490    studied in placebo-controlled trials, although it has been studied in non-placebo-controlled

491    clinical bioavailability studies.  Information on additional adverse evens associated with the

492    sustained-release formulation of bupropion in smoking cessation trials, as well as the

493    immediate-release formulation of bupropion, is included in a separate section (see Other Events

494    Observed During the Clinical Development and Postmarketing Experience of Bupropion).

495    Incidence in Controlled Trials With Bupropion: Adverse Events Associated With

496    Discontinuation of Treatment Among Patients Treated With Bupropion: In

497    placebo-controlled clinical trials, 9% and 11% of patients treated with 300 and 400 mg/day,

498    respectively, of the sustained-release formulation of bupropion and 4% of patients treated with

499    placebo discontinued treatment due to adverse events.  The specific adverse events in these trials

500    that led to discontinuation in at least 1% of patients treated with either 300 mg/day or

501    400 mg/day of WELLBUTRIN SR, the sustained-release formulation of bupropion, and at a rate

502    at least twice the placebo rate are listed in Table 3.

503     

504    Table 3. Treatment Discontinuation Due to Adverse Events in Placebo-Controlled Trials

Adverse Event Term	WELLBUTRIN SR 300 mg/day (n=376)	WELLBUTRIN SR 400 mg/day (n=114)	Placebo (n=385)
Rash Nausea Agitation Migraine	2.4% 0.8% 0.3% 0.0%	0.9% 1.8% 1.8% 1.8%	0.0% 0.3% 0.3% 0.3%

505     

506         In clinical trials with the immediate-release formulation of bupropion, 10% of patients and

507    volunteers discontinued due to an adverse event.  Events resulting in discontinuation, in addition

508    to those listed above for the sustained-release formulation of bupropion, included vomiting,

509    seizures, and sleep disturbances.

510    Adverse Events Occurring at an Incidence of 1% or More Among Patients

511    Treated With Bupropion:  Table 4 enumerates treatment-emergent adverse events that

512    occurred among patients treated with 300 and 400 mg/day of the sustained-release formulation of

513    bupropion and with placebo in controlled trials.  Events that occurred in either the 300- or

514    400-mg/day group at an incidence of 1% or more and were more frequent than in the placebo

515    group are included.  Reported adverse events were classified using COSTART-based

516    Dictionary.

517         Accurate estimates of the incidence of adverse events associated with the use of any drug are

518    difficult to obtain.  Estimates are influenced by drug dose, detection technique, setting, physician

519    judgments, etc.  The figures cited cannot be used to predict precisely the incidence of untoward

520    events in the course of usual medical practice where patient characteristics and other factors

521    differ from those that prevailed in the clinical trials.  These incidence figures also cannot

 

 

 

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