Contraindications:

Effexor XR is contraindicated in patients:

• with known hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate, or any excipients in the formulation.
• taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs) (including the MAOIs linezolid and intravenous methylene blue) because of the risk of serotonin syndrome.

Warnings and Precautions:

Serotonin Syndrome: Effexor XR can precipitate serotonin syndrome, a potentially life-threatening condition. There is an increased risk when co-administered with other serotonergic agents but also when taken alone. If it occurs, discontinue Effexor XR and serotonergic agents and initiate supportive treatment.

Elevated Blood Pressure: In controlled trials, there were dose-related increases in systolic and diastolic blood pressure, as well as cases of sustained hypertension. Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment.

Increased Risk of Bleeding: Effexor XR may increase risk of bleeding events. Concomitant use of aspirin, NSAIDS, other antiplatelet drugs, warfarin, and anticoagulants may increase risk. Based on data from the published observational studies, exposure to SNRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage. Inform patients about the risk of bleeding associated with the concomitant use of Effexor XR and NSAIDs, aspirin, or other drugs that affect coagulation.

Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles, treated with antidepressants.

Activation of Mania/Hypomania: Screen patients for bipolar disorder. In patients with bipolar disorder, treating a depressive episode with Effexor XR may precipitate a mixed/manic episode.

Discontinuation Syndrome: Abrupt discontinuation or dose reduction has been associated with the appearance of new symptoms. There have been postmarketing reports of serious discontinuation symptoms, which can be protracted and severe. Completed suicide, suicidal thoughts, aggression, and violent behavior have been observed in patients during reduction in Effexor XR dosage, including during discontinuation. Patients should be monitored for symptoms when discontinuing treatment with Effexor XR. A gradual reduction in the dose, rather than abrupt cessation, is recommended.

Seizures: Seizures have occurred with venlafaxine therapy. Effexor XR should be prescribed with caution in patients with a seizure disorder.

Hyponatremia: Hyponatremia can occur as a result of treatment with Effexor XR. Consider discontinuation of Effexor XR in patients with symptomatic hyponatremia.

Interstitial Lung Disease and Eosinophilic Pneumonia: Interstitial lung disease and eosinophilic pneumonia associated with venlafaxine therapy can occur and have been rarely reported.

Sexual Dysfunction: Effexor XR may cause symptoms of sexual dysfunction.

The most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo): nausea, somnolence, dry mouth, sweating, abnormal ejaculation, anorexia, constipation, impotence, and decreased libido.

Interference with Cognitive and Motor Performance: Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that Effexor XR therapy does not adversely affect their ability to engage in such activities.

Advise patients to avoid alcohol while taking Effexor XR.

Pregnancy: Third trimester use may increase risk for symptoms of poor neonatal adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate.

Hepatic Impairment: Dosage adjustment is recommended in patients with mild, moderate, or severe hepatic impairment or hepatic cirrhosis.

Renal Impairment: Dosage adjustment is recommended in patients with mild, moderate, or severe renal impairment, and in patients undergoing hemodialysis.

Indications

Effexor XR (venlafaxine extended-release) capsules are indicated in adults for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), social anxiety disorder (SAD), or panic disorder (PD).

Please see Full Prescribing Information, including BOXED WARNING and Medication Guide.