Perforomist Side Effects

Generic Name: formoterol fumarate

Please note - some side effects for Perforomist 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 Perforomist - for the Consumer

Perforomist Solution

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 Perforomist Solution:

Diarrhea; dizziness; dry mouth; headache; nausea; nervousness; sore throat; tiredness; tremor; trouble sleeping; vomiting.

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

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; 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).

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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Perforomist Side Effects - for the Professional

Perforomist

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

Beta2-Agonist Adverse Reaction Profile

Adverse reactions to Perforomist 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, muscle cramps, palpitations, nausea, dizziness, fatigue, malaise, insomnia, hypokalemia, hyperglycemia, and metabolic acidosis.

Clinical Trials Experience

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.

Adults with COPD

The data described below reflect exposure to Perforomist Inhalation Solution 20 mcg twice daily by oral inhalation in 586 patients, including 232 exposed for 6 months and 155 exposed for at least 1 year. Perforomist Inhalation Solution was studied in a 12-week, placebo- and active-controlled trial (123 subjects treated with Perforomist Inhalation Solution) and a 52-week, active-controlled trial (463 subjects treated with Perforomist Inhalation Solution). Patients were mostly Caucasians (88%) between 40-90 years old (mean, 64 years old) and had COPD, with a mean FEV1 of 1.33 L. Patients with significant concurrent cardiac and other medical diseases were excluded from the trials.

Table 1 shows adverse reactions from the 12-week, double-blind, placebo-controlled trial where the frequency was greater than or equal to 2% in the Perforomist Inhalation Solution group and where the rate in the Perforomist Inhalation Solution group exceeded the rate in the placebo group. In this trial, the frequency of patients experiencing cardiovascular adverse events was 4.1% for Perforomist Inhalation Solution and 4.4% for placebo. There were no frequently occurring specific cardiovascular adverse events for Perforomist Inhalation Solution (frequency greater than or equal to 1% and greater than placebo). The rate of COPD exacerbations was 4.1% for Perforomist Inhalation Solution and 7.9% for placebo.

TABLE 1

Number of patients with adverse reactions in the 12-week multiple-dose controlled clinical trial
Adverse Reaction	Perforomist Inhalation Solution 20 mcg		Placebo
	n	(%)	n	(%)
Total Patients	123	(100)	114	(100)
Diarrhea	6	(4.9)	4	(3.5)
Nausea	6	(4.9)	3	(2.6)
Nasopharyngitis	4	(3.3)	2	(1.8)
Dry Mouth	4	(3.3)	2	(1.8)
Vomiting	3	(2.4)	2	(1.8)
Dizziness	3	(2.4)	1	(0.9)
Insomnia	3	(2.4)	0	0

Patients treated with Perforomist Inhalation Solution 20 mcg twice daily in the 52-week open-label trial did not experience an increase in specific clinically significant adverse events above the number expected based on the medical condition and age of the patients.

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Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects have included angina, hypertension or hypotension, tachycardia, palpitations and arrhythmias.

Dermatologic

Dermatologic side effects have included rash (1.1%).

Endocrine

Endocrine side effects have included hyperglycemia.

Gastrointestinal

Gastrointestinal side effects have included dry mouth and nausea.

Metabolic

Metabolic side effects have included hypokalemia and metabolic acidosis.

Musculoskeletal

Musculoskeletal side effects have included muscle cramps.

Nervous system

Nervous system side effects have included nervousness, headache, tremor, dizziness, and insomnia.

Respiratory

Respiratory side effects have included bronchitis (4.6%), chest infection (2.7%), dyspnea (2.1%), dysphonia (1%) and tonsillitis (1.2%).

General

General side effects have included fatigue and malaise.

Hypersensitivity

Hypersensitivity side effects have included postmarketing reports of anaphylactic reactions, including severe hypotension and angioedema.

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