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Azasite Side Effects Center
Pharmacy Editor: Omudhome Ogbru, PharmD
Azasite (azithromycin ophthalmic solution) is a semi-synthetic macrolide antibiotic used for the treatment of bacterial conjunctivitis. The most common side effect of Azasite is eye irritation. Blurred vision, dry eye, and nasal congestion may also occur.
The recommended regimen of Azasite is 1 drop twice daily for the first two days and then 1 drop once daily for the next five days. There are no adequate studies of Azasite in pregnant women and it is not known whether Azasite is excreted in breast milk. Only use Azasite in pregnant or nursing mothers when absolutely necessary.
Our Azasite Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
Azasite 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.
Although the risk of serious side effects is low when azithromycin ophthalmic is used in the eyes, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream. Stop using the medicine and get emergency medical help if you have any signs of a severe skin reaction, such as:
- fever, sore throat;
- swelling in your face or tongue, burning in your eyes; or
- skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Stop using azithromycin ophthalmic and call your doctor at once if you have a serious side effect such as:
- drainage or crusting of your eye;
- severe burning, stinging, itching, or other irritation after using the eye drops;
- feeling like there is something in your eye;
- watery eyes, increased light sensitivity;
- eye redness or swelling; or
- any signs of a new infection.
Less serious side effects may include:
- blurred vision;
- stuffy nose; or
- mild stinging, burning, or irritation of your eyes.
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 Azasite (Azithromycin Ophthalmic Solution)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Azasite Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these rare but very serious side effects occur: vision changes, eye pain.
Use of this medication for prolonged or repeated periods may result in other types of eye infections, including fungal infections. Contact your doctor if you notice new or worsening eye symptoms.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Azasite (Azithromycin Ophthalmic Solution)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Azasite FDA Prescribing Information: Side Effects
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).
Read the entire FDA prescribing information for Azasite (Azithromycin Ophthalmic Solution)
Additional Azasite Information
Azasite - User Reviews
Azasite User Reviews
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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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