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Alvesco Side Effects

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

Alvesco Aerosol

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 Alvesco Aerosol:

Dizziness; headache; nasal congestion; nose or throat irritation.

Seek medical attention right away if any of these SEVERE side effects occur when using Alvesco Aerosol:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back or joint pain; depression; ear pain or discharge; mental or mood changes; new or worsening asthma symptoms (eg, increased wheezing); severe or persistent diarrhea or stomach pain; shortness of breath after using Alvesco Aerosol; signs of infection (eg, fever, chills, or sore throat); vision changes (eg, cloudy vision, decreased vision); white patches in the mouth or throat.

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Alvesco Side Effects - for the Professional

Alvesco

Most common adverse reactions (≥3%) are headache, nasopharyngitis, sinusitis, pharyngolaryngeal pain, upper respiratory infection, arthralgia, nasal congestion, pain in extremity and back pain (6)

Other adverse reactions have been reported (6)

To report SUSPECTED ADVERSE REACTIONS, contact Sepracor Inc. at 1-877-737-7226 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


For customer service, call 1-888-394-7377
For medical information, call 1-800-739-0565



See 17 for PATIENT COUNSELING INFORMATION

Revised: 07/2008
FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed

1 INDICATIONS AND USAGE

1.1 Treatment of Asthma

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

4.1 Status Asthmaticus

4.2 Hypersensitivity

5 WARNINGS AND PRECAUTIONS

5.1 Local Effects

5.2 Acute Asthma Episodes

5.3 Immunosuppression

5.4 Transferring Patients from Systemic Corticosteroid Therapy

5.5 Hypercorticism and Adrenal Suppression

5.6 Reduction in Bone Mineral Density

5.7 Effect on Growth

5.8 Glaucoma and Cataracts

5.9 Bronchospasm

6 ADVERSE REACTIONS

6.1 Clinical Trial Experience

6.2 Post-marketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Asthma

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Oral Candidiasis

17.2 Status Asthmaticus and Acute Asthma Symptoms

17.3 Immunosuppression

17.4 Hypercorticism and Adrenal Suppression

17.5 Reduction in Bone Mineral Density

17.6 Reduced Growth Velocity

17.7 Use Daily for Best Effect

17.8 How to Use Alvesco


FULL PRESCRIBING INFORMATION Top

Side Effects by Body System

Endocrine

Endocrine side effects have included adrenal suppression.

Musculoskeletal

Musculoskeletal side effects have included decreases in bone mineral density, arthralgia, pain in extremity, and back pain.

Nervous system

Nervous system side effects have included headache and dizziness.

Ocular

Ocular side effects have included cataracts, glaucoma, blurred vision, conjunctivitis, and increased intraocular pressure.

Respiratory

Respiratory side effects have included paradoxical bronchospasm, chest discomfort, cough, dysphonia, nasopharyngitis, sinusitis, pharyngolaryngeal pain, dry throat, sinusitis, hoarseness, influenza, pneumonia, upper respiratory infection, nasal congestion, and nasopharyngitis.

Gastrointestinal

Gastrointestinal side effects have included oral candidiasis, nausea, dry mouth, gastroenteritis, and dry throat.

Dermatologic

Dermatologic side effects have included urticaria.

Hypersensitivity

Hypersensitivity side effects have included immediate or delayed hypersensitivity reactions such as angioedema with swelling of lips, tongue, and pharynx.

General

General side effects have included face edema and fatigue.

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