Table 2. Common Adverse Events in WELLBUTRIN XL Bioavailability Studies
|
Adverse Event |
WELLBUTRIN XL (300 mg) N = 254 |
WELLBUTRIN IR (300 mg) N = 95 |
|
Headache |
9% |
11.6% |
|
Constipation |
6.7% |
13.7% |
|
Nausea |
4% |
2% |
|
Abdominal pain or discomfort |
4% |
8.4% |
|
Rash |
3.5% |
6.3% |
|
Tremor |
2% |
4.2% |
|
Dizziness |
1.6% |
5.3% |
C.
Safety Data from 3 Ongoing Clinical Trials Using WELLBUTRIN XL
As of November 19, 2002, there were 604 subjects
enrolled in the 3 clinical studies listed in Section IV.A. There have been no deaths or serious adverse
events reported from these trials.
Nineteen subjects from the SAD studies discontinued due to experiencing
events. The cases are described in the
table below.
(Table 3) Discontinuations due to Adverse Events in
Ongoing Trials
|
Study AK 130930 – Discontinuations due to Adverse
Events (n = 12) |
Study AK 130936 – Discontinuations due to Adverse
events (n = 7) |
|
allergic reaction |
Rash on hands, headache |
|
agitation, headache, and acne |
Dizziness, disorientation |
|
facial edema & truncal rash |
Hypertension |
|
hypertension |
Rash on extremities |
|
shortness of breath, chest pain, insomnia |
Fatigue and nightmares |
|
dry mouth, metallic taste, lethargy, impaired
concentration, depression |
Increased heart rate, decreased concentration,
lightheadedness |
|
headache, neck pain, jaw clenching, elevated blood
pressure |
Menstrual spotting |
|
insomnia |
|
|
4 non-serious AEs (illegible from CRF) |
|
|
insomnia, anxiety, panic, mental confusion |
|
|
acute allergic reaction |
|
|
panic attacks |
|
4
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