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Azasite (Azithromycin Ophthalmic) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Trials Experience

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: burning, stinging and irritation upon instillation, contact dermatitis, corneal erosion, dry eye, dysgeusia, nasal congestion, ocular discharge, punctate keratitis, and sinusitis.

Postmarketing Experience

In addition to adverse events reported from clinical trials, the following events have been identified during post approval use of AzaSite. These events were reported voluntarily from a population of unknown size, and the frequency of occurrence cannot be determined precisely. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to AzaSite or a combination of these factors.

Eye: blurring, eyelid swelling, itching, pain, visual acuity reduction.

General: allergic reactions including facial swelling, hives, periocular swelling, rash, urticaria.



REPORTS OF SUSPECTED AZASITE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Azasite. The information is not vetted and should not be considered as verified clinical evidence.

Possible Azasite side effects / adverse reactions in 81 year old female

Reported by a pharmacist from United States on 2011-12-15

Patient: 81 year old female

Reactions: Burning Sensation, Pruritus, Feeling Jittery, Rash, Nervousness

Suspect drug(s):
Azasite

Other drugs received by patient: Optifree; Systane; Replenish



Possible Azasite side effects / adverse reactions in 56 year old male

Reported by a health professional (non-physician/pharmacist) from Iran (Islamic Republic OF) on 2012-05-10

Patient: 56 year old male

Reactions: Drug Ineffective, Keratitis

Suspect drug(s):
Azasite

Other drugs received by patient: Moxifloxacin Hydrochloride



Possible Azasite side effects / adverse reactions in 56 year old male

Reported by a health professional (non-physician/pharmacist) from Iran (Islamic Republic OF) on 2012-05-14

Patient: 56 year old male

Reactions: Drug Ineffective, Keratitis

Suspect drug(s):
Azasite

Other drugs received by patient: Moxifloxacin Hydrochloride



See index of all Azasite side effect reports >>

Drug label data at the top of this Page last updated: 2009-04-07

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