| Product Quality Issue |
Death |
|
57 |
Male |
140 lb |
12/8/2008 |
Consumer |
United States |
|
| Mouth Ulceration |
Other Serious |
1/16/2009 |
|
Male |
243 lb |
2/11/2009 |
|
United States |
|
| Mouth Ulceration |
Other Serious |
1/16/2009 |
|
Male |
243 lb |
4/1/2009 |
|
United States |
|
| Type 2 Diabetes Mellitus |
Other Serious |
7/1/2003 |
29 |
Female |
|
4/3/2009 |
|
United States |
|
| Transposition Of The Great Vessels |
Congenital Anomaly |
11/11/2002 |
|
Female |
6 lb |
4/6/2009 |
Pharmacist |
United States |
|
| Upper Respiratory Tract Infection |
Other Serious |
5/30/2005 |
49 |
Female |
268 lb |
4/10/2009 |
|
United States |
|
| Violence-related Symptom |
Other Serious |
1/1/2008 |
|
Female |
200 lb |
4/10/2009 |
Consumer |
United States |
|
| Transposition Of The Great Vessels |
Hospitalization |
11/11/2002 |
|
Female |
6 lb |
4/13/2009 |
Pharmacist |
United States |
|
| Vocal Cord Disorder |
Other Serious |
11/1/2007 |
56 |
Male |
380 lb |
4/17/2009 |
Lawyer |
United States |
|
| Vomiting |
Other Serious |
1/1/2003 |
38 |
Female |
178 lb |
5/20/2009 |
|
United States |
|
| Iron Deficiency Anaemia |
Other Serious |
6/3/2009 |
|
Female |
114 lb |
7/2/2009 |
Physician |
United States |
|
| Flushing |
|
|
|
Female |
150 lb |
8/22/2009 |
|
United States |
|
| Insomnia |
|
6/2/2009 |
|
Female |
230 lb |
8/22/2009 |
|
United States |
|
| Wrist Fracture |
Other Serious |
6/2/2009 |
|
Female |
|
9/8/2009 |
Physician |
Canada |
|
| Transposition Of The Great Vessels |
Hospitalization |
11/11/2002 |
|
Female |
6 lb |
9/8/2009 |
Pharmacist |
United States |
|
| Diabetes Mellitus |
|
1/1/2005 |
38 |
Female |
|
9/23/2009 |
|
United States |
|
| Type 1 Diabetes Mellitus |
|
9/1/2006 |
28 |
Female |
200 lb |
9/23/2009 |
|
United States |
|
| Upper Limb Fracture |
Other Serious |
11/14/2003 |
|
Female |
|
10/23/2009 |
Lawyer |
United States |
|
| Weight Decreased |
Hospitalization |
|
61 |
Female |
|
11/17/2009 |
Lawyer |
United States |
|
| Thinking Abnormal |
Life Threatening |
10/29/2009 |
49 |
Male |
180 lb |
12/1/2009 |
Consumer |
United States |
|
| Wheezing |
Hospitalization |
11/27/2006 |
76 |
Female |
145 lb |
1/20/2010 |
Lawyer |
United States |
|
| Refusal Of Treatment By Patient |
Life Threatening |
|
59 |
Female |
|
1/15/2010 |
|
United States |
|
| Osteonecrosis |
Other Serious |
|
|
Female |
|
2/22/2010 |
Lawyer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Wheezing |
Hospitalization |
11/27/2006 |
76 |
Female |
145 lb |
3/3/2010 |
Lawyer |
United States |
|
| Urine Chloride Decreased |
Other Serious |
|
16 |
Male |
123 lb |
3/10/2010 |
Other Health Professional |
Canada |
|
| Unresponsive To Stimuli |
Other Serious |
1/1/2007 |
69 |
Female |
|
4/19/2010 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Decreased |
Other Serious |
1/1/2002 |
55 |
Female |
118 lb |
4/22/2010 |
|
United States |
|
| Weight Decreased |
Other Serious |
1/1/2002 |
55 |
Female |
118 lb |
4/28/2010 |
|
United States |
|
| Urinary Retention |
Other Serious |
|
60 |
Male |
236 lb |
4/22/2010 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Decreased |
Other Serious |
1/1/2002 |
55 |
Female |
118 lb |
5/3/2010 |
|
United States |
|
| Weight Decreased |
Other Serious |
1/1/2002 |
55 |
Female |
118 lb |
5/7/2010 |
|
United States |
|
| Weight Decreased |
Other Serious |
1/1/2002 |
55 |
Female |
118 lb |
5/12/2010 |
|
United States |
|
| Weight Decreased |
Other Serious |
1/1/2002 |
55 |
Female |
118 lb |
5/21/2010 |
|
United States |
|
| Weight Decreased |
Other Serious |
1/1/2002 |
55 |
Female |
118 lb |
6/2/2010 |
|
United States |
|
| Renal Failure Acute |
Hospitalization |
5/19/2010 |
70 |
Female |
170 lb |
5/28/2010 |
Other Health Professional |
United States |
|
| Nausea |
Other Serious |
8/26/2009 |
25 |
Female |
141 lb |
6/15/2010 |
Other Health Professional |
United States |
|
| Weight Decreased |
Other Serious |
1/1/2002 |
55 |
Female |
118 lb |
6/15/2010 |
|
United States |
|
| Nausea |
Other Serious |
8/26/2009 |
25 |
Female |
141 lb |
6/16/2010 |
Other Health Professional |
United States |
|
| Hypersensitivity |
Other Serious |
3/7/2008 |
30 |
Male |
295 lb |
6/24/2010 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Ventricular Fibrillation |
Other Serious |
1/1/2007 |
69 |
Female |
148 lb |
7/1/2010 |
Lawyer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Meniere's Disease |
Other Serious |
1/1/2007 |
56 |
Female |
150 lb |
7/16/2010 |
Consumer |
United States |
|
| Renal Tubular Acidosis |
Other Serious |
11/13/2006 |
|
Female |
|
7/20/2010 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Ventricular Fibrillation |
Life Threatening |
12/4/2007 |
69 |
Female |
326 lb |
7/19/2010 |
Lawyer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Urinary Tract Infection |
Hospitalization |
6/29/2010 |
53 |
Female |
130 lb |
7/22/2010 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Decreased |
Other Serious |
11/1/2005 |
56 |
Female |
123 lb |
7/29/2010 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Somnolence |
|
11/1/2008 |
66 |
Male |
292 lb |
7/31/2010 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Wheezing |
Disability |
1/1/2010 |
64 |
Female |
192 lb |
7/27/2010 |
Pharmacist |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Throat Irritation |
Other Serious |
7/1/2010 |
51 |
Female |
188 lb |
8/18/2010 |
Other Health Professional |
United States |
|
| Type 2 Diabetes Mellitus |
Other Serious |
1/1/2002 |
30 |
Female |
195 lb |
8/31/2010 |
|
United States |
|
| Type 2 Diabetes Mellitus |
Hospitalization |
1/1/2005 |
54 |
Female |
|
9/3/2010 |
|
United States |
|
| Type 2 Diabetes Mellitus |
Other Serious |
1/1/2000 |
25 |
Female |
261 lb |
9/3/2010 |
|
United States |
|
| Weight Increased |
Other Serious |
7/29/2010 |
65 |
Female |
250 lb |
9/2/2010 |
Consumer |
United States |
|
| Suicide Attempt |
Other Serious |
6/1/2007 |
41 |
Female |
|
9/14/2010 |
Lawyer |
United States |
|
| Diabetes Mellitus |
Hospitalization |
4/18/2003 |
45 |
Male |
286 lb |
9/20/2010 |
|
United States |
|
| Weight Decreased |
Other Serious |
11/1/2005 |
56 |
Female |
123 lb |
10/6/2010 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Other Serious |
7/29/2010 |
65 |
Female |
250 lb |
10/21/2010 |
Consumer |
United States |
|
| Weight Decreased |
Other Serious |
1/1/2006 |
15 |
Female |
181 lb |
11/10/2010 |
Other Health Professional |
United States |
|
| Weight Decreased |
Other Serious |
1/1/2006 |
15 |
Female |
181 lb |
11/11/2010 |
Other Health Professional |
United States |
|
| Vomiting |
Hospitalization |
9/20/2009 |
48 |
Male |
201 lb |
11/3/2010 |
|
United States |
|
| Weight Decreased |
Other Serious |
11/1/2005 |
56 |
Female |
123 lb |
11/15/2010 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| White Blood Cell Count Decreased |
|
2/1/2009 |
|
|
|
12/17/2010 |
Consumer |
United States |
|
| Weight Decreased |
Other Serious |
11/1/2005 |
56 |
Female |
123 lb |
12/24/2010 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Deep Vein Thrombosis |
Other Serious |
11/1/2005 |
56 |
Female |
123 lb |
1/7/2011 |
Lawyer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pleural Effusion |
Other Serious |
11/1/2005 |
56 |
Female |
123 lb |
1/18/2011 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Nausea |
Other Serious |
9/1/2008 |
20 |
Female |
118 lb |
1/19/2011 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Constipation |
|
1/17/2011 |
56 |
Male |
|
1/19/2011 |
Consumer |
United States |
|
| Cardiac Failure Congestive |
Other Serious |
|
62 |
Male |
427 lb |
2/1/2011 |
Other Health Professional |
United States |
|
| Vitreous Floaters |
Other Serious |
1/1/2010 |
65 |
Female |
250 lb |
1/20/2011 |
Consumer |
United States |
|
| Biliary Dyskinesia |
Hospitalization |
3/1/2005 |
32 |
Female |
190 lb |
2/4/2011 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Lymphoma |
Other Serious |
8/1/2010 |
57 |
Female |
121 lb |
2/10/2011 |
Consumer |
Brazil |
|
| Lymphoma |
Other Serious |
10/18/2010 |
57 |
Female |
121 lb |
2/23/2011 |
Consumer |
Brazil |
|
| Mesangioproliferative Glomerulonephritis |
Hospitalization |
1/1/2009 |
48 |
Female |
254 lb |
3/15/2011 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Skin Discolouration |
Other Serious |
|
51 |
Female |
|
3/18/2011 |
Consumer |
United States |
|
| Cholecystitis |
Other Serious |
8/30/2009 |
33 |
Female |
185 lb |
3/19/2011 |
Other Health Professional |
United States |
|
| Alcohol Abuse |
Other Serious |
7/1/2004 |
43 |
Male |
282 lb |
3/22/2011 |
Lawyer |
United States |
|
| Cholelithiasis |
Life Threatening |
1/1/2006 |
29 |
Female |
251 lb |
3/22/2011 |
Lawyer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Constipation |
|
1/17/2011 |
56 |
Male |
|
3/29/2011 |
Consumer |
United States |
|
| Biliary Fibrosis |
Hospitalization |
5/25/2005 |
27 |
Female |
280 lb |
4/6/2011 |
Consumer |
United States |
|
| Pneumonia |
Other Serious |
5/7/2003 |
50 |
Female |
240 lb |
4/7/2011 |
Consumer |
United States |
|
| Pneumonia |
Hospitalization |
|
|
Female |
262 lb |
4/7/2011 |
Physician |
Canada |
|
| Pneumonia |
Hospitalization |
3/12/2011 |
65 |
Female |
262 lb |
4/13/2011 |
Physician |
Canada |
|
| Anhedonia |
Hospitalization |
12/15/2005 |
56 |
Male |
146 lb |
4/18/2011 |
Consumer |
United States |
|
| Drug Ineffective |
|
2/1/2011 |
65 |
Female |
|
4/20/2011 |
Consumer |
United States |
|
| Oropharyngeal Pain |
Other Serious |
3/15/2011 |
51 |
Female |
|
4/27/2011 |
Consumer |
United States |
|
| Tendon Disorder |
Disability |
5/3/2004 |
55 |
Female |
219 lb |
4/19/2011 |
Physician |
United States |
|
| Pain |
Hospitalization |
1/1/2010 |
63 |
Female |
176 lb |
5/17/2011 |
Consumer |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Injury |
Hospitalization |
|
36 |
Female |
159 lb |
5/19/2011 |
Lawyer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Renal Failure |
Hospitalization |
5/6/2011 |
59 |
Female |
199 lb |
5/11/2011 |
Pharmacist |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cerebrovascular Accident |
Other Serious |
|
53 |
Female |
180 lb |
5/25/2011 |
Other Health Professional |
United States |
|
| Irritable Bowel Syndrome |
Other Serious |
|
|
Male |
215 lb |
6/2/2011 |
Physician |
Canada |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cholecystectomy |
Other Serious |
8/30/2009 |
33 |
Female |
185 lb |
6/7/2011 |
Lawyer |
United States |
|
| Oedema Peripheral |
Other Serious |
2/1/2010 |
45 |
Female |
216 lb |
6/8/2011 |
Lawyer |
United States |
|
| Pain |
Hospitalization |
1/1/2010 |
63 |
Female |
176 lb |
6/15/2011 |
Consumer |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Erythema |
Hospitalization |
5/1/2011 |
57 |
Female |
|
6/16/2011 |
Consumer |
United States |
|
| Deep Vein Thrombosis |
Other Serious |
3/1/2005 |
32 |
Female |
190 lb |
7/4/2011 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pneumonia |
Hospitalization |
3/12/2011 |
65 |
Female |
262 lb |
7/5/2011 |
Physician |
Canada |
|
| Blood Glucose Increased |
Hospitalization |
6/28/2011 |
48 |
Male |
210 lb |
7/8/2011 |
Physician |
United States |
|
| Diabetic Vascular Disorder |
Other Serious |
6/2/2004 |
68 |
Female |
287 lb |
7/12/2011 |
Physician |
United States |
|
| Depression |
|
2/1/2011 |
65 |
Female |
|
7/22/2011 |
Consumer |
United States |
|
| Conjunctivitis |
Other Serious |
1/1/2000 |
44 |
Female |
268 lb |
7/29/2011 |
Consumer |
United States |
|
| Dizziness |
Other Serious |
5/1/2011 |
57 |
Female |
|
8/1/2011 |
Consumer |
United States |
|
| Flushing |
|
11/1/2010 |
47 |
Male |
|
8/5/2011 |
Consumer |
United States |
|
| Depression |
Other Serious |
7/1/2009 |
52 |
Female |
174 lb |
8/4/2011 |
Lawyer |
United States |
|
| Wound Drainage |
Other Serious |
5/1/2011 |
57 |
Female |
|
9/13/2011 |
Consumer |
United States |
|
| Migraine |
Hospitalization |
11/1/2009 |
36 |
Female |
201 lb |
10/20/2011 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pulmonary Embolism |
Hospitalization |
11/1/2009 |
40 |
Female |
239 lb |
10/19/2011 |
Other Health Professional |
United States |
|
| Pulmonary Embolism |
Hospitalization |
11/1/2009 |
40 |
Female |
239 lb |
10/21/2011 |
Lawyer |
United States |
|
| Hypercoagulation |
Other Serious |
11/1/2005 |
56 |
Female |
123 lb |
11/17/2011 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| White Blood Cell Count Increased |
Hospitalization |
4/16/2006 |
71 |
Female |
|
11/9/2011 |
Lawyer |
United States |
|
| Pneumonia |
Hospitalization |
3/12/2011 |
65 |
Female |
262 lb |
1/17/2012 |
Physician |
Canada |
|
| Economic Problem |
Disability |
|
|
Female |
|
1/12/2012 |
Lawyer |
United States |
| Primary |
|
| Concomitant |
|
| Interacting |
|
|
| Incorrect Drug Administration Duration |
Other Serious |
|
|
Female |
190 lb |
1/16/2012 |
Lawyer |
United States |
|
| Sleep Apnoea Syndrome |
|
|
55 |
Female |
|
1/28/2012 |
Consumer |
United States |
|
| Sinus Headache |
|
9/14/2011 |
55 |
Male |
215 lb |
1/28/2012 |
Consumer |
United States |
|
| Bronchitis |
|
9/26/2011 |
37 |
Male |
|
1/28/2012 |
Consumer |
United States |
|
| Cholelithiasis |
Hospitalization |
1/1/2008 |
36 |
Female |
159 lb |
2/14/2012 |
Consumer |
United States |
|
| Convulsion |
Hospitalization |
|
70 |
Male |
|
2/10/2012 |
Pharmacist |
United States |
|
| Deep Vein Thrombosis |
Hospitalization |
11/1/2009 |
40 |
Female |
239 lb |
2/21/2012 |
Consumer |
United States |
|
| Hypercoagulation |
Other Serious |
11/1/2005 |
56 |
Female |
123 lb |
2/21/2012 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tremor |
Other Serious |
|
|
Female |
|
2/21/2012 |
|
United States |
|
| Blood Creatinine Increased |
|
1/1/2011 |
63 |
Female |
156 lb |
12/26/2011 |
Consumer |
United States |
|
| Mental Disorder |
Other Serious |
8/1/2009 |
22 |
Female |
175 lb |
3/6/2012 |
Other Health Professional |
United States |
|
| Renal Failure |
Other Serious |
4/1/2010 |
47 |
Female |
130 lb |
4/13/2012 |
Lawyer |
United States |
|
| Tremor |
Other Serious |
|
|
Female |
|
5/11/2012 |
Lawyer |
United States |
|
| Insomnia |
Hospitalization |
|
|
Female |
|
5/23/2012 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Incorrect Drug Administration Duration |
Other Serious |
|
|
Female |
|
5/24/2012 |
Lawyer |
United States |
|
| Breath Sounds Abnormal |
Disability |
|
|
Female |
226 lb |
6/8/2012 |
Lawyer |
United States |
|
| Wound |
Other Serious |
4/1/2012 |
54 |
Female |
|
6/26/2012 |
Consumer |
Canada |
|
| Chest X-ray Abnormal |
Other Serious |
|
61 |
Female |
160 lb |
7/2/2012 |
Consumer |
United States |
|
| Movement Disorder |
Other Serious |
|
|
Male |
|
6/27/2012 |
Consumer |
United States |
|
| Joint Swelling |
Other Serious |
|
|
Female |
|
7/9/2012 |
Physician |
United States |
|
| Dyspnoea |
|
6/29/2012 |
86 |
Female |
|
7/12/2012 |
Consumer |
United States |
|
| Colitis |
Life Threatening |
12/4/2008 |
17 |
Female |
180 lb |
8/3/2012 |
Other Health Professional |
United States |
|
| Wound |
Hospitalization |
4/1/2012 |
54 |
Female |
|
8/10/2012 |
Consumer |
Canada |
|
| Tardive Dyskinesia |
Other Serious |
|
|
Male |
211 lb |
10/12/2012 |
Lawyer |
Us |
|
| Weight Increased |
Hospitalization |
2011 |
|
Female |
164 lb |
10/5/2012 |
Physician |
Country Not Specified |
|
| Pulmonary Granuloma |
Other Serious |
1/2012 |
|
Male |
157 lb |
9/12/2012 |
Physician |
Us |
|
| Vision Blurred |
|
6/2012 |
53 |
Female |
212 lb |
9/13/2012 |
Physician |
Us |
|
| Injury |
Hospitalization |
6/2007 |
27 |
Female |
286 lb |
10/25/2012 |
Other Health Professional |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Fall |
Death |
|
|
Female |
|
10/23/2012 |
Physician |
Us |
|
| Drug Hypersensitivity |
|
|
62 |
Female |
|
9/20/2012 |
Other Health Professional |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Screaming |
Hospitalization |
7/27/2012 |
37 |
Female |
137 lb |
9/24/2012 |
|
Country Not Specified |
|
| Skin Necrosis |
Hospitalization |
5/15/2012 |
49 |
Female |
252 lb |
9/24/2012 |
Pharmacist |
Us |
|
| Urinary Incontinence |
|
2012 |
73 |
Female |
|
9/27/2012 |
Consumer |
Us |
|
| Pulmonary Embolism |
Hospitalization |
6/7/2011 |
30 |
Female |
|
10/5/2012 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Thrombophlebitis Superficial |
Hospitalization |
2/12/2008 |
28 |
Female |
|
10/25/2012 |
Consumer |
Us |
|
| Pain |
Other Serious |
|
|
Female |
271 lb |
12/21/2012 |
Consumer |
Br |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Melaena |
Hospitalization |
10/2012 |
|
Female |
271 lb |
12/19/2012 |
Physician |
Us |
|
| Visual Impairment |
Other Serious |
|
|
Female |
271 lb |
12/28/2012 |
Consumer |
Br |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vitamin D Deficiency |
Hospitalization |
2005 |
65 |
Male |
|
12/12/2012 |
|
Us |
|