| Epilepsy |
Other Serious |
1/1/2006 |
59 |
Female |
|
4/25/2006 |
Physician |
France |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Epilepsy |
Life Threatening |
1/1/2006 |
60 |
Female |
|
5/9/2006 |
Other Health Professional |
France |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Grand Mal Convulsion |
Other Serious |
|
26 |
Female |
|
6/27/2006 |
Physician |
France |
|
| Petit Mal Epilepsy |
Other Serious |
|
3 |
Male |
|
6/27/2006 |
Physician |
Italy |
|
| Salivary Hypersecretion |
Other Serious |
|
13 |
Male |
|
6/27/2006 |
Physician |
Italy |
|
| Epilepsy |
Life Threatening |
1/12/2006 |
60 |
Female |
|
1/17/2007 |
Other Health Professional |
France |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Interstitial Lung Disease |
Other Serious |
|
48 |
Male |
|
12/5/2008 |
|
Italy |
|
| Neuroblastoma |
Hospitalization |
8/1/2008 |
2 |
Female |
|
12/15/2008 |
Physician |
Germany |
|
| Interstitial Lung Disease |
Hospitalization |
|
48 |
Male |
|
12/23/2008 |
|
Italy |
|
| Pulmonary Function Test Abnormal |
Other Serious |
|
48 |
Male |
|
12/23/2008 |
Other Health Professional |
Italy |
|
| Stevens-johnson Syndrome |
Other Serious |
|
|
|
|
2/6/2009 |
Other Health Professional |
Norway |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Stevens-johnson Syndrome |
Other Serious |
|
|
|
|
2/20/2009 |
Other Health Professional |
Norway |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Speech Disorder |
Death |
|
3 |
Male |
|
4/15/2009 |
Consumer |
Turkey |
|
| Status Epilepticus |
Hospitalization |
|
12 |
Female |
|
4/20/2009 |
Other Health Professional |
Japan |
|
| Status Epilepticus |
Hospitalization |
|
34 |
Male |
|
4/21/2009 |
Other Health Professional |
Japan |
|
| Status Epilepticus |
Hospitalization |
|
12 |
Female |
|
4/21/2009 |
Other Health Professional |
Japan |
|
| Vision Blurred |
Other Serious |
1/1/2008 |
|
|
|
4/27/2009 |
Consumer |
Brazil |
|
| Urine Output Decreased |
Other Serious |
1/14/2009 |
|
Male |
|
5/1/2009 |
Consumer |
Switzerland |
|
| Stubbornness |
Other Serious |
10/1/2008 |
|
Male |
|
5/20/2009 |
Physician |
United States |
|
| Stevens-johnson Syndrome |
Other Serious |
|
50 |
Female |
|
5/27/2009 |
Other Health Professional |
Norway |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Febrile Convulsion |
Other Serious |
|
76 |
Male |
|
7/2/2009 |
Other Health Professional |
United States |
|
| Muscle Twitching |
Other Serious |
|
83 |
Female |
|
7/2/2009 |
Other Health Professional |
United States |
|
| Convulsion |
Other Serious |
1/1/2006 |
|
Male |
154 lb |
7/6/2009 |
Consumer |
Brazil |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Diabetic Retinopathy |
Other Serious |
6/23/2003 |
31 |
Male |
248 lb |
7/14/2009 |
|
United States |
|
| Muscle Twitching |
Other Serious |
|
83 |
Female |
|
7/28/2009 |
Physician |
United States |
|
| Syncope |
Other Serious |
|
37 |
Female |
|
8/11/2009 |
Other Health Professional |
Spain |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vomiting |
Other Serious |
8/1/2009 |
33 |
Male |
|
8/12/2009 |
Consumer |
United States |
|
| Convulsion |
Other Serious |
|
32 |
Female |
|
8/25/2009 |
Other Health Professional |
Germany |
|
| No Adverse Event |
|
8/7/2009 |
|
Male |
83 lb |
8/26/2009 |
Other Health Professional |
Brazil |
|
| Splenomegaly |
Other Serious |
|
18 |
Male |
|
8/28/2009 |
Other Health Professional |
Serbia |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Upper Respiratory Tract Infection |
Hospitalization |
|
12 |
Male |
|
8/28/2009 |
Other Health Professional |
China |
|
| Ovarian Infection |
Other Serious |
|
|
Female |
154 lb |
8/31/2009 |
Consumer |
Brazil |
|
| Vomiting |
Other Serious |
8/1/2009 |
|
Male |
|
9/21/2009 |
Physician |
United States |
|
| Ovarian Infection |
Other Serious |
|
|
Female |
154 lb |
9/28/2009 |
Consumer |
Brazil |
|
| Splenomegaly |
Other Serious |
|
18 |
Male |
|
10/21/2009 |
Other Health Professional |
Serbia |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| No Adverse Event |
|
8/7/2009 |
|
Male |
83 lb |
12/3/2009 |
Other Health Professional |
Brazil |
|
| Urinary Tract Infection |
Hospitalization |
11/27/2009 |
|
Male |
|
1/27/2010 |
Consumer |
United States |
|
| Urinary Tract Malformation |
Congenital Anomaly |
1/1/2009 |
|
|
|
3/9/2010 |
Other Health Professional |
Israel |
|
| Surgery |
Other Serious |
|
7 |
Male |
|
4/26/2010 |
Other Health Professional |
Italy |
|
| Upper Gastrointestinal Haemorrhage |
Life Threatening |
3/17/2000 |
7 |
Male |
|
5/10/2010 |
|
Brazil |
|
| Hypospadias |
Other Serious |
|
7 |
Male |
36 lb |
5/26/2010 |
|
Italy |
|
| Drug Exposure During Pregnancy |
Other Serious |
|
|
Female |
|
6/1/2010 |
Other Health Professional |
Italy |
|
| Growth Retardation |
Other Serious |
|
|
Male |
36 lb |
6/1/2010 |
Other Health Professional |
Italy |
|
| Somnolence |
Other Serious |
|
76 |
Female |
|
6/1/2010 |
Other Health Professional |
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Somnolence |
Other Serious |
|
76 |
Female |
|
6/1/2010 |
Other Health Professional |
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Somnolence |
Other Serious |
|
76 |
Female |
|
6/1/2010 |
Other Health Professional |
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Myoclonus |
Hospitalization |
|
76 |
Female |
|
5/28/2010 |
|
France |
|
| Rash Erythematous |
Hospitalization |
|
1 |
Female |
|
6/16/2010 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Rash Erythematous |
Hospitalization |
|
1 |
Female |
|
6/25/2010 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Exposure During Pregnancy |
Other Serious |
|
|
Female |
|
6/28/2010 |
Other Health Professional |
Italy |
|
| Growth Retardation |
Other Serious |
|
|
Male |
36 lb |
6/28/2010 |
Other Health Professional |
Italy |
|
| Myoclonus |
Other Serious |
|
76 |
Female |
|
6/30/2010 |
|
|
|
| Status Epilepticus |
Other Serious |
9/11/2008 |
39 |
Male |
|
7/1/2010 |
Physician |
Japan |
|
| Urethral Repair |
Other Serious |
|
40 |
Male |
|
7/21/2010 |
Other Health Professional |
Netherlands |
|
| Mental Disability |
Other Serious |
|
|
Female |
|
7/22/2010 |
Other Health Professional |
Netherlands |
|
| Nose Deformity |
Other Serious |
|
|
Male |
|
7/23/2010 |
Other Health Professional |
Netherlands |
|
| Infantile Spasms |
Other Serious |
|
|
Female |
|
8/23/2010 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hepatic Adenoma |
Other Serious |
|
|
|
|
8/25/2010 |
Other Health Professional |
United States |
|
| Surgery |
Other Serious |
|
22 |
Male |
|
8/30/2010 |
Other Health Professional |
United States |
|
| Infantile Spasms |
Other Serious |
|
|
Female |
|
8/31/2010 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hyperammonaemic Encephalopathy |
Hospitalization |
|
5 |
Male |
|
9/3/2010 |
Other Health Professional |
India |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hepatic Adenoma |
Other Serious |
|
22 |
Male |
|
9/9/2010 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hepatic Adenoma |
Other Serious |
|
22 |
Male |
|
9/13/2010 |
Other Health Professional |
United States |
|
| Somnolence |
|
11/1/2009 |
86 |
Female |
132 lb |
9/14/2010 |
Consumer |
United States |
|
| Hepatic Adenoma |
Other Serious |
|
22 |
Male |
|
9/23/2010 |
Other Health Professional |
United States |
|
| Peritonitis Sclerosing |
Other Serious |
|
14 |
Female |
|
9/28/2010 |
Other Health Professional |
United States |
|
| Myoclonus |
Other Serious |
|
23 |
Male |
|
9/27/2010 |
Other Health Professional |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Surgery |
Other Serious |
1/1/1995 |
7 |
Male |
|
10/5/2010 |
Consumer |
Brazil |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Grand Mal Convulsion |
Other Serious |
|
56 |
Female |
|
9/29/2010 |
Other Health Professional |
France |
|
| Vanishing Bile Duct Syndrome |
Other Serious |
|
|
|
|
10/29/2010 |
Other Health Professional |
United States |
|
| Vomiting |
Other Serious |
9/28/2010 |
51 |
Female |
113 lb |
10/18/2010 |
|
Japan |
|
| Restlessness |
Other Serious |
9/28/2010 |
51 |
Female |
113 lb |
10/15/2010 |
|
Japan |
|
| Hyperammonaemic Encephalopathy |
Hospitalization |
|
5 |
Male |
|
11/4/2010 |
Other Health Professional |
India |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vanishing Bile Duct Syndrome |
Other Serious |
|
31 |
Female |
|
11/19/2010 |
Other Health Professional |
United States |
|
| Respiratory Tract Infection |
Hospitalization |
11/22/2006 |
45 |
Male |
2 lb |
11/26/2010 |
Physician |
Japan |
|
| Vanishing Bile Duct Syndrome |
Required Intervention |
|
31 |
Female |
|
11/9/2010 |
Other Health Professional |
United States |
|
| Kidney Transplant Rejection |
Other Serious |
10/1/2009 |
57 |
Male |
161 lb |
11/29/2010 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Ileus |
Other Serious |
1/1/2010 |
49 |
Male |
|
12/27/2010 |
Pharmacist |
Japan |
|
| Convulsion |
Other Serious |
|
60 |
Female |
|
12/31/2010 |
Consumer |
France |
|
| Enterocolitis Viral |
Other Serious |
1/1/2010 |
49 |
Male |
|
1/3/2011 |
Pharmacist |
Japan |
|
| Aggression |
Death |
|
12 |
Female |
|
1/6/2011 |
Other Health Professional |
Brazil |
|
| Somnolence |
Other Serious |
|
|
|
|
1/26/2011 |
Other Health Professional |
China |
|
| Arachnoid Cyst |
Other Serious |
|
|
Male |
|
3/10/2011 |
Consumer |
Brazil |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Renal Failure Acute |
Hospitalization |
|
|
|
|
3/17/2011 |
Other Health Professional |
Japan |
|
| Metabolic Acidosis |
Hospitalization |
|
50 |
Female |
|
3/23/2011 |
Consumer |
United Kingdom |
|
| Tachypnoea |
Hospitalization |
|
50 |
Female |
|
4/21/2011 |
Other Health Professional |
United Kingdom |
|
| Abortion Induced |
Other Serious |
|
|
Female |
|
4/13/2011 |
Other Health Professional |
Italy |
|
| Metabolic Acidosis |
Hospitalization |
5/1/2010 |
50 |
Female |
|
4/26/2011 |
Other Health Professional |
United Kingdom |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Depressed Level Of Consciousness |
Other Serious |
|
50 |
Female |
|
4/29/2011 |
Other Health Professional |
United Kingdom |
|
| Tachypnoea |
Hospitalization |
|
50 |
Female |
|
5/4/2011 |
Other Health Professional |
United Kingdom |
|
| Unevaluable Event |
Death |
|
|
Female |
|
6/22/2011 |
Other Health Professional |
United Kingdom |
|
| Atrioventricular Block Complete |
Hospitalization |
1/1/2005 |
57 |
Male |
|
6/23/2011 |
Physician |
Japan |
|
| Face Injury |
Hospitalization |
1/1/2009 |
23 |
Female |
82 lb |
6/24/2011 |
Consumer |
Brazil |
|
| Malaise |
Hospitalization |
6/8/2011 |
36 |
Female |
|
6/27/2011 |
Consumer |
Brazil |
|
| Pyroglutamate Increased |
Hospitalization |
|
50 |
Female |
|
7/6/2011 |
Other Health Professional |
United Kingdom |
|
| Kidney Transplant Rejection |
Other Serious |
|
57 |
Male |
161 lb |
1/23/2012 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Motor Dysfunction |
Hospitalization |
3/21/2012 |
45 |
Male |
|
4/2/2012 |
Consumer |
Brazil |
|
| Pain In Extremity |
Hospitalization |
3/21/2012 |
45 |
Male |
|
7/9/2012 |
Consumer |
Brazil |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Syncope |
Life Threatening |
|
37 |
Female |
|
1/11/2013 |
|
De |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Human Herpesvirus 6 Infection |
Other Serious |
|
34 |
Male |
|
1/11/2013 |
|
Nl |
|
| Stevens-johnson Syndrome |
Other Serious |
|
50 |
Female |
|
1/2/2013 |
|
No |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| White Blood Cell Count Increased |
Hospitalization |
|
48 |
Male |
|
1/4/2013 |
|
De |
|
| Rash |
Other Serious |
|
17 |
Female |
|
1/2/2013 |
|
Country Not Specified |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Rash |
Other Serious |
|
53 |
Male |
|
1/7/2013 |
|
De |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Transplant Rejection |
Other Serious |
|
57 |
Male |
161 lb |
10/4/2012 |
Physician |
Us |
|
| Hyperammonaemic Encephalopathy |
Other Serious |
|
32 |
Female |
|
11/13/2012 |
Other Health Professional |
Country Not Specified |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Hyperammonaemic Encephalopathy |
Other Serious |
|
42 |
Male |
|
11/13/2012 |
Other Health Professional |
Country Not Specified |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Drug Ineffective |
Other Serious |
|
8 |
Female |
|
10/16/2012 |
Physician |
Country Not Specified |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Ineffective |
Other Serious |
|
17 |
Female |
|
10/16/2012 |
Physician |
Country Not Specified |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Ineffective |
Other Serious |
|
20 |
Male |
|
10/16/2012 |
Physician |
Country Not Specified |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Head Injury |
Other Serious |
|
|
Male |
|
8/16/2012 |
Other Health Professional |
Jp |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Head Injury |
Other Serious |
|
|
Female |
|
8/16/2012 |
Other Health Professional |
Jp |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Toxicity To Various Agents |
Other Serious |
|
20 |
Male |
|
8/31/2012 |
Other Health Professional |
Country Not Specified |
|
| Drug Ineffective |
Hospitalization |
|
52 |
Female |
|
9/15/2012 |
Physician |
Country Not Specified |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vanishing Bile Duct Syndrome |
Hospitalization |
|
31 |
Female |
|
8/31/2012 |
Physician |
Us |
|
| Toxicity To Various Agents |
Other Serious |
|
20 |
Male |
|
9/12/2012 |
Other Health Professional |
Cu |
|
| Urinary Tract Infection |
Other Serious |
8/2012 |
26 |
Female |
102 lb |
9/23/2012 |
|
Us |
|
| Potentiating Drug Interaction |
Hospitalization |
|
45 |
Male |
|
9/29/2012 |
Other Health Professional |
Co |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Potentiating Drug Interaction |
Hospitalization |
|
32 |
Female |
|
9/29/2012 |
Other Health Professional |
Co |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Ventricular Septal Defect |
Congenital Anomaly |
|
|
|
|
9/20/2012 |
Physician |
Us |
|
| Ventricular Septal Defect |
Congenital Anomaly |
|
|
|
|
10/3/2012 |
Physician |
Us |
|
| Stevens-johnson Syndrome |
Other Serious |
|
31 |
Male |
104 lb |
10/5/2012 |
Other Health Professional |
Jp |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Convulsion |
Other Serious |
|
|
Male |
|
10/16/2012 |
Physician |
Us |
|
| Surgery |
Death |
|
|
|
|
11/5/2012 |
Other Health Professional |
De |
|
| Nystagmus |
Other Serious |
|
42 |
Female |
|
10/25/2012 |
Other Health Professional |
Jp |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Gait Disturbance |
Other Serious |
|
80 |
Male |
|
11/16/2012 |
Other Health Professional |
Es |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Somnolence |
Hospitalization |
|
64 |
Male |
|
11/27/2012 |
Physician |
Jp |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hyperammonaemic Encephalopathy |
Other Serious |
|
32 |
Female |
|
12/5/2012 |
Other Health Professional |
Co |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Status Epilepticus |
Other Serious |
|
40 |
Male |
|
12/5/2012 |
Physician |
Jp |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hyperammonaemic Encephalopathy |
Other Serious |
|
45 |
Male |
|
12/5/2012 |
Other Health Professional |
Co |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Nystagmus |
Hospitalization |
|
42 |
Female |
|
12/10/2012 |
Other Health Professional |
Jp |
|
| Intentional Self-injury |
Other Serious |
11/30/2011 |
38 |
Female |
|
12/18/2012 |
Physician |
Jp |
|
| Tremor |
Other Serious |
|
13 |
Male |
|
12/27/2012 |
Physician |
Country Not Specified |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Toxicity To Various Agents |
Death |
|
|
NotSpecified |
|
1/10/2013 |
Physician |
Br |
|
| Toxic Encephalopathy |
Other Serious |
|
51 |
Female |
|
1/25/2013 |
Other Health Professional |
Kr |
|
| Vulvovaginal Mycotic Infection |
|
6/6/2012 |
54 |
Female |
150 lb |
1/31/2013 |
Consumer |
Country Not Specified |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Convulsion |
Hospitalization |
|
25 |
Female |
|
2/4/2013 |
Consumer |
Gb |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Convulsion |
Hospitalization |
|
25 |
Female |
|
2/17/2013 |
Physician |
Gb |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Traumatic Intracranial Haemorrhage |
Hospitalization |
1/15/2010 |
18 |
Male |
121 lb |
3/15/2013 |
Physician |
Ph |
|
| Urinary Incontinence |
Hospitalization |
2/8/2013 |
55 |
Male |
397 lb |
2/21/2013 |
Consumer |
Br |
|
| Status Epilepticus |
Other Serious |
|
53 |
Male |
|
2/6/2013 |
Other Health Professional |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tendon Injury |
Other Serious |
2/9/2013 |
42 |
Female |
132 lb |
3/27/2013 |
Other Health Professional |
Country Not Specified |
|
| Convulsion |
Other Serious |
|
|
Male |
|
4/3/2013 |
Physician |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Unevaluable Event |
Hospitalization |
|
|
Female |
|
3/7/2013 |
Other Health Professional |
Us |
|
| Pregnancy |
Other Serious |
|
|
Female |
|
3/25/2013 |
Physician |
It |
|
| Hypersensitivity |
Hospitalization |
3/2013 |
61 |
Female |
163 lb |
4/19/2013 |
Consumer |
Country Not Specified |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Myocarditis |
Other Serious |
|
14 |
Male |
|
4/15/2013 |
Physician |
Country Not Specified |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Ineffective |
|
|
43 |
Male |
133 lb |
5/23/2013 |
Other Health Professional |
Us |
|
| Status Epilepticus |
Other Serious |
|
|
Male |
|
5/2/2013 |
Other Health Professional |
Jp |
|
| Status Epilepticus |
Other Serious |
|
|
Female |
|
5/6/2013 |
Other Health Professional |
Jp |
|