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Asmanex Side Effects

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

Asmanex Twisthaler Powder

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 Asmanex Twisthaler Powder:

Decreased appetite; flu-like symptoms; headache; indigestion; nausea; runny nose; sinus swelling; sore throat; stomach pain or upset; stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur when using Asmanex Twisthaler Powder:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; lack of energy; menstrual changes or painful menstruation; mental or mood changes; muscle or bone pain; new or worsening breathing problems; shakiness; shortness of breath; swelling; tiredness; vision changes; vomiting; weakness; wheezing; white curd-like patches or rash in the mouth.

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Asmanex Side Effects - for the Professional

Asmanex

The most common adverse reactions (incidence ≥5%) are headache, allergic rhinitis, pharyngitis, upper respiratory tract infection, sinusitis, oral candidiasis, dysmenorrhea, musculoskeletal pain, back pain, and dyspepsia. (6.1).



To report SUSPECTED ADVERSE REACTIONS, contact Schering-Plough at 1-800-526-4099 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch



See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling

Revised: 02/2008
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

 2.1 Recommended Dosages in Patients 4 Years of Age and Older

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 Studies Experience

7 DRUG INTERACTIONS

7.1 Inhibitors of Cytochrome P450 3A4

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment

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

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Asthma

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Oral Candidiasis

17.2 Acute Asthma Episodes

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 Instructions for Use

17.9 FDA Approved Patient Labeling


FULL PRESCRIBING INFORMATION Top

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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