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Effexor XR (Venlafaxine Hydrochloride) - Summary

 
 



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 Effexor XR 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. Effexor XR is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use)

 

EFFEXOR XR SUMMARY

Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant.

Effexor XR is indicated for the following:

Major Depressive Disorder

Effexor XR (venlafaxine hydrochloride) extended-release capsules is indicated for the treatment of major depressive disorder.

The efficacy of Effexor XR in the treatment of major depressive disorder was established in 8‑ and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials).

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.

The efficacy of Effexor (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of Effexor XR in hospitalized depressed patients have not been adequately studied.

The efficacy of Effexor XR in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor (immediate release) in maintaining a response in patients with recurrent major depressive disorder 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 Effexor/Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

Generalized Anxiety Disorder

Effexor XR is indicated for the treatment of Generalized Anxiety Disorder (GAD) as defined in DSM-IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

The efficacy of Effexor XR in the treatment of GAD was established in 8-week and 6-month placebo-controlled trials in adult outpatients diagnosed with GAD according to DSM-IV criteria (see Clinical Trials).

Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance.

Although the effectiveness of Effexor XR has been demonstrated in 6-month clinical trials in patients with GAD, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

Social Anxiety Disorder

Effexor XR is indicated for the treatment of Social Anxiety Disorder, also known as Social Phobia, as defined in DSM-IV (300.23).

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.

The efficacy of Effexor XR in the treatment of Social Anxiety Disorder was established in four 12-week and one 6-month placebo-controlled trials in adult outpatients with Social Anxiety Disorder (DSM-IV) (see Clinical Trials).

Although the effectiveness of Effexor XR has been demonstrated in a 6-month clinical trial in patients with Social Anxiety Disorder, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

Panic Disorder

Effexor XR is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM‑IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.

Panic disorder (DSM-IV) is characterized by recurrent, unexpected panic attacks, ie, a discrete period of intense fear or discomfort, in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: 1) palpitations, pounding heart, or accelerated heart rate; 2) sweating; 3) trembling or shaking; 4) sensations of shortness of breath or smothering; 5) feeling of choking; 6) chest pain or discomfort; 7) nausea or abdominal distress; 8) feeling dizzy, unsteady, lightheaded, or faint; 9) derealization (feelings of unreality) or depersonalization (being detached from oneself); 10) fear of losing control; 11) fear of dying; 12) paresthesias (numbness or tingling sensations); 13) chills or hot flushes.

The efficacy of Effexor XR in the treatment of panic disorder was established in two 12-week placebo-controlled trials in adult outpatients with panic disorder (DSM-IV). The efficacy of Effexor XR in prolonging time to relapse in panic disorder among responders following 12 weeks of open-label acute treatment was demonstrated in a placebo-controlled study (see CLINICAL PHARMACOLOGY, Clinical Trials). Nevertheless, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).


See all Effexor XR indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Effexor XR (Venlafaxine)

Sexual function in women on estradiol or venlafaxine for hot flushes: a randomized controlled trial. [2014]
estradiol or venlafaxine for hot flushes... CONCLUSION: Overall sexual function among nondepressed midlife women experiencing

Evaluation of the efficacy and safety of pregabalin, venlafaxine, and carbamazepine in patients with painful diabetic peripheral neuropathy. A randomized, double-blind trial. [2014]
venlafaxine in patients with painful diabetic neuropathy (PDN)... CONCLUSION: This study showed the efficacy of venlafaxine, pregabalin, and

Specificity profile of venlafaxine and sertraline in major depression: metaregression of double-blind, randomized clinical trials. [2014]
Despite the well-known efficacy of selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) in the treatment of major depressive disorder, there is a lack of indications for each drug in different groups of patients...

Interaction between polymorphisms in serotonin transporter (SLC6A4) and serotonin receptor 2A (HTR2A) genes predict treatment response to venlafaxine XR in generalized anxiety disorder. [2013]
Variation in genes involved in serotonergic signaling is thought to be associated with antidepressant treatment response in generalized anxiety disorder (GAD). We examined a possible interaction between the serotonin transporter gene (SLC6A4) 5-HTTLPR/rs25531 haplotype and the serotonin 2A receptor gene (HTR2A) single-nucleotide polymorphism (SNP) rs7997012 in antidepressant treatment outcome in GAD...

Catechol-O-methyltransferase genotype as modifier of superior responses to venlafaxine treatment in major depressive disorder. [2013]
Responses to venlafaxine treatment in major depressive disorder were stratified by COMT genotypes (Val158Met, rs4680) in a randomized, double-blind, placebo-controlled clinical trial. Improvements in depression scores among subjects with Val/Val genotypes were larger than those in Met/Met genotypes, suggesting that venlafaxine may alter noradrenergic flux differentially according to COMT activity..

more studies >>

Clinical Trials Related to Effexor XR (Venlafaxine)

Co-Administration of LDX (SPD489) and Venlafaxine XR (EFFEXOR XR) in Healthy Volunteers [Completed]
This study will examine the effects of co-administration of SPD489 and the antidepressant EFFEXOR XR on the pharmacokinetics of lisdexamfetamine, d-amphetamine, and EFFEXOR XR. In addition, serial blood pressure and pulse measures will be obtained and examined to ensure that there are no unexpected changes in vital signs following co administration of SPD489 and EFFEXOR XR that would impact the further study of this drug combination. The hypothesis is that a drug drug interaction could possibly exist.

Study to Examine the Effect of Gastric Bypass Surgery on Venlafaxine ER Blood Levels [Active, not recruiting]
The purpose of the study is to determine whether a significant and predictable change in bioavailability of extended-release venlafaxine occurs following Roux-en-Y gastric bypass.

Venlafaxine 25 mg Tablets Under Fasting Conditions [Completed]

Venlafaxine 25 mg Tablets Under Non-Fasting Conditions [Completed]

Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fed Conditions [Completed]
The objective of this study was to compare the rate and extent of absorption of venlafaxine hydrochloride 150 mg extended-release capsules (test) versus EffexorŽ XR (reference) administered as 1 x 150 mg extended-release capsule under fed conditions.

more trials >>

Reports of Suspected Effexor XR (Venlafaxine) Side Effects

Depression (216)Drug Ineffective (193)Withdrawal Syndrome (178)Feeling Abnormal (158)Anxiety (145)Malaise (143)Dizziness (142)Headache (139)Nausea (112)Suicidal Ideation (82)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 46 ratings/reviews, Effexor XR has an overall score of 6.46. The effectiveness score is 7.43 and the side effect score is 6.65. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Effexor XR review by 35 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Depression/Anxiety
Dosage & duration:   37.5, 75, 150 (dosage frequency: once per day) for the period of 4 years
Other conditions:   Eating Disorder-Bulimia and Anorexia; post-partum depression
Other drugs taken:   None
  
Reported Results
Benefits:   Immediately felt like "the cloud had lifted." Anxiety essentially disappeared and life really did get easier. Removed the sense of "running in concrete."
Side effects:   At first, sleeping was intermittent and was full of bizarre dreams. This quickly passed.
Comments:   Effexor was prescribed after Serzone has run it's course. Treated for depression (dysthymia) and anxiety related to Post Traumatic Stress Disorder. Excellent results compared to Serzone and Paxil.

 

Effexor XR review by 43 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   Depression
Dosage & duration:   75mg taken daily for the period of 1 year
Other conditions:   Migraines
Other drugs taken:   Maxalt
  
Reported Results
Benefits:   Effexor was very effective at alleviating my symptoms of depression. My mood improved dramatically, I felt happy and engaged in life again. It also worked fairly quickly. I began feeling the effects within the first week.
Side effects:   The side effects I experienced while taking Effexor were insomnia, rapid heartbeat and grinding my teeth at night. Also, I found myself incessantly jiggling my leg while sitting at my desk, watching tv, etc.. All in all, these were minor and as easy trade-off. The major side effect I noticed was a complete loss of libido and inability to reach orgasm. Simply put, it was as if a switch had been turned off on my sex drive. This side effect was the reason I chose to stop taking Effexor.
Comments:   My physician started me out on 37.5mg/day for 1 week then increased the dosage to 75mg/day for another week and, finally, to 150mg/day. After taking 150mg/day for about a week, I felt it was too much...my heart was always racing, I couldn't sleep, and I generally just felt "nervous". My physician dropped my dosage back to 75mg/day and that seemed to work best for me. I absolutely feel that the Effexor helped lift my depression. However, I eventually chose to stop taking it because of the sexual side effects. After being on Effexor for about a year, I both wanted and needed to have a healthy sexual relationship with my husband again. I dropped the dosage back to 37.5mg/day for a week, then one every other day for about another week before stopping altogether. I don't recall having any "withdrawal" symptoms. Within a few days of the last dose, all sexual functions were back.

 

Effexor XR review by 29 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   Depression
Dosage & duration:   375mg/day taken 3xa day for the period of 6 months
Other conditions:   PTSD, Neuropathic pain, Arthritis,Migraine
Other drugs taken:   Co codamol
  
Reported Results
Benefits:   None.
Side effects:   I was desperate to feel better, but after the first pill was swallowed, I felt physically and mentally awful. I had palpitations, nausea, uncontrolable shaking, severe headache and felt strangely detatched from the world (it was as if I was watching the world through a dense fog).
Comments:   This was my Psychiatrist and GP`s last hope of treating my depression with medication, and I was told that I probably would suffer no adverse effects ("very rare", apparently). However, after telling them at my appointment a month after starting Effexor XR, I was told that dissociative symptoms of PTSD are rarely made worse by effexor.

See all Effexor XR reviews / ratings >>

Page last updated: 2015-08-10

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