Brovana
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Brovana
Brovana Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Brovana (arformoterol tartrate) Inhalation Solution is used to prevent bronchoconstriction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It will not treat a bronchospasm attack that has already begun. This medication is a bronchodilator. Common side effects include shakiness (tremor), nausea, headache, nervousness, dizziness, dry mouth, or trouble sleeping.
The recommended dose of Brovana Inhalation Solution is one 15 mcg unit-dose vial administered twice daily (morning and evening) by nebulization. Brovana may interact with aminophylline, theophylline, antibiotics, antidepressants, beta-blockers, diuretics (water pills), heart rhythm medicines, MAO inhibitors, narcotics, or steroids. Tell your doctor all medications you use. During pregnancy, Brovana should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Our Brovana (arformoterol tartrate) 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.
Brovana 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 a serious side effect such as:
- bronchospasm (wheezing, chest tightness, trouble breathing);
- chest pain, fast or pounding heart beats, restless feeling, tremor;
- feeling short of breath, even with mild exertion;
- swelling, rapid weight gain;
- white patches or sores inside your mouth or on your lips; or
- dry mouth, increased thirst, drowsiness, restless feeling, confusion, nausea, vomiting, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, or fainting.
Less serious side effects may include:
- weakness; headache, sleep problems (insomnia);
- nausea, vomiting, diarrhea;
- leg cramps;
- fever;
- stuffy nose; or
- hoarseness or deepened 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 Brovana (Arformoterol Tartrate Inhalation Solution) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Brovana Overview - Patient Information: Side Effects
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/pounding/irregular/slow heartbeat, muscle weakness/cramps, increased thirst/urination.
Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, severe dizziness, fainting.
Rarely, this medication has caused severe (possibly fatal), sudden worsening of breathing problems (paradoxical bronchospasm). If you have trouble breathing or experience sudden wheezing, 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 symptoms of a serious allergic reaction, including: 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 Brovana (Arformoterol Tartrate Inhalation Solution)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Brovana FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Long acting beta2-adrenergic agonists increase the risk of asthma-related death [See BOXED WARNING and WARNINGS AND PRECAUTIONS].
Beta2-Agonist Adverse Reaction Profile
Adverse reactions to BROVANA Inhalation Solution are expected to be similar in nature to other beta2-adrenergic receptor agonists including: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in 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 practice.
The safety data described below for adults ≥ 35 years of age are based on 2 clinical trials of 12 weeks. In the 2 trials of 12 weeks duration, 1456 patients (860 males and 596 females, ages 34 to 89 years old) with COPD were treated with BROVANA Inhalation Solution 15 mcg twice daily, 25 mcg twice daily, 50 mcg once daily, Salmeterol 42 mcg twice daily, or placebo. The racial/ethnic distribution in these two trials included 1383 Caucasians, 49 Blacks, 10 Asians, and 10 Hispanics, and 4 patients classified as Other.
Adults with COPD
Among 1,456 COPD patients in two 12-week, placebo-controlled trials, 288 were treated with BROVANA Inhalation Solution 15 mcg twice daily and 293 were treated with placebo. Doses of 25 mcg twice daily and 50 mcg once daily were also evaluated.
Table 1 shows adverse reaction rates among patients from these two trials where the frequency was greater than or equal to 2% in the BROVANA Inhalation Solution 15 mcg twice daily group and where the rate in the BROVANA Inhalation Solution 15 mcg twice daily group exceeded the rate in the placebo group. The total number and percent of patients who reported adverse events were 202 (70%) in the 15 mcg twice daily and 219 (75%) in the placebo groups. Ten adverse events demonstrated a dose relationship: asthenia, fever, bronchitis, COPD, headache, vomiting, hyperkalemia, leukocytosis, nervousness, and tremor.
Table 1: Number of Patients Experiencing Adverse Events from
Two 12-Week, Double-Blind, Placebo Controlled Clinical Trials
| Total Patients | BROVANA | Placebo | ||
| 15 mcg twice daily | ||||
| n | (%) | n | (%) | |
| 288 | (100) | 293 | (100) | |
| Pain | 23 | (8) | 16 | (5) |
| Chest Pain | 19 | (7) | 19 | (6) |
| Back Pain | 16 | (6) | 6 | (2) |
| Diarrhea | 16 | (6) | 13 | (4) |
| Sinusitis | 13 | (5) | 11 | (4) |
| Leg Cramps | 12 | (4) | 6 | (2) |
| Dyspnea | 11 | (4) | 7 | (2) |
| Rash | 11 | (4) | 5 | (2) |
| Flu Syndrome | 10 | (3) | 4 | (1) |
| Peripheral Edema | 8 | (3) | 7 | (2) |
| Lung Disorder* | 7 | (2) | 2 | (1) |
| * Reported terms coded to “Lung Disorder” were predominantly pulmonary or chest congestion. | ||||
Adverse events occurring in patients treated with BROVANA Inhalation Solution 15 mcg twice daily with a frequency of < 2%, but greater than placebo were as follows:
Body as a Whole: abscess, allergic reaction, digitalis intoxication, fever, hernia, injection site pain, neck rigidity, neoplasm, pelvic pain, retroperitoneal hemorrhage
Cardiovascular: arteriosclerosis, atrial flutter, AV block, congestive heart failure, heart block, myocardial infarct, QT interval prolonged, supraventricular tachycardia, inverted
T-wave Digestive: constipation, gastritis, melena, oral moniliasis, periodontal abscess, rectal hemorrhage
Metabolic and Nutritional Disorders: dehydration, edema, glucose tolerance decreased, gout, hyperglycemia, hyperlipemia, hypoglycemia, hypokalemia
Musculoskeletal: arthralgia, arthritis, bone disorder, rheumatoid arthritis, tendinous contracture
Nervous: agitation, cerebral infarct, circumoral paresthesia, hypokinesia, paralysis, somnolence, tremor
Respiratory: carcinoma of the lung, respiratory disorder, voice alteration
Skin and Appendages: dry skin, herpes simplex, herpes zoster, skin discoloration, skin hypertrophy
Special Senses: abnormal vision, glaucoma
Urogenital: breast neoplasm, calcium crystalluria, cystitis, glycosuria, hematuria, kidney calculus, nocturia, PSA increase, pyuria, urinary tract disorder, urine abnormality.
In these trials the overall frequency of all cardiovascular adverse events was 6.9% in BROVANA Inhalation Solution 15 mcg twice daily and 13.3% in the placebo group. There were no frequently occurring specific cardiovascular adverse events for BROVANA Inhalation Solution (frequency ≥ 1% and greater than placebo). The rate of COPD exacerbations was also comparable between the BROVANA Inhalation Solution 15 mcg twice daily and placebo groups, 12.2% and 15.1%, respectively
Read the entire FDA prescribing information for Brovana (Arformoterol Tartrate Inhalation Solution) »
Additional Brovana Information
Brovana - User Reviews
Brovana User Reviews
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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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