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Foradil

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Foradil Aerolizer

Foradil Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Foradil Aerolizer (formoterol fumarate) Inhalation Powder is used to prevent bronchospasm in people with reversible obstructive airways disease, including symptoms of night-time asthma. It is also used in people with chronic obstructive pulmonary disease (COPD) such as emphysema and chronic bronchitis. It is a long-acting bronchodilator. Common side effects include shakiness (tremor), nausea, headache, dizziness, nervousness, dry mouth, stomach upset, tiredness, trouble sleeping, or hoarseness.

For adults and children 5 years of age and older, the usual dosage is the inhalation of the contents of one 12-mcg Foradil capsule every 12 hours using the Aerolizer Inhaler. Foradil may interact with cisapride, droperidolm, methadone, pentamidine, caffeine, diet pills, cold medicine, stimulants, antibiotics, medicines to treat psychiatric disorders, heart rhythm medicines, beta-blockers, antidepressants, diuretics (water pills) or MAO inhibitors. Tell your doctor all prescription and over-the-counter medicines you use. During pregnancy Foradil Aerolizer should be used only when prescribed. It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Foradil Aerolizer (formoterol fumarate) 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.

Foradil 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:

  • chest pain, fast or pounding heartbeats, tremors, shaking, or restless feeling;
  • wheezing, choking, or other breathing problems after using this medication;
  • increased thirst or hunger, urinating more than usual; or
  • worsening asthma symptoms.

Less serious side effects may include:

  • dizziness, anxiety, headache;
  • sleep problems (insomnia);
  • back pain, muscle cramps;
  • sore throat, dry mouth, cough, stuffy nose;
  • skin rash, itching; or
  • changes in your voice.

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 Foradil (Formoterol Fumarate Inhalation Powder) »

What is Patient Information Overview?

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

Foradil Overview - Patient Information: Side Effects

SIDE EFFECTS: Shakiness (tremor), nausea, headache, dizziness, nervousness, dry mouth, stomach upset, tiredness, trouble sleeping, or hoarseness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips; chew (sugarless) gum, drink water, or use a saliva substitute.

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: fast breathing, muscle weakness/cramping, fast/pounding/irregular heartbeat, increased thirst/urination.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, severe dizziness, fainting.

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

Rarely, formoterol can cause a worsening of breathing problems (paradoxical bronchospasm) that may be life-threatening. If this occurs, immediately seek medical attention.

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 Foradil (Formoterol Fumarate Inhalation Powder)»

What is Prescribing information?

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

Foradil FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Long-acting beta2-adrenergic agonists (LABA), including formoterol, the active ingredient in FORADIL AEROLIZER, 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 suggested a higher incidence of serious asthma exacerbations in patients who received FORADIL AEROLIZER than in those who received placebo [see WARNINGS AND PRECAUTIONS].

Adverse reactions common to LABA drugs include: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia.

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 clinical trials.

Asthma

Of the 5,824 patients in multiple-dose controlled clinical trials, 1,985 were treated with FORADIL AEROLIZER at the recommended dose of 12 mcg twice daily. The following table shows treatment-emergent adverse reactions where the frequency was greater than or equal to 1% in the FORADIL twice daily group and where the rates in the FORADIL group exceeded placebo. Three treatment-emergent adverse reactions showed dose ordering among tested doses of 6, 12 and 24 mcg administered twice daily; tremor, dizziness and dysphonia.

Number and Frequency of Treatment-Emergent Adverse Reactions in Patients 5 Years of Age and Older from Multiple-Dose Controlled Clinical Trials

Treatment-Emergent
Adverse Reaction
Foradil Aerolizer 12 mcg twice daily Placebo
n (%) n (%)
Total Patients 1985 (100) 969 (100)
Infection viral 341 (17.2) 166 (17.1)
Bronchitis 92 (4.6) 42 (4.3)
Chest infection 54 (2.7) 4 (0.4)
Dyspnea 42 (2.1) 16 (1.7)
Chest pain 37 (1.9) 13 (1.3)
Tremor 37 (1.9) 4 (0.4)
Dizziness 31 (1.6) 15 (1.5)
Insomnia 29 (1.5) 8 (0.8)
Tonsilitis 23 (1.2) 7 (0.7)
Rash 22 (1.1) 7 (0.7)
Dysphonia 19 (1) 9 (0.9)

In patients 5-12 years of age, the numbers and percent of patients who reported treatment-emergent adverse reactions were comparable in the 12 mcg twice daily and placebo groups. In general, the pattern of the treatment-emergent adverse reactions observed in children differed from the usual pattern seen in adults. Treatment-emergent adverse reactions that were more frequent in the formoterol group than in the placebo group reflected infection/inflammation (viral infection, rhinitis, tonsillitis, gastroenteritis) or abdominal complaints (abdominal pain, nausea, dyspepsia).

Serious Asthma Exacerbations in Adolescents and Adults 12 Years of Age and Older

In two 12-week controlled trials 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 12 mcg twice daily Foradil 24 mcg twice daily Albuterol 180 mcg four times daily Placebo
Trial #1
Serious asthma exacerbations 0/136 (0) 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%)
1patient required intubation
2patients had respiratory arrest; 1 of the patients died

In a 16-week, randomized, multi-center, double-blind, parallel-group trial, patients who received either 24 mcg twice daily or 12 mcg twice daily doses of FORADIL AEROLIZER experienced more serious asthma exacerbations than patients who received placebo [see Clinical Trials]. 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 12 mcg twice daily Foradil 24 mcg twice daily Placebo
Serious asthma exacerbations 3/527 (0.6%) 2/527 (0.4%) 1/514 (0.2%)

Serious Asthma Exacerbations in Children 5-11 Years of Age

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

COPD

Of the 1634 patients in two pivotal multiple-dose Chronic Obstructive Pulmonary Disease (COPD) controlled trials, 405 were treated with FORADIL AEROLIZER 12 mcg twice daily. Treatment-emergent adverse reactions reported were similar to those seen in asthmatic patients, but with a higher incidence of COPD-related events in both placebo and formoterol treated patients.

The following table shows treatment-emergent adverse reactions where the frequency was greater than or equal to 1% in the FORADIL AEROLIZER group and where the rates in the FORADIL AEROLIZER group exceeded placebo. The two clinical trials included doses of 12 mcg and 24 mcg, administered twice daily. Seven treatment-emergent adverse reactions showed dose ordering among tested doses of 12 and 24 mcg administered twice daily; pharyngitis, fever, muscle cramps, increased sputum, dysphonia, myalgia, and tremor.

Number and Frequency of Treatment-Emergent Adverse Reactions in Adult COPD Patients Treated in Multiple-Dose Controlled Clinical Trials

Treatment-Emergent
Adverse Reaction
Foradil Aerolizer 12 mcg twice daily Placebo
n (%) n (%)
Total Patients 405 (100) 420 (100)
Upper respiratory tract infection 30 (7.4) 24 (5.7)
Pain back 17 (4.2) 17 (4)
Pharyngitis 14 (3.5) 10 (2.4)
Pain chest 13 (3.2) 9 (2.1)
Sinusitis 11 (2.7) 7 (1.7)
Fever 9 (2.2) 6 (1.4)
Cramps leg 7 (1.7) 2 (0.5)
Cramps muscle 7 (1.7) 0
Anxiety 6 (1.5) 5 (1.2)
Pruritis 6 (1.5) 4 (1)
Sputum increased 6 (1.5) 5 (1.2)
Mouth dry 5 (1.2) 4 (1)

Overall, the frequency of all cardiovascular treatment-emergent adverse reactions in the two pivotal studies was6.4% for FORADIL AEROLIZER 12 mcg twice daily, and 6.0% for placebo. There were no frequently-occurring specific cardiovascular treatment-emergent adverse reactions for FORADIL AEROLIZER (frequency greater than or equal to 1% and greater than placebo).

Post Marketing Experience

The following adverse reactions have been identified during post approval use of FORADIL. 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.

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 AND PRECAUTIONS], a few have occurred in patients with less severe asthma. It is not possible to determine from these individual case reports whether FORADIL AEROLIZER contributed to the events.

Immune system disorders: rare reports of anaphylactic reactions, including severe hypotension and angioedema

Metabolism and nutrition disorders: Hypokalemia, hyperglycemia

Respiratory, thoracic and mediastinal disorders: Cough

Skin and subcutaneous tissue disorders: Rash

Cardiac disorders: Atrial fibrillation, angina pectoris, ventricular extrasystoles, tachyarrhythmia

Investigations: Electrocardiogram QT prolonged, blood pressure increased (including hypertension)

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

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Foradil Aerolizer - User Reviews

Foradil Aerolizer User Reviews

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