| Treatment Noncompliance |
Required Intervention |
|
44 |
Male |
|
1/27/2006 |
|
United States |
|
| Pyrexia |
Other Serious |
|
36 |
Male |
|
2/2/2006 |
|
Italy |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Decreased |
Other Serious |
9/1/2004 |
44 |
Male |
|
2/24/2006 |
|
United States |
|
| Intra-uterine Death |
Other Serious |
1/1/2002 |
32 |
Female |
|
2/28/2006 |
|
|
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pre-eclampsia |
Other Serious |
1/1/2002 |
42 |
Female |
|
2/28/2006 |
|
|
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pre-eclampsia |
Other Serious |
1/1/2002 |
28 |
Female |
|
2/28/2006 |
|
|
|
| Electrocardiogram Qt Prolonged |
Other Serious |
|
44 |
Female |
|
3/20/2006 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Ventricular Tachycardia |
Other Serious |
|
31 |
Male |
|
3/20/2006 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vomiting |
Hospitalization |
3/10/2000 |
|
Female |
|
3/31/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Urine Uric Acid Decreased |
Hospitalization |
1/30/2006 |
37 |
Male |
|
7/7/2006 |
Other Health Professional |
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| White Blood Cell Count Decreased |
Other Serious |
12/4/1998 |
|
Male |
|
7/7/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| White Blood Cell Count Decreased |
Other Serious |
12/4/1998 |
|
Male |
|
7/19/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vomiting |
Hospitalization |
3/10/2000 |
|
Female |
|
7/19/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Muscular Weakness |
Hospitalization |
|
38 |
Male |
|
8/10/2006 |
|
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Jaundice |
Other Serious |
9/1/2000 |
58 |
Male |
|
8/28/2006 |
|
|
|
| Otitis Media |
Other Serious |
10/23/2000 |
64 |
Male |
|
8/28/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hemiparesis |
Other Serious |
|
36 |
Male |
|
8/28/2006 |
Other Health Professional |
Spain |
|
| Osteonecrosis |
Other Serious |
1/1/2001 |
|
Male |
|
9/8/2006 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Viral Mutation Identified |
Other Serious |
|
|
Male |
|
10/1/2006 |
|
Germany |
|
| Viral Mutation Identified |
Other Serious |
|
|
Male |
|
10/6/2006 |
|
Germany |
|
| Death |
Death |
6/30/2005 |
|
Male |
|
10/12/2006 |
|
United States |
|
| Osteonecrosis |
Hospitalization |
8/1/1996 |
47 |
Male |
|
10/18/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Gait Disturbance |
Other Serious |
|
36 |
Male |
|
10/27/2006 |
|
Canada |
| Primary |
|
| Secondary |
|
| Concomitant |
|
| Interacting |
|
|
| Vertigo |
Other Serious |
|
36 |
Male |
|
10/27/2006 |
|
Canada |
| Primary |
|
| Secondary |
|
| Concomitant |
|
| Interacting |
|
|
| Platelet Count Decreased |
Other Serious |
8/1/1996 |
47 |
Male |
|
10/27/2006 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pulmonary Amyloidosis |
Death |
1/1/1998 |
|
Male |
|
11/20/2006 |
|
|
|
| Neutropenia Neonatal |
Hospitalization |
5/7/1999 |
|
Male |
8 lb |
12/1/2006 |
Consumer |
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Platelet Count Increased |
Hospitalization |
1/1/1999 |
0 |
Male |
7 lb |
12/1/2006 |
Consumer |
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Muscle Fatigue |
Hospitalization |
6/1/1999 |
|
Female |
|
12/1/2006 |
Consumer |
France |
|
| Transaminases Increased |
Hospitalization |
|
0 |
Male |
8 lb |
12/11/2006 |
Consumer |
France |
|
| Rhinitis |
Other Serious |
1/22/1998 |
|
Female |
|
1/8/2007 |
Consumer |
France |
|
| Blood Triglycerides Increased |
Life Threatening |
4/2/1998 |
49 |
Male |
|
3/20/2007 |
Other Health Professional |
United States |
|
| Pulmonary Hypertension |
Life Threatening |
3/18/2000 |
24 |
Male |
|
5/7/2007 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tuberculosis |
Life Threatening |
|
32 |
Female |
97 lb |
6/15/2007 |
|
Belgium |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vertigo |
Other Serious |
|
32 |
Male |
|
8/3/2007 |
|
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Visual Disturbance |
Other Serious |
1/1/2002 |
|
Male |
|
10/5/2007 |
Other Health Professional |
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Visceral Leishmaniasis |
Other Serious |
3/1/2000 |
46 |
Male |
|
10/19/2007 |
Other Health Professional |
Italy |
|
| Visceral Leishmaniasis |
Other Serious |
3/1/2000 |
46 |
Male |
|
10/22/2007 |
Other Health Professional |
Italy |
|
| Visceral Leishmaniasis |
Other Serious |
10/1/1996 |
46 |
Male |
|
11/1/2007 |
|
|
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Seborrhoeic Dermatitis |
Hospitalization |
8/1/2003 |
55 |
Male |
|
11/28/2007 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vomiting |
Hospitalization |
3/10/2000 |
|
Female |
|
12/19/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vomiting |
Hospitalization |
3/10/2000 |
|
Female |
|
12/28/2007 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Homicide |
Death |
6/30/2005 |
|
Male |
|
2/6/2008 |
|
United States |
|
| Death |
Death |
6/30/2005 |
|
Male |
|
2/12/2008 |
|
United States |
|
| Metastasis |
Other Serious |
|
69 |
Male |
|
2/26/2008 |
|
United Kingdom |
|
| Gun Shot Wound |
Death |
6/30/2005 |
|
Male |
|
2/27/2008 |
|
United States |
|
| Metastases To Skin |
Death |
1/1/2005 |
|
Male |
|
2/28/2008 |
|
|
|
| Neoplasm Malignant |
Other Serious |
|
69 |
Male |
|
3/4/2008 |
Other Health Professional |
United Kingdom |
|
| Lipoatrophy |
Other Serious |
|
55 |
Male |
|
3/5/2008 |
Physician |
Spain |
|
| Metastasis |
Other Serious |
1/1/2005 |
69 |
Male |
|
3/12/2008 |
|
United Kingdom |
|
| Drug Resistance |
Other Serious |
|
30 |
Female |
|
3/13/2008 |
|
United States |
|
| Neoplasm Malignant |
Other Serious |
1/1/2005 |
69 |
Male |
|
3/13/2008 |
Other Health Professional |
United Kingdom |
|
| Lipoatrophy |
Other Serious |
|
55 |
Male |
|
3/13/2008 |
|
United States |
|
| Stress |
Other Serious |
|
36 |
Male |
|
3/14/2008 |
|
United States |
|
| Gastrointestinal Disorder |
Other Serious |
|
30 |
Female |
|
3/14/2008 |
|
United States |
|
| Lipoatrophy |
Other Serious |
|
55 |
Male |
|
3/14/2008 |
|
United States |
|
| Lipoatrophy |
Other Serious |
|
55 |
Male |
|
3/19/2008 |
|
United States |
|
| Neoplasm Malignant |
Other Serious |
1/1/2005 |
69 |
Male |
|
3/24/2008 |
Other Health Professional |
United Kingdom |
|
| Progressive Multifocal Leukoencephalopathy |
Other Serious |
|
51 |
Male |
|
3/28/2008 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Progressive Multifocal Leukoencephalopathy |
Other Serious |
|
45 |
Male |
|
3/28/2008 |
Other Health Professional |
United States |
|
| Waist Circumference Increased |
Hospitalization |
|
50 |
Male |
|
4/1/2008 |
Consumer |
Italy |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Reversible Posterior Leukoencephalopathy Syndrome |
Hospitalization |
|
40 |
Male |
|
3/27/2008 |
|
Italy |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Thrombocytopenia |
Life Threatening |
|
19 |
Male |
|
4/9/2008 |
Physician |
Mexico |
|
| Angiolipoma |
Other Serious |
|
35 |
Female |
|
4/16/2008 |
|
|
|
| Tracheostomy |
Other Serious |
|
19 |
Male |
|
4/15/2008 |
Physician |
Mexico |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hepatic Steatosis |
Other Serious |
|
46 |
Male |
|
4/29/2008 |
|
United States |
|
| Vomiting |
Hospitalization |
3/10/2000 |
|
Female |
|
5/8/2008 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pancreatitis |
Other Serious |
|
17 |
|
|
5/27/2008 |
Other Health Professional |
Romania |
|
| Pancreatitis |
Other Serious |
|
17 |
|
|
5/29/2008 |
Other Health Professional |
Romania |
|
| Vomiting |
Required Intervention |
|
19 |
Male |
|
6/13/2008 |
|
Mexico |
|
| Thrombocytopenia |
Life Threatening |
|
19 |
Male |
|
7/10/2008 |
|
|
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Lipodystrophy Acquired |
Other Serious |
|
|
Male |
|
7/21/2008 |
|
United States |
|
| Renal Tubular Disorder |
Other Serious |
|
|
Male |
|
7/30/2008 |
Consumer |
Spain |
|
| Vomiting |
Hospitalization |
|
13 |
Male |
|
7/25/2008 |
|
Spain |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Rash |
Other Serious |
|
39 |
Male |
|
9/11/2008 |
Other Health Professional |
United States |
|
| Pneumocystis Jiroveci Pneumonia |
Other Serious |
|
22 |
Male |
|
9/12/2008 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Rash |
Other Serious |
|
|
|
|
9/16/2008 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Supraventricular Tachycardia |
Other Serious |
|
50 |
Female |
|
9/17/2008 |
Other Health Professional |
United States |
|
| Pneumocystis Jiroveci Pneumonia |
Other Serious |
|
22 |
Male |
|
9/17/2008 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Ophthalmoplegia |
Other Serious |
|
50 |
Female |
|
9/19/2008 |
|
United States |
|
| Neoplasm Malignant |
Other Serious |
1/1/2005 |
69 |
Male |
|
9/19/2008 |
Other Health Professional |
United Kingdom |
|
| Metastasis |
Other Serious |
1/1/2005 |
69 |
Male |
|
9/23/2008 |
|
United Kingdom |
|
| Varices Oesophageal |
Required Intervention |
|
38 |
Female |
|
9/22/2008 |
|
France |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Other Serious |
|
|
Male |
195 lb |
10/17/2008 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tongue Disorder |
Other Serious |
6/1/2004 |
47 |
Male |
|
10/29/2008 |
Other Health Professional |
Italy |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Lichenoid Keratosis |
Other Serious |
|
47 |
Male |
|
11/3/2008 |
Other Health Professional |
Italy |
|
| Lichenoid Keratosis |
Other Serious |
3/1/2004 |
47 |
Male |
|
11/5/2008 |
Other Health Professional |
Italy |
|
| Oral Lichen Planus |
Other Serious |
6/1/2004 |
47 |
Male |
|
11/6/2008 |
Other Health Professional |
Italy |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Supraventricular Tachycardia |
Other Serious |
|
50 |
Female |
|
11/10/2008 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Supraventricular Tachycardia |
Other Serious |
|
50 |
Female |
|
11/11/2008 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Supraventricular Tachycardia |
Other Serious |
|
50 |
Female |
|
11/14/2008 |
|
United States |
|
| Oral Lichen Planus |
Other Serious |
6/1/2004 |
47 |
Male |
|
11/14/2008 |
Physician |
Italy |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Lichenoid Keratosis |
Other Serious |
|
47 |
Male |
|
1/19/2009 |
Physician |
Italy |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Decreased |
Death |
|
33 |
Female |
|
4/7/2009 |
Physician |
Brazil |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Decreased |
Other Serious |
|
33 |
Female |
|
4/27/2009 |
Consumer |
Brazil |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Polydactyly |
Congenital Anomaly |
8/7/2001 |
|
Male |
8 lb |
5/1/2009 |
Physician |
United States |
|
| Drug Ineffective |
Other Serious |
|
52 |
Male |
|
5/5/2009 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Abortion Missed |
Other Serious |
5/1/2001 |
32 |
Female |
|
5/7/2009 |
|
United States |
|
| Nodular Regenerative Hyperplasia |
Other Serious |
|
40 |
Male |
|
5/7/2009 |
|
|
|
| White Blood Cell Count Decreased |
Other Serious |
12/1/2006 |
38 |
Female |
|
6/10/2009 |
Other Health Professional |
France |
|
| Nodular Regenerative Hyperplasia |
Other Serious |
|
|
|
|
6/19/2009 |
Consumer |
France |
|
| Nodular Regenerative Hyperplasia |
Other Serious |
|
|
|
|
6/19/2009 |
Consumer |
France |
|
| Portal Vein Thrombosis |
Life Threatening |
|
38 |
Female |
|
6/26/2009 |
Other Health Professional |
Belgium |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Portal Vein Thrombosis |
Life Threatening |
|
38 |
Female |
|
6/30/2009 |
Other Health Professional |
Belgium |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Other Serious |
4/1/2001 |
|
|
|
7/1/2009 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Other Serious |
4/1/2001 |
50 |
Male |
190 lb |
7/6/2009 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vomiting |
Hospitalization |
3/10/2000 |
|
Female |
|
7/20/2009 |
|
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Acute Myeloid Leukaemia |
Hospitalization |
|
54 |
Male |
|
7/29/2009 |
Other Health Professional |
Spain |
|
| Progressive External Ophthalmoplegia |
Other Serious |
|
54 |
Male |
|
7/31/2009 |
|
|
|
| Progressive External Ophthalmoplegia |
Other Serious |
|
52 |
Male |
|
7/31/2009 |
|
|
|
| Nodular Regenerative Hyperplasia |
Other Serious |
|
|
Male |
|
8/24/2009 |
|
|
|
| Nodular Regenerative Hyperplasia |
Other Serious |
|
|
Male |
|
8/24/2009 |
|
|
|
| Varices Oesophageal |
Hospitalization |
|
46 |
Female |
|
8/27/2009 |
|
|
|
| Varices Oesophageal |
Hospitalization |
|
36 |
Female |
|
8/27/2009 |
|
|
|
| Varices Oesophageal |
Hospitalization |
|
57 |
Male |
|
8/27/2009 |
|
|
|
| Varices Oesophageal |
Hospitalization |
|
43 |
Female |
|
8/27/2009 |
|
|
|
| Pulmonary Hypertension |
Other Serious |
|
57 |
Male |
|
9/4/2009 |
Other Health Professional |
Spain |
|
| Pulmonary Hypertension |
Other Serious |
|
43 |
Female |
|
9/4/2009 |
Other Health Professional |
Spain |
|
| Portal Hypertension |
Other Serious |
|
46 |
Female |
|
9/4/2009 |
Other Health Professional |
Spain |
|
| Portal Hypertension |
Other Serious |
|
36 |
Female |
|
9/4/2009 |
Other Health Professional |
Spain |
|
| Progressive External Ophthalmoplegia |
Other Serious |
|
52 |
Male |
|
9/8/2009 |
Consumer |
United States |
|
| Portal Hypertension |
Other Serious |
|
46 |
Female |
|
9/8/2009 |
Other Health Professional |
Spain |
|
| Portal Hypertensive Gastropathy |
Other Serious |
|
36 |
Female |
|
9/9/2009 |
Other Health Professional |
Spain |
|
| Portal Hypertension |
Other Serious |
|
57 |
Male |
|
9/9/2009 |
Other Health Professional |
Spain |
|
| Portal Hypertension |
Other Serious |
|
43 |
Female |
|
9/9/2009 |
Other Health Professional |
Spain |
|
| Portal Hypertension |
Other Serious |
|
46 |
Female |
|
9/14/2009 |
Other Health Professional |
Spain |
|
| Portal Hypertension |
Other Serious |
|
36 |
Female |
|
9/14/2009 |
Other Health Professional |
Spain |
|
| Portal Hypertension |
Other Serious |
|
57 |
Male |
|
9/14/2009 |
Other Health Professional |
Spain |
|
| Portal Hypertension |
Other Serious |
|
43 |
Female |
|
9/14/2009 |
Other Health Professional |
Spain |
|
| Pulmonary Hypertension |
Other Serious |
|
57 |
Male |
|
9/17/2009 |
Other Health Professional |
Spain |
|
| Portal Hypertension |
Other Serious |
|
46 |
Female |
|
9/17/2009 |
Other Health Professional |
Spain |
|
| Portal Hypertension |
Other Serious |
|
36 |
Female |
|
9/17/2009 |
Other Health Professional |
Spain |
|
| Pulmonary Hypertension |
Other Serious |
|
43 |
Female |
|
9/17/2009 |
Other Health Professional |
Spain |
|
| Progressive External Ophthalmoplegia |
Other Serious |
|
58 |
Male |
|
9/17/2009 |
Other Health Professional |
Canada |
|
| Progressive External Ophthalmoplegia |
Other Serious |
|
54 |
Male |
|
9/17/2009 |
Other Health Professional |
Canada |
|
| Progressive External Ophthalmoplegia |
Other Serious |
|
52 |
Male |
|
9/17/2009 |
Other Health Professional |
Canada |
|
| Varices Oesophageal |
Other Serious |
|
46 |
Female |
|
9/11/2009 |
|
|
|
| Splenomegaly |
Other Serious |
|
43 |
Female |
|
9/11/2009 |
|
|
|
| Splenomegaly |
Other Serious |
|
36 |
Female |
|
9/11/2009 |
|
|
|
| Ophthalmoplegia |
Other Serious |
|
52 |
Male |
|
9/23/2009 |
Other Health Professional |
Canada |
|
| Mitochondrial Toxicity |
Other Serious |
|
54 |
Male |
|
9/23/2009 |
Other Health Professional |
Canada |
|
| Ophthalmoplegia |
Other Serious |
|
58 |
Male |
|
9/23/2009 |
Other Health Professional |
Canada |
|
| Virologic Failure |
Other Serious |
|
|
Female |
|
9/15/2009 |
|
United Kingdom |
|
| Virologic Failure |
Other Serious |
|
|
Female |
|
9/24/2009 |
Other Health Professional |
United Kingdom |
|
| Ophthalmoplegia |
Other Serious |
|
58 |
Male |
|
10/20/2009 |
Physician |
Canada |
|
| Mitochondrial Toxicity |
Other Serious |
|
54 |
Male |
|
10/20/2009 |
Physician |
Canada |
|
| Ophthalmoplegia |
Other Serious |
|
52 |
Male |
|
10/20/2009 |
Physician |
Canada |
|
| Varices Oesophageal |
Other Serious |
|
36 |
Female |
|
10/21/2009 |
Physician |
Spain |
|
| Varices Oesophageal |
Other Serious |
|
46 |
Female |
|
10/21/2009 |
Physician |
Spain |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Sinus Tachycardia |
Other Serious |
|
34 |
Male |
|
11/13/2009 |
|
Portugal |
|