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Ozurdex Side Effects

Please note - some side effects for Ozurdex 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).



Ozurdex Side Effects - for the Professional

Ozurdex

The most common adverse reactions reported by ≥20% of patients included increased intraocular pressure and conjunctival hemorrhage. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-433-8871 or www.allergan.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.



See 17 for PATIENT COUNSELING INFORMATION

Revised: 06/2009
FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Information

2.2 Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

4.1 Ocular or Periocular Infections

4.2 Advanced Glaucoma

4.3 Hypersensitivity

5 WARNINGS AND PRECAUTIONS

5.1 Intravitreal Injection-related Effects

5.2 Potential Steroid-related Effects

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

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

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION


FULL PRESCRIBING INFORMATION Top

Side Effects by Body System

Ocular

Ocular side effects have included elevation of intraocular pressure with possible development of glaucoma, visual acuity and visual field defects, subcapsular cataract formation, optic nerve damage, secondary ocular infection and perforation of the globe. Less frequent side effects of dexamethasone ophthalmic include burning and stinging upon instillation.

Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis, keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation, and ptosis.

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