effexor versus effexor xr
The frequencies presented, therefore, represent the proportion effexor versus effexor xr 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. The reduction in REM sleep is greatest early in treatment, but gradually returns towards baseline during long-term therapy; however, ROL remains long. 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. The same study reported an increase in the average pulse rate of 1.1 to 4.5 beats per minute.
Another study (n=7) suggests that venlafaxine may promote adverse cardiovascular and cerebrovascular events by increasing platelet activity in susceptible patients.
An increase in heart rate of 4 beats per minute has been reported.
According to a retrospective review, in the overdose setting (up to 3 g of venlafaxine), tachycardia, hypertension, mydriasis, QTc effexor versus effexor xr and transient arrhythmia can be effexor versus effexor xr Experience with the immediate-release venlafaxine showed that sustained hypertension was dose-related, increasing from 3% to effexor versus effexor xr at 100 to 300 mg/day to 13% at doses above 300 mg/day. Although these events effexor versus effexor xr during effexor versus effexor xr 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. 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. 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. The onset of withdrawal symptoms ranges from 14 to 48 hours effexor versus effexor xr the last dose of venlafaxine extended-release and symptoms tend to resolve rapidly (range, within 2 to 24 hours) after resumption of therapy. Symptoms resolved following discontinuation of therapy.
Genitourinary side effects have frequently included male and effexor versus effexor xr sexual dysfunction such as abnormal ejaculation in up to 16% of male patients, decreased libido (13%), impotence (13%), and organic dysfunction effexor versus effexor xr 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, effexor versus effexor xr 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. 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 effexor versus effexor xr 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.
Respiratory
Respiratory side effects have frequently included pharyngitis, sinusitis, and yawning.
Respiratory side effects reported in premarketing effexor versus effexor xr 3 trials have included increased cough, dyspnea, effexor versus effexor xr chest congestion, epistaxis, hyperventilation, laryngismus, laryngitis, pneumonia, voice alteration, atelectasis, hemoptysis, hypoventilation, hypoxia, larynx edema, pleurisy, pulmonary embolus, and sleep apnea. Following discontinuation of therapy the amount of REM sleep tends to rebound. 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 effexor versus effexor xr 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 effexor versus effexor xr adverse effexor versus effexor xr 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 effexor versus effexor xr more common adverse events associated with Effexor use, as shown in the table that follows. 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, effexor versus effexor xr 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, effexor versus effexor xr Syndrome, hyperchlorhydria, hypokinesia, hysteria, impulse control difficulties, increased libido, motion sickness, neuritis, nystagmus, paresis, decreased or increased reflexes, and torticollis. Following discontinuation of venlafaxine, symptoms resolved within approximately 72 hours. 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 effexor versus effexor xr mg/dL or 2) an average on‑therapy effexor versus effexor xr 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 with 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. 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. 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 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. Clinically relevant increases effexor versus effexor xr serum cholesterol, effexor versus effexor xr 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 effexor versus effexor xr 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 with 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. A case of increased libido and spontaneous erections has also been reported.
Although rare, several cases of effexor versus effexor xr induced urinary symptoms including nocturia, enuresis, increased urge/frequency, and incontinence have been reported. ough effexor versus effexor xr and dysmenorrhea3.
— Incidence less than 1%.
2 Incidence based on effexor versus effexor xr of male patients.
3 Incidence based effexor versus effexor xr 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 versus effexor xr 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. It is important to effexor versus effexor xr that, although the events reported occurred during treatment with venlafaxine, they were not necessarily caused by it.
Events are further categorized by body system and listed in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring on one or more occasions in at least effexor versus effexor xr patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.
Body as a whole—Frequent: accidental injury, chest pain substernal, neck pain; Infrequent: face edema, intentional injury, effexor versus effexor xr moniliasis, neck rigidity, pelvic pain, effexor versus effexor xr reaction, suicide attempt, effexor versus effexor xr syndrome; Rare: appendicitis, bacteremia, carcinoma, cellulitis.
Cardiovascular system—Frequent: migraine; Infrequent: angina pectoris, arrhythmia, extrasystoles, hypotension, peripheral vascular disorder (mainly cold feet and/or cold hands), syncope, thrombophlebitis; Rare: aortic aneurysm, arteritis, first-degree atrioventricular block, bigeminy, bradycardia, bundle effexor versus effexor xr block, capillary fragility, cardiovascular disorder (mitral valve and circulatory disturbance), cerebral ischemia, coronary artery disease, congestive heart failure, effexor versus effexor xr arrest, mucocutaneous hemorrhage, myocardial infarct, pallor.
Digestive system—Frequent: eructation; Infrequent: bruxism, colitis, dysphagia, tongue edema, esophagitis, gastritis, gastroenteritis, gastrointestinal effexor versus effexor xr gingivitis, glossitis, effexor versus effexor xr hemorrhage, hemorrhoids, melena, oral moniliasis, stomatitis, mouth ulceration; Rare: cheilitis, cholecystitis, cholelithiasis, duodenitis, esophageal spasm, hematemesis, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, ileitis, jaundice, intestinal obstruction, parotitis, periodontitis, proctitis, increased salivation, soft stools, tongue discoloration.
Endocrine system—Rare: goiter, hyperthyroidism, hypothyroidism, thyroid nodule, thyroiditis.
Hemic and lymphatic system—Frequent: ecchymosis; Infrequent: anemia, leukocytosis, leukopenia, lymphadenopathy, effexor versus effexor xr thrombocytopenia; Rare: basophilia, bleeding time increased, effexor versus effexor xr eosinophilia, lymphocytosis, multiple myeloma, purpura.
Metabolic and nutritional—Frequent: edema, weight gain; Infrequent: alkaline phosphatase increased, dehydration, hypercholesteremia, hyperglycemia, hyperlipemia, hypokalemia, SGOT (AST) increased, SGPT (ALT) increased, thirst; Rare: alcohol intolerance, bilirubinemia, BUN increased, creatinine increased, diabetes mellitus, glycosuria, gout, healing abnormal, hemochromatosis, hypercalcinuria, hyperkalemia, hyperphosphatemia, hyperuricemia, hypocholesteremia, hypoglycemia, hyponatremia, hypophosphatemia, hypoproteinemia, uremia.
Musculoskeletal system—Infrequent: arthritis, arthrosis, bone pain, bone spurs, bursitis, leg cramps, myasthenia, tenosynovitis; Rare: pathological fracture, myopathy, osteoporosis, osteosclerosis, plantar fasciitis, rheumatoid arthritis, tendon rupture.
Nervous system—Frequent: trismus, vertigo; Infrequent: akathisia, apathy, ataxia, circumoral paresthesia, CNS stimulation, emotional lability, euphoria, hallucinations, hostility, hyperesthesia, hyperkinesia, hypotonia, incoordination, libido increased, manic effexor versus effexor xr myoclonus, neuralgia, neuropathy, psychosis, seizure, abnormal speech, stupor; Rare: akinesia, alcohol abuse, aphasia, bradykinesia, buccoglossal syndrome, cerebrovascular accident, loss of consciousness, delusions, dementia, dystonia, facial paralysis, feeling drunk, abnormal gait, Guillain-Barre Syndrome, hyperchlorhydria, hypokinesia, impulse control difficulties, neuritis, nystagmus, paranoid reaction, paresis, psychotic depression, reflexes decreased, reflexes increased, suicidal ideation, torticollis.
Respiratory system—Frequent: bronchitis, dyspnea; Infrequent: asthma, chest congestion, epistaxis, hyperventilation, laryngismus, laryngitis, pneumonia, voice alteration; Rare: atelectasis, hemoptysis, hypoventilation, hypoxia, larynx edema, pleurisy, pulmonary embolus, sleep apnea.
Skin and appendages—Infrequent: acne, alopecia, brittle nails, contact dermatitis, dry skin, eczema, skin hypertrophy, maculopapular rash, psoriasis, effexor versus effexor xr Rare: erythema nodosum, exfoliative dermatitis, lichenoid dermatitis, hair discoloration, skin discoloration, furunculosis, hirsutism, leukoderma, petechial effexor versus effexor xr pustular rash, vesiculobullous rash, seborrhea, skin atrophy, skin striae.
Special senses—Frequent: abnormality of accommodation, abnormal vision; Infrequent: cataract, conjunctivitis, corneal lesion, diplopia, dry eyes, eye pain, hyperacusis, otitis media, parosmia, photophobia, taste loss, visual field defect; Rare: blepharitis, chromatopsia, conjunctival edema, deafness, exophthalmos, glaucoma, retinal hemorrhage, subconjunctival hemorrhage, keratitis, labyrinthitis, miosis, papilledema, decreased pupillary reflex, otitis externa, scleritis, uveitis.
Urogenital system—Frequent: metrorrhagia*, prostatic disorder (prostatitis and enlarged prostate)*, vaginitis*; Infrequent: albuminuria, amenorrhea*, cystitis, dysuria, hematuria, leukorrhea*, menorrhagia*, nocturia, bladder pain, breast pain, polyuria, pyuria, urinary incontinence, urinary urgency, vaginal hemorrhage*; Rare: abortion*, anuria, balanitis*, breast discharge, breast engorgement, breast enlargement, endometriosis*, fibrocystic breast, calcium crystalluria, cervicitis*, ovarian cyst*, prolonged erection*, gynecomastia (male)*, hypomenorrhea*, kidney calculus, kidney pain, kidney effexor versus effexor xr abnormal, female lactation*, mastitis, menopause*, oliguria, orchitis*, pyelonephritis, salpingitis*, urolithiasis, uterine hemorrhage*, uterine spasm*, vaginal dryness*.
* Based on the number of men and women as appropriate.
Postmarketing Reports
Voluntary reports of other adverse events temporally associated with the use of venlafaxine that have been received since market introduction and that may have no causal relationship with the use of venlafaxine include the following: agranulocytosis, anaphylaxis, angioedema, aplastic anemia, catatonia, congenital anomalies, impaired coordination and balance, CPK increased, deep vein thrombophlebitis, delirium, EKG abnormalities such as QT prolongation; cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia, ventricular extrasystole, and rare reports of ventricular fibrillation and ventricular tachycardia, including torsade de pointes; toxic epidermal necrolysis/Stevens-Johnson effexor versus effexor xr erythema multiforme, extrapyramidal symptoms (including dyskinesia and tardive dyskinesia), angle-closure glaucoma, hemorrhage (including eye and gastrointestinal bleeding), hepatic events (including GGT elevation; abnormalities of unspecified liver function tests; liver damage, necrosis, or failure; and fatty liver), interstitial lung disease, involuntary movements, LDH increased, neutropenia, night sweats, pancreatitis, pancytopenia, panic, prolactin increased, renal failure, rhabdomyolysis, shock-like electrical sensations or tinnitus effexor versus effexor xr some cases, subsequent to the discontinuation of venlafaxine or tapering of dose), and syndrome of inappropriate antidiuretic hormone secretion (usually in the elderly).
There have been reports of elevated clozapine levels that were temporally associated with adverse events, including seizures, following the addition of venlafaxine. Tests for potential dose relationships for these events (Cochran-Armitage Test, with a criterion effexor versus effexor xr 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.
Although rare, interstitial pneumonitis secondary to venlafaxine therapy has been reported. effexor versus effexor xr 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 reflux disease, gastrointestinal effexor versus effexor xr 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.
There is a single effexor versus effexor xr report of breast pain associated with venlafaxine therapy.
Dermatologic
At least 3 cases of venlafaxine- induced alopecia have been reported. 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. effexor versus effexor xr
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