Safety and Tolerability

The safety and tolerability of SPIRIVA has been established in clinical studies. 2

Adverse events in 1-year clinical registration trials vs placebo and ipratropium (% patients with frequency ≥5% and where rate exceeded placebo by ≥1%) 2

Adverse event data pooled from pre- and post-approval clinical trials support the long-term safety profile of SPIRIVA 10

Over the course of 19 placebo-controlled trials (ranging from 90 to 180+ days) with 4,435 COPD patients, SPIRIVA maintained a safety profile consistent with the original 1-year registration trials. 10

The most commonly reported adverse drug reaction was dry mouth, which was usually mild and often resolved during continued treatment. Other reactions reported in individual patients and consistent with possible anticholinergic effects included constipation, increased heart rate, blurred vision, glaucoma, urinary difficulty, and urinary retention. 2

Concomitant use

In clinical trials SPIRIVA has been used concomitantly with other drugs commonly used in COPD without increases in adverse drug reactions. These include:

  • Albuterol
  • Theophyline
  • Oral/inhaled steroids

The co-administration of SPIRIVA with other anticholinergic-containing drugs (e.g., ipratropium) has not been studied and is therefore not recommended.2

Inhaled medicines, including SPIRIVA, may cause paradoxical bronchospasm. If this occurs, treatment with SPIRIVA should be stopped and other treatments considered.

Immediate hypersensitivity reactions, including angioedema, may occur after administration of SPIRIVA. If such a reaction occurs, therapy with SPIRIVA should be stopped at once and alternative treatments should be considered.