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Author: Admin | 2025-04-28
Thoughts and Behaviors [see Warnings and Precautions (5.1)] • Agranulocytosis [see Warnings and Precautions (5.2)] • Serotonin Syndrome [see Contraindications (4), Warnings and Precautions (5.3), Drug Interactions (7)] • Angle-Closure Glaucoma [see Warnings and Precautions (5.4)] • QT Prolongation and Torsades de Pointes [see Warnings and Precautions (5.5)] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.6)] • Increased Appetite and Weight Gain [see Warnings and Precautions (5.7)] • Somnolence [see Warnings and Precautions (5.8)] • Activation of Mania or Hypomania [see Warnings and Precautions (5.9)] • Seizures [see Warnings and Precautions (5.10)] • Elevated Cholesterol and Triglycerides [see Warnings and Precautions (5.11)] • Hyponatremia [see Warnings and Precautions (5.12)] • Transaminase Elevations [see Warnings and Precautions (5.13)] • Discontinuation Syndrome [see Warnings and Precautions (5.14)] • Use in Patients with Concomitant Illness [see Warnings and Precautions (5.15)] 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below are from clinical trials in which mirtazapine tablets were administered to 2,796 patients in phase 2 and 3 clinical studies. The trials consisted of double-blind controlled and open-label studies, inpatient and outpatient studies, fixed dose, and titration studies. Adverse Reactions Leading to Discontinuation of Treatment Approximately 16% of the 453 patients who received mirtazapine tablets in U.S. 6-week placebo-controlled clinical trials discontinued treatment due to an adverse reaction, compared to 7% of the 361 placebo-treated patients in those studies. The most common reactions leading to discontinuation (≥ 1% and at a rate at least twice that of placebo) are included in Table 2: Table 2: Adverse Reactions (≥ 1% and at least twice placebo) Leading to Discontinuation of Mirtazapine Tablets in 6-Week Clinical Trials in Patients with MDD Mirtazapine Tablets (n=453) Placebo (n=361) Somnolence 10.4% 2.2% Nausea 1.5% 0% Common Adverse Reactions The most common adverse reactions (≥ 5% and twice placebo) associated with the use of mirtazapine tablets are listed in Table 3. Table 3: Adverse Reactions (≥ 5% and twice placebo) in 6-Week U.S. Clinical Trials of Mirtazapine Tablets in Patients with MDD Mirtazapine Tablets (n=453) Placebo (n=361) Somnolence 54% 18% Increased Appetite 17% 2% Weight Gain 12% 2% Dizziness 7% 3% Table 4 enumerates
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