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Side Effects > Durezol

Durezol Side Effects

Please note - some side effects for Durezol 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 Durezol - for the Consumer

Durezol Emulsion

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision (eg, blurred vision, decreased vision); continued or worsening itching, tearing, or irritation; delayed healing after surgery; discharge from the eye; eye pain; foreign body sensation; new or worsening redness or swelling of the eye or eyelid; sensitivity to light.

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Durezol Side Effects - for the Professional

Durezol

To report SUSPECTED ADVERSE REACTIONS, contact Sirion Therapeutics at 1-866-4SIRION (1-866-474-7466) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.



See 17 for PATIENT COUNSELING INFORMATION

Revised: 09/2008
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 IOP Increase

5.2 Cataracts

5.3 Delayed healing

5.4 Bacterial infections

5.5 Viral infections

5.6 Fungal infections

5.7 Topical ophthalmic use only

6 ADVERSE REACTIONS

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, and Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Postoperative Ocular Inflammation and Pain

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 5 mL BOTTLE

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 5 mL CARTON


FULL PRESCRIBING INFORMATION Top

More resources:

Drugs.com Durezol

MedFacts Durezol Emulsion

FDA Durezol

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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