Reboxetine Mesylate Side effects

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Side effects of Reboxetine Mesylate in details

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Adverse effects in reboxetine-treated patients appear early, tend to diminish with time and are of mild to moderate severity.

In placebo-controlled studies, adverse events were reported in approximately 70% of reboxetine-treated patients and in approximately 60% of placebo-treated patients. Discontinuation rates for adverse events were similar between reboxetine- and placebo-treated patients and were <10%.

Adverse events that occurred with statistically greater frequency in reboxetine-treated patients than in placebo-treated patients include: Dry mouth, constipation, insomnia, increased sweating, tachycardia, vertigo, urinary hesitancy/retention and impotence. Impotence was mainly observed in patients treated with doses >8 mg/day.

The most relevant between gender difference in adverse event rate was related to the frequency of urinary hesitancy/retention which occurred more often in male patients.

The overall frequency (approximately 1%) of serious adverse events in adult reboxetine-treated patients was not different from that found in the placebo-treated population.

The only modification in vital signs was an increase in heart rate upon standing. Apart from tachycardia, no consistent changes in electrocardiogram (ECG) tracings were observed during reboxetine treatment in adult patients. In the elderly population, newly observed rhythm disorders (mainly tachycardia) and conduction disorders were apparent in the ECG in approximately 15% of cases.

In studies of longer than 8 weeks, newly emergent adverse events were reported in approximately 30% of the reboxetine-treated patients and approximately 25% of the placebo-treated patients. These adverse events were associated with discontinuation rates of 4% and 1%, respectively.

Constipation was the only event which was observed more commonly in the reboxetine-treated group.

Discontinuation emergent adverse events were infrequent and occurred in approximately 4% of the reboxetine-treated patients and approximately 6% of placebo-treated patients.

Reboxetine Mesylate contraindications

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Hypersensitivity to the constituents of this medicine.

References

  1. HSDB. "REBOXETINE". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
  2. KEGG. "Target-based classification of drugs". http://www.genome.jp/kegg-bin/get_ht... (accessed September 17, 2018).
  3. ClinicalTrials.gov. "Reboxetine". https://clinicaltrials.gov/ (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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