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Important Safety Information
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. |
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- 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.
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Prescribing Information and Medication Guide
