For US Healthcare Professionals
Adverse Reactions
Adverse reactions in placebo-controlled COPD clinical
studies:
Adverse reactions occurring in the TUDORZA group at a frequency of ≥1% and exceeding
placebo1,*
| Adverse Reaction | TUDORZA 400 mcg BID (n=636) n (%) | Placebo (n=640) n (%) |
| Headache | 42 (6.6) | 32 (5.0) |
| Nasopharyngitis | 35 (5.5) | 25 (3.9) |
| Cough | 19 (3.0) | 14 (2.2) |
| Diarrhea | 17 (2.7) | 9 (1.4) |
| Sinusitis | 11 (1.7) | 5 (0.8) |
| Rhinitis | 10 (1.6) | 8 (1.2) |
| Toothache | 7 (1.1) | 5 (0.8) |
| Fall | 7 (1.1) | 3 (0.5) |
| Vomiting | 7 (1.1) | 3 (0.5) |
*Pooled safety analysis from two 12-week and one 24-week placebo-controlled studies in patients with COPD.
- The incidence of common anticholinergic adverse events was <1%, including dry mouth (0.8% vs 0.6%), constipation (0.0% vs 0.9%), and urinary retention (0.2% vs 0.0%), for TUDORZA vs placebo, respectively2
- Fewer patients discontinued treatment with TUDORZA (n=29, 4.6%) due to adverse events compared
to placebo (n=33, 5.1%)2
- The adverse event most commonly leading to discontinuation was COPD exacerbation (1.9% for TUDORZA vs 2.5% for placebo)2
Long-term Safety
TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) 400 mcg BID was assessed in 3 long-term safety studies, 2 double-blind and 1 open-label, ranging from 40 to 52 weeks in patients with moderate to severe COPD. The adverse events reported in the long-term safety studies were similar to those occurring in the placebo-controlled studies of 3 and 6 months.1
Postmarketing experience
In postmarketing experience with TUDORZA PRESSAIR, immediate hypersensitivity reactions, including anaphylaxis, angioedema (including swelling of the lips, tongue, or throat), urticaria, rash, bronchospasm, or itching have been reported. Additionally, nausea, dysphonia, blurred vision, urinary retention, tachycardia and stomatitis have been observed.1