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For Healthcare Professionals

SPIRIVA® RESPIMAT®

For COPD

Side effects and safety

Description of selected adverse reactions

In clinical studies in COPD, the commonly observed undesirable effects were anticholinergic undesirable effects. Total of 3,282 subjects received SPIRIVA® RESPIMAT® in the 7 placebo-controlled clinical trials in COPD ranging from 4 weeks to 1 year, which translated into 2,440 person-years of exposure.1

Adverse reactions reported for SPIRIVA® RESPIMAT® included dehydration, dizziness, insomnia, glaucoma, increased intraocular pressure, blurred vision, atrial fibrillation, heart palpitations, supraventricular tachycardia, tachycardia, cough, nose bleed, pharyngitis, dysphonia, bronchospasm, laryngitis, sinusitis, dry mouth, constipation, oropharyngeal candidiasis, difficulty swallowing, gastroesophageal reflux disease, gingivitis, glossitis, stomatitis, intestinal obstruction including ileus paralytic, rash, pruritus, angioedema, urticaria, skin infection and skin ulcer, dry skin, other allergic reactions (including anaphylactic reaction), joint swelling, urinary retention, dysuria and urinary tract infection.1

For full safety information, please refer to the SPIRIVA® RESPIMAT® Summary of Product Characteristics.

Reference:

  1. SPIRIVA® RESPIMAT® Summary of Product Characteristics.

Reporting adverse events

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