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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