| Underdose |
|
11/29/2005 |
62 |
Male |
180 lb |
2/2/2006 |
Consumer |
United States |
|
| Insomnia |
|
11/1/2005 |
70 |
Male |
186 lb |
2/2/2006 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Ineffective |
|
11/11/2005 |
39 |
Female |
140 lb |
2/2/2006 |
|
United States |
|
| Middle Insomnia |
|
1/1/2006 |
56 |
Female |
101 lb |
4/3/2006 |
Consumer |
United States |
|
| Respiratory Rate Decreased |
Hospitalization |
3/1/2006 |
|
Male |
239 lb |
6/26/2006 |
Physician |
United States |
|
| Drug Ineffective |
|
1/21/2006 |
55 |
Female |
115 lb |
5/5/2006 |
Consumer |
United States |
|
| Somnolence |
|
2/1/2006 |
55 |
Female |
152 lb |
5/5/2006 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Middle Insomnia |
|
2/17/2006 |
48 |
Female |
138 lb |
5/5/2006 |
Consumer |
United States |
|
| Wheezing |
Other Serious |
7/1/2006 |
62 |
Female |
|
8/1/2006 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Restlessness |
Hospitalization |
8/19/2006 |
70 |
Male |
169 lb |
9/26/2006 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vasculitis |
|
1/1/2006 |
|
Male |
|
8/1/2006 |
Other Health Professional |
United States |
|
| Restlessness |
|
6/14/2006 |
48 |
Female |
163 lb |
8/1/2006 |
Physician |
United States |
|
| Upper Respiratory Tract Infection |
|
3/22/2006 |
40 |
Male |
325 lb |
8/1/2006 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pharmaceutical Product Complaint |
Required Intervention |
8/22/2006 |
72 |
Female |
190 lb |
10/19/2006 |
|
United States |
|
| Hallucination |
|
9/19/2006 |
75 |
Female |
140 lb |
11/6/2006 |
Consumer |
United States |
|
| Initial Insomnia |
|
9/13/2006 |
52 |
Female |
160 lb |
11/6/2006 |
Consumer |
United States |
|
| Vomiting |
Hospitalization |
2/26/2006 |
|
Female |
171 lb |
1/25/2007 |
Physician |
United States |
|
| Middle Insomnia |
|
9/14/2006 |
44 |
Female |
112 lb |
11/6/2006 |
Consumer |
United States |
|
| Poor Quality Sleep |
|
8/7/2006 |
72 |
Male |
155 lb |
11/6/2006 |
|
United States |
|
| Respiratory Distress |
Required Intervention |
8/22/2006 |
72 |
Female |
190 lb |
1/30/2007 |
Physician |
United States |
|
| Metabolic Syndrome |
Other Serious |
10/14/2006 |
35 |
Female |
|
2/12/2007 |
Physician |
United States |
|
| Middle Insomnia |
|
11/1/2005 |
71 |
Male |
192 lb |
11/6/2006 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Middle Insomnia |
|
7/25/2006 |
84 |
Female |
132 lb |
11/6/2006 |
Consumer |
United States |
|
| Insomnia |
|
10/11/2006 |
49 |
Male |
210 lb |
11/6/2006 |
Consumer |
United States |
|
| Vomiting |
Hospitalization |
11/1/2004 |
15 |
Female |
126 lb |
4/6/2007 |
Physician |
United States |
|
| Paralysis |
Hospitalization |
10/1/2000 |
57 |
Female |
|
4/16/2007 |
Consumer |
United States |
|
| Middle Insomnia |
|
1/1/2006 |
45 |
Female |
170 lb |
2/6/2007 |
Consumer |
United States |
|
| Poor Quality Sleep |
|
12/21/2006 |
57 |
Male |
210 lb |
2/6/2007 |
|
United States |
|
| Drug Ineffective |
|
11/1/2006 |
47 |
Female |
250 lb |
2/6/2007 |
Consumer |
United States |
|
| Insomnia |
|
11/1/2005 |
71 |
Male |
192 lb |
5/7/2007 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Fatigue |
|
1/23/2007 |
50 |
Female |
145 lb |
5/11/2007 |
Consumer |
United States |
|
| Initial Insomnia |
|
1/1/2007 |
76 |
Female |
128 lb |
5/11/2007 |
|
United States |
|
| Hypersomnia |
|
3/14/2007 |
34 |
Female |
299 lb |
5/11/2007 |
|
United States |
|
| Poor Quality Sleep |
|
4/12/2007 |
51 |
Female |
240 lb |
5/11/2007 |
Consumer |
United States |
|
| Poor Quality Sleep |
|
1/31/2007 |
64 |
Female |
170 lb |
5/11/2007 |
Consumer |
United States |
|
| Nasopharyngitis |
|
3/2/2007 |
49 |
Female |
170 lb |
5/11/2007 |
Consumer |
United States |
|
| Asthenia |
|
3/6/2007 |
80 |
Female |
156 lb |
5/11/2007 |
|
United States |
|
| Prescribed Overdose |
|
12/1/2006 |
54 |
Female |
140 lb |
5/11/2007 |
Consumer |
United States |
|
| Middle Insomnia |
|
4/3/2007 |
56 |
Female |
150 lb |
5/11/2007 |
|
United States |
|
| Somnolence |
|
5/19/2007 |
58 |
Female |
145 lb |
6/11/2007 |
Consumer |
United States |
|
| Visual Acuity Reduced |
Other Serious |
5/1/2007 |
53 |
Female |
|
6/27/2007 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Visual Field Defect |
Other Serious |
5/1/2007 |
53 |
Female |
188 lb |
7/23/2007 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Nausea |
|
|
|
Female |
|
7/23/2007 |
Consumer |
United States |
|
| Paralysis |
Hospitalization |
10/1/2000 |
57 |
Female |
170 lb |
8/6/2007 |
Other Health Professional |
United States |
|
| Rebound Effect |
|
1/1/2005 |
44 |
Male |
195 lb |
7/10/2007 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Grand Mal Convulsion |
Other Serious |
8/7/2007 |
34 |
Female |
150 lb |
8/21/2007 |
Physician |
United States |
|
| Chills |
Hospitalization |
10/1/2000 |
57 |
Female |
170 lb |
8/24/2007 |
Other Health Professional |
United States |
|
| Ovarian Cyst |
Other Serious |
8/7/2007 |
34 |
Female |
150 lb |
8/24/2007 |
Physician |
United States |
|
| Visual Field Defect |
Other Serious |
5/1/2007 |
53 |
Female |
188 lb |
9/6/2007 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Nervousness |
Other Serious |
8/7/2007 |
34 |
Female |
150 lb |
8/31/2007 |
Physician |
United States |
|
| Injection Site Bruising |
Hospitalization |
10/1/2000 |
57 |
Female |
170 lb |
9/12/2007 |
Other Health Professional |
United States |
|
| Poor Quality Sleep |
|
3/1/2005 |
44 |
Male |
195 lb |
8/13/2007 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Middle Insomnia |
|
7/12/2007 |
66 |
Female |
120 lb |
8/13/2007 |
Consumer |
United States |
|
| Poor Quality Sleep |
|
3/6/2007 |
68 |
Female |
110 lb |
8/13/2007 |
Consumer |
United States |
|
| Drug Ineffective |
|
5/1/2007 |
76 |
Female |
148 lb |
8/13/2007 |
Consumer |
United States |
|
| Respiratory Rate Increased |
Other Serious |
8/7/2007 |
34 |
Female |
150 lb |
10/2/2007 |
Physician |
United States |
|
| Somnambulism |
|
1/1/2007 |
51 |
Male |
195 lb |
10/25/2007 |
Physician |
United States |
|
| Osteoporosis |
Hospitalization |
8/1/2006 |
|
Female |
225 lb |
11/12/2007 |
Consumer |
United States |
|
| Palpitations |
Other Serious |
11/1/2006 |
|
Female |
180 lb |
11/14/2007 |
Physician |
United States |
|
| Pharmaceutical Product Complaint |
Other Serious |
11/16/2007 |
|
Male |
252 lb |
11/18/2007 |
Consumer |
United States |
|
| Middle Insomnia |
|
8/2/2007 |
42 |
Female |
180 lb |
11/8/2007 |
Consumer |
United States |
|
| Nightmare |
|
|
53 |
Female |
207 lb |
11/8/2007 |
Physician |
United States |
|
| Middle Insomnia |
|
7/1/2007 |
46 |
Female |
97 lb |
11/8/2007 |
Consumer |
United States |
|
| Middle Insomnia |
|
6/1/2007 |
65 |
Female |
225 lb |
11/8/2007 |
Consumer |
United States |
|
| Drug Ineffective |
|
|
53 |
Female |
|
11/8/2007 |
Consumer |
United States |
|
| Overdose |
|
1/1/2007 |
78 |
Male |
145 lb |
11/8/2007 |
Consumer |
United States |
|
| Deep Vein Thrombosis |
Other Serious |
11/18/2007 |
|
Male |
|
12/5/2007 |
Other Health Professional |
United States |
|
| Deep Vein Thrombosis |
Other Serious |
11/18/2007 |
|
Male |
|
12/21/2007 |
Other Health Professional |
United States |
|
| Osteoporosis |
Hospitalization |
8/1/2006 |
|
Female |
225 lb |
1/31/2008 |
Physician |
United States |
|
| Poor Quality Sleep |
|
11/28/2007 |
71 |
Female |
132 lb |
1/30/2008 |
Consumer |
United States |
|
| Loss Of Dreaming |
|
1/1/2006 |
57 |
Female |
136 lb |
1/30/2008 |
Consumer |
United States |
|
| Diarrhoea |
|
|
38 |
Female |
178 lb |
4/18/2008 |
Consumer |
United States |
|
| Somnolence |
|
3/1/2008 |
74 |
Male |
182 lb |
5/1/2008 |
Consumer |
United States |
|
| Lethargy |
|
3/20/2008 |
31 |
Male |
150 lb |
5/1/2008 |
Consumer |
United States |
|
| Middle Insomnia |
|
11/1/2007 |
61 |
Female |
194 lb |
5/1/2008 |
Consumer |
United States |
|
| Somnolence |
|
3/1/2008 |
74 |
Male |
182 lb |
7/24/2008 |
Consumer |
United States |
|
| Anaphylactic Reaction |
Other Serious |
8/28/2008 |
|
Female |
120 lb |
9/19/2008 |
Physician |
United States |
|
| Tyramine Reaction |
Other Serious |
8/1/2008 |
|
Female |
250 lb |
12/5/2008 |
|
United States |
|
| Weight Decreased |
Other Serious |
1/1/2008 |
|
Female |
114 lb |
12/26/2008 |
Pharmacist |
United States |
|
| Swollen Tongue |
Other Serious |
11/1/2008 |
|
Female |
245 lb |
2/2/2009 |
Consumer |
United States |
|
| Vomiting |
Other Serious |
11/19/2002 |
|
Female |
128 lb |
2/6/2009 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Proctalgia |
Hospitalization |
2/16/2009 |
52 |
Female |
|
3/5/2009 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Swollen Tongue |
Other Serious |
11/1/2008 |
|
Female |
245 lb |
3/11/2009 |
Consumer |
United States |
|
| Mucosal Inflammation |
Hospitalization |
2/16/2009 |
|
Female |
|
3/11/2009 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Therapeutic Agent Toxicity |
Other Serious |
10/10/2007 |
|
Male |
190 lb |
3/27/2009 |
Consumer |
|
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Therapeutic Agent Toxicity |
Other Serious |
10/10/2007 |
|
Male |
190 lb |
3/30/2009 |
Consumer |
|
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Proctalgia |
Hospitalization |
2/16/2009 |
52 |
Female |
|
4/27/2009 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Mucosal Inflammation |
Hospitalization |
2/16/2009 |
|
Female |
162 lb |
4/29/2009 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pruritus Generalised |
|
9/5/2008 |
51 |
Female |
170 lb |
4/30/2009 |
|
United States |
|
| Diverticulum Intestinal |
Hospitalization |
11/1/2007 |
|
Female |
|
5/8/2009 |
Physician |
United States |
|
| Large Intestine Perforation |
Other Serious |
11/1/2007 |
57 |
Female |
|
5/14/2009 |
Consumer |
United States |
|
| Rectal Tenesmus |
Other Serious |
11/1/2008 |
57 |
Female |
|
5/18/2009 |
Physician |
United States |
|
| Rectal Tenesmus |
Other Serious |
11/1/2008 |
57 |
Female |
|
6/9/2009 |
Physician |
United States |
|
| Vulvovaginal Candidiasis |
Other Serious |
11/19/2002 |
|
Female |
128 lb |
7/8/2009 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Anxiety Disorder |
Other Serious |
6/16/2009 |
|
Female |
229 lb |
7/10/2009 |
Consumer |
United States |
|
| Type 2 Diabetes Mellitus |
Other Serious |
1/1/2002 |
45 |
Female |
204 lb |
7/15/2009 |
|
United States |
|
| Neuropathy Peripheral |
Other Serious |
1/1/1999 |
40 |
Female |
134 lb |
7/16/2009 |
|
United States |
|
| Pancreatitis Chronic |
Other Serious |
1/1/2006 |
33 |
Female |
|
7/22/2009 |
|
United States |
|
| Vulvovaginal Candidiasis |
Other Serious |
11/19/2002 |
|
Female |
128 lb |
9/1/2009 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Sinus Headache |
Other Serious |
11/16/2005 |
67 |
Male |
102 lb |
9/23/2009 |
Other Health Professional |
United States |
|
| Urinary Tract Infection |
|
1/1/2002 |
42 |
Female |
196 lb |
9/23/2009 |
|
United States |
|
| Type 2 Diabetes Mellitus |
Other Serious |
1/1/2006 |
44 |
Female |
118 lb |
10/14/2009 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Thrombocytopenia |
Life Threatening |
7/6/2007 |
|
Female |
110 lb |
10/16/2009 |
Physician |
United States |
|
| Tremor |
Other Serious |
7/6/2009 |
78 |
Male |
|
10/23/2009 |
Physician |
United States |
|
| Sinus Tachycardia |
Hospitalization |
9/26/2009 |
46 |
Female |
193 lb |
11/9/2009 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Decreased |
Hospitalization |
|
75 |
Female |
|
11/17/2009 |
|
United States |
|
| Weight Decreased |
Hospitalization |
|
75 |
Female |
|
11/24/2009 |
Lawyer |
United States |
|
| Vulvovaginal Candidiasis |
Other Serious |
11/19/2002 |
|
Female |
128 lb |
12/15/2009 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Retinal Pigmentation |
Other Serious |
1/1/2008 |
|
Female |
|
12/17/2009 |
|
United States |
|
| Toothache |
Other Serious |
12/16/2004 |
|
Female |
|
12/17/2009 |
Physician |
United States |
|
| Weight Decreased |
Hospitalization |
|
75 |
Female |
|
1/13/2010 |
Lawyer |
United States |
|
| Vulvovaginal Candidiasis |
Other Serious |
11/19/2002 |
|
Female |
128 lb |
1/26/2010 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Toothache |
Other Serious |
5/8/2003 |
|
Female |
|
2/11/2010 |
Physician |
United States |
|
| Wound Drainage |
Other Serious |
7/30/2003 |
|
Female |
87 lb |
2/12/2010 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Toothache |
Other Serious |
1/12/2002 |
|
Female |
|
3/8/2010 |
Physician |
United States |
|
| Vulvovaginal Candidiasis |
Other Serious |
11/19/2002 |
|
Female |
128 lb |
3/11/2010 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Toothache |
Other Serious |
1/12/2002 |
|
Female |
|
3/19/2010 |
Physician |
United States |
|
| Toothache |
Other Serious |
1/12/2002 |
|
Female |
|
3/30/2010 |
Physician |
United States |
|
| Vomiting |
Other Serious |
1/12/2002 |
54 |
Female |
|
4/13/2010 |
Pharmacist |
United States |
|
| Weight Decreased |
Hospitalization |
|
75 |
Female |
|
4/13/2010 |
|
United States |
|
| Vomiting |
Other Serious |
4/15/2003 |
55 |
Female |
|
5/13/2010 |
|
United States |
|
| Weight Decreased |
Hospitalization |
|
75 |
Female |
|
6/11/2010 |
Lawyer |
United States |
|
| Hypoaesthesia |
|
5/7/2007 |
36 |
Female |
223 lb |
6/28/2010 |
Consumer |
United States |
|
| Memory Impairment |
Hospitalization |
6/10/2010 |
46 |
Male |
194 lb |
7/1/2010 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Memory Impairment |
Hospitalization |
6/10/2010 |
46 |
Male |
194 lb |
7/15/2010 |
Other Health Professional |
United States |
|
| Vomiting |
Other Serious |
4/15/2003 |
55 |
Female |
|
7/16/2010 |
|
United States |
|
| Product Substitution Issue |
Required Intervention |
6/14/2010 |
53 |
Female |
250 lb |
7/12/2010 |
|
United States |
|
| Suicidal Ideation |
Other Serious |
6/1/2007 |
55 |
Female |
|
7/23/2010 |
Lawyer |
United States |
|
| Rash |
|
|
|
Female |
224 lb |
7/31/2010 |
Other Health Professional |
United States |
|
| Weight Increased |
Other Serious |
1/1/2008 |
53 |
Female |
205 lb |
8/3/2010 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Swelling Face |
Other Serious |
|
|
Female |
199 lb |
8/3/2010 |
Other Health Professional |
United States |
|
| Vomiting |
Other Serious |
8/16/2009 |
28 |
Female |
130 lb |
9/7/2010 |
Pharmacist |
United States |
|
| Vomiting |
Other Serious |
8/16/2008 |
27 |
Female |
130 lb |
9/9/2010 |
Pharmacist |
United States |
|
| International Normalised Ratio Increased |
Required Intervention |
6/14/2010 |
53 |
Female |
250 lb |
8/27/2010 |
|
United States |
|
| Type 2 Diabetes Mellitus |
Other Serious |
1/1/2006 |
33 |
Female |
120 lb |
9/20/2010 |
|
United States |
|
| Vomiting |
Other Serious |
4/15/2003 |
55 |
Female |
|
10/27/2010 |
|
United States |
|
| Product Quality Issue |
|
|
58 |
Male |
|
10/13/2010 |
Consumer |
United States |
|
| Pain |
Required Intervention |
7/1/2010 |
66 |
Female |
140 lb |
11/8/2010 |
Physician |
United States |
|
| Vertebral Artery Occlusion |
Other Serious |
|
66 |
Male |
|
12/3/2010 |
|
United States |
|
| Cardiomyopathy |
Other Serious |
4/15/2003 |
55 |
Female |
|
1/19/2011 |
Other Health Professional |
United States |
|
| Rash Generalised |
|
10/1/2010 |
52 |
Male |
|
1/26/2011 |
Consumer |
United States |
|
| Skin Discolouration |
Other Serious |
|
|
Male |
190 lb |
3/1/2011 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Nausea |
Hospitalization |
8/16/2009 |
27 |
Female |
130 lb |
3/23/2011 |
Consumer |
United States |
|
| Pancreatitis |
Hospitalization |
8/16/2009 |
27 |
Female |
130 lb |
3/23/2011 |
Pharmacist |
United States |
|
| Cholecystitis Acute |
Hospitalization |
2/1/2007 |
39 |
Female |
120 lb |
8/23/2011 |
Lawyer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Haemorrhage |
Other Serious |
|
56 |
Female |
|
9/7/2011 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Arthralgia |
Other Serious |
1/1/2009 |
63 |
Female |
208 lb |
9/19/2011 |
Lawyer |
United States |
|
| Hiatus Hernia |
Disability |
1/27/2009 |
45 |
Male |
240 lb |
9/19/2011 |
Lawyer |
United States |
|
| Cardiovascular Disorder |
Hospitalization |
9/1/2008 |
36 |
Female |
|
9/22/2011 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cholelithiasis |
Other Serious |
|
19 |
Female |
165 lb |
10/21/2011 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|