Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with the rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to AzaSite in 698 patients.
The population was between 1 and 87 years old with clinical signs and symptoms of bacterial conjunctivitis.
The most frequently reported ocular adverse reaction reported in patients receiving AzaSite was eye irritation.
This reaction occurred in approximately 1 to 2% of patients.
Other adverse reactions associated with the use of AzaSite were reported in less than 1% of patients and included ocular reactions (blurred vision, burning, stinging and irritation upon instillation, contact dermatitis, corneal erosion, dry eye, eye pain, itching, ocular discharge, punctate keratitis, visual acuity reduction) and non-ocular reactions (dysgeusia, facial swelling, hives, nasal congestion, periocular swelling, rash, sinusitis, urticaria).
Most common adverse reaction reported in patients was eye irritation (1 to 2% of patients).
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Thea Pharma Inc.
at 1-833-838-4028 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
5 WARNINGS AND PRECAUTIONS For topical ophthalmic use only.
( 5.1 ) Anaphylaxis and hypersensitivity have been reported with systemic use of azithromycin.
( 5.2 ) Growth of resistant organisms may occur with prolonged use.
( 5.3 ) Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.
( 5.4 ) 5.1 Topical Ophthalmic Use Only NOT FOR INJECTION.
Like all medications, Azasite can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: