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International Journal of Phytomedicine and Phytotherapy

Table 5 Adverse Drug Reactions during Observational Period (Safety Set without 37 patients who started HMP intake before enrollment)

From: A non-interventional, prospective, multicenter study for evaluation of the use of the herbal medicinal product Canephron® N in the pediatric outpatient population in Russia

  HMP form
  Total Oral solution Tablets
Preferred Term (N = 597) (N = 393) (N = 204)
Any treatment-emergent adverse drug reaction 5 (0.8%) 3 (0.8%) 2 (1.0%)
 Dermatitis 3 (0.5%) 3 (0.8%) 0
 Dyspepsia 1 (0.2%) 0 1 (0.5%)
 Renal colica 1 (0.2%) 0 1 (0.5%)
  1. aRenal colic was the only serious adverse drug reaction (1 patient; unexpected)