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Table 2 Pooled analysis of AEs extracted from the studies on erdosteine, carbocysteine, and NAC in COPD patients and ranked by frequency in agreement with EMA guidelines [37]

From: Efficacy and safety profile of mucolytic/antioxidant agents in chronic obstructive pulmonary disease: a comparative analysis across erdosteine, carbocysteine, and N-acetylcysteine

  Erdosteine Carbocysteine NAC Placebo
Total number of subjects 354 557 553 1151
Frequency (%) of all AEs 1.32 (+++) 2.26 (+++) 18.26 (++++) 8.43 (+++)
Frequency (%) of specific AEs:
 respiratory tract infection ND 0.56 (+++) 10.85 (++++) 4.26 (+++)
 gastrointestinal disorders 0.44 (++) 1.13 (+++) 4.16 (+++) 4.26 (+++)
 pruritus ND ND 1.08 (+++) 2.69 (+++)
 cerebrovascular disorders 0.44 (++) ND 0.90 (++) 0.09 (+)
 dizziness ND ND 0.72 (++) 0.09 (+)
 musculoskeletal disorders ND 0.28 (++) 0.54 (++) 0.78 (++)
 hepatobiliary disorders 0.44 (++) ND ND ND
 malaise ND 0.28 (++) ND 0.09 (+)
 insomnia ND ND ND 0.26 (++)
 increased cough ND ND ND 0.17 (++)
  1. ++++: very common (≥1/10); +++: common (≥1/100 to < 1/10); ++: uncommon (≥1/1000 to < 1/100); +: rare (≥1/10,000 to < 1/1000); AEs: adverse events; COPD: chronic obstructive pulmonary disease; EMA: European Medicine Agency; NAC: N-acetylcysteine; ND: not detectable (frequency not known)