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Adverse reaction information concerning DuoNeb (ipratropium bromide and albuterol sulfate) was derived from the 12-week controlled clinical trial.

ADVERSE EVENTS OCCURRING IN ≥ 1% OF ≥ 1 TREATMENT GROUP(S) AND WHERE THE COMBINATION TREATMENT SHOWED THE HIGHEST PERCENTAGE

Body System COSTART Term Albuterol
n (%)
Ipratropium
n (%)
DuoNeb
n (%)
NUMBER OF PATIENTS 761 754 765
N (%) Patients with AE 327 (43.0) 329 (43.6) 367 (48.0)
BODY AS A W HOLE
  Pain 8 (1.1) 4 (0.5) 10 (1.3)
  Pain chest 11 (1.4) 14 (1.9) 20 (2.6)
DIGESTIVE
  Diarrhea 5 (0.7) 9 (1.2) 14 (1.8)
  Dyspepsia 7 (0.9) 8 (1.1) 10 (1.3)
  Nausea 7 (0.9) 6 (0.8) 11 (1.4)
MUSCULO-SKELETAL
  Cramps leg 8 (1.1) 6 (0.8) 11 (1.4)
RESPIRATORY
  Bronchitis 11 (1.4) 13 (1.7) 13 (1.7)
  Lung Disease 36 (4.7) 34 (4.5) 49 (6.4)
  Pharyngitis 27 (3.5) 27 (3.6) 34 (4.4)
  Pneumonia 7 (0.9) 8 (1.1) 10 (1.3)
UROGENITAL
  Infection urinary tract 3 (0.4) 9 (1.2) 12 (1.6)

Additional adverse reactions reported in more than 1% of patients treated with DuoNeb (ipratropium bromide and albuterol sulfate) included constipation and voice alterations.

In the clinical trial, there was a 0.3% incidence of possible allergic-type reactions, including skin rash, pruritus, and urticaria.

Additional information derived from the published literature on the use of albuterol sulfate and ipratropium bromide singly or in combination includes precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, paradoxical bronchospasm, wheezing, exacerbation of COPD symptoms, drowsiness, aching, flushing, upper respiratory tract infection, palpitations, taste perversion, elevated heart rate, sinusitis, back pain, sore throat, and metabolic acidosis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.