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Side Effects > Azasite

Azasite Side Effects

Please note - some side effects for Azasite may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).


Side Effects of Azasite - for the Consumer

Azasite Drops

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Azasite Drops. Seek medical attention right away if any of these SEVERE side effects occur when using Azasite Drops:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); discharge from the eye; red, swollen, blistered, or peeling skin; severe or persistent burning, stinging, or irritation of the eye.

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Azasite Side Effects - for the Professional

AzaSite

Most common adverse reaction reported in patients was eye irritation (1-2% of patients). (6)



To report SUSPECTED ADVERSE REACTIONS, contact Inspire Pharmaceuticals, Inc. at 1-888-881-4696 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch



See 17 for PATIENT COUNSELING INFORMATION

Revised: 04/2009
FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Topical Ophthalmic Use Only

5.2 Anaphylaxis and Hypersensitivity with Systemic Use of Azithromycin

5.3 Growth of Resistant Organisms with Prolonged Use

5.4 Avoidance of Contact Lenses

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION


FULL PRESCRIBING INFORMATION Top

More resources:

Drugs.com AzaSite

MedFacts Azasite Drops

FDA AzaSite

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.


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