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The following adverse reactions are discussed in greater detail in other sections of the label: Hypersensitivity [see CONTRAINDICATIONS ] Suicidal Thoughts and Behaviors in Children, Adolescents, and Adults [see WARNINGS AND PRECAUTIONS ] Serotonin Syndrome [see WARNINGS AND PRECAUTIONS ] Elevations in Blood Pressure [see WARNINGS AND PRECAUTIONS ] Abnormal Bleeding [see WARNINGS AND PRECAUTIONS ] Angle Closure Glaucoma [see WARNINGS AND PRECAUTIONS ] Activation of Mania/Hypomania [see WARNINGS AND PRECAUTIONS ] Discontinuation Syndrome [see WARNINGS AND PRECAUTIONS ] Seizure [see WARNINGS AND PRECAUTIONS ] Hyponatremia [see WARNINGS AND PRECAUTIONS ] Weight and Height changes in Pediatric Patients [see WARNINGS AND PRECAUTIONS ] Appetite Changes in Pediatric Patients [see WARNINGS AND PRECAUTIONS ] Interstitial Lung Disease and Eosinophilic Pneumonia [see WARNINGS AND PRECAUTIONS ] Clinical Studies Experience. Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Most Common Adverse Reactions. The most commonly observed adverse reactions in the clinical study database in Effexor XR treated patients in MDD, GAD, SAD, and PD (incidence ? 5% and at least twice the rate of placebo) were: nausea (30. Adverse Reactions Reported As Reasons For Discontinuation Of Treatment. Combined across short-term, placebo-controlled premarketing studies for all indications, 12% of the 3,558 patients who received Effexor XR (37. The most common adverse reactions leading to discontinuation in ? 1% of the Effexor XR treated patients in the short-term studies (up to 12 weeks) across indications are shown in Table 7. Table 7: Incidence (%) of Patients Reporting Adverse Reactions Leading to Discontinuation in Placebo-controlled Clinical Studies (up to 12 Weeks Duration) Body System Adverse Reaction Effexor XR n = 3,558 Placebo n = 2,197 Body as a whole Asthenia 1, best websites to buy anabolic steroids. Common Adverse Reactions In Placebo-Controlled Studies. The number of patients receiving multiple doses of Effexor XR during the premarketing assessment for each approved indication is shown in Table 8. The conditions and duration of exposure to venlafaxine in all 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. Table 8: Patients Receiving Effexor XR in Premarketing Clinical Studies Indication Effexor XR MDD 705 a GAD 1,381 SAD 819 PD 1,314 a In addition, in the premarketing assessment of Effexor, multiple doses were administered to 2,897 patients in studies for MDD. The incidences of common adverse reactions (those that occurred in ? 2% of Effexor XR treated patients [357 MDD patients, 1,381 GAD patients, 819 SAD patients, and 1,001 PD patients] and more frequently than placebo) in Effexor XR treated patients in short-term, placebo-controlled, fixed-and flexible-dose clinical studies (doses 37. The adverse reaction profile did not differ substantially between the different patient populations. Table 9: Common Adverse Reactions: Percentage of Patients Reporting Adverse Reactions (? 2% and > placebo) in Placebo-controlled Studies (up to 12 Weeks Duration) across All Indications Body System Adverse Reaction Effexor XR n = 3,558 Placebo n = 2,197 Body as a whole Asthenia 12. 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