Home FDA labels 4530e3c8-862e-4330-9cd7-12b9d5edcfdf FDA label 4530e3c8-862e-4330-9cd7-12b9d5edcfdf openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
SPL set ID 1e087f61-fc72-4cf9-b3ec-cb433ab25824
SPL ID 4530e3c8-862e-4330-9cd7-12b9d5edcfdf
Version 3
Effective date 2023-01-10
Source export date 2026-10-12
Source partition 2
Source file https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
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boxed warning Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of venlafaxine hydrochloride extended-release capsules or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. 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. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Venlafaxine hydrochloride extended-release capsules are not approved for use in pediatric patients (see WARNINGS : Clinical Worsening and Suicide Risk , PRECAUTIONS : Information for Patients, and PRECAUTIONS: Pediatric Use )
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warnings table <table ID="ID51" width="101%"><caption>Table 4Final On-Therapy Mean Changes from Baseline in Supine Systolic and Diastolic Blood Pressure (mm Hg) Results by Indication, Study Duration, and Dose in Placebo-Controlled Trials</caption><col width="28%"/><col width="15%"/><col width="12%"/><col width="12%"/><col width="13%"/><col width="12%"/><col width="9%"/><thead><tr><td align="left" valign="top" colspan="1" styleCode=" Lrule Rrule Botrule Toprule"><content styleCode="bold"> </content></td><td align="left" valign="top" colspan="1" styleCode=" Lrule Rrule Botrule Toprule"><content styleCode="bold">Venlafaxine </content><content styleCode="bold">Hydrochloride </content><content styleCode="bold">Extended</content><content styleCode="bold">-</content><content styleCode="bold">release </content><content styleCode="bold">Capsules </content><content styleCode="bold">mg</content><content styleCode="bold">/</content><content styleCode="bold">day</content><content styleCode="bold"> </content></td><td align="left" valign="top" colspan="1" styleCode=" Lrule Rrule Botrule Toprule"><content styleCode="bold"> </content></td><td align="left" valign="top" colspan="1" styleCode=" Lrule Rrule Botrule Toprule"><content styleCode="bold"> </content></td><td align="left" valign="top" colspan="1" styleCode=" Lrule Rrule Botrule Toprule"><content styleCode="bold"> </content></td><td align="left" valign="top" colspan="1" styleCode=" Lrule Rrule Botrule Toprule"><content styleCode="bold">Placebo </content><content styleCode="bold"> </content></td><td align="left" valign="top" colspan="1" styleCode=" Lrule Rrule Botrule Toprule"><content styleCode="bold"> </content></td></tr></thead><tfoot><tr><td align="left" colspan="7"><paragraph styleCode="Footnote"><sup>1</sup> Supine Systolic Blood Pressure </paragraph></td></tr><tr><td align="left" colspan="7"><paragraph styleCode="Footnote"><sup>2</sup> Supine Diastolic Blood Pressure </paragraph></td></tr></tfoot><tbody><tr><td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td><td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">≤ 75 </td><td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td><td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">> 75 </td><td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td><td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td><td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td></tr><tr><td align="left" valign="middle" styleCode=" Lrule Rrule Botrule Toprule"> </td><td align="left" valign="middle" styleCode=" Lrule Rrule Botrule Toprule"><content styleCode="bold">SSBP1</content><content styleCode="bold"> </content></td><td align="left" valign="middle" styleCode=" Lrule Rrule Botrule Toprule"><content styleCode="bold">SDBP2 </content><content styleCode="bold"> </content></td><td align="left" valign="middle" styleCode=" Lrule Rrule Botrule Toprule"><content styleCode="bold">SSBP</content><content styleCode="bold"> </content></td><td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule"><content styleCode="bold">SDBP</content><content styleCode="bold"> </content></td><td align="left" valign="middle" styleCode=" Lrule Rrule Botrule Toprule"><content styleCode="bold">SSBP </content><content styleCode="bold"> </content></td><td align="left" valign="middle" styleCode=" Lrule Rrule Botrule Toprule"><content styleCode="bold">SDBP</content><content styleCode="bold"> </content></td></tr><tr><td align="left" valign="top" styleCode=" Lrule Rrule Toprule">Major Depressive Disorder </td><td align="left" valign="top" styleCode=" Lrule Rrule Toprule"> </td><td align="left" valign="top" styleCode=" Lrule Rrule Toprule"> </td><td align="left" valign="top" styleCode=" Lrule Rrule Toprule"> </td><td align="left" valign="top" styleCode=" Lrule Rrule Toprule"> </td><td align="left" valign="top" styleCode=" Lrule Rrule Toprule"> </td><td align="left" valign="top" styleCode=" Lrule Rrule Toprule"> </td></tr><tr><td align="left" valign="middle" styleCode=" Lrule Rrule">8 to12 weeks </td><td align="left" valign="middle" styleCode=" Lrule Rrule">-0.28 </td><td align="left" valign="middle" styleCode=" Lrule Rrule">0.37 </td><td align="left" valign="middle" styleCode=" Lrule Rrule">2.93 </td><td align="left" valign="middle" styleCode=" Lrule Rrule">3.56 </td><td align="left" valign="middle" styleCode=" Lrule Rrule">-1.08 </td><td align="left" valign="middle" styleCode=" Lrule Rrule">-0.10 </td></tr><tr><td align="left" valign="middle" styleCode=" Lrule Rrule">Social Anxiety Disorder </td><td align="left" valign="middle" styleCode=" Lrule Rrule"> </td><td align="left" valign="middle" styleCode=" Lrule Rrule"> </td><td align="left" valign="middle" styleCode=" Lrule Rrule"> </td><td align="left" valign="middle" styleCode=" Lrule Rrule"> </td><td align="left" valign="middle" styleCode=" Lrule Rrule"> </td><td align="left" valign="middle" styleCode=" Lrule Rrule"> </td></tr><tr><td align="left" valign="middle" styleCode=" Lrule Rrule">12 weeks </td><td align="left" valign="middle" styleCode=" Lrule Rrule">-0.29 </td><td align="left" valign="middle" styleCode=" Lrule Rrule">-1.26 </td><td align="left" valign="middle" styleCode=" Lrule Rrule">1.18 </td><td align="left" valign="middle" styleCode=" Lrule Rrule">1.34 </td><td align="left" valign="middle" styleCode=" Lrule Rrule">-1.96 </td><td align="left" valign="middle" styleCode=" Lrule Rrule">-1.22 </td></tr><tr><td align="left" valign="middle" styleCode=" Lrule Rrule Botrule">6 months </td><td align="left" valign="middle" styleCode=" Lrule Rrule Botrule">-0.98 </td><td align="left" valign="middle" styleCode=" Lrule Rrule Botrule">-0.49 </td><td align="left" valign="middle" styleCode=" Lrule Rrule Botrule">2.51 </td><td align="left" valign="middle" styleCode=" Lrule Rrule Botrule">1.96 </td><td align="left" valign="middle" styleCode=" Lrule Rrule Botrule">-1.84 </td><td align="left" valign="middle" styleCode=" Lrule Rrule Botrule">-0.65 </td></tr></tbody></table>
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adverse reactions ADVERSE REACTIONS
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