- Does Dulera (formoterol and mometasone furoate) cause side effects?
- What are the important side effects of Dulera (formoterol and mometasone furoate)?
- Dulera (formoterol and mometasone furoate) side effects list for healthcare professionals
- What drugs interact with Dulera (formoterol and mometasone furoate)?
Does Dulera (formoterol and mometasone furoate) cause side effects?
In patients with asthma, the smaller airways (bronchioles) through which air moves in and out of the lungs can be narrowed by accumulation of mucus, spasm of the muscles that surround these airways, or swelling of the lining of the airways due to inflammation.
Airway narrowing leads to symptoms of shortness of breath, wheezing, cough, and congestion. Medications used in treating asthma include those that open airways, called bronchodilators, and those that reduce inflammation.
Beta-2 agonists are medications that attach to beta-2 receptors on the smooth muscle cells that surround the airways, causing the muscle cells to relax and open the airways. Glucocorticoid steroids have potent anti-inflammatory actions.
In people with asthma, the suppression of inflammation within the airways reduces the swelling caused by inflammation that narrows the airways. At the same time, production of mucus is reduced.
Common side effects of Dulera include
- hoarseness or deepened voice,
- dry mouth,
- sore throat,
- stuffy nose,
- sinus pain,
- changes in menstrual periods,
- sleep problems (insomnia),
- muscle cramps,
- back pain,
- skin rash, and
Serious side effects of Dulera include
- worsening asthma symptoms,
- chest pain,
- fast or pounding heartbeats,
- shortness of breath,
- blurred vision,
- tunnel vision,
- eye pain or redness,
- seeing halos around lights,
- oral thrush (sores or white patches in the mouth or throat, trouble swallowing),
- high blood sugar (increased thirst, increased urination, dry mouth, fruity breath odor), and
- low potassium levels (leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling).
Drug interactions of Dulera include the following, which may increase the levels of mometasone in the body by reducing the breakdown of mometasone by liver enzymes and thus increase the side effects of Dulera:
- nelfinavir, and
Additional drug interactions include the following:
- Monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants may increase the effect of formoterol on the heart and blood pressure.
- Since Dulera contains formoterol, it should not be used with or within two weeks of discontinuing monoamine oxidase inhibitors or tricyclic antidepressants.
- Beta-blockers block the therapeutic effects of beta2-agonists, such as formoterol, a component of Dulera, and may produce severe bronchospasm in patients with asthma. Patients with asthma should not be treated with beta blockers.
It is unknown if the small amounts of Dulera components that may appear in breast milk have an effect on the infant. Consult your doctor before breastfeeding.
What are the important side effects of Dulera (formoterol and mometasone furoate)?
- Dulera should not be used for treatment of acute asthmatic attacks.
- Use of long acting agents like formoterol, an active ingredient in Dulera, may increase the risk of asthma-related death. Therefore, Dulera should only be used in patients whose asthma is uncontrolled by other agents, including long-term asthma-controlling medications such as an inhaled corticosteroid.
- Dulera may cause bronchospasm.
Dulera (formoterol and mometasone furoate) side effects list for healthcare professionals
LABA use may result in the following:
- Serious asthma-related events - hospitalizations, intubations, and death.
- Cardiovascular and central nervous system effects.
Systemic and local corticosteroid use may result in the following:
- Candida albicans infection
- Hypercorticism and adrenal suppression
- Growth effects in pediatrics
- Glaucoma and cataracts
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.
Clinical Trials Experience
- The safety data described below is based on 3 clinical trials which randomized 1913 patients 12 years of age and older with asthma, including 679 patients exposed to Dulera for 12 to 26 weeks and 271 patients exposed for 1 year.
- Dulera was studied in two placebo-and active-controlled trials (n=781 and n=728, respectively) and in a long-term 52-week safety trial (n=404).
the 12 to 26week clinical trials, the population was
- 12 to 84 years of age,
- 41% male and 59% female,
- 73% Caucasians,
- 27% non-Caucasians.
- Patients received two inhalations twice daily of Dulera (100 mcg/5 mcg or 200 mcg/5 mcg), mometasone furoate MDI (100 mcg or 200 mcg), formoterol MDI (5 mcg) or placebo.
- In the
long-term 52-week active-comparator safety trial, the population was
- 12 years to 75 years of age with asthma,
- 37% male and 63% female,
- 47% Caucasians,
- 53% non-Caucasians and received two inhalations twice daily of Dulera 100 mcg/5 mcg or 200 mcg/5 mcg, or an active comparator.
- The incidence of treatment emergent adverse reactions associated with Dulera in Table 2 below is based upon pooled data from 2 clinical trials 12 to 26 weeks in duration in patients 12 years and older treated with two inhalations twice daily of Dulera (100 mcg/5 mcg or 200 mcg/5 mcg), mometasone furoate MDI (100 mcg or 200 mcg), formoterol MDI (5mcg) or placebo.
Table 2: Treatment-Emergent Adverse Reactions in
Dulera Groups Occurring at an Incidence of ≥3% and More Commonly than
|Adverse Reactions||Dulera*||Mometasone Furoate*||Formoterol*||Placebo*
|100 mcg/5 mcg
|200 mcg/5 mcg
|Nasopharyngitis||20 (4.7)||12 (4.7)||15 (7.8)||13 (5.4)||13 (6.4)||7 (3.6)|
|Sinusitis||14 (3.3)||5 (2.0)||6 (3.1)||4 (1.7)||7 (3.5)||2 (1.0)|
|Headache||19 (4.5)||5 (2.0)||10 (5.2)||8 (3.3)||6 (3.0)||7 (3.6)|
|Average Duration of Exposure (days)||116||81||165||79||131||138|
|*All treatments were administered as two inhalations twice daily.|
- Oral candidiasis has been reported in clinical trials at an incidence of 0.7% in patients using Dulera 100 mcg/5 mcg, 0.8% in patients using Dulera 200 mcg/5 mcg and 0.5% in the placebo group.
Long-Term Clinical Trial Experience
- In a long-term safety trial in patients 12 years and older treated for 52 weeks with Dulera 100 mcg/5 mcg (n=141), Dulera 200 mcg/5 mcg (n=130) or an active comparator (n=133), safety outcomes in general were similar to those observed in the shorter 12 to 26 week controlled trials.
- No asthma-related deaths were observed. Dysphonia was observed at a higher frequency in the longer term treatment trial at a reported incidence of 7/141 (5%) patients receiving Dulera 100 mcg/5 mcg and 5/130 (3.8%) patients receiving Dulera 200 mcg/5 mcg.
- No clinically significant changes in blood chemistry, hematology, or ECG were observed.
The following adverse reactions have been reported during post-approval use of Dulera or post-approval use with inhaled mometasone furoate or inhaled formoterol fumarate. 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.
- Cardiac disorders: angina pectoris, cardiac arrhythmias, e.g., atrial fibrillation, ventricular extrasystoles, tachyarrhythmia Immune system disorders: immediate and delayed hypersensitivity reactions including anaphylactic reaction, angioedema, severe hypotension, rash, pruritus
- Investigations: electrocardiogram QT prolonged, blood pressure increased (including hypertension)
- Metabolism and nutrition disorders: hypokalemia, hyperglycemia
- Respiratory, thoracic and mediastinal disorders: asthma aggravation, which may include cough, dyspnea, wheezing and bronchospasm
What drugs interact with Dulera (formoterol and mometasone furoate)?
In clinical trials, concurrent administration of Dulera and other drugs, such as short-acting beta2-agonist and intranasal corticosteroids have not resulted in an increased frequency of adverse drug reactions. No formal drug interaction studies have been performed with Dulera. The drug interactions of the combination are expected to reflect those of the individual components.
Inhibitors Of Cytochrome P450 3A4
- The main route of metabolism of corticosteroids, including mometasone furoate, a component of Dulera, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4).
- After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally inhaled mometasone furoate increased.
- Concomitant administration of CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, mometasone furoate.
- Caution should be exercised when considering the coadministration of Dulera with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin).
- If additional adrenergic drugs are to be administered by any route, they should be used with caution because the pharmacologically predictable sympathetic effects of formoterol, a component of Dulera, may be potentiated.
- Concomitant treatment with xanthine derivatives may potentiate any hypokalemic effect of formoterol, a component of Dulera.
- Concomitant treatment with diuretics may potentiate the possible hypokalemic effect of adrenergic agonists.
- The ECG changes and/or hypokalemia that may result from the administration of non-potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded.
- Although the clinical significance of these effects is not known, caution is advised in the coadministration of Dulera with non-potassium-sparing diuretics.
Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, And Drugs Known To Prolong The QTc Interval
- Dulera should be administered with caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, macrolides, or drugs known to prolong the QTc interval or within 2 weeks of discontinuation of such agents, because the action of formoterol, a component of Dulera, on the cardiovascular system may be potentiated by these agents.
- Drugs that are known to prolong the QTc interval have an increased risk of ventricular arrhythmias.
Beta-Adrenergic Receptor Antagonists
- Beta-adrenergic receptor antagonists (beta-blockers) and formoterol may inhibit the effect of each other when administered concurrently.
- Beta-blockers not only block the therapeutic effects of beta2-agonists, such as formoterol, a component of Dulera, but may produce severe bronchospasm in patients with asthma.
- Therefore, patients with asthma should not normally be treated with beta-blockers.
- However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with asthma.
- In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
- There is an elevated risk of arrhythmias in patients receiving concomitant anesthesia with halogenated hydrocarbons.
Dulera (formoterol and mometasone furoate) is a combination of a long-acting beta-2 adrenergic agonist (LABA) bronchodilator and an anti-inflammatory corticosteroid used to treat asthma. Common side effects of Dulera include hoarseness or deepened voice, dry mouth, sore throat, cough, headache, stuffy nose, sinus pain, changes in menstrual periods, dizziness, anxiety, headache, sleep problems (insomnia), muscle cramps, back pain, skin rash, and itching. Use of Dulera during pregnancy has not been adequately evaluated. It is unknown if components of Dulera are secreted in breast milk.
Multimedia: Slideshows, Images & Quizzes
What Is Asthma? Symptoms, Causes, and Treatments
What is asthma? What is the main cause of asthma? Learn information about asthma, a chronic disease of the bronchiole tubes....
Asthma is a chronic disease of the airways of the lungs, which can be managed with proper treatment. Triggered by two main...
What is Asthma? Asthma Myths Debunked
What are asthma myths and facts? There is currently no cure for asthma, and no specific, single cause for asthma has been...
Asthma and Your Diet: Foods That Help and Hurt
Even though there's no specific asthma diet that can help your condition, certain foods may help or harm your breathing. Learn...
Asthma Attacks: Triggers, Symptoms, and Treatment
Asthma symptoms include coughing, wheezing, headache, fatigue, dark circles under the eyes, trouble sleeping, and loss of...
10 Worst Smog Cities in America
Learn the worst smog cities in America. See the 10 cities with the most polluted, unclean and smoggy air.
Asthma: Natural Ways to Ease Asthma Symptoms
You can do more than take medication to manage your asthma. Several other things can help you breathe more easily.
Related Disease Conditions
COPD vs. Asthma (Differences and Similarities)
COPD (chronic obstructive pulmonary disease) and asthma both have common symptoms like coughing, wheezing, shortness of breath, and a tight feeling in the chest. COPD is caused by tobacco smoking, while asthma is caused by your inherited genetic makeup and their interactions with the environment. Risk factors for asthma are obesity, exposure to cigarette smoke (even secondhand smoke), and personal history of hay fever. There is no cure for either disease, but symptoms can be managed with medication. A person with asthma has a better prognosis and life expectancy than someone with COPD.
Asthma is a condition in which hyperreactive airways constrict and result in symptoms like wheezing, coughing, and shortness of breath. Causes of asthma include genetics, environmental factors, personal history of allergies, and other factors. Asthma is diagnosed by a physician based on a patient's family history and results from lung function tests and other exams. Inhaled corticosteroids (ICS) and long-acting bronchodilators (LABAs) are used in the treatment of asthma. Generally, the prognosis for a patient with asthma is good. Exposure to allergens found on farms may protect against asthma symptoms.
Asthma Over-the-Counter Treatment
Patients who have infrequent, mild bouts of asthma attacks may use over-the-counter (OTC) medications to treat their asthma symptoms. OTC asthma medicines are limited to epinephrine and ephedrine. These OTC drugs are best used with the guidance of a physician, as there may be side effects and the drugs may not be very effective.
What Is Asthma? 19 Complex Facts
There are many unusual symptoms of asthma, including sighing, difficulty sleeping, anxiety, chronic cough, recurrent walking pneumonia, and rapid breathing. These symptoms may vary from individual to individual. These asthma complexities make it difficult to accurately diagnose and treat asthma.
There are two types of asthma medications: long-term control with anti-inflammatory drugs and quick relief from bronchodilators. Asthma medicines may be inhaled using a metered-dose inhaler or nebulizer or they may be taken orally. People with high blood pressure, diabetes, thyroid disease, or heart disease shouldn't take OTC asthma drugs like Primatene Mist and Bronkaid.
Asthma in Children
Asthma in children manifests with symptoms such as coughing and wheezing. Rates of asthma in children are increasing. Asthma in children is usually diagnosed based on the description of symptoms. Lung function tests may also be used. A variety of medications are used for the treatment of childhood asthma.
Adult-onset asthma is asthma that is diagnosed in people over 20 years of age. Symptoms include wheezing, coughing, shortness of breath and difficulty breathing. Treatment may involve anti-inflammatory medications or bronchodilators.
What Are the Four Types of Asthma?
Asthma is a chronic inflammatory disease of the airways (bronchi). Bronchi generally allow for the passage of air in and out of the lungs. In asthma, these airways develop hypersensitivity, inflammation, and narrowing. This causes difficulty in breathing. The four types are mild intermittent, mild persistent, moderate persistent, and severe persistent.
Can Asthma Go Away on Its Own?
Asthma is a long-term condition for many people, particularly if it first develops when you're an adult. In children, it sometimes goes away or improves during the teenage years, but can come back later in life.
Occupational asthma is a type of asthma caused by exposure to a substance in the workplace. Symptoms and signs include wheezing, chest tightness, and shortness of breath. The usual treatment for occupational asthma involves removal from exposure and the use of bronchodilators and inhaled anti-inflammatory medicines.
Treatment & Diagnosis
- Asthma FAQs
- What if I Get COVID-19 with Asthma?
- Methotrexate Spares Steroids in Asthmatics
- Asthma Rates Increasing
- Exercise Preventing Asthma?
- Asthma in Women, Asthma in Pregnancy
- Can Asthma Go Away and Come Back?
- What Are the Side Effects of Asthma Inhalers?
- Does Altitude Affect Asthma?
- What Is Exercise-Induced Asthma?
- Can Asthma Medication Hide Churg-Strauss Syndrome?
- Best Exercises for Asthma: Yoga, Swimming, Biking, and Walking
- Does Stress Cause Asthma?
- Can Asthma Cause a Heart Attack?
- What Causes Asthma?
Medications & Supplements
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.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.