Name: Accolate

Do I need a prescription for this drug?

Yes, your doctor or other health care professional must write you a prescription for this drug.

Why is this medication prescribed?

Zafirlukast is used to prevent asthma symptoms. Zafirlukast is in a class of medications called leukotriene receptor antagonists (LTRAs). It works by blocking the action of certain natural substances that cause swelling and tightening of the airways.

Brand names

  • Accolate®


Antiasthmatic agent; leukotriene-receptor antagonist.1 2 3 4 5 10 11 12 21 22 23 24 25 26 44 45

Uses for Accolate


Prevention and long-term symptomatic management of asthma.a 1 14 15 16 17 21 22 23 24 25 45 66 74

In patients with mild persistent asthma, low-dose orally inhaled corticosteroids considered first-line agents for long-term control.43 74 Alternative agents, including certain leukotriene modifiers (i.e., zafirlukast, montelukast), may be used but are less effective than inhaled corticosteroids and are not preferred as initial therapy.43 74 76

In patients with moderate persistent asthma, low-dose inhaled corticosteroids with a long-acting inhaled β2-agonist bronchodilator (e.g., salmeterol, formoterol) or monotherapy with medium-dose inhaled corticosteroids preferred.43 74 However, the National Asthma Education and Prevention Program (NAEPP) recommends that beneficial effects of long-acting inhaled β2-agonists be weighed carefully against increased risk of severe asthma exacerbations and asthma-related deaths associated with daily use of such agents.74

Alternative agents, including certain leukotriene modifiers (i.e., zafirlukast, montelukast), can be added to a low dosage of inhaled corticosteroid for treatment of moderate persistent asthma, but these options are less effective.43 74 Considerations favoring combination with orally inhaled corticosteroids include intolerance to long-acting β2-adrenergic agonists, marked preference for oral therapy, and demonstration of superior responsiveness to these leukotriene modifiers.74

In adults and children ≥5 years of age with severe persistent asthma, NAEPP and the Global Initiative for Asthma (GINA) state that maintenance therapy with inhaled corticosteroids at medium to high dosages and adjunctive therapy with a long-acting inhaled β2-agonist is preferred.43 74 Alternatives to a long-acting inhaled β2-agonist in such patients receiving medium-dose inhaled corticosteroids include certain leukotriene modifiers (i.e., zafirlukast, montelukast), but these agents are generally not preferred.43 74

Therapy with zafirlukast may be especially useful in patients who are unable or unwilling to comply with therapy using inhaled drugs (e.g., children).11 12 22 23 25 53 74

Not recommended for relief of acute bronchospasm; however, may continue therapy during acute asthma exacerbations.1 45 52 (See Acute Asthma under Cautions.)

Allergic Rhinitis

Has been used for symptomatic management of seasonal allergic rhinitis†.12 23 48

Exercise-induced Bronchospasm

Has been used for prevention of exercise-induced bronchospasm†.22 24 49 50 53

Leukotriene modifiers not included as first-line agents or as alternative agents to orally inhaled β2-adrenergic agonists in current guidelines.74 b

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • A burning, numbness, or tingling feeling that is not normal.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • A heartbeat that does not feel normal.
  • Chest pain.
  • Change in the way you act.
  • Mood changes.
  • Low mood (depression).
  • Not able to sleep.
  • Sinus irritation.
  • Flu-like signs.
  • Fever or chills.
  • Very bad sore throat.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Accolate (zafirlukast) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Accolate. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017


Zafirlukast is a synthetic, selective peptide leukotriene receptor antagonist (LTRA), with the chemical name 4-(5-cyclopentyloxy-carbonylamino-1-methyl-indol-3-ylmethyl)-3-methoxy-N-o-tolylsulfonylbenzamide. The molecular weight of zafirlukast is 575.7 and the structural formula is:

The empirical formula is: C31H33N3O6S

Zafirlukast, a fine white to pale yellow amorphous powder, is practically insoluble in water. It is slightly soluble in methanol and freely soluble in tetrahydrofuran, dimethylsulfoxide, and acetone.

Accolate is supplied as 10 and 20 mg tablets for oral administration.

Inactive Ingredients: Film-coated tablets containing croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, povidone, hypromellose, and titanium dioxide.

Indications and usage

Accolate is indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.

Accolate Overview

Accolate is a prescription medication used for prevention and chronic treatment of asthma in adults and children 5 years and older.

This medication belongs to a group of drugs called leukotriene receptor antagonists. Accolate works by blocking the actions of leukotriene, a natural substance that causes swelling and tightening of the airways.

Accolate comes in tablet form and is usually taken twice daily on an empty stomach, 1 hour before, or 2 hours after a meal.

Common side effects include headache, nausea, and diarrhea.

Uses of Accolate

Accolate is a prescription medication used for prevention and chronic treatment of asthma in adults and children 5 years of age and older.

Asthma is a chronic lung disease that causes airway inflammation and difficulty breathing.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Accolate Usage

Take Accolate exactly as prescribed. 

Accolate comes in tablet form and is typically taken twice per day, on an empty stomach. Take Accolate 1 hour before, or 2 hours after a meal.

If you miss a dose by several hours, skip the missed dose and take your next dose at the regular time. Do not take two doses of Accolate at the same time.

Accolate Overdose

If you take too much Accolate, call your local Poison Control Center or seek emergency medical attention right away.




Status asthmaticus

Hepatic impairment, including cirrhosis; Cmax and AUC ~50-60% greater than those of normal adults


Not immediately effective and not for acute bronchospasm

Increased risk of infection if age >55 yr

Discontinue if hepatic dysfunction suspected, do not resume if confirmed

May cause eosinophilia, eosinophilic pneumonia, or vasculitis consistent with emergence of Churg-Strauss syndrome

Behavioral changes reported with therapy

Concomitant use with warfarin can result in clinical significant increase in INR

Not for use in the treatment of acute asthma attacks, including status asthmaticus

Administrative Information

LactMed Record Number


Last Revision Date



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