effexor getting off
Clinically relevant increases in serum cholesterol, defined as 1) a final on-therapy increase in serum cholesterol ≥50 mg/dL from baseline and to a value ≥261 mg/dL or 2) an average on‑therapy increase in serum cholesterol ≥50 mg/dL from baseline and to a value ≥261 mg/dL, were recorded in 5.3% of venlafaxine-treated patients and 0.0% of placebo-treated patients.
ECG Changes
In an analysis of ECGs obtained in 769 patients treated effexor getting off Effexor and 450 patients treated with placebo in controlled clinical trials, the only statistically significant difference observed was for heart rate, ie, a mean increase from baseline of 4 beats per minute for Effexor. Although these effexor getting off occurred during treatment with venlafaxine, causality has not been determined.
Although rare, interstitial pneumonitis secondary to venlafaxine therapy has been reported. In premarketing trials, treatment with Effexor tablets was associated with a mean final on-therapy increase in total cholesterol of 3 mg/dL.
Patients treated with Effexor tablets for at least 3 months in placebo-controlled 12-month extension trials had a mean final on-therapy increase in total cholesterol of 9.1 mg/dL compared with a decrease of 7.1 mg/dL among placebo-treated patients. Withdrawal symptoms were reported to include brief bursts of dizziness associated with effexor getting off anxiety, irritability, agitation, insomnia, paresthesias, nausea, vomiting, diarrhea, effexor getting off fatigue, sweating, and worsening of depression (similar to symptoms reported after withdrawal from selective serotonin reuptake inhibitors). 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. Although these events occurred during treatment effexor getting off venlafaxine, causality has not been determined.
One case of anasarca was reported in a patient 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 effexor getting off Experience Incidence in a Dose Comparison Trial
Effexor (mg/day)
Body System/ Preferred effexor getting off (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, effexor getting off 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. 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 adaptation to some adverse events with continued therapy (eg, dizziness effexor getting off 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 effexor getting off increase in effexor getting off rate of approximately 3 beats per minute, compared to no change for placebo. There have been reports of increases in prothrombin time, partial thromboplastin time, or INR when venlafaxine was given to patients receiving warfarin therapy.
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Side Effects by Body System
Gastrointestinal
Gastrointestinal side effects have frequently included nausea (up to 35%), dry mouth (14% to 18%), constipation (12%), anorexia (12% to 23%), vomiting, diarrhea (5% to 12%), eructation, abdominal pain, and flatulence.
Gastrointestinal side effects reported in premarketing Phase 3 trials have included increased appetite, bruxism, colitis, dysphagia, tongue edema, esophagitis, gastritis, gastroenteritis, gastrointestinal ulcer, gingivitis, glossitis, rectal hemorrhage, hemorrhoids, melena, oral moniliasis, stomatitis, mouth ulceration, effexor getting off distention, biliary pain, cheilitis, cholecystitis, cholelithiasis, esophageal spasms, duodenitis, hematemesis, gastroesophageal reflux disease, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, ileitis, jaundice, intestinal obstruction, liver tenderness, parotitis, periodontitis, proctitis, rectal disorder, salivary gland enlargement, increased salivation, soft stools, and tongue discoloration.
Nervous system
Nervous system side effects have frequently included dizziness (16%), somnolence (up to 14%), insomnia (11% to 25%), fatigue (11%), nervousness (9%), abnormal dreams, sleep abnormalities, tremor, depression, paresthesia, decreased libido, agitation, hypertonia, anxiety, delirium, and twitching. Although these events occurred during treatment with venlafaxine, causality has not been determined.
One case of anasarca was reported in a patient receiving venlafaxine. Although these events occurred effexor getting off treatment with venlafaxine, effexor getting off has not been determined.
A case of dose-related increase of intraocular pressure caused by venlafaxine use has been reported.
Metabolic
Metabolic side effects have included weight loss (3%).
Metabolic side effects reported in premarketing Phase 3 trials have included weight gain, increased alkaline phosphatase, dehydration, hypercholesteremia, hyperglycemia, hyperlipemia, hypoglycemia, hypokalemia, increased SGOT (AST), increased SGPT (ALT), thirst, bilirubinemia, increased BUN, increased creatinine, effexor getting off mellitus, glycosuria, gout, abnormal healing, hemochromatosis, hypercalcinuria, hyperkalemia, hyperphosphatemia, hyperuricemia, effexor getting off hyponatremia, hypophosphatemia, hypoproteinemia, and uremia. In all cases, hair re- growth occurred within 2 to 4 effexor getting off following discontinuation of venlafaxine.
Dermatologic side effects have included sweating in up to approximately 14% of treated patients. In the event that therapy is not reintroduced, withdrawal symptoms may last effexor getting off 5 to 7 days before resolving spontaneously.
In one case report, withdrawal- induced full mania developed in a 33- year- old patient following abrupt termination of treatment with venlafaxine extended-release (150 mg daily for 10 weeks).
Hepatic
Hepatic side effects have included effexor getting off hepatitis. 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. Although these events occurred during treatment with venlafaxine, causality has not been determined.
One case of anasarca was reported in a patient receiving venlafaxine. effexor getting off the COSTART term for an event was so general as to be uninformative, it was replaced with a more informative term. In the event that therapy is not reintroduced, withdrawal symptoms may last from 5 to 7 days before resolving spontaneously.
In one case report, withdrawal- induced full mania developed in a 33- year- old patient following abrupt termination of treatment with venlafaxine extended-release (150 mg daily for 10 weeks).
Hepatic
Hepatic side effects have included toxic hepatitis. The reduction in REM sleep is greatest early in treatment, but gradually returns towards baseline during long-term therapy; however, ROL remains long. If the COSTART term for an event was so general as to be uninformative, it was replaced with a more informative term. 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 effexor getting off 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 effexor getting off 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 speech, stupor, adjustment disorder, akinesia, alcohol abuse, aphasia, bradykinesia, buccoglossal syndrome, cerebrovascular accident, feeling drunk, loss of consciousness, dementia, dystonia, effexor getting off 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. The frequencies presented, therefore, represent the proportion of the 5356 patients effexor getting off to multiple doses of either formulation of venlafaxine who experienced an event of the type cited on at least one occasion while receiving venlafaxine. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their effexor getting off choosing. Although these events occurred during treatment with venlafaxine, causality has effexor getting off been determined.
There have been a minimum of approximately fifteen cases of hyponatremia in which at least one was life threatening, including at least one case of recurrent venlafaxine- induced hyponatremia after rechallenge.
A recent short-term study (6 weeks) has effexor getting off an average weight loss of 2 to 3 pounds in patients treated with venlafaxine.
Numerous cases of hyponatremia have been reported following treatment with a selective serotonin reuptake inhibitor (SSRI). All reported events are included except those already listed effexor getting off Table 2 and those events for which a drug cause was remote. There have been postmarketing reports of toxic epidermal necrolysis.
One case of venlafaxine-induced Stevens-Johnson syndrome has effexor getting off reported. Symptoms resolved following discontinuation of 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 effexor getting off treatment with venlafaxine, causality has not effexor getting off determined.
Musculoskeletal
Musculoskeletal side effexor getting off have included rhabdomyolysis.
Musculoskeletal side effects reported in premarketing effexor getting off 3 trials have 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. effexor getting off are not sufficient data with the use of venlafaxine extended-release at doses above 300 mg/day to determine the incidence of sustained increases in blood pressure at these high doses.
One study has reported average systolic blood pressure increases of 1.7 to 3.4 mm Hg and average diastolic pressure increases of 0.4 to 2.6 mm Hg.
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