What is venlafaxine used for?

Indications and Usage, quoted from the label by Advagen Pharma Ltd. (ANDA203332). Cross-references to other label sections are left out.

Venlafaxine hydrochloride extended-release capsules is indicated in adults for the treatment of:

• Major Depressive Disorder (MDD) [see Clinical Studies]
• Generalized Anxiety Disorder (GAD) [see Clinical Studies]
• Social Anxiety Disorder (SAD) [see Clinical Studies]
• Panic Disorder (PD) [see Clinical Studies]

Source: DailyMed label, set id 48a75840-64e4-4d44-9a62-009373003105, version 4, effective August 25, 2026. NDC 72888-179, one of 164 listings for this product.

Indications and Usage, quoted from the label by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (ANDA078554). Cross-references to other label sections are left out.

Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder.

The efficacy of Venlafaxine tablets USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS ).

A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.

The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Venlafaxine Tablets USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use Venlafaxine Tablets, USP / venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Source: DailyMed label, set id 80ac757d-c629-4579-8afd-cae0ee9cd614, version 23, effective June 19, 2026. NDC 23155-246, one of 114 listings for this product.

Indications and Usage, quoted from the label by Ajanta Pharma USA Inc. (ANDA214691). Cross-references to other label sections are left out.

Major Depressive Disorder

Venlafaxine extended-release tablets are indicated for the treatment of major depressive disorder (MDD).

Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD.

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

Social Anxiety Disorder

Venlafaxine extended-release tablets are indicated for the treatment of Social Anxiety Disorder (SAD), also known as Social Phobia, as defined in DSM-IV.

Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.

Efficacy of venlafaxine extended-release in the treatment of SAD was established in short-term SAD trials.

Source: DailyMed label, set id 22d4817c-1f19-4490-8a38-d8904f0374f7, version 5, effective November 27, 2025. NDC 27241-221, one of 48 listings for this product.