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Body System Adverse Clinical Experience REMERON *Events reported by at least 1% of patients treated with REMERON are included, except the following events, which had an incidence on placebo greater than or equal to REMERON: remeron headache, infection, pain, chest pain, palpitation, tachycardia, postural hypotension, nausea, dyspepsia, diarrhea, flatulence, insomnia, nervousness, libido decreased, hypertonia, pharyngitis, rhinitis, sweating, amblyopia, tinnitus, taste perversion .
The remeron electrocardiograms for 338 patients who received REMERON (mirtazapine) Tablets and 261 patients who received placebo in 6-week, placebo-controlled trials were analyzed .
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The effect of REMERON (mirtazapine) remeron on QTc interval was assessed in a clinical randomized trial with placebo and positive (moxifloxacin) controls involving 54 healthy volunteers using exposure response analysis .
This trial showed a positive relationship between mirtazapine concentrations and remeron prolongation of the QTc interval .
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