Information for Health Care Professionals
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Understanding Side Effects

As with any medication, you may experience side effects while taking PRISTIQ. In clinical studies, the most common side effect with PRISTIQ was nausea. It was generally mild to moderate and occurred most frequently during the first week of treatment. Other side effects included dizziness, sweating, constipation, and decreased appetite. In general, side effects occurred most frequently during the first week of treatment in clinical studies. These are not all the possible side effects of PRISTIQ (see Important Safety Information). In clinical studies of the recommended 50-mg dose, the percentage of people who stopped taking PRISTIQ due to side effects was similar to placebo (sugar pill).

Tell your health care professional about any side effect that bothers you or does not go away. Call your health care professional for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. For more information on these and other side effects associated with PRISTIQ, talk to your health care professional or call our toll-free number at 1-888-PRISTIQ.

In clinical studies of the recommended 50-mg dose of PRISTIQ, there was no clinical difference in weight gain versus placebo (sugar pill) and a low incidence of sexual function disorders in men and women.

Important safety information you should know

  • Suicide is a known risk of depression and some other psychiatric disorders.
  • Antidepressant drugs increased the risk of suicidal thinking and behavior in studies of children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. No increased risk has been shown for adults over age 24, and the risk decreased for those aged 65 and older.
  • All patients being treated with antidepressants for any reason should be monitored appropriately and observed closely for worsening depression symptoms, suicidal thoughts or behavior, and unusual changes in behavior, especially during the first few months of treatment, or when the dose is increased or decreased. PRISTIQ is not approved for use in children under 18.