Appendix 8.4
Summary
of Serious Adverse Events Occurring in Protocols 203, 205, and 208 Possibly or
Reasonably-Attributable to Bupropion Sustained-Release
Patient # |
Protocol # |
Age |
Gender |
Dose (mg/d) |
Duration (days) |
Adverse Events |
2043 |
205 |
37 |
F |
400 |
8 |
Nausea,
Vomiting, Diarrhea, Dehydration |
011-004 |
028 |
49 |
M |
300 |
1 |
Generalized
Convulsive Seizure |
040-013 |
208 |
48 |
M |
200 |
1 |
Panic
Attack |
063-024 |
208 |
33 |
M |
300 |
1 |
Facial
Edema/Allergic Reaction |
073-003 |
208 |
64 |
M |
100 |
1 |
Panic
Attack |
073-006 |
208 |
47 |
M |
300 |
Prolonged |
Somnolence |
073-024 |
208 |
44 |
M |
100 |
1 |
Generalized
Convulsive Seizure |
054-004 |
208* |
43 |
M |
300 |
1 |
Generalized
Convulsive Seizure |
Bupropion
Sustained-Release Clinical Review 60
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