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Alvesco

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Alvesco

Alvesco Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Alvesco (cicleonide) Inhalation Aerosol is in a corticosteroid drug class and is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. Alvesco is not available as a generic. Side effects include but are not limited to: Candidia albicans infection, immunosuppression, hypercorticism, adrenal suppression, growth effects, glaucoma and cataracts.

Alvesco (80 or 160 mcg strength) should be administered by the orally inhaled route. In clinical studies, concurrent administration of ciclesonide and other drugs commonly used in the treatment of asthma (albuterol, formoterol) has no effect on pharmacokinetics of ciclesonide. There are no adequate and well-controlled studies in pregnant women. Alvesco should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if ciclesonide is secreted in human milk. Caution should be used when Alvesco is administered to nursing women. Use in the pediatric population above age 12 is approved; there are 2 studies in younger children.

Our Alvesco (cicleonide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Alvesco in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • wheezing, choking, or other breathing problems after using this medication;
  • sores or white patches in your mouth or throat;
  • vision problems, such as tunnel vision or blurred vision; or
  • worsening asthma symptoms.

Less serious side effects may include:

  • unpleasant taste in your mouth;
  • dry mouth, burning or irritation in your mouth;
  • white patches or sores inside your mouth;
  • runny or stuffy nose, sore throat;
  • hoarse voice;
  • mild itching or skin rash;
  • joint pain, back pain; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Alvesco (Ciclesonide Inhalation Aerosol) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Alvesco Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Precautions section.

Dry/irritated throat, hoarseness, a bad taste in the mouth, or coughing may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: white patches in your mouth or on your tongue.

Tell your doctor immediately if any of these rare but very serious side effects occur: vision changes, unusual/persistent headache, poor wound healing, puffy face, unexpected weight gain, muscle pain/weakness, mental/mood changes (e.g., depression, agitation), increased thirst/urination.

Infrequently, this medication may cause severe sudden worsening of breathing problems/asthma immediately after use. If you have sudden worsening of breathing, use your quick-relief inhaler and seek immediate medical attention.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Alvesco (Ciclesonide Inhalation Aerosol)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Alvesco FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Systemic and local corticosteroid use may result in the following:

Clinical Trial Experience

The safety data described below for adults and adolescents 12 years of age and older reflect exposure to ALVESCO in doses ranging from 80 mcg to 640 mcg twice daily in five double-blind placebo-controlled clinical trials. Studies with once daily dosing are omitted from the safety database because the doses studied once daily are lower than the highest recommended twice daily doses. The five studies were of 12 to 16 weeks treatment duration, one of which included a safety extension follow up of one year. In the 12 to 16 week treatment studies, 720 patients (298 males and 422 females) aged 12 years and older were exposed to ALVESCO. In the long-term safety trial, 197 patients (82 males and 115 females) with severe persistent asthma from one of the 12-week trials were re-randomized and treated for up to one year with ALVESCO 320 mcg twice daily. Safety information for pediatric patients 4 to 11 years of age, is obtained from once daily dosing studies. Two of these studies were designed with a 12-week double-blind treatment period followed by a long-term open label safety extension of one year, and one study was an open label safety study of one year duration [see Pediatric Use].

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adult and Adolescent 12 Years of Age and Older

Four of the five trials included a total of 624 patients ages 12 years and older (359 females and 265 males) with asthma of varying severity who were treated with ALVESCO 80 mcg, 160 mcg, or 320 mcg twice daily for 12 to 16 weeks. These studies included patients previously using either controller therapy (predominantly inhaled corticosteroids) or reliever therapy (bronchodilator therapy alone). In these trials, the mean age was 39.1 years, and the majority of the patients (79.0%) were Caucasian. In these trials, 52.3%, 59.8% and 54.1% of the patients in the ALVESCO 80 mcg, 160 mcg, and 320 mcg treatment groups, respectively, had at least one adverse event compared to 58.0% in the placebo group.

Table 1 includes adverse reactions for the recommended doses of ALVESCO that occurred at an incidence of ≥ 3% in any of the ALVESCO groups and which were more frequent with ALVESCO compared to placebo.

Table 1: Adverse Reactions with ≥ 3% Incidence Reported in Patients ≥ 12 Years of Age with ALVESCO in US Placebo-Controlled Clinical Trials in Patients Previously on Bronchodilators and/or Inhaled Corticosteroids

Adverse Reaction Placebo
(N=507) %
ALVESCO
80 mcg BID
(N=325) %
160 mcg BID
(N=127) %
320 mcg BID
(N=172) %
Headache 7.3 4.9 11.0 8.7
Nasopharyngitis 7.5 10.5 8.7 7.0
Sinusitis 3.0 3.1 5.5 5.2
Pharyngolaryngeal pain 4.3 4.3 2.4 4.7
Upper respiratory Inf. 6.5 7.1 8.7 4.1
Arthralgia 1.0 0.9 2.4 3.5
Nasal congestion 1.6 1.8 5.5 2.9
Pain in extremity 1.0 0.3 3.1 2.3
Back pain 2.0 0.6 3.1 1.2

The following adverse reactions occurred in these clinical trials using ALVESCO with an incidence of less than 1% and occurred at a greater incidence with ALVESCO than with placebo.

Infections and Infestations: Oral candidiasis

Respiratory Disorders: Cough

Gastrointestinal Disorders: Dry mouth, nausea

General disorders and administrative site conditions: Chest discomfort

Respiratory, Thoracic, and Mediastinal Disorders: Dysphonia, dry throat

The fifth study was a 12-week clinical trial in asthma patients 12 years of age and older who previously required oral corticosteroids (average daily dose of oral prednisone of 12 mg/day), in which the effects of ALVESCO 320 mcg twice daily (n = 47) and 640 mcg twice daily (n = 49) were compared with placebo (n = 45) for the frequency of reported adverse reactions. The following adverse reactions occurred at an incidence of ≥ 3% in the ALVESCO-treated patients and were more frequent compared to placebo: sinusitis, hoarseness, oral candidiasis, influenza, pneumonia, nasopharyngitis, arthralgia, back pain, musculoskeletal chest pain, headache, urticaria, dizziness, gastroenteritis, face edema, fatigue, and conjunctivitis.

Pediatric Patients less than 12 Years of Age

The safety of ALVESCO in pediatric patients 4 to 11 years of age was evaluated in two studies in which ALVESCO 40 mcg, 80 mcg, and 160 mcg was administered once daily for 12 weeks and in one study in pediatric patients 2 to 6 years of age in which ALVESCO 40 mcg, 80 mcg, and 160 mcg was administered once daily for 24 weeks. Studies have not been conducted in patients less than 2 years of age. [see Pediatric Use]

Long-Term Clinical Trials Experience

A total of 197 patients 12 years of age and older (82 males and 115 females) from one of the 12-week treatment placebo-controlled studies were re-randomized to ciclesonide 320 mcg twice daily and followed for one year. The safety profile from the one-year follow up was similar to that seen in the 12- and 16-week treatment studies. Long term safety information for pediatric patients 4 to 11 years of age is obtained from three open label one year safety studies [see Pediatric Use].

Post-marketing Experience

In addition to adverse reactions identified from clinical trials, the following adverse reactions have been identified during worldwide post-marketing use of ciclesonide oral inhalation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: Immediate or delayed hypersensitivity reactions such as angioedema with swelling of the lips, tongue and pharynx.

Read the entire FDA prescribing information for Alvesco (Ciclesonide Inhalation Aerosol) »

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Alvesco - User Reviews

Alvesco User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Alvesco sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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