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Foradil Certihaler

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Foradil Certihaler

Foradil Certihaler Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Foradil Certihaler (formoterol fumarate) Inhalation Powder is a bronchodilator used to treat asthma and to prevent bronchospasm as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid, in adults and children 5 years of age and older with reversible obstructive airway disease. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include cold symptoms, headache, upper respiratory infections, cough, fever, vomiting, tremor, and congestion.

For adults and children 5 years of age and older, the usual dosage is one 10 mcg inhalation from the Foradil Certihaler every 12 hours. Foradil Certihaler may interact with xanthine derivatives, steroids, diuretics, monamine oxidase inhibitors (MAOIs), antidepressants, or beta-blockers. Tell your doctor all medications and supplements you use. During pregnancy, Foradil Certihaler should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Foradil Certihaler (formoterol fumarate) Inhalation Powder 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 Prescribing information?

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

Foradil Certihaler FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Long-acting beta2-adrenergic agonists (LABA), including formoterol, the active ingredient in FORADIL CERTIHALER (formoterol fumarate inhalation powder) , increase the risk of asthma-related death and may increase the risk of asthma-related hospitalizations in pediatric and adolescent patients. Clinical trials with FORADIL AEROLIZER (consists of a single-dose dry powder inhaler and capsules containing formoterol fumarate and lactose) suggested a higher incidence of serious asthma exacerbations in patients who received FORADIL AEROLIZER than in those who received placebo. (See WARNINGS)

Experience in Pediatric, Adolescent and Adult Patients with Asthma

Of the 1,118 patients in multiple-dose controlled clinical trials of more than one month exposure, 414 were treated with FORADIL CERTIHALER (formoterol fumarate inhalation powder) at the recommended dose of 10 mcg twice daily. The following table shows adverse events where the frequency was greater than or equal to 1% in the FORADIL 10 mcg twice daily group and where the rates in the FORADIL group exceeded placebo.

NUMBER AND FREQUENCY OF ADVERSE EXPERIENCES IN PATIENTS 5 YEARS OF AGE AND OLDER FROM MULTIPLE-DOSE CONTROLLED CLINICAL TRIALS OF MORE THAN ONE MONTH EXPOSURE

Adverse Event FORADIL
CERTIHALER
10 mcg twice daily
Placebo
n (%) n (%)
Total Patients 414 (100) 416 (100)
Nasopharyngitis 34 (8.2) 24 (5.8)
Headache NOS 34 (8.2) 33 (7.9)
Upper respiratory tract infection NOS 33 (8.0) 31 (7.5)
Cough 21 (5.1) 17 (4.1)
Pyrexia 19 (4.6) 11 (2.6)
Vomiting NOS 15 (3.6) 7 (1.7)
Tremor 11 (2.7) 2 (0.5)
Nasal congestion 10 (2.4) 8 (1.9)
Rhinitis allergic NOS 10 (2.4) 1 (0.2)
Viral infection NOS 10 (2.4) 5 (1.2)
Influenza 9 (2.2) 4 (1.0)
Bronchitis NOS 9 (2.2) 2 (0.5)
Upper respiratory tract infection viral NOS 7 (1.7) 4 (1.0)
Back pain 7 (1.7) 4 (1.0)
Conjunctivitis 6 (1.4) 2 (0.5)
Rash NOS 6 (1.4) 0 0
Dyspepsia 6 (1.4) 2 (0.5)
Pharyngitis streptococcal 5 (1.2) 3 (0.7)
Urinary tract infection NOS 4 (1.0) 3 (0.7)
Diarrhea NOS 4 (1.0) 3 (0.7)
Bronchitis acute NOS 4 (1.0) 1 (0.2)
Respiratory tract infection 4 (1.0) 1 (0.2)
Muscle cramps 4 (1.0) 1 (0.2)
Insomnia 4 (1.0) 2 (0.5)
Asthma NOS 4 (1.0) 3 (0.7)
NOS = not otherwise specified

In two 12-week controlled trials for FORADIL AEROLIZER with combined enrollment of 1095 patients 12 years of age and older, FORADIL AEROLIZER 12 mcg twice daily was compared to FORADIL AEROLIZER 24 mcg twice daily, albuterol 180 mcg four times daily, and placebo. Serious asthma exacerbations (acute worsening of asthma resulting in hospitalization) occurred more commonly with FORADIL AEROLIZER 24 mcg twice daily than with the recommended dose of FORADIL AEROLIZER 12 mcg twice daily, albuterol, or placebo. The results are shown in the following table.

NUMBER AND FREQUENCY OF SERIOUS ASTHMA EXACERBATIONS IN PATIENTS 12 YEARS OF AGE AND OLDER FROM TWO 12-WEEK CONTROLLED CLINICAL TRIALS

  Foradil Aerolizer
12 mcg twice
daily
Foradil Aerolizer
24 mcg twice
daily
Albuterol
180 mcg four
times daily
Placebo
  Trial #1
Serious asthma exacerbations 0/136 4/135 (3.0%)1 2/134 (1.5%) 0/136 (0)
  Trial #2
Serious asthma exacerbations 1/139 (0.7%) 5/136 (3.7%)2 0/138 (0) 2/141 (1.4%)
1 1 patient required intubation
2 2 patients had respiratory arrest; 1 of the patients died

A 16-week, randomized, multi-center, double-blind, parallel-group study of FORADIL AEROLIZER enrolled 1568 patients 12 years of age and older with mild-to-moderate asthma (defined as FEV1 ≥ 40% of the patient's predicted normal value) in three treatment groups. The study's primary endpoint was the incidence of serious asthma-related adverse events. Patients who received either 24 mcg or 12 mcg twice daily doses of FORADIL AEROLIZER experienced more serious asthma exacerbations than patients who received placebo. The results are shown in the following table.

NUMBER AND FREQUENCY OF SERIOUS ASTHMA EXACERBATIONS IN PATIENTS 12 YEARS OF AGE AND OLDER FROM A 16-WEEK TRIAL

  Foradil Aerolizer
12 mcg twice
daily
Foradil Aerolizer
24 mcg twice
daily
Placebo
Serious asthma exacerbations 3/527 (0.6%) 2/527 (0.4%) 1/514 (0.2%)

The size of this study was not adequate to precisely quantify the differences in serious asthma exacerbation rates between treatment groups. All serious asthma exacerbations resulted in hospitalizations. While there were no deaths in the study, the duration and size of this study were not adequate to quantify the rate of asthma-related death. See WARNINGS for information about a study which compared another long-acting beta2-adrenergic agonist to placebo.

Experience in Children with Asthma

The safety of FORADIL CERTIHALER (formoterol fumarate inhalation powder) compared to placebo was investigated in a large, 12-week, multicenter, randomized, double-blind clinical trial in 249 children with asthma (ages 5-12 years) in need of daily bronchodilators. The numbers and percent of patients who reported adverse events were comparable in the 10 mcg twice daily and placebo groups. In general, the adverse events observed in children were similar to those described above for the overall asthma population in multiple-dose controlled trials of at least one month exposure. Adverse events that were frequently occurring (incidence of at least 1% and greater than placebo) only for children included viral gastroenteritis, acute sinusitis, pharyngitis, abrasion, rash and contact dermatitis.

The safety of FORADIL AEROLIZER 12 mcg twice daily compared to FORADIL AEROLIZER 24 mcg twice daily and placebo was investigated in one large, multicenter, randomized, double-blind, 52-week clinical trial in 518 children with asthma (ages 5-12 years) in need of daily bronchodilators and antiinflammatory treatment. More children who received FORADIL AEROLIZER 24 mcg twice daily than children who received FORADIL AEROLIZER 12 mcg twice daily or placebo experienced serious asthma exacerbations, as shown in the next table.

NUMBER AND FREQUENCY OF SERIOUS ASTHMA EXACERBATIONS IN PATIENTS 5-12 YEARS OF AGE FROM A 52-WEEK TRIAL

  Foradil Aerolizer 12
mcg twice daily
Foradil Aerolizer 24
mcg twice daily
Placebo
Serious asthma exacerbations 8/171 (4.7%) 11/171 (6.4%) 0/176 (0)

Other adverse reactions to FORADIL are similar in nature to other selective beta2-adrenoceptor agonists; e.g., angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia.

Post Marketing Experience

In extensive worldwide marketing experience with FORADIL, serious exacerbations of asthma, including some that have been fatal, have been reported. While most of these cases have been in patients with severe or acutely deteriorating asthma (see WARNINGS), a few have occurred in patients with less severe asthma. It is not possible to determine from these individual case reports whether FORADIL contributed to the events.

Rare reports of anaphylactic reactions, including severe hypotension and angioedema, have also been received in association with the use of formoterol fumarate inhalation powder.

Drug Abuse And Dependence

There was no evidence in clinical trials of drug dependence with the use of FORADIL.

Read the entire FDA prescribing information for Foradil Certihaler (Formoterol Fumarate Inhalation Powder) »

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