effexor may not work for everyone

It is important to emphasize 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 1/100 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, malaise, moniliasis, neck rigidity, pelvic pain, photosensitivity reaction, suicide attempt, withdrawal 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, effexor may not work for everyone branch block, capillary fragility, cardiovascular disorder (mitral effexor may not work for everyone and circulatory disturbance), cerebral ischemia, coronary artery disease, congestive heart failure, heart arrest, mucocutaneous hemorrhage, myocardial infarct, pallor. Digestive system—Frequent: eructation; Infrequent: bruxism, colitis, dysphagia, effexor may not work for everyone edema, esophagitis, gastritis, gastroenteritis, gastrointestinal effexor may not work for everyone gingivitis, glossitis, rectal 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, effexor may not work for everyone nodule, thyroiditis. Hemic and lymphatic system—Frequent: ecchymosis; Infrequent: anemia, leukocytosis, leukopenia, lymphadenopathy, thrombocythemia, thrombocytopenia; Rare: basophilia, bleeding time effexor may not work for everyone cyanosis, eosinophilia, lymphocytosis, multiple myeloma, purpura. Metabolic and nutritional—Frequent: edema, weight gain; Infrequent: alkaline phosphatase increased, dehydration, hypercholesteremia, hyperglycemia, hyperlipemia, hypokalemia, effexor may not work for everyone (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, effexor may not work for everyone stimulation, emotional lability, euphoria, hallucinations, hostility, hyperesthesia, hyperkinesia, hypotonia, incoordination, libido increased, manic effexor may not work for everyone 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, urticaria; Rare: erythema nodosum, exfoliative dermatitis, lichenoid effexor may not work for everyone hair discoloration, skin effexor may not work for everyone furunculosis, hirsutism, leukoderma, petechial rash, pustular rash, vesiculobullous rash, seborrhea, skin atrophy, skin striae. Special senses—Frequent: abnormality of accommodation, abnormal effexor may not work for everyone 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 effexor may not work for everyone 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 function 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 effexor may not work for everyone 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 Syndrome, 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, effexor may not work for everyone increased, renal failure, rhabdomyolysis, shock-like electrical sensations or tinnitus (in 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 effexor may not work for everyone following the addition of venlafaxine. The onset of venlafaxine- associated interstitial pneumonitis has ranged from 1 to 18 effexor may not work for everyone after initial exposure to the drug and symptomatic improvement occurred after discontinuation of effexor may not work for everyone and treatment with corticosteroids. Top More Effexor resources Effexor Detailed Consumer Information (PDR) Effexor Prescribing Information (FDA) Effexor Consumer Overview Effexor Advanced Consumer (Micromedex) - Includes Dosage Information Effexor MedFacts Consumer Leaflet (Wolters Kluwer) Venlafaxine Prescribing Information (FDA) Effexor XR Prescribing Information (FDA) Effexor XR Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer). There have been effexor may not work for everyone 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 (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 effexor may not work for everyone 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, effexor may not work for everyone and twitching. 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 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. Following discontinuation of venlafaxine, symptoms resolved within approximately 72 hours. The onset of withdrawal symptoms ranges from 14 to 48 hours after the last dose of venlafaxine extended-release and symptoms tend to resolve rapidly (range, within 2 to 24 hours) after resumption of therapy. Symptoms can be minimized by slow tapering or switching to a drug with a longer effexor may not work for everyone (e.g., fluoxetine). Risk effexor may not work for everyone 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 been identified. There have been postmarketing reports of toxic epidermal necrolysis. One case of venlafaxine-induced Stevens-Johnson syndrome has been reported. 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. Although these events occurred during treatment with venlafaxine, causality has not been 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. Following discontinuation of therapy the amount of REM sleep tends to rebound. In a flexible-dose study, with doses in the range of 200 effexor may not work for everyone 375 mg/day and mean dose greater than 300 mg/day, the mean change in heart rate was 8.5 beats per minute compared with 1.7 beats per minute for placebo. Other Events Observed During the Premarketing Evaluation of Venlafaxine During its premarketing assessment, effexor may not work for everyone doses of Effexor were administered to 2897 patients in Phase 2 and Phase 3 studies. 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. Following discontinuation of venlafaxine, symptoms resolved within approximately 72 hours. Additional data are required to confirm this finding. Cardiovascular side effects effexor may not work for everyone frequently included vasodilatation, hypertension, palpitation, postural hypotension, and tachycardia. Cardiovascular side effects reported in premarketing Phase 3 trials have included angina pectoris, arrhythmia, bradycardia, effexor may not work for everyone hypotension, peripheral vascular disorder (mainly cold feet and/or cold hands), effexor may not work for everyone 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. Clinically relevant increases in serum cholesterol, defined as 1) a final on-therapy increase in serum cholesterol ≥50 mg/dL from baseline and effexor may not work for everyone 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 effexor may not work for everyone of ECGs obtained in 769 effexor may not work for everyone treated with Effexor and 450 patients treated with placebo in controlled clinical trials, the only statistically significant difference observed was for heart rate, ie, effexor may not work for everyone mean increase from baseline of 4 beats per minute for Effexor. Tests for potential dose relationships for these events (Cochran-Armitage Test, with a criterion of exact effexor may not work for everyone 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 effexor may not work for everyone 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 effexor may not work for everyone trials was associated with a mean increase in pulse rate of approximately 3 beats per minute, compared to no change effexor may not work for everyone placebo. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories. In the tabulations that effexor may not work for everyone reported adverse events were classified using a standard COSTART-based Dictionary terminology.

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