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Cayston Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Cayston in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- bronchospasm (wheezing, chest tightness, trouble breathing) right after using the medicine; or
- any new or worsening symptoms.
Less serious side effects may include:
- mild stomach discomfort, vomiting;
- cough, sore throat;
- stuffy nose; or
- low fever.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Cayston (Aztreonam for Inhalation Solution) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Cayston FDA Prescribing Information: Side Effects
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)
|CAYSTON 75 mg 3 times a day (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%).
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
Read the entire FDA prescribing information for Cayston (Aztreonam for Inhalation Solution) »
Additional Cayston Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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