TABLE 8

Summary of Treatment-Emergent AEs or Adverse Drug Reactions Identified as Risks With Propranolol, by Data Source and Preferred Term

Manufacturer’s Pooled Dataa
PropranololPropranolol
1 mg/kg per day (n = 200)3 mg/kg per day (n = 235)All (N = 435)Placebo (N = 236)CUP (N = 1661)Literature Data (N = 3766)
Cardiovascular disorders
 Hypotension31.531.361.410.440.21183.1
 Bradycardia10.510.420.530.2531.4
 Bundle branch block, right10.510.420.5
 Atrioventricular block1b0.510.21c0.1
 Cardiac failure10.1
 Sinus arrest10.1
Investigations
 BP decreased1564.1
 HR decreased1664.4d
Respiratory disorders
 Bronchiolitis115.5166.8276.2104.2382.3100.3
 Bronchitis115.53012.8419.4104.270.480.2
 Bronchospasm20.920.520.860.4110.3
 Bronchial hyperreactivity10.410.280.2
Metabolic and nutritional disorders
 Hypoglycemia10.510.420.570.4240.6
 Hypoglycemic seizure20.120.1
  • a Manufacturer’s pooled clinical trial data: AEs in the 3-mg/kg-per-day arm included those that occurred during the uptitration period; patients in study 301 who received 2 mg/kg per day of propranolol were analyzed with the 3-mg/kg-per-day group for data described by dose and in the “all propranolol” column describing all patients treated with propranolol whatever the dose. All AEs presented are treatment-emergent AEs. Data are presented by dose of propranolol or placebo (whatever the assigned regimen) and for all patients treated with propranolol whatever the dose. Therefore, for those patients assigned to one of the two 3-mo propranolol regimens (followed by 3 mo taking placebo), data are presented within both the propranolol and placebo groups according to the period during which the event occurred.

  • b Second-degree atrioventricular block.

  • c Full atrioventricular block.

  • d Vital sign events not reported as an AE/adverse drug reaction by the authors of literature data (eg, BP decreased) were captured as AEs as a conservative approach for the purpose of this review (see Supplemental Appendix 1).