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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

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.

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; 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; trouble speaking.

For the professional

Brovana

Experience in Adult Patients with COPD

Of the 1,456 COPD patients in the two 12-week, placebo-controlled trials, 288 were treated with Brovana (arformoterol tartrate) 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. The numbers and percent of patients who reported adverse events were comparable in the 15 mcg twice daily and placebo groups.

The following table shows adverse events where the frequency was greater than or equal to 2% in the Brovana 15 mcg twice daily group and where the rates of adverse events in the Brovana 15 mcg twice daily group exceeded placebo. Ten adverse events demonstrated a dose relationship: asthenia, fever, bronchitis, COPD, headache, vomiting, hyperkalemia, leukocytosis, nervousness, and tremor.

Adverse events occurring in patients treated with Brovana 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.

Overall, the frequency of all cardiovascular adverse events for Brovana in the two placebo controlled trials was low and comparable to placebo (6.9% in Brovana 15 mcg twice daily and 13.3% in the placebo group). There were no frequently occurring specific cardiovascular adverse events for Brovana (frequency ≥1% and greater than placebo). The rate of COPD exacerbations was also comparable between the Brovana 15 mcg twice daily and placebo groups, 12.2% and 15.1%, respectively.

Other adverse reactions which may occur with selective beta2-adrenoceptor agonists such as Brovana 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.

Drug Abuse and Dependence

There were no reported cases of abuse or evidence of drug dependence with the use of Brovana in the clinical trials.

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