Brovana Side Effects

Please note - some side effects for Brovana may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Brovana - for the Consumer

Brovana

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Brovana:

Back pain; diarrhea; dry mouth; headache; nausea; nervousness; stuffy nose; tiredness; tremor; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Brovana:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness); chest pain; fast or irregular heartbeat; fever, chills, or persistent sore throat; leg swelling; new or worsening breathing problems (eg, increased chest tightness, coughing, shortness of breath, wheezing); severe or persistent headache, dizziness, tremor, or nervousness; severe or persistent muscle pain or cramps; symptoms of high blood sugar (eg, increased thirst, urination, or hunger; unusual weakness or drowsiness; confusion); trouble speaking.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Brovana Side Effects - for the Professional

Brovana

Long acting beta2-adrenergic agonists increase the risk of asthma-related death [See BOXED WARNING and WARNINGS AND PRECAUTIONS (5.1)].

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

* Reported terms coded to “Lung Disorder” were predominantly pulmonary or chest congestion.
	Brovana 15 mcg twice daily		Placebo
	n	(%)	n	(%)
Total Patients	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)

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

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Side Effects by Body System - for Healthcare Professionals

Respiratory

Respiratory side effects have included dyspnea, sinusitis, and pulmonary or chest congestion.

Cardiovascular

Cardiovascular side effects have included peripheral edema.

Dermatologic

Dermatologic side effects have included rash.

Gastrointestinal

Gastrointestinal side effects have included diarrhea.

Musculoskeletal

Musculoskeletal side effects have included lag cramps.

General

General side effects have included pain, chest pain, back pain, and flu syndrome.

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