effexor patient info
Risk factors for the development of SSRI- associated hyponatremia including advanced age, female gender, concomitant use of diuretics, low body weight, and lower baseline serum sodium levels have effexor patient info identified. Although these events occurred during treatment with venlafaxine, causality 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 effexor patient info 3 trials have included effexor patient info 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. Experience with the immediate-release venlafaxine showed that sustained hypertension was dose-related, increasing from effexor patient info to 7% at 100 to 300 mg/day to 13% at doses above 300 mg/day. The reduction in REM sleep is greatest early in treatment, but gradually returns towards baseline during long-term therapy; however, ROL remains long. Symptoms can be minimized by slow tapering or switching effexor patient info a drug with a longer half-life (e.g., fluoxetine). Although these events occurred during treatment with venlafaxine, causality has not been determined.
Ocular
Ocular side effects have included abnormal vision, primarily blurred effexor patient info in approximately 6% of patients. Additional data are required to confirm effexor patient info finding.
Cardiovascular side effects have frequently included vasodilatation, hypertension, palpitation, effexor patient info 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. 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. In addition, effexor patient info 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. 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 effexor patient info 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, effexor patient info neck rigidity, pelvic pain, photosensitivity reaction, suicide attempt, appendicitis, bacteremia, carcinoma, and cellulitis. There have been postmarketing reports of toxic epidermal necrolysis.
One case of venlafaxine-induced Stevens-Johnson syndrome has been reported. 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 effexor patient info trazodone.
One small study has suggested that venlafaxine may improve effexor patient info 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 effexor patient info 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, motion sickness, neuritis, nystagmus, paresis, decreased or increased effexor patient info and torticollis. Symptoms can be minimized by slow tapering or switching to a drug with a longer half-life (e.g., fluoxetine). Following discontinuation of therapy the amount of REM sleep tends to rebound. These antidepressants effexor patient info marked dose-dependent effects on rapid eye movement (REM) effexor patient info causing reductions in the overall amount of REM sleep over the night and delays the first entry into REM sleep (increased REM sleep onset latency (ROL)), both in healthy effexor patient info and depressed 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. 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 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. Although these events occurred during effexor patient info with venlafaxine, causality has not been determined.
There have been postmarketing reports of angioedema.
Genitourinary
One case of unexpected orgasm and subsequent ejaculation with no erection as well as orgasmic episodes with no ejaculation or erection has also been reported. Although these events occurred during treatment with venlafaxine, causality 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 effexor patient info included weight gain, increased alkaline phosphatase, dehydration, hypercholesteremia, hyperglycemia, hyperlipemia, effexor patient info hypokalemia, increased SGOT (AST), increased SGPT (ALT), thirst, bilirubinemia, increased BUN, increased creatinine, diabetes effexor patient info glycosuria, gout, abnormal healing, hemochromatosis, hypercalcinuria, hyperkalemia, effexor patient info hyperuricemia, hypocholesteremia, hyponatremia, hypophosphatemia, hypoproteinemia, and uremia. 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, abdominal distention, biliary pain, cheilitis, cholecystitis, cholelithiasis, esophageal spasms, duodenitis, hematemesis, gastroesophageal effexor patient info 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.
Although rare, interstitial pneumonitis secondary to venlafaxine therapy has been reported. Although these events occurred during treatment with venlafaxine, effexor patient info has not been determined.
Ocular
Ocular side effects have included abnormal vision, primarily blurred vision, in approximately 6% of patients. 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 (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 effexor patient info that follows. Although these events occurred during treatment with venlafaxine, causality has not been determined.
Ocular
Ocular side effects have included abnormal vision, primarily blurred vision, in approximately 6% of patients. Although these events occurred during treatment with venlafaxine, causality has not been determined.
Psychiatric
Psychiatric side effects have included visual hallucinations, hypomania, and mania.
Psychiatric side effects reported in premarketing Phase 3 trials have included emotional lability, delusions, euphoria, hallucinations, manic reaction, psychosis, suicidal ideation, abnormal/changed behavior, homicidal ideation, paranoid reaction, and psychotic depression. 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 effexor patient info 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 patient info 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 effexor patient info increased libido, motion sickness, neuritis, nystagmus, paresis, decreased or increased reflexes, and torticollis.
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