Generic Name

Formoterol

Brand Names
Perforomist, Duaklir Pressair
FDA approval date: October 01, 2007
Classification: beta2-Adrenergic Agonist
Form: Powder, Solution

What is Perforomist (Formoterol)?

For many people living with chronic obstructive pulmonary disease (COPD), each breath can feel like a struggle. Shortness of breath, fatigue, and persistent coughing can make daily activities from walking to speaking feel exhausting. Perforomist (formoterol) is designed to help ease that burden, giving patients steadier breathing and better control over their symptoms. 

Perforomist is a long-acting beta₂-adrenergic agonist (LABA) used for the maintenance treatment of COPD, including chronic bronchitis and emphysema. It is not a rescue inhaler but a controller medication that works continuously to help the lungs stay open and functioning more efficiently. Approved by the U.S. Food and Drug Administration (FDA), Perforomist offers sustained relief from COPD symptoms and helps improve lung function and overall quality of life when used as prescribed. 

What does Perforomist do? 

Perforomist helps manage chronic obstructive pulmonary disease (COPD), a long-term condition that makes it hard to breathe because of airway inflammation and obstruction. In COPD, the airways become narrow and clogged with mucus, leading to difficulty exhaling air from the lungs. 

Perforomist is used regularly to prevent symptoms, not for sudden breathing problems. By helping airways stay open for up to 12 hours, it allows oxygen to move more freely through the lungs, reducing breathlessness and improving endurance. 

In clinical studies, patients who used formoterol experienced significant improvement in lung capacity (measured by FEV₁) and reported fewer COPD flare-ups compared to placebo groups (NIH, 2024). Many patients find that regular use of Perforomist helps them perform daily activities with less fatigue and shortness of breath, contributing to a better quality of life. 

How does Perforomist work? 

Perforomist contains formoterol fumarate, a long-acting bronchodilator. It works by targeting beta₂-adrenergic receptors in the smooth muscles that line the airways of the lungs. 

When activated, these receptors cause the muscles to relax, which widens (dilates) the airways and allows air to pass through more easily. Unlike short-acting inhalers that provide immediate but brief relief, formoterol starts working within minutes and continues to keep airways open for about 12 hours. 

This mechanism helps prevent the daily cycle of airway tightening that leads to breathlessness, coughing, and wheezing. By maintaining open airways around the clock, Perforomist supports steady, easier breathing and reduces the risk of exacerbations or hospitalizations. 

Clinically, this long-term bronchodilation is essential for COPD management because it helps the lungs work more efficiently, preserves oxygen exchange, and reduces strain on the heart and respiratory muscles. 

Perforomist side effects 

Most patients tolerate Perforomist well, but like all medications, it can cause side effects. These are usually mild and manageable with proper monitoring. 

Common side effects may include: 

  • Tremors or shakiness 
     
  • Headache 
     
  • Nervousness or restlessness 
     
  • Muscle cramps 
     
  • Throat irritation or cough 
     
  • Nausea or upset stomach 

Less common but serious side effects: 

  • Chest pain or fast, irregular heartbeat 
     
  • Severe dizziness or fainting 
     
  • Worsening shortness of breath immediately after use 
     
  • Low blood potassium (which can cause muscle weakness or irregular heartbeat) 
     
  • Signs of allergic reaction such as rash, itching, or swelling of the face or throat 

Because Perforomist is a LABA, it should not be used alone to treat asthma, as this has been linked to an increased risk of asthma-related complications. However, it is safe and FDA-approved for COPD when used as directed. 

People with heart disease, high blood pressure, diabetes, thyroid disorders, or seizure disorders should discuss these conditions with their healthcare provider before using the medication. 

Seek emergency medical care if you experience chest pain, severe palpitations, or trouble breathing after using the medication. Regular follow-ups with a doctor help ensure that side effects are caught early and treatment remains effective. 

Perforomist dosage 

Perforomist is an inhalation solution delivered via a nebulizer, ideal for patients who struggle with traditional inhalers. It’s typically used twice daily, 12 hours apart, for consistent relief, and patients should not exceed this frequency. Perforomist is not a rescue medication for sudden breathing problems; a separate short-acting bronchodilator is prescribed for acute symptoms. 

Doctors advise regular lung function, heart rate, and blood potassium checks for safe treatment, especially for older adults or those with cardiovascular issues. Mild liver or kidney impairment usually doesn’t require dosage adjustments, but a healthcare provider should always review individual responses. 

Does Perforomist have a generic version? 

Yes. Formoterol fumarate inhalation solution, the generic version of Perforomist, is FDA-approved and available in the United States. It contains the same active ingredient, dosage strength, and formulation as Perforomist, providing the same effectiveness and safety profile. 

Generic formoterol is a safe, FDA-approved, and affordable alternative that improves access to long-term therapy. Other combination inhalers containing formoterol, like Symbicort and Dulera, are distinct medications and should be used only as prescribed. 

Conclusion 

Perforomist (formoterol) is a proven, long-acting bronchodilator that helps people with COPD breathe more comfortably and live more actively. By relaxing airway muscles and improving airflow, it provides sustained symptom control and reduces the frequency of flare-ups that can interrupt daily life. 

While Perforomist is not a quick-relief medication, its consistent, twice-daily use can make a significant difference in long-term respiratory stability and overall well-being. Most patients tolerate it well, and regular monitoring ensures that any side effects or complications are managed promptly. 

With guidance from a healthcare professional, Perforomist can be a safe, effective cornerstone of COPD treatment, helping patients breathe easier, move with confidence, and enjoy a fuller life. 

References 

  1. U.S. Food and Drug Administration (FDA). (2024). Perforomist (formoterol fumarate) inhalation solution – prescribing information. Retrieved from https://www.accessdata.fda.gov 
     
  1. Mayo Clinic. (2024). Formoterol (inhalation route): Drug information. Retrieved from https://www.mayoclinic.org 
     
  1. MedlinePlus. (2024). Formoterol inhalation: Uses, side effects, and precautions. National Library of Medicine. Retrieved from https://medlineplus.gov 
     
  1. National Institutes of Health (NIH). (2024). Long-acting beta-agonists in COPD management. Retrieved from https://www.nih.gov 

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Brand Information

    Perforomist (formoterol fumarate dihydrate)
    1DOSAGE AND ADMINISTRATION
    The recommended dose of PERFOROMIST (formoterol fumarate) 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 Inhalation Solution should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor. The safety and efficacy of PERFOROMIST Inhalation Solution have been established in clinical trials when administered using the PARI-LC Plus
    PERFOROMIST Inhalation Solution should always be stored in the foil pouch, and only removed IMMEDIATELY BEFORE USE. Contents of any partially used container should be discarded.
    If the recommended maintenance treatment regimen fails to provide the usual response, medical advice should be sought immediately, as this is often a sign of destabilization of COPD. Under these circumstances, the therapeutic regimen should be re-evaluated and additional therapeutic options should be considered.
    The drug compatibility (physical and chemical), efficacy, and safety of PERFOROMIST Inhalation Solution when mixed with other drugs in a nebulizer have not been established.
    2DOSAGE FORMS AND STRENGTHS
    PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as a sterile solution for nebulization in low-density polyethylene unit-dose vials. Each vial contains formoterol fumarate dihydrate, USP equivalent to 20 mcg/2 mL of formoterol fumarate.
    3CONTRAINDICATIONS
    Use of a LABA, including PERFOROMIST, without an inhaled corticosteroid is contraindicated in patients with asthma WARNINGS and PRECAUTIONS (5.1)]. PERFOROMIST is not indicated for the treatment of asthma.
    4ADVERSE REACTIONS
    Long-acting beta
    4.1Beta-Agonist Adverse Reaction Profile
    Adverse reactions to PERFOROMIST Inhalation Solution are expected to be similar in nature to other beta
    4.2Clinical 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.
    4.2.1Adults 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 FEV
    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.
    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.
    4.3Postmarketing 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
    5OVERDOSAGE
    The expected signs and symptoms with overdosage of PERFOROMIST Inhalation Solution are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms listed under
    Treatment of overdosage consists of discontinuation of PERFOROMIST Inhalation Solution together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of PERFOROMIST Inhalation Solution. Cardiac monitoring is recommended in cases of overdosage.
    For additional information about overdose treatment, call a poison control center (1-800-222-1222).
    6DESCRIPTION
    PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate.
    The active component of PERFOROMIST Inhalation Solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta
    Structural Formula
    Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C
    PERFOROMIST Inhalation Solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance.
    Using the PARI-LC Plus
    7HOW SUPPLIED/STORAGE AND HANDLING
    PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as a 2 mL sterile solution for nebulization in 2.5 mL low-density polyethylene unit dose vials. Each vial is overwrapped in a foil pouch and supplied in cartons as listed below.
    Carton of 30 individually wrapped unit dose vials,
    Carton of 60 individually wrapped unit dose vials,
    Storage and Handling:
    Prior to dispensing to the patient: Store in a refrigerator, 2°C to 8°C (36°F to 46°F). Protect pouch from light and heat.
    After dispensing to the patient: Store in a refrigerator at 2°C to 8°C (36°F to 46°F) and discard when drug expires or store at room temperature, 20°C to 25°C (68°F to 77°F) and discard if not used after 3 months. Protect pouch from light and heat.
    • PERFOROMIST Inhalation Solution should only be administered via a standard jet nebulizer connected to an air compressor with an adequate airflow and equipped with a facemask or mouthpiece.
    • Vial should always be stored in the foil pouch, and only removed IMMEDIATELY before use.
    • Do not take by mouth.
    • Contents of any partially used container should be discarded.
    • Discard the container and top after use.
    • Keep out of the reach of children
    8PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
    Serious Asthma-Related Events
    Inform patients that long-acting beta agonist, such as PERFOROMIST, when used as monotherapy [without an inhaled corticosteroid], increase the risk of serious asthma-related events, including asthma-related death. PERFOROMIST is not indicated for the treatment of asthma.
    Acute Exacerbations or Deteriorations
    PERFOROMIST Inhalation Solution is not indicated for relief of acute symptoms, and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta
    Appropriate Dosing
      Patients should not stop using PERFOROMIST Inhalation Solution unless told to do so by a healthcare provider because symptoms may get worse. Patients should not inhale more than the prescribed number of vials at any one time. The daily dosage of PERFOROMIST Inhalation Solution should not exceed one vial twice daily (40 mcg total daily dose). Excessive use of sympathomimetics may cause significant cardiovascular effects and may be fatal.
    Concomitant Therapy
    Patients who have been taking inhaled, short-acting beta
    Common Adverse Reactions with Beta
    Patients should be informed that treatment with beta
    Instructions for Administration
    It is important that patients understand how to use PERFOROMIST Inhalation Solution with a nebulizer appropriately
    Manufactured for:
    Manufactured by:
    U.S. Pat. No. 6,667,344

    FORMIS:R3
    The brands listed are trademarks of their respective owners.
    9PATIENT INFORMATION
    This Patient Information has been approved by the U.S. Food and Drug Administration     Issued: 5/2019                                                                                                                                                  PIL:FORMIS:R1
    Instructions for Using PERFOROMIST (formoterol fumarate) Inhalation Solution
    PERFOROMIST Inhalation Solution is used only in a standard jet nebulizer machine connected to an air compressor. Make sure you know how to use your nebulizer machine before you use it to breathe in PERFOROMIST Inhalation Solution or other medicines.
    Do not mix PERFOROMIST Inhalation Solution with other medicines in your nebulizer machine.
    PERFOROMIST Inhalation Solution comes sealed in a foil pouch. Do not open a sealed pouch until you are ready to use a dose of PERFOROMIST Inhalation Solution.
    1. Remove vial from the foil pouch.
    2. Twist the cap completely off the vial and squeeze all the medicine into the nebulizer medicine cup (reservoir) (Figure 1).
    3. Connect the nebulizer reservoir to the mouthpiece or facemask (Figure 2).
    4. Connect the nebulizer to the compressor.
    5. Sit in a comfortable, upright position. Place the mouthpiece in your mouth (Figure 3) or put on the facemask (Figure 4); and turn on the compressor.
    6. Breathe as calmly, deeply and evenly as possible through your mouth until no more mist is formed in the nebulizer reservoir. The average nebulization time is 9 minutes. At this point, the treatment is finished.
    7. Discard the PERFOROMIST Inhalation Solution container and top after use.
    8. Clean the nebulizer (see manufacturer’s instructions).
    Manufactured for:
    Manufactured by:
    This Instructions for Use has been approved by the U.S. Food and Drug Administration
    Revised: 5/2019
    10PRINCIPAL DISPLAY PANEL – 20 mcg/2 mL
    NDC 49502-605-30
    Perforomist
    (formoterol fumarate) INHALATION SOLUTION
    20 mcg/2 mL vial
    Patient Information for Patients Enclosed
    Sterile Unit Dose Vials -
    EACH 2 mL VIAL CONTAINS: ACTIVE: Formoterol fumarate, USP.
    INACTIVES: Citric acid, sodium citrate, sodium chloride, and water.
    CARTON CONTAINS: 30 individually wrapped 2 mL vials
    Discard three months
    STORAGE CONDITIONS:
    PRIOR TO DISPENSING TO THE PATIENT: Store refrigerated, 2°C to 8°C (36°F to 46°F). Protect pouch from light and heat.
    AFTER DISPENSING TO THE PATIENT: Store in a refrigerator at 2°C to 8°C (36°F to 46°F) and discard when drug expires or store at room temperature, 20°C to 25°C (68°F to 77°F) and discard if not used after 3 months. Protect pouch from light and heat.
    VIAL SHOULD ALWAYS BE STORED IN THE FOIL POUCH, AND ONLY REMOVED IMMEDIATELY BEFORE USE.
    Keep out of reach of children.
    FOR THE HEALTHCARE PROVIDER: When Perforomist
    FOR THE PATIENT: Use Perforomist
    Rx only
    Manufactured for:
    Manufactured by:
    U.S. Pat. Nos. 6,667,344, 6,814,953, 7,348,362, 7,462,645, 8,623,922, and 9,730,890
    Mylan Specialty L.P., Morgantown, WV 26505
    MS:605:30C:R3 RPSC0340
    Perforomist 20 mcg/2 mL Carton Label
    Perforomist has been selected.