panic disorder effexor xr

The reduction in REM sleep is greatest early in treatment, but gradually returns towards baseline during long-term therapy; however, ROL remains long. 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, panic disorder effexor xr leg cramps, myasthenia, tenosynovitis, bone pain, pathological fracture, muscle cramp, muscle spasms, musculoskeletal stiffness, myopathy, osteoporosis, osteosclerosis, plantar fasciitis, rheumatoid arthritis, and tendon rupture. Dermatologic side effects reported in premarketing Phase 3 trials have included pruritus, acne, alopecia, contact dermatitis, dry skin, eczema, maculopapular rash, psoriasis, urticaria, brittle nails, erythema nodosum, exfoliative dermatitis, lichenoid dermatitis, hair discoloration, skin discoloration, furunculosis, hirsutism, leukoderma, miliaria, petechial rash, pruritic rash, pustular rash, vesiculobullous rash, seborrhea, skin atrophy, skin hypertrophy, skin striae, and decreased sweating. 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. 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. 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). Although these events occurred during treatment with venlafaxine, causality has not been determined. There is a single case report of breast pain associated with venlafaxine therapy. Dermatologic At least 3 cases of venlafaxine- induced alopecia have been reported. Although these events occurred during treatment 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. 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. Angle-closure glaucoma has been reported rarely. Ocular side effects reported in premarketing Phase panic disorder effexor xr trials have included abnormality of accommodation, mydriasis, conjunctivitis, diplopia, dry eyes, eye pain, photophobia, visual field defect, blepharitis, cataract, chromatopsia, conjunctival edema, panic disorder effexor xr lesion, exophthalmos, eye hemorrhage, glaucoma, retinal hemorrhage, subconjunctival hemorrhage, keratitis, miosis, papilledema, decreased pupillary reflex, scleritis, and uveitis. 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. 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 panic disorder effexor xr 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, motion sickness, neuritis, nystagmus, paresis, decreased or increased reflexes, and torticollis. There are not sufficient data with the use of venlafaxine extended-release at doses above 300 mg/day to determine the incidence of sustained increases in blood pressure at these high doses. One study has reported average systolic blood pressure increases of 1.7 to 3.4 mm Hg and average diastolic pressure increases of 0.4 to 2.6 mm Hg. Although these events occurred during treatment with venlafaxine, causality has not been panic disorder effexor xr coordination and balance have been reported in postmarketing studies. Seizures have been reported in 0.26% of treated patients during premarketing testing. Although panic disorder effexor xr events occurred during treatment with venlafaxine, causality has not panic disorder effexor xr 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 panic disorder effexor xr and tendon rupture. 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, panic disorder effexor xr 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, panic disorder effexor xr 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 panic disorder effexor xr per minute, compared to no change for placebo. Although these events occurred during treatment with venlafaxine, causality has not been determined. This increase was duration dependent over the study period and tended to be greater with higher doses. 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 authors state that it is possible that the anasarca was due to an allergic or delayed- type hypersensitivity reaction given the circumstances. There are numerous case reports of withdrawal symptoms following abrupt discontinuation of treatment, and a single case report of severe tinnitus associated with venlafaxine. Withdrawal effects occur upon abrupt discontinuation of treatment and the severity of symptoms appears to be dependent on length of therapy and dose (including low dose therapy). In a flexible-dose panic disorder effexor xr 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 compared 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 were administered to 2897 patients in Phase 2 and Phase 3 studies. 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, bundle branch block, capillary fragility, cardiovascular disorder (mitral valve 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, tongue edema, esophagitis, gastritis, gastroenteritis, gastrointestinal ulcer, gingivitis, glossitis, rectal hemorrhage, hemorrhoids, melena, panic disorder effexor xr 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, thrombocythemia, thrombocytopenia; Rare: basophilia, bleeding time increased, cyanosis, eosinophilia, lymphocytosis, multiple myeloma, purpura. Metabolic and nutritional—Frequent: edema, panic disorder effexor xr 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, panic disorder effexor xr stimulation, emotional lability, euphoria, hallucinations, hostility, hyperesthesia, hyperkinesia, hypotonia, incoordination, libido increased, manic reaction, 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 panic disorder effexor xr contact dermatitis, dry skin, eczema, skin hypertrophy, maculopapular rash, psoriasis, urticaria; Rare: erythema nodosum, exfoliative dermatitis, lichenoid dermatitis, hair discoloration, skin discoloration, furunculosis, hirsutism, leukoderma, petechial rash, pustular rash, vesiculobullous rash, seborrhea, panic disorder effexor xr 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, panic disorder effexor xr 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 panic disorder effexor xr 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 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 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, prolactin 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 panic disorder effexor xr clozapine levels that were temporally associated with adverse events, including seizures, following the addition of venlafaxine. There have been postmarketing reports of toxic epidermal necrolysis. One case of venlafaxine-induced Stevens-Johnson syndrome has been reported. 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 Phase 3 trials panic disorder effexor xr included increased cough, dyspnea, asthma, chest congestion, epistaxis, hyperventilation, laryngismus, laryngitis, pneumonia, voice alteration, atelectasis, hemoptysis, hypoventilation, hypoxia, larynx edema, pleurisy, pulmonary embolus, and sleep apnea. 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), panic disorder effexor xr hypertension, mydriasis, QTc prolongation, and transient arrhythmia can be expected. 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 compared 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 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. 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). The onset of venlafaxine- associated interstitial pneumonitis has ranged from 1 to 18 months after initial exposure to panic disorder effexor xr drug and symptomatic improvement occurred after discontinuation of venlafaxine 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 panic disorder effexor xr (Wolters Kluwer) Venlafaxine Prescribing Information (FDA) Effexor XR Prescribing Information (FDA) Effexor XR Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer). 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 follow, reported adverse events were classified using a standard COSTART-based Dictionary terminology. 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 panic disorder effexor xr 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 panic disorder effexor xr 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.

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