Incidence and duration of antidepressant-induced nausea:
duloxetine compared with paroxetine and fluoxetine

Greist J, McNamara RK, Mallinckrodt CH, Rayamajhi JN, Raskin J.
Healthcare Technology Systems, Madison, Wisconsin, USA
Clin Ther. 2004 Sep;26(9):1446-55


OBJECTIVE:: This analysis assessed the incidence, severity, onset, and duration of nausea among patients with major depressive disorder (MDD) treated with the new antidepressant duloxetine. METHODS:: Data were pooled from 8 double-blind, randomized, placebo- and active comparator-controlled trials employing patients with MDD that were submitted to the US Food and Drug Administration to support duloxetine's new drug application for treatment of MDD. RESULTS:: The numbers of patients receiving each regimen were as follows: placebo, n = 777; duloxetine 40 mg/d, n = 177; duloxetine 60 mg/d, n = 251; duloxetine 80 mg/d, n = 363; duloxetine 120 mg/d, n = 348; paroxetine 20 mg/d, n = 359; and fluoxetine 20 mg/d, n = 70. In acute placebo-controlled trials of duloxetine 40 to 120 mg/d, treatment-emergent nausea was reported by more duloxetine-treated patients than those receiving placebo (19.9% [227/1139] vs 6.9% [l54/777], respectively; P <). Among duloxetine-treated patients, the median time to onset of nausea was 1 day, and the median duration of nausea was 7 days. The incidence of nausea was similar to placebo rates after 1 week. In paroxetine-controlled studies, the incidence of treatment-emergent nausea in patients receiving duloxetine did not differ significantly from paroxetine (14.4% vs 12.0%, respectively). In head-to-head studies, the incidence of treatment-emergent nausea with duloxetine did not differ significantly from that with fluoxetine (17.1% vs 15.7%, respectively). Most duloxetine-treated patients reported nausea to be mild (52.9%) or moderate (41.4%). Treatment discontinuation secondary to nausea occurred in more duloxetine-treated patients than those receiving placebo (1.4% [16/1139] vs 0.1% [1/777], respectively;P = 0.002). Following abrupt discontinuation after acute treatment, 5.9% of duloxetine-treated patients exhibited nausea compared with 0.3% of patients receiving placebo (P < 0.001). The incidence of treatment-emergent nausea during 6-month continuation of duloxetine treatment (80 mg/d, 2.1%; 120 mg/d, 1.3%) was similar to placebo (1.6%). Following abrupt discontinuation after 8 months of treatment, nausea was reported by 1.6% of patients receiving duloxetine 120 mg/d compared with 0% for those receiving duloxetine 80 mg/d and 0% for placebo. CONCLUSIONS:: Duloxetine induced mild to moderate nausea in a subset of patients with MDD during treatment initiation. Nausea resolved rapidly with continued treatment. The incidence of duloxetine-induced nausea resembled that produced by paroxetine and fluoxetine.
Alpha2 antagonism
Duloxetine and the liver
Duloxetine: hope or hype?
Duloxetine and depression
Duloxetine for major depression
Duloxetine (Cymbalta): structure
Duloxetine for urinary incontinence
Duloxetine: efficacy and tolerability
Duloxetine (Cymbalta), serotonin and noradrenaline
Duloxetine (Cymbalta) and painful physical symptoms

and further reading

Future Opioids
BLTC Research
Utopian Surgery?
The Abolitionist Project
The Hedonistic Imperative
The Reproductive Revolution
Critique of Huxley's Brave New World

The Good Drug Guide
The Good Drug Guide

The Responsible Parent's Guide
To Healthy Mood Boosters For All The Family