effexor and mdma
ough increased, and dysmenorrhea3.
— Incidence less than 1%.
2 Incidence based on number of male patients.
3 Incidence based on number of female patients.
Body as a Whole
Headache
25%
24%
Asthenia
12%
6%
Infection
6%
5%
Chills
3%
—
Chest pain
2%
1%
Trauma
2%
1%
Cardiovascular
Vasodilatation
4%
3%
Increased blood pressure/hypertension
2%
—
Tachycardia
2%
—
Postural hypotension
1%
—
Dermatological
Sweating
12%
3%
Rash
3%
2%
Pruritus
1%
—
Gastrointestinal
Nausea
37%
11%
Constipation
15%
7%
Anorexia
11%
2%
Diarrhea
8%
7%
Vomiting
6%
2%
Dyspepsia
5%
4%
Flatulence
3%
2%
Metabolic
Weight loss
1%
—
Nervous System
Somnolence
23%
9%
Dry mouth
22%
11%
Dizziness
19%
7%
Insomnia
18%
10%
Nervousness
13%
6%
Anxiety
6%
3%
Tremor
5%
1%
Abnormal effexor and mdma decreased
2%
—
Agitation
2%
—
Confusion
2%
1%
Thinking abnormal
2%
1%
Depersonalization
1%
—
Depression
1%
—
Urinary retention
1%
—
Twitching
1%
—
Respiration
Yawn
3%
—
Special Senses
Blurred vision
6%
2%
Taste perversion
2%
—
Tinnitus
2%
—
Mydriasis
2%
—
Urogenital System
Abnormal ejaculation/ orgasm
12%2
—2
Impotence
6%2
—2
Urinary frequency
3%
2%
Urination impaired
2%
—
Orgasm disturbance
2%3
—3
Dose Dependency of Adverse Events
A comparison of adverse event rates in a fixed-dose study comparing Effexor (venlafaxine hydrochloride) 75, 225, and 375 mg/day with placebo revealed a dose dependency for some of the more common adverse events associated with Effexor use, as shown in the table that follows. The frequencies presented, therefore, represent the proportion of the 5356 effexor and mdma 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. All reported events are included except those already listed in Table 2 and those events for which effexor and mdma drug cause was remote. The reported incidence of each effexor and mdma these effects ranges between 10% and 20% of treated patients. 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. The antidepressants that increase serotonin function appear to have the greatest effect on REM sleep. In addition, in premarketing assessment of Effexor XR (the extended release form of venlafaxine), multiple doses were administered to 705 patients in Phase 3 major depressive disorder studies and Effexor was administered to 96 patients. Some of these drugs (i.e., bupropion, mirtazapine, nefazodone, trazodone, trimipramine) appear to have a modest or minimal effect on REM sleep.
Cardiovascular
There are reports of sustained hypertension (some requiring immediate treatment). 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 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.
There have been a minimum of approximately fifteen cases of hyponatremia in which at least effexor and mdma was life threatening, including at least one case of recurrent venlafaxine- induced hyponatremia after rechallenge.
A recent short-term study effexor and mdma weeks) has reported 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). The conditions and duration of exposure to venlafaxine in effexor and mdma 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 titration studies. Following discontinuation of therapy the amount of REM sleep tends to rebound. All reported events are included except those already listed in Table 2 and those events for which a drug cause was remote. Some of these drugs (i.e., bupropion, mirtazapine, nefazodone, trazodone, trimipramine) appear to have a modest or minimal effect on REM sleep.
Cardiovascular
There are reports of sustained hypertension (some requiring immediate treatment). The reported incidence of each of these effects ranges between 10% and 20% of treated patients. 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. Hyponatremia tends to develop within the first few weeks of treatment (range 3 to 120 days) and typically resolves within 2 weeks (range 48 hours to 6 weeks) after therapy has been discontinued with some patients requiring treatment. There have been reports of increases in prothrombin time, partial thromboplastin time, or INR when venlafaxine was given to patients receiving warfarin therapy.
Top
Side Effects by Body System
Gastrointestinal
Gastrointestinal side effects have frequently included nausea (up to 35%), dry mouth (14% to 18%), constipation (12%), anorexia effexor and mdma 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, abdominal 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, effexor and mdma decreased libido, agitation, hypertonia, anxiety, delirium, and twitching.
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