SIDE EFFECTS
Associated with Discontinuation of Treatment
Of the 1087 OCD and depressed patients treated with fluvoxamine maleate in controlled clinical trials conducted in North America, 22% discontinued treatment due to an adverse event. The most common events (> 1%,) associated with discontinuation and considered to be drug related (i.e., those events associated with dropout at a rate at least twice that of placebo) included:
Table 1: ADVERSE EVENTS ASSOCIATED WITH DISCONTINUATION OF TREATMENT IN OCD AND DEPRESSION POPULATIONS
| BODY SYSTEM
ADVERSE EVENT |
PERCENTAGE OF PATIENTS |
|
FLUVOXAMINE |
PLACEBO |
|
| BODY AS A WHOLE | ||
| Headache | 3% |
1% |
| Asthenia | 2% |
<1% |
| Abdominal Pain | 1% |
0% |
| DIGESTIVE | ||
| Nausea | 0% |
1% |
| Diarrhea | 1% |
<1% |
| Vomiting | 2% |
<1% |
| Anorexia | 1% |
<1% |
| Dyspepsia | 1% |
<1% |
| NERVOUS SYSTEM | ||
| Insomnia | 4% |
1% |
| Somnolence | 4% |
<1% |
| Nervousness | 2% |
<1% |
| Agitation | 2% |
<1% |
| Dizziness | 2% |
<1% |
| Anxiety | 1% |
<1% |
| Dry Mouth | 1% |
<1% |
Luvox's Half-Life & Average Time to Clear Out of Your System: 15.6 hours, the shortest of all true SSRIs.