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Perforomist

Last reviewed on RxList: 12/28/2016
Perforomist Side Effects Center

Last reviewed on RxList 1/7/2016

Perforomist (formoterol fumarate) Inhalation Solution is a long-acting bronchodilator used to prevent bronchospasm in people with reversible obstructive airways disease, including symptoms of night-time asthma. Perforomist is also used in people with chronic obstructive pulmonary disease (COPD) such as emphysema and chronic bronchitis. Common side effects of Perforomist include shakiness (tremor), nausea, headache, nervousness, dizziness, dry mouth, trouble sleeping (insomnia), anxiety, back pain, muscle cramps, sore throat, cough, stuffy nose, skin rash, itching, or changes in your voice.

The recommended dose of Perforomist Inhalation Solution is one 20 mcg unit-dose vial administered twice daily (morning and evening) by nebulization. A total daily dose greater than 40 mcg is not recommended. Perforomist may interact with cisapride, droperidol, methadone, pentamidin, caffeine, diet pills, cold medicine, stimulants, antibiotics, medicines to treat psychiatric disorders, heart rhythm medicines, beta-blockers, antidepressants, diuretics (water pills), or MAO inhibitors. Tell your doctor all medications and supplements you use. During pregnancy, Perforomist should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Perforomist (formoterol fumarate) 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.

Perforomist Consumer Information

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 any of these serious side effects:

  • chest pain, fast or pounding heartbeats, tremors, headache, or restless feeling;
  • seizure (convulsions);
  • wheezing, choking, or other breathing problems after using this medication;
  • increased thirst or hunger, urinating more than usual; or
  • worsening asthma symptoms.

Less serious side effects may include:

  • dizziness, anxiety, headache;
  • sleep problems (insomnia);
  • back pain, muscle cramps;
  • sore throat, dry mouth, cough, stuffy nose;
  • skin rash, itching; or
  • changes in your 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 Perforomist (Formoterol Fumarate Inhalation Solution)

Perforomist Professional Information

SIDE EFFECTS

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

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-weekmultiple-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 (18)
Dry Mouth 4 (3.3) 2 (18)
Vomiting 3 (2.4) 2 (18)
Dizzines 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.

Postmarketing Experience

The following adverse reactions have been reported during post-approval use of PERFOROMIST Inhalation Solution. 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.

Anaphylactic reactions, urticaria, angioedema (presenting as face, lip, tongue, eye, pharyngeal, or mouth edema), rash, and bronchospasm

Read the entire FDA prescribing information for Perforomist (Formoterol Fumarate Inhalation Solution)

Related Resources for Perforomist

Read the Perforomist User Reviews »

© Perforomist Patient Information is supplied by Cerner Multum, Inc. and Perforomist Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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