Azithromycin (ophthalmic) adverse reactions: Difference between revisions
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__NOTOC__ | __NOTOC__ | ||
{{Azithromycin}} | {{Azithromycin (ophthalmic)}} | ||
{{CMG}} | {{CMG}}; {{AE}} {{SS}} | ||
==Adverse Reactions== | ==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. | 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 1-2% 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]]).<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = |title = AZASITE (AZITHROMYCIN) SOLUTION [INSPIRE PHARMACEUTICALS, INC.] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5dc0f75a-1e14-469f-af4f-c668a32f2328 |publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
{{Reflist}} | {{Reflist}} | ||
Latest revision as of 21:49, 5 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
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 1-2% 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).[1]
References
Adapted from the FDA Package Insert.