1.1 Major Depressive Disorder (MDD) Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment...
The following adverse reactions are discussed in greater detail in other sections of the labeling: • Suicidal thoughts and behaviors in children, adolescents, and young adults [see WARNINGS AND PRECAUTIONS (5.1)] • Neuropsychiatric adverse events and suicide risk in smoking cessation treatment [see WARNINGS AND PRECAUTIONS (5.2)] • Seizure [see WARNINGS AND PRECAUTIONS (5.3)] • Hypertension [see WARNINGS AND PRECAUTIONS (5.4)] • Activation of mania or hypomania [see WARNINGS AND PRECAUTIONS (5.5...
Source: OpenFDA. This is not medical advice.