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Common Side Effects of Effexor (Venlafaxine Hydrochloride) Drug Center. SIDE EFFECTSAssociated With Discontinuation Of Treatment. Nineteen percent (5. Phase. 2 and Phase 3 depression studies discontinued treatment due to an adverse. The more common events ( . This table shows the. ![]() Reported adverse events were classified. COSTART- based Dictionary terminology. What are the possible side effects of venlafaxine (Effexor, Effexor XR)? Get emergency medical help if you have any of these signs of an allergic reaction: skin rash.![]() Wellbutrin xl online prescription. Bristol Decking is a Well established decking and landscaping company with over 14 years of experience. We work within both the private and commercial sector. Effexor XR official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions, pharmacology and more. The prescriber should be aware that these figures cannot be. Similarly, the cited frequencies cannot. The cited figures, however, do. TABLE 2: Treatment- Emergent Adverse Experience Incidence. Week Placebo- Controlled Clinical Trials. Body System/Preferred Term. Effexor (venlafaxine) is an antidepressant used for treatment of major depression. A generic version of Effexor is available. Side effects of Effexor include. Effexor(n=1. 03. 3)Placebo (n=6. Body as a Whole Headache. Asthenia. 12%6%Infection. Chills. 3%- Chest pain. Trauma. 2%1%Cardiovascular. Vasodilatation. 4%3%Increased blood pressure/hypertension. Tachycardia. 2%- Postural hypotension 1% - Dermatological Sweating 1. Rash 3%2%Pruritus 1%- Gastrointestinal Nausea 3. Constipation 1. 5%7%Anorexia 1. Diarrhea 8%7%Vomiting 6%2%Dyspepsia 5%4%Flatulence 3%2%Metabolic Weight loss 1%- Nervous System Somnolence 2. Dry mouth 2. 2%1. Dizziness 1. 9%7%Insomnia 1. Nervousness 1. 3%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. Tinnitus. 2%- Mydriasis. Urogenital System Abnormal ejaculation/ orgasm 1. Impotence 6%2- 2. Urinary frequency 3%2%Urination impaired 2%- Orgasm disturbance 2%3- 3. Events reported by at least 1% of patients. USP are included, and are rounded to the. Events for which the venlafaxine tablets, USP incidence was equal to. Incidence less than 1%. Incidence based on number of male patients. Incidence based on number of female patients. Dose Dependency Of Adverse Events. A comparison of adverse event rates in a fixed- dose study. USP 7. 5, 2. 25, and 3. USP use, as shown in the table that follows. The rule. for including events was to enumerate those that occurred at an incidence of 5%. USP group. Tests for potential dose relationships for these events (Cochran- Armitage. Test, with a criterion of exact 2 sided p- value . In a. flexible- dose study, with doses in the range of 2. In controlled clinical trials, venlafaxine tablets, USP was. Hg averaged over all dose groups, compared to mean decreases ranging. Hg for placebo. However, there is a dose dependency for. WARNINGS). Laboratory Changes. Of the serum chemistry and hematology parameters monitored. USP, a statistically significant. In premarketing. trials, treatment with venlafaxine tablets, USP was associated with a mean. L. Patients treated with venlafaxine tablets, USP for at least. L compared with a decrease. L among placebo- treated patients. This increase was duration dependent. Clinically. relevant increases in serum cholesterol, defined as 1) a final on- therapy. In a flexible- dose study, with doses in the range of. PRECAUTIONS, General, Use in Patients With Concomitant. Illness). Other Events Observed During The Premarketing Evaluation Of Venlafaxine. During its premarketing assessment, multiple doses of. USP were administered to 2. Phase 2 and. Phase 3 studies. In addition, in premarketing assessment of venlafaxine hydrochloride. Phase 3 major depressive disorder studies and venlafaxine tablets, USP was. During its premarketing assessment, multiple doses. Phase 3 GAD studies and 2. Phase 3 Social Anxiety. Disorder studies. The conditions and duration of exposure to venlafaxine in. USP only) and outpatient studies, fixed- dose. Untoward events associated with this exposure were. The. frequencies presented, therefore, represent the proportion of the 5. All reported events are included except those already listed in. TABLE 2 and those events for which a drug cause was remote. If the COSTART term. It is important to emphasize that, although the events. Events are further categorized by body system and listed in. Body as a whole- Frequent: accidental injury. Infrequent: face edema, intentional. Rare: appendicitis. Cardiovascular system- Frequent: migraine; Infrequent. Rare. aortic aneurysm, arteritis, first- degree atrioventricular block, bigeminy, bradycardia. Digestive system- Frequent: eructation; Infrequent. Rare: cheilitis, cholecystitis, cholelithiasis, duodenitis, esophageal. Endocrine system- Rare: goiter. Hemic and lymphatic system- Frequent. Infrequent: anemia, leukocytosis, leukopenia, lymphadenopathy. Rare: basophilia, bleeding time. Metabolic and nutritional- Frequent: edema. Infrequent: alkaline phosphatase increased, dehydration. SGOT (AST). increased, SGPT (ALT) increased, thirst; Rare: alcohol intolerance. BUN increased, creatinine increased, diabetes mellitus. Musculoskeletal system- Infrequent: arthritis. Rare: pathological fracture, myopathy, osteoporosis. Nervous system- Frequent: trismus, vertigo; Infrequent. CNS stimulation, emotional. Rare. akinesia, alcohol abuse, aphasia, bradykinesia, buccoglossal syndrome. Guillain- Barre Syndrome, hyperchlorhydria. Respiratory system- Frequent: bronchitis. Infrequent: asthma, chest congestion, epistaxis, hyperventilation. Rare: atelectasis. Skin and appendages- Infrequent: acne. Rare: erythema nodosum. Special senses- Frequent: abnormality of. Infrequent: cataract, conjunctivitis. Rare. blepharitis, chromatopsia, conjunctival edema, deafness, exophthalmos. Urogenital system- Frequent: metrorrhagia*. Infrequent. albuminuria, amenorrhea*, cystitis, dysuria, hematuria, leukorrhea*, menorrhagia*. Rare: abortion*, anuria. Based on the number of men and women as appropriate. Postmarketing Reports. Voluntary reports of other adverse events temporally. CPK. increased, deep vein thrombophlebitis, delirium, EKG abnormalities such as QT. Stevens- Johnson syndrome, erythema multiforme. GGT elevation; abnormalities of unspecified liver function. LDH increased, neutropenia, night sweats. There have been reports of elevated clozapine levels that. There have been reports of increases in. INR when venlafaxine was. Controlled Substance. Venlafaxine tablets, USP is not a controlled substance. Physical And Psychological Dependence. In vitro studies revealed that venlafaxine has virtually no. PCP), or. N- methyl- D- aspartic acid (NMDA) receptors. Venlafaxine was not found to have any significant CNS. In primate drug discrimination studies. Discontinuation effects have been reported in patients. DOSAGE AND ADMINISTRATION). While venlafaxine tablets, USP has not been systematically. However, it is not possible to. CNS. active drug will be misused, diverted, and/or abused once marketed. Effexor XR - FDA prescribing information, side effects and uses. Major Depressive Disorder. Effexor XR (venlafaxine hydrochloride) extended- release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short- term (4, 8, and 1. Generalized Anxiety Disorder. Effexor XR is indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8- week and two 2. Social Anxiety Disorder. Effexor XR is indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 1. Panic Disorder. Effexor XR is indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 1. Effexor XR Dosage and Administration. Effexor XR should be administered in a single dose with food, either in the morning or in the evening at approximately the same time each day . Each capsule should be swallowed whole with fluid and not divided, crushed, chewed, or placed in water or it may be administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of applesauce. This drug/food mixture should be swallowed immediately without chewing and followed with a glass of water to ensure complete swallowing of the pellets (spheroids). Major Depressive Disorder. For most patients, the recommended starting dose for Effexor XR is 7. For some patients, it may be desirable to start at 3. Patients not responding to the initial 7. Dose increases should be in increments of up to 7. In the clinical studies establishing efficacy, upward titration was permitted at intervals of 2 weeks or more. It should be noted that, while the maximum recommended dose for moderately depressed outpatients is also 2. Effexor (immediate- release), more severely depressed inpatients in one study of the development program for that product responded to a mean dose of 3. Whether or not higher doses of Effexor XR are needed for more severely depressed patients is unknown; however, the experience with Effexor XR doses higher than 2. Generalized Anxiety Disorder. For most patients, the recommended starting dose for Effexor XR is 7. For some patients, it may be desirable to start at 3. Patients not responding to the initial 7. Dose increases should be in increments of up to 7. There was no evidence that higher doses confer any additional benefit. Panic Disorder. The recommended starting dose is 3. Effexor XR for 7 days. Patients not responding to 7. Dose increases should be in increments of up to 7. Switching Patients from Effexor Tablets. Depressed patients who are currently being treated at a therapeutic dose with Effexor (immediate release) may be switched to Effexor XR at the nearest equivalent dose (mg per day), e. Effexor XR once daily. However, individual dosage adjustments may be necessary. Specific Populations. Patients with Hepatic Impairment. The total daily dose should be reduced by 5. Child- Pugh=5–6) to moderate (Child- Pugh=7–9) hepatic impairment. In patients with severe hepatic impairment (Child- Pugh=1. In patients undergoing hemodialysis or with severe renal impairment (CLcr < 3. L/min), the total daily dose should be reduced by 5. Because there was much individual variability in clearance between patients with renal impairment, individualization of dosage may be desirable in some patients . Effexor XR/Effexor have demonstrated continuation of response in clinical studies up to 5. It is not known whether or not the dose of Effexor XR needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment. In patients with GAD and SAD, Effexor XR has been shown to be effective in 6- month clinical studies. The need for continuing medication in patients with GAD and SAD who improve with Effexor XR treatment should be periodically reassessed. In a clinical study for PD, patients continuing Effexor XR at the same dose at which they responded during the initial 1. The need for continuing medication in patients with PD who improve with Effexor XR treatment should be periodically reassessed. Discontinuing Effexor XRA gradual reduction in the dose, rather than abrupt cessation, is recommended whenever possible. In clinical studies with Effexor XR, tapering was achieved by reducing the daily dose by 7. Individualization of tapering may be necessary . In addition, at least 7 days should be allowed after stopping Effexor XR before starting an MAOI intended to treat psychiatric disorders . In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization should be considered . If acceptable alternatives to linezolid or intravenous methylene blue are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Effexor XR should be stopped promptly, and linezolid or intravenous methylene blue can be administered. Monitor the patient for symptoms of serotonin syndrome for 7 days or until 2. Therapy with Effexor XR can be resumed 2. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use . The use of Effexor XR within 1. MAOI (intended to treat psychiatric disorders) is also contraindicated . Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long- standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short- term placebo- controlled studies of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 1. MDD and other psychiatric disorders. Short- term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 2. The pooled analyses of placebo- controlled studies in children and adolescents with MDD, Obsessive Compulsive Disorder (OCD), or other psychiatric disorders included a total of 2. The pooled analyses of placebo- controlled studies in adults with MDD or other psychiatric disorders included a total of 2. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug versus placebo), however, were relatively stable within age strata and across indications. These risk differences (drug- placebo difference in the number of cases of suicidality per 1,0. Table 1. Table 1: Difference in the Number of Cases of Suicidality per 1,0. Patients Treated versus Placebo. Age Range. Increases Compared to Placebo< 1. Decreases Compared to Placebo. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about drug effect on suicide. It is unknown whether the suicidality risk extends to longer term use, i. However, there is substantial evidence from placebo- controlled maintenance studies in adults with depression that the use of antidepressants can delay the recurrence of depression. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for MDD, as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms. If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms . Such monitoring should include daily observation by families and caregivers. Prescriptions for Effexor XR should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose. Screening Patients for Bipolar Disorder. A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled studies) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown.
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