Stiolto Respimat Side Effects

6 ADVERSE REACTIONS LABA, such as olodaterol, one of the active components in STIOLTO RESPIMAT, as monotherapy (without an inhaled corticosteroid) for asthma, increase the risk of asthma-related events.

STIOLTO RESPIMAT is not indicated for the treatment of asthma [see Warning and Precautions (5.1) ].

The following adverse reactions are described, or described in greater detail, in other sections: Immediate hypersensitivity reactions [see Warnings and Precautions (5.4) ] Paradoxical bronchospasm [see Warnings and Precautions (5.5) ] Worsening of narrow-angle glaucoma [see Warnings and Precautions (5.8) ] Worsening of urinary retention [see Warnings and Precautions (5.9) ] The most common adverse reactions (>3% incidence and more than an active control) were nasopharyngitis, cough, and back pain.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc.

at 1-800-542-6257 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 Clinical Trials Experience in Chronic Obstructive Pulmonary Disease Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions observed in the clinical trials of a drug cannot be directly compared to the incidences in the clinical trials of another drug and may not reflect the incidences observed in practice.

The clinical program for STIOLTO RESPIMAT included 7,151 subjects with COPD in two 52-week active-controlled trials, one 12-week placebo-controlled trial, three 6-week placebo-controlled cross-over trials, and four additional trials of shorter duration.

A total of 1,988 subjects received at least 1 dose of STIOLTO RESPIMAT.

Adverse reactions observed in the ≤12-week trials were consistent with those observed in the 52-week trials, which formed the primary safety database.

The primary safety database consisted of pooled data from the two 52-week double-blind, active-controlled, parallel group confirmatory clinical trials (Trials 1 and 2).