| Pyrexia |
Hospitalization |
9/24/2008 |
|
Female |
35 lb |
9/29/2008 |
Other Health Professional |
United States |
|
| Tremor |
Other Serious |
4/7/2009 |
52 |
Female |
157 lb |
4/13/2009 |
Consumer |
United States |
|
| Urine Output Decreased |
Other Serious |
1/14/2009 |
|
Male |
|
5/1/2009 |
Consumer |
Switzerland |
|
| Somnolence |
Other Serious |
2/2/2006 |
|
Male |
|
5/1/2009 |
|
France |
|
| Staphylococcal Infection |
Life Threatening |
12/1/2008 |
17 |
Female |
|
8/3/2009 |
Other Health Professional |
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Syncope |
Other Serious |
|
37 |
Female |
|
8/11/2009 |
Other Health Professional |
Spain |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cerebral Atrophy |
Other Serious |
|
20 |
Female |
|
9/18/2009 |
Other Health Professional |
Germany |
|
| Maternal Drugs Affecting Foetus |
Congenital Anomaly |
6/23/2009 |
|
|
|
9/29/2009 |
Physician |
Italy |
|
| Pancytopenia |
Hospitalization |
|
59 |
Female |
|
10/19/2009 |
Other Health Professional |
France |
|
| Myoclonic Epilepsy |
Other Serious |
6/29/2009 |
9 |
Male |
|
10/13/2009 |
|
Germany |
|
| Thrombocytopenia |
Hospitalization |
5/15/2005 |
|
Female |
119 lb |
10/26/2009 |
Physician |
France |
|
| Drug Rash With Eosinophilia And Systemic Symptoms |
Other Serious |
|
70 |
Female |
|
12/16/2009 |
Other Health Professional |
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Rash With Eosinophilia And Systemic Symptoms |
Hospitalization |
|
40 |
Female |
|
12/16/2009 |
Other Health Professional |
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Rash With Eosinophilia And Systemic Symptoms |
Other Serious |
|
70 |
Female |
|
12/23/2009 |
Other Health Professional |
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Rash With Eosinophilia And Systemic Symptoms |
Hospitalization |
|
40 |
Female |
|
12/23/2009 |
Other Health Professional |
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Condition Aggravated |
Other Serious |
|
1 |
Female |
|
12/30/2009 |
Other Health Professional |
Kuwait |
|
| Metabolic Acidosis |
Hospitalization |
|
9 |
Female |
|
4/26/2010 |
|
|
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Anorgasmia |
Other Serious |
|
41 |
Male |
|
5/12/2010 |
|
|
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Metabolic Acidosis |
Hospitalization |
|
9 |
Female |
|
5/8/2010 |
Physician |
United States |
|
| Status Epilepticus |
Life Threatening |
4/7/2010 |
25 |
Female |
110 lb |
5/26/2010 |
Physician |
Japan |
|
| Nephrolithiasis |
Other Serious |
|
29 |
Female |
|
6/29/2010 |
Other Health Professional |
Italy |
|
| Haemangioma |
Congenital Anomaly |
|
|
Female |
5 lb |
6/29/2010 |
Other Health Professional |
Italy |
|
| Drug Effect Decreased |
Hospitalization |
|
|
Female |
22 lb |
6/22/2010 |
|
United States |
|
| Drug Resistance |
Other Serious |
|
3 |
Female |
|
8/19/2010 |
Other Health Professional |
Germany |
|
| Hyperammonaemic Encephalopathy |
Hospitalization |
|
5 |
Male |
|
9/3/2010 |
Other Health Professional |
India |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Renal Failure Acute |
Hospitalization |
|
|
Male |
141 lb |
9/3/2010 |
Physician |
United States |
|
| Grand Mal Convulsion |
Other Serious |
|
56 |
Female |
|
9/29/2010 |
Other Health Professional |
France |
|
| Somnolence |
Hospitalization |
7/20/2009 |
|
Female |
26 lb |
10/21/2010 |
Consumer |
|
|
| Hyperammonaemic Encephalopathy |
Hospitalization |
|
5 |
Male |
|
11/4/2010 |
Other Health Professional |
India |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Respiratory Distress |
Other Serious |
|
|
|
|
11/8/2010 |
Physician |
Turkey |
|
| Unresponsive To Stimuli |
Death |
|
44 |
Male |
|
11/8/2010 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pneumonia Aspiration |
Other Serious |
|
67 |
Female |
|
11/19/2010 |
Physician |
Italy |
|
| Somnolence |
Hospitalization |
7/20/2009 |
|
Female |
26 lb |
11/22/2010 |
Consumer |
|
|
| Pneumonia Aspiration |
Other Serious |
|
67 |
Female |
|
12/10/2010 |
Physician |
Italy |
|
| Kidney Transplant Rejection |
Other Serious |
10/1/2009 |
57 |
Male |
161 lb |
11/29/2010 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Neutropenia |
Hospitalization |
7/27/2010 |
30 |
Male |
|
1/11/2011 |
Physician |
France |
|
| Thrombocytopenia |
Other Serious |
|
45 |
Female |
|
1/21/2011 |
Other Health Professional |
Italy |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Leukopenia |
Other Serious |
|
45 |
Female |
121 lb |
1/25/2011 |
Other Health Professional |
Italy |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Encephalopathy |
Hospitalization |
8/21/2007 |
37 |
Female |
154 lb |
1/14/2011 |
Other Health Professional |
Korea, Republic Of |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cardiac Index Decreased |
Death |
10/3/2010 |
50 |
Female |
|
1/31/2011 |
Pharmacist |
Canada |
|
| Agitation |
Life Threatening |
|
36 |
Female |
|
2/1/2011 |
|
|
|
| Somnolence |
Other Serious |
|
|
|
|
1/26/2011 |
Other Health Professional |
China |
|
| Gait Disturbance |
Other Serious |
|
73 |
Male |
|
4/8/2011 |
Other Health Professional |
Germany |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pregnancy |
Other Serious |
|
|
Female |
|
4/13/2011 |
Other Health Professional |
Spain |
|
| Abortion Induced |
Other Serious |
|
|
Female |
|
4/13/2011 |
Other Health Professional |
Italy |
|
| Kidney Transplant Rejection |
Other Serious |
|
57 |
Male |
161 lb |
1/23/2012 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Oral Infection |
Other Serious |
3/1/2012 |
54 |
Male |
220 lb |
4/3/2012 |
Consumer |
United States |
|
| Oral Infection |
Other Serious |
3/1/2012 |
54 |
Male |
220 lb |
4/16/2012 |
Other Health Professional |
United States |
|
| 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 |
|
|
| Syncope |
Life Threatening |
|
37 |
Female |
|
1/11/2013 |
|
De |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Status Epilepticus |
Death |
10/3/2010 |
50 |
Female |
|
11/18/2013 |
Pharmacist |
Ca |
|
| 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 |
|
17 |
Female |
|
10/16/2012 |
Physician |
Country Not Specified |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Head Injury |
Other Serious |
|
|
Female |
|
8/16/2012 |
Other Health Professional |
Jp |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hypothyroidism |
Hospitalization |
|
46 |
Female |
|
8/30/2012 |
Other Health Professional |
Us |
|
| Toxicity To Various Agents |
Other Serious |
|
20 |
Male |
|
8/31/2012 |
Other Health Professional |
Country Not Specified |
|
| Hypothyroidism |
Hospitalization |
|
|
|
|
9/5/2012 |
|
Us |
|
| Hypothyroidism |
Hospitalization |
|
46 |
Female |
88 lb |
10/22/2012 |
Physician |
Us |
|
| Septic Shock |
Hospitalization |
|
46 |
Female |
|
8/31/2012 |
Other Health Professional |
Us |
|
| Drug Ineffective |
Hospitalization |
|
52 |
Female |
|
9/15/2012 |
Physician |
Country Not Specified |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hypothyroidism |
Hospitalization |
|
46 |
Female |
88 lb |
10/25/2012 |
Other Health Professional |
Us |
|
| Hypothyroidism |
Hospitalization |
|
46 |
Female |
88 lb |
8/27/2012 |
Physician |
Us |
|
| Toxicity To Various Agents |
Other Serious |
|
20 |
Male |
|
9/12/2012 |
Other Health Professional |
Cu |
|
| Death |
Death |
|
39 |
Male |
|
9/21/2012 |
Physician |
Ch |
|
| Atrial Fibrillation |
Other Serious |
|
67 |
Female |
|
2/6/2013 |
Physician |
Us |
|
| Hypotonia |
Other Serious |
|
0 |
Male |
18 lb |
9/28/2012 |
Other Health Professional |
Kr |
|
| No Therapeutic Response |
Other Serious |
|
0 |
|
|
9/28/2012 |
Physician |
Es |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hyperammonaemic Encephalopathy |
Hospitalization |
|
42 |
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 |
|
|
| Hypothyroidism |
Other Serious |
|
46 |
Female |
88 lb |
9/25/2012 |
Other Health Professional |
Us |
|
| Disease Progression |
Hospitalization |
|
46 |
Female |
88 lb |
10/5/2012 |
Other Health Professional |
Country Not Specified |
|
| Weight Decreased |
Hospitalization |
|
28 |
Female |
|
12/5/2012 |
Physician |
Jp |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hyperammonaemic Encephalopathy |
Hospitalization |
|
42 |
Male |
|
10/18/2012 |
Physician |
Co |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Convulsion |
Hospitalization |
10/13/2012 |
15 |
Male |
62 lb |
12/21/2012 |
Physician |
Ve |
|
| Convulsion |
Death |
|
42 |
Male |
|
10/25/2012 |
Other Health Professional |
Us |
|
| Suicidal Ideation |
Death |
|
43 |
Female |
|
10/25/2012 |
Other Health Professional |
Us |
|
| Lactic Acidosis |
Death |
|
50 |
Female |
|
11/12/2012 |
Pharmacist |
Ca |
|
| Stevens-johnson Syndrome |
Other Serious |
|
|
|
|
11/27/2012 |
|
Cn |
|
| Stevens-johnson Syndrome |
Other Serious |
|
2 |
Female |
|
11/20/2012 |
Other Health Professional |
Cn |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hyperammonaemic Encephalopathy |
Other Serious |
|
32 |
Female |
|
12/5/2012 |
Other Health Professional |
Co |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Hyperammonaemic Encephalopathy |
Other Serious |
|
42 |
Male |
|
12/5/2012 |
Other Health Professional |
Co |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Status Epilepticus |
Death |
|
56 |
Female |
|
12/12/2012 |
Other Health Professional |
Ar |
| Primary |
|
| Secondary |
|
| Concomitant |
|
| Interacting |
|
|
| Status Epilepticus |
Other Serious |
|
56 |
Female |
|
12/7/2012 |
Other Health Professional |
Ar |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Thrombosis |
|
1/2011 |
35 |
Female |
110 lb |
12/19/2012 |
Consumer |
Us |
|
| Stevens-johnson Syndrome |
Hospitalization |
|
2 |
Female |
|
12/14/2012 |
Physician |
Cn |
|
| Tremor |
Other Serious |
|
13 |
Male |
|
12/27/2012 |
Physician |
Country Not Specified |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Physical Disability |
Other Serious |
|
36 |
Female |
|
1/4/2013 |
Physician |
Ch |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Ineffective For Unapproved Indication |
Other Serious |
|
58 |
Male |
|
1/4/2013 |
Physician |
Ch |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Myositis |
Other Serious |
12/4/2012 |
58 |
Male |
254 lb |
7/9/2013 |
Consumer |
Nl |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hyperammonaemia |
Other Serious |
|
25 |
Male |
|
1/25/2013 |
Other Health Professional |
Kr |
|
| Anaemia |
|
2003 |
25 |
Female |
|
1/25/2013 |
Physician |
It |
|
| Stevens-johnson Syndrome |
Other Serious |
|
2 |
Female |
|
2/9/2013 |
Other Health Professional |
Country Not Specified |
|
| Stevens-johnson Syndrome |
Hospitalization |
|
2 |
Female |
|
1/15/2013 |
Physician |
Cn |
|
| Hypophosphataemia |
Hospitalization |
2/6/2013 |
54 |
Male |
154 lb |
4/24/2013 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Decreased |
Other Serious |
|
|
NotSpecified |
|
2/22/2013 |
Other Health Professional |
De |
|
| Acute Respiratory Distress Syndrome |
Other Serious |
|
31 |
Male |
|
1/21/2013 |
Physician |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tachycardia |
Other Serious |
|
0 |
Male |
|
2/28/2013 |
|
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pneumonitis |
Other Serious |
|
1 |
Male |
|
3/5/2013 |
Other Health Professional |
Us |
|
| Weight Decreased |
Other Serious |
12/2012 |
58 |
Male |
262 lb |
11/26/2013 |
Other Health Professional |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vomiting |
Other Serious |
2/18/2013 |
78 |
Female |
144 lb |
10/16/2013 |
Physician |
Gb |
|
| Neurological Decompensation |
Death |
|
16 |
Female |
|
3/15/2013 |
Other Health Professional |
De |
|
| Renal Failure Acute |
Hospitalization |
2/26/2013 |
54 |
Male |
155 lb |
10/4/2013 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pregnancy |
Other Serious |
|
|
Female |
|
3/25/2013 |
Physician |
It |
|
| Pregnancy |
Other Serious |
|
|
Female |
|
3/26/2013 |
Physician |
Es |
|
| Sepsis |
Other Serious |
8/6/2012 |
7 |
Male |
55 lb |
5/17/2013 |
Other Health Professional |
Jp |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Rash Maculo-papular |
Other Serious |
|
10 |
Male |
|
4/11/2013 |
Other Health Professional |
Country Not Specified |
|
| Myocarditis |
Other Serious |
|
14 |
Male |
|
4/15/2013 |
Physician |
Country Not Specified |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Toxicity To Various Agents |
Hospitalization |
|
38 |
Male |
|
4/15/2013 |
Pharmacist |
Jp |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Spina Bifida |
Congenital Anomaly |
|
|
NotSpecified |
1 lb |
4/16/2013 |
Consumer |
De |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| No Therapeutic Response |
Death |
|
0 |
Male |
7 lb |
4/30/2013 |
Other Health Professional |
Au |
|
| Drug Ineffective For Unapproved Indication |
Death |
|
32 |
Male |
|
4/29/2013 |
Physician |
Be |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Blindness Cortical |
Other Serious |
|
|
Male |
|
5/9/2013 |
Other Health Professional |
Us |
|
| Death |
Death |
|
1 |
Male |
|
5/21/2013 |
Physician |
Be |
|
| Congenital Anomaly |
Congenital Anomaly |
|
|
NotSpecified |
|
6/14/2013 |
Other Health Professional |
It |
|
| Pneumothorax |
Hospitalization |
|
19 |
Female |
|
6/17/2013 |
Physician |
Us |
|
| Hypoglycaemia |
Other Serious |
|
74 |
Male |
|
6/14/2013 |
Other Health Professional |
Fr |
|
| Hypoglycaemia |
Other Serious |
|
74 |
Male |
|
6/19/2013 |
Other Health Professional |
Fr |
|
| Hypoglycaemia |
Other Serious |
|
74 |
Male |
|
6/28/2013 |
Other Health Professional |
Fr |
|
| Drug Ineffective |
|
|
0 |
Male |
|
7/2/2013 |
Physician |
Es |
|
| Respiratory Distress |
Life Threatening |
4/13/2013 |
79 |
Female |
|
7/2/2013 |
Pharmacist |
Us |
|
| Sepsis |
Other Serious |
|
39 |
Male |
|
8/1/2013 |
Physician |
Th |
|
| Sepsis |
Other Serious |
|
75 |
Female |
|
8/2/2013 |
Physician |
Th |
|
| Sepsis |
Death |
|
65 |
Male |
|
8/2/2013 |
Physician |
Th |
|
| Drug Ineffective For Unapproved Indication |
Death |
|
20 |
Female |
|
8/2/2013 |
Physician |
Th |
|
| Tinnitus |
Other Serious |
|
|
Male |
|
8/16/2013 |
Physician |
Us |
|
| Hypoaesthesia |
Other Serious |
|
32 |
Male |
|
8/28/2013 |
Other Health Professional |
Pl |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Unevaluable Event |
Other Serious |
1/2013 |
36 |
Male |
180 lb |
9/13/2013 |
Consumer |
Us |
|
| Sinusitis |
|
1/28/2013 |
35 |
Male |
|
3/5/2013 |
Consumer |
Us |
|
| Drug Ineffective |
Death |
|
1 |
Male |
|
9/25/2013 |
Other Health Professional |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Ineffective |
|
|
45 |
Female |
|
9/30/2013 |
Physician |
Us |
|
| Vision Blurred |
Hospitalization |
|
50 |
Female |
|
10/1/2013 |
Other Health Professional |
It |
|
| Drug Ineffective |
Hospitalization |
|
1 |
Male |
|
10/3/2013 |
Other Health Professional |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Potentiating Drug Interaction |
Other Serious |
|
42 |
Male |
|
9/25/2013 |
Other Health Professional |
Co |
|
| Status Epilepticus |
Life Threatening |
|
1 |
Male |
|
10/1/2013 |
Other Health Professional |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Status Epilepticus |
Hospitalization |
|
0 |
Female |
|
10/1/2013 |
Other Health Professional |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Status Epilepticus |
Life Threatening |
|
15 |
Male |
|
10/1/2013 |
Other Health Professional |
Us |
|
| Status Epilepticus |
Hospitalization |
|
12 |
Male |
|
10/4/2013 |
Physician |
Sk |
|
| Status Epilepticus |
Other Serious |
|
10 |
Female |
|
10/8/2013 |
Physician |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Septic Shock |
Other Serious |
|
0 |
Female |
|
10/8/2013 |
Physician |
Us |
|
| Vision Blurred |
Other Serious |
|
50 |
Female |
|
10/8/2013 |
Other Health Professional |
It |
|
| Depressed Level Of Consciousness |
Other Serious |
|
30 |
Male |
|
10/9/2013 |
Other Health Professional |
Ca |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Off Label Use |
Hospitalization |
|
30 |
Male |
|
10/10/2013 |
Other Health Professional |
Ca |
|
| Vision Blurred |
Other Serious |
|
50 |
Female |
|
10/22/2013 |
Physician |
It |
|
| Drug Ineffective |
|
|
|
Male |
|
9/25/2013 |
Physician |
Us |
|
| Maternal Drugs Affecting Foetus |
Congenital Anomaly |
7/15/2013 |
27 |
Female |
150 lb |
10/21/2013 |
Pharmacist |
Us |
|
| Drug Ineffective |
Death |
|
68 |
Female |
|
10/25/2013 |
Other Health Professional |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Suicide Attempt |
Hospitalization |
|
46 |
Female |
|
10/9/2013 |
|
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Leukocytosis |
Hospitalization |
|
29 |
Male |
|
11/4/2013 |
|
Us |
|