change extended immediate release effexor
Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types change extended immediate release effexor untoward events into a smaller number of standardized event categories.
In the tabulations that follow, reported change extended immediate release effexor events were classified using a standard COSTART-based Dictionary terminology. In addition, at least one case of photo-induced telangiectasia has been associated with venlafaxine use.
Other
Other side effects have frequently included asthenia (up change extended immediate release effexor 21%), headache (up to 34%), flu syndrome (6%), and accidental injury (5%).
Other side effects reported in premarketing Phase 3 trials have included edema, hyperacusis, otitis media, parosmia, loss of taste, deafness, labyrinthitis, otitis externa, substernal chest pain, chills, fever, neck pain, face edema, intentional injury, malaise, change extended immediate release effexor neck rigidity, pelvic pain, photosensitivity reaction, suicide attempt, appendicitis, bacteremia, change extended immediate release effexor and cellulitis. Tests for potential dose relationships for these change extended immediate release effexor (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/ Preferred 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), change extended immediate release effexor 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. The proposed mechanism for the development of hyponatremia involves the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) via release of antidiuretic hormone.
Use of venlafaxine has been associated with small but statistically significant increases in total cholesterol, high- density lipoprotein cholesterol and low- density lipoprotein cholesterol.
Renal
Renal side effects reported in premarketing Phase 3 trials change extended immediate release effexor included kidney calculus, kidney pain, abnormal kidney function, and pyelonephritis. The antidepressants that increase serotonin function appear to have the greatest change extended immediate release effexor on REM sleep. In a flexible-dose study, with doses in 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 compared 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 change extended immediate release effexor mean decreases ranging from 0.9 to 3.8 mm Hg for placebo. In all cases, hair re- growth occurred within 2 to 4 weeks following discontinuation of venlafaxine.
Dermatologic side effects have included sweating in change extended immediate release effexor to approximately 14% change extended immediate release effexor treated patients. Symptoms resolved following discontinuation change extended immediate release effexor therapy.
Genitourinary side effects have frequently included male and female sexual dysfunction such as abnormal ejaculation in up to 16% of male patients, decreased libido (13%), impotence (13%), and organic dysfunction (anorgasmia or abnormal orgasm) in up to 8% of female patients.
Genitourinary side effects reported in premarketing Phase 3 trials have included prostatic disorder (prostatitis, enlarged prostate, and prostate irritability), impaired urination, albuminuria, amenorrhea, cystitis, dysuria, hematuria, leukorrhea, menorrhagia, metrorrhagia, nocturia, breast pain, polyuria, urinary incontinence, urinary retention, urinary urgency, vaginal hemorrhage, vaginitis, abortion, anuria, breast discharge, breast engorgement, balanitis, breast enlargement, endometriosis, female lactation, fibrocystic breast, calcium crystalluria, cervicitis, orchitis, ovarian cyst, bladder pain, prolonged erection, gynecomastia (male), hypomenorrhea, mastitis, menopause, oliguria, salpingitis, urolithiasis, uterine hemorrhage, uterine spasm, and vaginal dryness. Although these events occurred during treatment with venlafaxine, causality has not been determined.
A case of dose-related increase of change extended immediate release effexor pressure caused by venlafaxine use has been reported.
Metabolic
Metabolic side effects have included change extended immediate release effexor loss (3%).
Metabolic side change extended immediate release effexor reported in premarketing Phase 3 trials have included change extended immediate release effexor gain, increased alkaline phosphatase, dehydration, hypercholesteremia, hyperglycemia, hyperlipemia, hypoglycemia, hypokalemia, increased SGOT (AST), increased SGPT (ALT), thirst, bilirubinemia, increased BUN, increased creatinine, diabetes mellitus, glycosuria, gout, abnormal healing, hemochromatosis, hypercalcinuria, hyperkalemia, hyperphosphatemia, hyperuricemia, hypocholesteremia, hyponatremia, hypophosphatemia, hypoproteinemia, and uremia. Dyskinesia has also been reported.
Venlafaxine has been reported to increase the pain tolerance threshold to electrical sural nerve stimulation and the threshold at which pain increases (pain summation).
One case of serotonin syndrome has been reported which is believed to have been precipitated by the combination of venlafaxine and trazodone.
One small study has suggested that venlafaxine may improve attention, concentration, memory, and reaction time performance after single oral doses.
Nervous system side effects reported in premarketing Phase 3 trials have included amnesia, confusion, depersonalization, hypesthesia, abnormal thinking, trismus, vertigo, akathisia, apathy, ataxia, circumoral paresthesia, central nervous system (CNS) stimulation, hostility, hyperesthesia, hyperkinesia, hypotonia, incoordination, myoclonus, neuralgia, neuropathy, seizure, abnormal change extended immediate release effexor stupor, adjustment disorder, akinesia, alcohol abuse, aphasia, bradykinesia, buccoglossal syndrome, cerebrovascular accident, change extended immediate release effexor drunk, loss of consciousness, dementia, change extended immediate release effexor increased energy, facial paralysis, abnormal gait, Guillain-Barre Syndrome, hyperchlorhydria, hypokinesia, hysteria, impulse control difficulties, increased libido, motion sickness, neuritis, nystagmus, paresis, decreased or increased reflexes, and torticollis. This increase was duration dependent over the study period and tended to be greater with higher doses. In a flexible-dose study, with doses in the range of 200 to 375 mg/day and mean dose greater than 300 mg/day, the mean change in heart rate was 8.5 beats per minute compared with 1.7 beats per minute for placebo.
Other Events Observed During the Premarketing Evaluation of Venlafaxine
During its premarketing assessment, multiple doses of Effexor were administered to 2897 patients change extended immediate release effexor Phase 2 and Phase 3 studies. In addition, at least one case of photo-induced telangiectasia has been associated with venlafaxine use.
Other
Other side effects have frequently included asthenia (up to 21%), headache (up to 34%), flu syndrome (6%), and accidental injury (5%).
Other side effects reported in premarketing Phase 3 trials have included edema, hyperacusis, otitis media, parosmia, loss of taste, deafness, labyrinthitis, otitis externa, substernal chest pain, chills, fever, neck pain, face edema, intentional injury, malaise, moniliasis, neck rigidity, pelvic pain, photosensitivity reaction, suicide attempt, appendicitis, bacteremia, carcinoma, and cellulitis. The frequencies presented, therefore, represent the proportion of the 5356 patients exposed to multiple doses of either formulation of venlafaxine who experienced an event of the type cited on at least one occasion while receiving venlafaxine. 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/ Preferred 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 change extended immediate release effexor to some adverse events with continued therapy (eg, dizziness and change extended immediate release effexor but less to other effects (eg, abnormal ejaculation and change extended immediate release effexor 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.
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