/17/2010 |
79 |
Male |
|
1/28/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Psychomotor Retardation |
Hospitalization |
7/21/2007 |
37 |
Female |
129 lb |
1/31/2011 |
Other Health Professional |
Korea, Republic Of |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Speech Disorder |
Other Serious |
|
21 |
Female |
|
2/2/2011 |
Other Health Professional |
Denmark |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Grand Mal Convulsion |
Other Serious |
|
21 |
Female |
|
2/4/2011 |
|
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Convulsion |
Hospitalization |
|
|
Female |
134 lb |
|
Physician |
United States |
|
| Convulsion |
Other Serious |
|
|
Male |
187 lb |
3/4/2011 |
Physician |
United States |
|
| Fall |
Hospitalization |
|
|
Female |
134 lb |
2/25/2011 |
Physician |
United States |
|
| Quadriparesis |
Other Serious |
|
74 |
Female |
|
3/14/2011 |
Other Health Professional |
Germany |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Psychotic Disorder |
Other Serious |
1/1/2009 |
39 |
Male |
|
3/7/2011 |
Physician |
Germany |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Balance Disorder |
Other Serious |
|
37 |
Female |
|
3/21/2011 |
Other Health Professional |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Incorrect Route Of Drug Administration |
Death |
|
52 |
Female |
|
4/12/2011 |
Other Health Professional |
United Kingdom |
|
| Abortion Spontaneous |
Other Serious |
|
|
Female |
|
4/13/2011 |
Other Health Professional |
United Kingdom |
|
| Convulsion |
Other Serious |
4/18/2011 |
72 |
Male |
|
4/26/2011 |
Pharmacist |
Japan |
|
| Death |
Death |
|
52 |
Female |
|
4/15/2011 |
Physician |
United Kingdom |
|
| Epilepsy |
Other Serious |
4/18/2011 |
70 |
Male |
|
4/26/2011 |
Physician |
Japan |
|
| Epilepsy |
Other Serious |
4/18/2011 |
72 |
Male |
|
5/3/2011 |
Physician |
Japan |
|
| Convulsion |
Other Serious |
4/18/2011 |
72 |
Male |
|
5/3/2011 |
Pharmacist |
Japan |
|
| Drug Ineffective |
Other Serious |
|
27 |
Female |
|
5/4/2011 |
Other Health Professional |
United Kingdom |
|
| Brain Herniation |
Other Serious |
|
27 |
Female |
|
4/20/2011 |
Other Health Professional |
United Kingdom |
|
| Encephalocele |
Other Serious |
|
27 |
Female |
|
4/28/2011 |
Other Health Professional |
United Kingdom |
|
| Drug Ineffective |
Other Serious |
|
27 |
Female |
|
4/27/2011 |
Other Health Professional |
United Kingdom |
|
| Encephalocele |
Other Serious |
|
27 |
Female |
|
5/3/2011 |
Other Health Professional |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cervical Vertebral Fracture |
Hospitalization |
2/9/2011 |
27 |
Female |
140 lb |
5/6/2011 |
Physician |
United States |
|
| Drug Ineffective |
Other Serious |
|
27 |
Female |
|
5/11/2011 |
Other Health Professional |
United Kingdom |
|
| Drug Ineffective |
|
|
27 |
Female |
|
5/3/2011 |
Other Health Professional |
United Kingdom |
|
| Vomiting |
Other Serious |
6/15/2010 |
27 |
Male |
196 lb |
5/20/2011 |
Physician |
Japan |
|
| Status Epilepticus |
Hospitalization |
8/26/2010 |
73 |
Male |
|
5/23/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pancytopenia |
Other Serious |
5/1/2009 |
13 |
Female |
|
5/24/2011 |
Other Health Professional |
Japan |
|
| Grand Mal Convulsion |
Hospitalization |
5/7/2011 |
27 |
Female |
140 lb |
5/16/2011 |
Physician |
United States |
|
| Epilepsy |
Other Serious |
4/20/2011 |
72 |
Male |
|
5/31/2011 |
Physician |
Japan |
|
| Drug Eruption |
Hospitalization |
1/9/2010 |
35 |
Male |
|
6/10/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Suicidal Ideation |
Other Serious |
|
27 |
Female |
172 lb |
6/6/2011 |
Other Health Professional |
Germany |
|
| Epilepsy |
Other Serious |
4/20/2011 |
72 |
Male |
|
6/16/2011 |
Physician |
Japan |
|
| Fall |
Hospitalization |
|
|
Female |
165 lb |
6/24/2011 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Agranulocytosis |
Other Serious |
|
50 |
Male |
|
7/5/2011 |
Other Health Professional |
Japan |
|
| Fall |
Hospitalization |
|
|
Female |
165 lb |
7/11/2011 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hallucination |
Other Serious |
4/1/2011 |
21 |
Female |
|
7/22/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| White Blood Cell Count Decreased |
Other Serious |
9/6/2001 |
4 |
Female |
40 lb |
7/26/2011 |
Other Health Professional |
Japan |
|
| Multiple Sclerosis |
Other Serious |
|
|
Female |
165 lb |
7/28/2011 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Fall |
Other Serious |
|
|
Female |
165 lb |
7/28/2011 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Acute Tonsillitis |
Hospitalization |
7/19/2011 |
3 |
Male |
|
8/5/2011 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Fall |
Hospitalization |
|
|
Female |
165 lb |
8/12/2011 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Rhabdomyolysis |
Other Serious |
|
1 |
Male |
|
8/12/2011 |
Physician |
Japan |
|
| Convulsion |
Other Serious |
|
67 |
Male |
|
8/15/2011 |
Other Health Professional |
Japan |
|
| Oculomucocutaneous Syndrome |
Hospitalization |
|
51 |
Female |
|
8/19/2011 |
Physician |
Japan |
|
| Convulsion |
Other Serious |
|
67 |
Male |
|
8/24/2011 |
Other Health Professional |
Japan |
|
| Status Epilepticus |
Hospitalization |
|
|
Female |
|
8/26/2011 |
Physician |
Japan |
|
| Cervical Vertebral Fracture |
Other Serious |
2/9/2011 |
27 |
Female |
134 lb |
8/19/2011 |
Physician |
United States |
|
| Hypotension |
Hospitalization |
8/19/2011 |
45 |
Male |
|
8/26/2011 |
|
United States |
|
| Malaise |
Other Serious |
1/1/2008 |
67 |
Male |
|
9/2/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Feeling Abnormal |
Other Serious |
1/1/2008 |
67 |
Male |
|
9/2/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Band Neutrophil Percentage Increased |
Hospitalization |
8/4/2011 |
51 |
Female |
|
9/2/2011 |
Physician |
Japan |
|
| Feeling Abnormal |
Other Serious |
1/1/2008 |
67 |
Male |
|
9/6/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Oedema Peripheral |
Hospitalization |
7/27/2011 |
19 |
Female |
|
9/14/2011 |
Physician |
Japan |
|
| Vomiting |
Other Serious |
7/1/2011 |
|
Male |
|
9/19/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Haematocrit Increased |
Hospitalization |
8/4/2011 |
51 |
Female |
|
9/19/2011 |
Physician |
Japan |
|
| Pyrexia |
Hospitalization |
7/14/2011 |
36 |
Female |
229 lb |
9/23/2011 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pyrexia |
Hospitalization |
8/4/2011 |
51 |
Female |
|
9/23/2011 |
Physician |
Japan |
|
| Pyrexia |
Hospitalization |
7/14/2011 |
36 |
Female |
229 lb |
10/3/2011 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Rhabdomyolysis |
Hospitalization |
7/14/2011 |
|
Male |
|
10/3/2011 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Mucosal Erosion |
Hospitalization |
8/4/2011 |
51 |
Female |
|
10/5/2011 |
Physician |
Japan |
|
| Hallucination, Auditory |
Other Serious |
4/13/2011 |
21 |
Female |
|
10/12/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Prescribing Error |
Other Serious |
7/1/2011 |
|
Male |
|
10/14/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Epilepsy |
Death |
10/1/2009 |
23 |
Female |
|
10/17/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Liver Disorder |
Hospitalization |
10/1/2009 |
23 |
Female |
|
10/19/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Liver Disorder |
Death |
10/1/2009 |
23 |
Female |
|
10/20/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Dyshidrosis |
Other Serious |
7/1/2011 |
|
Male |
|
10/24/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Psychomotor Retardation |
Other Serious |
|
|
Male |
|
10/24/2011 |
Other Health Professional |
India |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cellulitis |
Hospitalization |
1/9/2010 |
35 |
Male |
|
11/4/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vomiting |
Other Serious |
7/1/2011 |
|
Male |
|
11/4/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Prescribing Error |
Other Serious |
6/27/2011 |
|
Male |
|
11/11/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hyperammonaemia |
Death |
10/1/2009 |
23 |
Female |
|
11/14/2011 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Suicidal Ideation |
Hospitalization |
1/14/2003 |
34 |
Male |
|
11/21/2011 |
Consumer |
United States |
|
| Somnolence |
Other Serious |
2/14/2009 |
42 |
Female |
|
11/23/2011 |
Consumer |
United States |
|
| Fatigue |
|
6/7/2011 |
55 |
Female |
|
9/8/2011 |
Consumer |
United States |
|
| Vomiting |
Hospitalization |
7/19/2011 |
3 |
Male |
|
12/19/2011 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Near Drowning |
Hospitalization |
10/1/2009 |
23 |
Female |
|
1/13/2012 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Dehydration |
Hospitalization |
7/1/2011 |
|
Male |
|
1/17/2012 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Poisoning |
Death |
6/9/2009 |
59 |
Female |
157 lb |
1/20/2012 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Convulsion |
Other Serious |
|
21 |
Female |
|
2/7/2012 |
Other Health Professional |
United States |
|
| Rash |
|
11/6/2011 |
56 |
Female |
135 lb |
12/10/2011 |
|
United States |
|
| Memory Impairment |
Hospitalization |
1/10/2000 |
15 |
Female |
|
12/13/2011 |
Consumer |
United States |
|
| Malaise |
Other Serious |
|
29 |
Female |
220 lb |
12/13/2011 |
Consumer |
United States |
|
| Adverse Drug Reaction |
Hospitalization |
1/1/2009 |
39 |
Female |
|
12/13/2011 |
|
United States |
|
| Myoclonic Epilepsy |
Hospitalization |
4/23/2011 |
6 |
Male |
|
12/13/2011 |
|
United States |
|
| Cyanosis |
Other Serious |
2/4/2011 |
43 |
Female |
|
3/9/2012 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Platelet Count Decreased |
Other Serious |
9/6/2001 |
4 |
Female |
40 lb |
3/9/2012 |
|
Japan |
|
| Cyanosis |
Other Serious |
2/4/2011 |
43 |
Female |
|
3/16/2012 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Injection Site Rash |
Other Serious |
1/1/2010 |
53 |
Female |
|
8/18/2011 |
Physician |
United States |
|
| Ecchymosis |
Other Serious |
1/1/2010 |
53 |
Female |
|
8/18/2011 |
Physician |
United States |
|
| Death |
Other Serious |
3/5/2012 |
90 |
Female |
|
3/22/2012 |
Pharmacist |
United States |
|
| Hypoaesthesia |
Other Serious |
|
53 |
Female |
|
5/18/2011 |
Physician |
United States |
|
| Injection Site Erythema |
Other Serious |
|
53 |
Female |
|
5/18/2011 |
Physician |
United States |
|
| Cyanosis |
Other Serious |
2/4/2011 |
43 |
Female |
|
5/22/2012 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Abscess |
Hospitalization |
7/27/2009 |
9 |
Male |
35 lb |
5/30/2012 |
Physician |
Japan |
|
| Partial Seizures |
Other Serious |
|
31 |
Female |
|
6/20/2012 |
Other Health Professional |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Protrusion Tongue |
Other Serious |
|
31 |
Female |
|
7/9/2012 |
Other Health Professional |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Gait Disturbance |
Other Serious |
|
31 |
Female |
|
7/13/2012 |
Other Health Professional |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Partial Seizures |
Other Serious |
|
31 |
Female |
|
7/10/2012 |
Other Health Professional |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Movement Disorder |
Other Serious |
|
31 |
Female |
|
7/10/2012 |
Consumer |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Mobility Decreased |
Other Serious |
|
31 |
Female |
|
7/10/2012 |
Consumer |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| General Physical Health Deterioration |
Other Serious |
|
31 |
Female |
|
7/10/2012 |
Other Health Professional |
|
| Primary |
|
| Secondary |
|
| Concomitant |
|
|