Indicated for:

Major Depressive Disorder:

• The treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials.

Generalized Anxiety Disorder:

• For the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials.

Social Anxiety Disorder:

• The treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26-week, placebo-controlled trials.

Panic Disorder:

• The treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials.

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies.These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older.

In patients of all ages who are started on antidepressant therapy monitor closely for clinical worsening and emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.

The total daily dose should be reduced by 50% in patients with mild (Child-Pugh=5-6) to moderate (Child-Pugh=7-9) hepatic impairment. In patients with severe hepatic impairment (Child-Pugh=10-15) or hepatic cirrhosis, it may be necessary to reduce the dose by 50% or more.

The total daily dose should be reduced by 25% to 50% in patients with mild (CLcr= 60-89 mL/min) or moderate (CLcr= 30-59 mL/min) renal impairment. In patients undergoing hemodialysis or with severe renal impairment (CLcr < 30 mL/min), the total daily dose should be reduced by 50% or more. Because there was much individual variability in clearance between patients with renal impairment, individualization of dosage may be desirable in some patients.

Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that Effexor XR is not approved for use in treating bipolar depression.

Monitor blood pressure before initiating treatment with Effexor XR and regularly during treatment. Control pre-existing hypertension before initiating treatment with Effexor XR. Use caution in treating patients with pre-existing hypertension or cardiovascular or cerebrovascular conditions that might be compromised by increases in blood pressure.

Abrupt discontinuation or dose reduction of venlafaxine at various doses has been found to be associated with the appearance of new symptoms, the frequency of which increased with increased dose level and with longer duration of treatment. 

A gradual reduction in the dose, rather than abrupt cessation, is recommended when discontinuing therapy with Effexor XR. In clinical studies with Effexor XR, tapering was achieved by reducing the daily dose by 75 mg at one-week intervals. Individualization of tapering may be necessary. In some patients, discontinuation may need to occur over a period of several months.

Discontinuation symptoms have been systematically evaluated in patients taking venlafaxine, including prospective analyses of clinical studies in GAD and retrospective surveys of studies in MDD and SAD.

SSRIs and SNRIs, including Effexor XR, may increase the risk of bleeding events, ranging from ecchymoses, hematomas, epistaxis, petechiae, and gastrointestinal hemorrhage to life-threatening hemorrhage. Concomitant use of aspirin, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), warfarin, and other anticoagulants or other drugs known to affect platelet function may add to this risk.

Effexor XR should be used cautiously in patients with a history of mania or hypomania.

The pupillary dilation that occurs following use of many antidepressant drugs including Effexor XR may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

Seizures have occurred with venlafaxine therapy.

Use of SNRIs, including Effexor XR, may cause symptoms of sexual dysfunction. In male patients, SNRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SNRI use may result in decreased libido and delayed or absent orgasm.

Hyponatremia can occur as a result of treatment with SSRIs and SNRIs, including Effexor XR. In many cases, the hyponatremia appears to be the result of the Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion.

Interstitial lung disease and eosinophilic pneumonia associated with venlafaxine therapy have been rarely reported. The possibility of these adverse events should be considered in venlafaxine-treated patients who present with progressive dyspnea, cough or chest discomfort.

At least 14 days should elapse between discontinuation of an MAOI (intended to treat psychiatric disorders) and initiation of therapy with Effexor XR. In addition, at least 7 days should be allowed after stopping Effexor XR before starting an MAOI intended to treat psychiatric disorders.

Do not start Effexor XR in a patient who is being treated with linezolid or intravenous methylene blue, because there is an increased risk of serotonin syndrome.

The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Effexor XR alone, but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s wort) and with drugs that impair metabolism of serotonin in particular, MAOIs, both those intended to treat psychiatric disorders and others, such as linezolid or intravenous methylene blue). 

The use of psychotropic drugs that interfere with serotonin reuptake is associated with the occurrence of upper gastrointestinal bleeding and concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are co-administered with warfarin.

The safety and efficacy of venlafaxine therapy in combination with weight loss agents, including phentermine, have not been established. Co-administration of Effexor XR and weight loss agents is not recommended.

The risk of using venlafaxine in combination with other CNS-active drugs has not been systematically evaluated. Consequently, caution is advised when Effexor XR is taken in combination with other CNS active drugs.

Based on animal data, may cause fetal harm.

Venlafaxine and ODV have been reported to be excreted in human milk.

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• Use in patients under 18 years of age. GoToSource

• Migraines, diabetic neuropathy and perimenopausal symptoms. GoToSource

• Attention deficit/hyperactivity disorder. GoToSource

• Neuropathic pain. GoToSource

• Fibromyalgia. GoToSource

• Obsessive-compulsive disorder. GoToSource

• Premenstrual dysphoric disorder. GoToSource

• Bipolar depression. GoToSource

• Stress urinary incontinence. GoToSource

• Hot flashes in women with a history of breast cancer. GoToSource

• Non-cardiac chest pain. GoToSource

• Post-traumatic stress disorder. GoToSource

• Borderline personality disorder, obesity, smoking cessation and alcoholism. GoToSource

Serotonin syndrome or neuroleptic malignant syndrome (life-threatening adverse reactions). GoToSource

Suicidal thinking and behavior (suicidality). GoToSource

Insomnia, constipation, confusion, agitation, increased cholesterol, tachycardia, confusion, changes in vision, mania, seizures and impaired detrusor contractility (bladder voiding dysfunction). GoToSource

Hyponatremia (low sodium level in blood). GoToSource

Liver injury. GoToSource

Increased risk for preeclampsia. GoToSource

Status cataplecticus (sudden episode of muscle weakness). GoToSource

Bone loss and fractures. GoToSource

Birth defects. GoToSource

Upper gastrointestinal bleeding in elderly patients. GoToSource

Hypertriglyceridemic pancreatitis (high triglyceride levels that also increase risk of acute pancreatitis). GoToSource

Fatal agranulocytosis (deficiency of a type of white blood cell). GoToSource

Rhabdomyolysis (breakdown of muscle fibers). GoToSource

Takotsubo cardiomyopathy (heart muscle becomes suddenly weakened). GoToSource

Myocardial infarction, stroke/transient ischaemic attack and falls. GoToSource

Acute eosinophilic pneumonia. GoToSource 

Hypertensive encephalopathy (sudden elevation of blood pressure affecting brain function). GoToSource

Elevation of blood pressure. GoToSource

Discontinuation syndrome (confusion, impaired coordination, sensory disturbances, vertigo, delirium, stroke-like symptoms, and depersonalization). GoToSource

Sexual dysfunction. GoToSource

Lawsuits filed for suicide, birth defects, infant persistent pulmonary hypertension, death in patients with coronary artery disease, withdrawal effects and tardive dyskinesia.