Important Safety Information

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Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, teens, and young adults. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. EFFEXOR XR® (venlafaxine HCl) is not approved for use in children and teens.

  • People taking MAOIs should not take EFFEXOR XR.
  • All patients taking antidepressants should be watched closely for signs that their condition is getting worse or that they are becoming suicidal, especially when they first start therapy, or when their dose is increased or decreased. Patients should also be watched for becoming agitated, irritable, hostile, aggressive, impulsive, or restless. Such symptoms should be reported to the patient's doctor right away.
  • Before starting EFFEXOR XR, tell your doctor if you're taking or plan to take any prescription or over-the-counter drugs, including migraine headache medication, herbal preparations, and nutritional supplements, to avoid a potentially life-threatening condition.
  • Taking EFFEXOR XR with aspirin, nonsteroidal anti-inflammatory drugs, warfarin, or other drugs that affect coagulation may increase the risk of bleeding events.
  • EFFEXOR XR may raise blood pressure in some patients. Your blood pressure should be controlled before starting treatment and should be monitored regularly.
  • Mydriasis (prolonged dilation of the pupil of the eye) has been reported with EFFEXOR XR. You should notify your physician if you have a history of glaucoma or increased eye pressure.
  • When people suddenly stop using or quickly lower their daily dose of EFFEXOR XR, discontinuation symptoms may occur. Talk to your doctor before discontinuing or reducing your dose of EFFEXOR XR.
  • Pregnant or nursing women shouldn't take any antidepressant without consulting their doctor.
  • Until you see how EFFEXOR XR affects you, be careful doing such activities as driving a car or operating machinery. Avoid drinking alcohol while taking EFFEXOR XR.
  • In clinical studies, the most common side effects with EFFEXOR XR (reported in at least 10% of patients and at least twice as often as with placebo) were constipation, dizziness, dry mouth, insomnia, loss of appetite, nausea, nervousness, sexual side effects, sleepiness, sweating, and weakness. Ask your doctor if EFFEXOR XR is right for you.