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Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of drugs cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of CAYSTON was evaluated in 344 patients from two placebo-controlled trials and one open-label follow-on trial. In controlled trials, 146 patients with CF received 75 mg CAYSTON 3 times a day for 28 days.

Table 1 displays adverse reactions reported in more than 5% of patients treated with CAYSTON 3 times a day in placebo-controlled trials. The listed adverse reactions occurred more frequently in CAYSTON-treated patients than in placebo-treated patients.

Table 1: Adverse Reactions Reported in more than 5% of Patients Treated with CAYSTON in the Placebo-Controlled Trials

Event (Preferred Term) Placebo
(N = 160)
n (%)
CAYSTON 75 mg 3 times a day (N = 146)
n (%)
Cough 82 (51%) 79 (54%)
Nasal congestion 19 (12%) 23 (16%)
Wheezing 16 (10%) 23 (16%)
Pharyngolaryngeal pain 17 (11%) 18 (12%)
Pyrexia 9 (6%) 19 (13%)
Chest discomfort 10 (6%) 11 (8%)
Abdominal Pain 8 (5%) 10 (7%)
Vomiting 7 (4%) 9 (6%)

Adverse reactions that occurred in less than 5% of patients treated with CAYSTON were bronchospasm (3%) [see WARNINGS AND PRECAUTIONS] and rash (2%).

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following possible adverse reactions have been identified during post-approval use of CAYSTON. Because these events have been reported voluntarily from a population of unknown size, estimates of frequency cannot be made.

Musculoskeletal And Connective Tissue Disorders

Arthralgia, joint swelling