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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)