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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 (aztreonam for inhalation solution) 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 (aztreonam for inhalation solution) 3 times a day for 28 days.

Table 1 displays adverse reactions reported in more than 5% of patients treated with CAYSTON (aztreonam for inhalation solution) 3 times a day in placebo­controlled trials. The listed adverse reactions occurred more frequently in CAYSTON (aztreonam for inhalation solution) -treated patients than in placebo-treated patients. 

Table 1: Adverse Reactions Reported in more than 5% of Patients Treated with CAYSTON (aztreonam for inhalation solution) in the Placebo-Controlled Trials 

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

No formal clinical studies of drug interactions with CAYSTON (aztreonam for inhalation solution) have been conducted.

Last reviewed on RxList: 3/11/2010
This monograph has been modified to include the generic and brand name in many instances.