effexor benadryl
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 one was life threatening, including at least one case of recurrent venlafaxine- induced hyponatremia after rechallenge.
A recent short-term study (6 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). 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 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 have included kidney calculus, kidney pain, abnormal kidney function, and pyelonephritis. Dyskinesia has also been reported.
Venlafaxine has been reported to increase the pain tolerance threshold to electrical sural nerve stimulation and the effexor benadryl 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 speech, stupor, adjustment disorder, akinesia, alcohol abuse, aphasia, bradykinesia, buccoglossal syndrome, cerebrovascular accident, feeling drunk, loss of consciousness, dementia, dystonia, increased energy, facial paralysis, abnormal gait, Guillain-Barre Syndrome, hyperchlorhydria, hypokinesia, hysteria, impulse control difficulties, increased libido, effexor benadryl sickness, neuritis, nystagmus, paresis, decreased or increased reflexes, and torticollis. Although these effexor benadryl occurred during treatment with venlafaxine, causality has not been determined.
One case of anasarca was reported in a patient receiving venlafaxine. 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 dreams
4%
3%
Hypertonia
3%
2%
Paresthesia
3%
2%
Libido 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 effexor benadryl 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. Symptoms resolved following treatment with IV steroids and antidepressant therapy was safely switched to paroxetine. Symptoms can be minimized by slow tapering or switching to a drug with a longer half-life (e.g., fluoxetine). 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 titration studies. If the COSTART term for an event was so general as to be uninformative, it was replaced with a more informative term. Although these events occurred during treatment with venlafaxine, causality has not effexor benadryl determined.
Hematologic
Hematologic side effects have included have frequently included abnormal bleeding (most commonly ecchymosis).
Hematologic side effects reported in premarketing Phase 3 trials have included anemia, leukocytosis, leukopenia, lymphadenopathy, thrombocythemia, basophilia, increased bleeding time, cyanosis, eosinophilia, lymphocytosis, multiple myeloma, purpura, and thrombocytopenia. Additional data are required to confirm this finding.
Cardiovascular side effects have frequently included vasodilatation, hypertension, palpitation, postural hypotension, and tachycardia.
Cardiovascular side effects reported in premarketing Phase 3 trials have included angina pectoris, arrhythmia, bradycardia, extrasystoles, hypotension, peripheral vascular disorder (mainly cold feet and/or cold hands), syncope, thrombophlebitis, aortic aneurysm, arteritis, first-degree atrioventricular block, bigeminy, bundle branch block, capillary fragility, cerebral ischemia, coronary artery disease, congestive heart failure, heart arrest, hematoma, cardiovascular disorder (mitral valve and circulatory disturbance), mucocutaneous hemorrhage, myocardial infarct, pallor, and sinus arrhythmia. 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. Although these events occurred during treatment with venlafaxine, causality has not been determined.
Impaired coordination and balance have been reported effexor benadryl postmarketing studies.
Seizures have been reported in 0.26% of treated patients during premarketing testing. 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 effexor benadryl 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, effexor benadryl 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, 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. 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 effexor benadryl 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 benadryl were administered to 2897 patients in Phase 2 and Phase 3 studies.
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