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Cetraxal Side Effects

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

Cetraxal Ear Drops

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cetraxal Ear Drops:

Discomfort, pain, or itching in the ear; headache.

Seek medical attention right away if any of these SEVERE side effects occur when using Cetraxal Ear Drops:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased hearing; severe or persistent ear pain, itching, or irritation.

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Cetraxal Side Effects - for the Professional

Cetraxal

The most common adverse reactions reported in 2-3% of patients treated with Cetraxal were application site pain, ear pruritus, fungal ear superinfection, and headache. (6)



To report SUSPECTED ADVERSE REACTIONS, contact WraSer Pharmaceuticals at 1-888-252-3901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch



See 17 for PATIENT COUNSELING INFORMATION

Revised: 05/2009
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 Otic Use Only

5.2 Hypersensitivity

5.3 Growth of Resistant Organisms with Prolonged Use

5.4 Lack of Clinical Response

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

12.4 Microbiology

13 NON-CLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Directions for Use

17.2 Hypersensitivity


FULL PRESCRIBING INFORMATION Top

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