zoloft and effexor
Tachycardia and QTc prolongation appear to occur in a dose-dependent manner.
In one case report, venlafaxine (75 mg 3 times/day) may have contributed to an elevation in defibrillation threshold in a patient with nonischemic cardiomyopathy and an implantable cardioverter- defibrillator. In all cases, hair re- growth occurred within 2 to 4 weeks following discontinuation of venlafaxine.
Dermatologic side effects have included sweating in up to approximately 14% of treated patients. The manufacturer recommends that therapy be discontinued in patients who develop seizures.
The impact of venlafaxine on pain summation may indicate a potential analgesic effect for clinical neuropathic pain.
Nearly all selective serotonin reuptake inhibitors, mixed serotonin/norepinephrine reuptake inhibitors, and tricyclic antidepressants cause sleep abnormalities to some extent. Although these events occurred during treatment with venlafaxine, causality has not been determined.
Musculoskeletal
Musculoskeletal side effects have included rhabdomyolysis.
Musculoskeletal side effects reported in premarketing Phase 3 trials zoloft and effexor included arthralgia, arthritis, arthrosis, bone spurs, bursitis, leg cramps, myasthenia, tenosynovitis, bone pain, pathological fracture, muscle cramp, muscle spasms, musculoskeletal stiffness, myopathy, osteoporosis, osteosclerosis, plantar fasciitis, rheumatoid arthritis, and tendon rupture. The manufacturer recommends that therapy be discontinued in patients who develop seizures.
The impact of venlafaxine on pain summation may indicate a potential analgesic effect for clinical zoloft and effexor pain.
Nearly all selective zoloft and effexor reuptake inhibitors, mixed serotonin/norepinephrine reuptake inhibitors, and tricyclic antidepressants cause sleep abnormalities to some extent. During its premarketing assessment, multiple doses of Effexor XR were also administered to 1381 patients in Phase 3 GAD studies and 277 patients in Phase 3 Social Anxiety Disorder studies. The same study reported an increase in the average zoloft and effexor rate of 1.1 to 4.5 beats per minute.
Another study (n=7) suggests that venlafaxine may promote adverse cardiovascular zoloft and effexor cerebrovascular events by increasing platelet activity in susceptible patients.
An increase in heart rate of 4 beats per minute has been reported.
According to a retrospective review, in the overdose setting (up to 3 g of venlafaxine), tachycardia, hypertension, mydriasis, QTc prolongation, and transient arrhythmia can be expected. The antidepressants that increase serotonin function appear to have the greatest effect on REM sleep. Although these events occurred during treatment with venlafaxine, causality has not been determined.
Respiratory
Respiratory side effects have frequently included pharyngitis, sinusitis, and yawning.
Respiratory side effects reported in premarketing Phase 3 trials have included increased cough, dyspnea, asthma, chest congestion, epistaxis, hyperventilation, laryngismus, laryngitis, pneumonia, voice alteration, atelectasis, hemoptysis, hypoventilation, hypoxia, larynx edema, pleurisy, pulmonary embolus, and sleep apnea. If the COSTART term for an event was so general as to be uninformative, it was replaced with a more informative term. During its premarketing assessment, multiple doses of Effexor XR were also administered to 1381 patients in Phase 3 GAD studies and 277 patients in Phase 3 Social Anxiety Disorder studies. The onset of venlafaxine- associated interstitial pneumonitis has ranged from 1 to 18 months after initial exposure to the drug and symptomatic improvement occurred after discontinuation of venlafaxine and treatment with corticosteroids.
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More Effexor resources
Effexor Detailed Consumer Information (PDR)
Effexor Prescribing Information zoloft and effexor Consumer Overview
Effexor Advanced Consumer (Micromedex) - Includes Dosage Information
Effexor MedFacts Consumer Leaflet (Wolters Kluwer)
Venlafaxine Prescribing Information (FDA)
Effexor XR Prescribing Information (FDA)
Effexor XR Extended-Release zoloft and effexor MedFacts Consumer Leaflet (Wolters Kluwer). Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. This increase was duration dependent over the study period and tended to be greater with higher doses. The conditions and duration of exposure to venlafaxine in both development programs varied greatly, and included (in overlapping categories) open and double-blind studies, uncontrolled and controlled studies, inpatient (Effexor only) and outpatient studies, fixed-dose and zoloft and effexor studies. Although these events occurred during treatment with venlafaxine, causality has not been determined.
Respiratory
Respiratory side effects have frequently included pharyngitis, sinusitis, and yawning.
Respiratory side effects reported in premarketing Phase 3 trials have included increased cough, dyspnea, asthma, chest congestion, epistaxis, hyperventilation, laryngismus, laryngitis, pneumonia, voice alteration, atelectasis, hemoptysis, hypoventilation, hypoxia, larynx edema, pleurisy, pulmonary embolus, and sleep apnea. In a flexible-dose study, with doses zoloft and effexor the range of 200 to 375 mg/day and mean dose greater than 300 mg/day, the mean pulse was increased by about 2 beats per minute zoloft and effexor with a decrease of about 1 beat per minute for placebo.
In controlled clinical trials, Effexor was associated with mean increases in diastolic blood pressure ranging from 0.7 to 2.5 mm Hg averaged over all dose groups, compared to mean decreases ranging from 0.9 to 3.8 mm Hg for placebo. If the COSTART term for an event was so general as to be uninformative, it was replaced with a more informative term. A case of increased libido and spontaneous erections has also been reported.
Although rare, several cases of venlafaxine- induced urinary symptoms including nocturia, enuresis, increased urge/frequency, and incontinence have been reported. During its premarketing assessment, multiple doses of Effexor XR were also administered to 1381 patients in Phase 3 GAD studies and 277 patients in Phase 3 Social Anxiety Disorder studies. There have been postmarketing reports of toxic epidermal necrolysis.
One case of venlafaxine-induced Stevens-Johnson syndrome has been reported. Tests for potential dose relationships for these events (Cochran-Armitage Test, with a criterion of exact 2-sided p-value ≤ 0.05) suggested a dose-dependency for several adverse events in this list, including chills, hypertension, anorexia, nausea, agitation, dizziness, somnolence, tremor, yawning, sweating, and abnormal ejaculation.
TABLE 3 Treatment-Emergent Adverse Experience Incidence in a Dose Comparison Trial
Effexor (mg/day)
Body System/ zoloft and effexor Term
Placebo (n=92)
75 (n=89)
225 (n=89)
375 (n=88)
Body as a Whole
Abdominal pain
3.3%
3.4%
2.2%
8.0%
Asthenia
3.3%
16.9%
14.6%
14.8%
Chills
1.1%
2.2%
5.6%
6.8%
Infection
2.2%
2.2%
5.6%
2.3%
Cardiovascular System
Hypertension
1.1%
1.1%
2.2%
4.5%
Vasodilatation
0.0%
4.5%
5.6%
2.3%
Digestive System
Anorexia
2.2%
14.6%
13.5%
17.0%
Dyspepsia
2.2%
6.7%
6.7%
4.5%
Nausea
14.1%
32.6%
38.2%
58.0%
Vomiting
1.1%
7.9%
3.4%
6.8%
Nervous System
Agitation
0.0%
1.1%
2.2%
4.5%
Anxiety
4.3%
11.2%
4.5%
2.3%
Dizziness
4.3%
19.1%
22.5%
23.9%
Insomnia
9.8%
22.5%
20.2%
13.6%
Libido decreased
1.1%
2.2%
1.1%
5.7%
Nervousness
4.3%
21.3%
13.5%
12.5%
Somnolence
4.3%
16.9%
18.0%
26.1%
Tremor
0.0%
1.1%
2.2%
10.2%
Respiratory System
Yawn
0.0%
4.5%
5.6%
8.0%
Skin and Appendages
Sweating
5.4%
6.7%
12.4%
19.3%
Special Senses
Abnormality of accommodation
0.0%
9.1%
7.9%
5.6%
Urogenital System
Abnormal ejaculation/orgasm
0.0%
4.5%
2.2%
12.5%
Impotence
0.0%
5.8%
2.1%
3.6%
(Number of men)
(n=63)
(n=52)
(n=48)
(n=56)
Adaptation to Certain Adverse Events
Over a 6-week period, there was evidence of adaptation to some adverse events with continued therapy (eg, dizziness and nausea), but less to other effects (eg, abnormal ejaculation and dry mouth).
Vital Sign Changes
Effexor (venlafaxine hydrochloride) treatment (averaged over all dose groups) in clinical trials was associated with a mean increase in pulse rate of approximately 3 beats per minute, compared to no change for placebo. Although these events occurred during treatment with venlafaxine, causality has not been determined.
Impaired coordination and balance have been reported in postmarketing studies.
Seizures have been reported in 0.26% of treated patients during premarketing testing.
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