Wellbutrin:
Table 1. Treatment-Emergent Adverse Experience Incidence in Placebo-Controlled Clinical Trials* (Percent of Patients Reporting)
Wellbutrin:
Table 1. Treatment-Emergent Adverse Experience Incidence in Placebo-Controlled Clinical Trials* (Percent of Patients Reporting)
Adverse Experience |
WELLBUTRIN Patients (n = 323) |
Placebo Patients (n = 185) |
| Cardiovascular | ||
| Cardiac arrhythmias | 5.3 |
4.3 |
| Dizziness | 22.3 |
16.2 |
| Hypertension | 4.3 |
1.6 |
| Hypotension | 2.5 |
2.2 |
| Palpitations | 3.7 |
2.2 |
| Syncope | 1.2 |
0.5 |
| Tachycardia | 10.8 |
8.6 |
| Dermatologic | ||
| Pruritus | 2.2 |
0 |
| Rash | 8 |
6.5 |
| Gastrointestinal | ||
| Anorexia | 18.3 |
18.4 |
| Appetite increase | 3.7 |
2.2 |
| Constipation | 26 |
17.3 |
| Diarrhea | 6.8 |
8.6 |
| Dyspepsia | 3.1 |
2.2 |
| Nausea/vomiting | 22.9 |
18.9 |
| Weight gain | 13.6 |
22.7 |
| Weight loss | 23.2 |
23.2 |
| Genitourinary | ||
| Impotence | 3.4 |
3.1 |
| Menstrual complaints | 4.7 |
1.1 |
| Urinary frequency | 2.5 |
2.2 |
| Urinary retention | 1.9 |
2.2 |
| Musculoskeletal | ||
| Arthritis | 3.1 |
2.7 |
| Neurological | ||
| Akathisia | 1.5 |
1.1 |
| Akinesia/bradykinesia | 8 |
8.6 |
| Cutaneoustemperature | 1.9 |
1.6 |
| disturbance | ||
| Dry mouth | 27.6 |
18.4 |
| Excessive sweating | 22.3 |
14.6 |
| Headache/migraine | 25.7 |
22.2 |
| Impaired sleep quality | 4 |
1.6 |
| Increased salivary flow | 3.4 |
3.8 |
| Insomnia | 18.6 |
15.7 |
| Muscle spasms | 1.9 |
3.2 |
| Pseudoparkinsonism | 1.5 |
1.6 |
| Sedation | 19.8 |
19.5 |
| Sensory disturbance | 4 |
3.2 |
| Tremor | 21.1 |
7.6 |
| Neuropsychiatric | ||
| Agitation | 31.9 |
22.2 |
| Anxiety | 3.1 |
1.1 |
| Confusion | 8.4 |
4.9 |
| Decreased libido | 3.1 |
1.6 |
| Delusions | 1.2 |
1.1 |
| Disturbed concentration | 3.1 |
3.8 |
| Euphoria | 1.2 |
0.5 |
| Hostility | 5.6 |
3.8 |
| Nonspecific | ||
| Fatigue | 5 |
8.6 |
| Fever/chills | 1.2 |
0.5 |
| Respiratory | ||
| Upper respiratory complaints | 5 |
11.4 |
| Special Senses | ||
| Auditory disturbance | 5.3 |
3.2 |
| Blurred vision | 14.6 |
10.3 |
| Gustatory disturbance | 3.1 |
1.1 |
*Events reported by at least 1% of patients receiving WELLBUTRIN are included.
WARNINGS
Clinical Worsening and Suicide Risk: Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. There has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients. Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders.
Pooled analyses of short-term placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with MDD, OCD, or other psychiatric disorders (a total of 24 trials involving over 4,400 patients) have revealed a greater risk of adverse events representing suicidal behavior or thinking (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. There was considerable variation in risk among drugs, but a tendency toward an increase for almost all drugs studied. The risk of suicidality was most consistently observed in the MDD trials, but there were signals of risk arising from some trials in other psychiatric indications (obsessive compulsive disorder and social anxiety disorder) as well. No suicides occurred in any of these trials. It is unknown whether the suicidality risk in pediatric patients extends to longer-term use, i.e., beyond several months. It is also unknown whether the suicidality risk extends to adults.
