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Accolate Side Effects

Generic name: zafirlukast

Medically reviewed by Last updated on Dec 17, 2023.

Note: This document contains side effect information about zafirlukast. Some dosage forms listed on this page may not apply to the brand name Accolate.

Applies to zafirlukast: oral tablet.

Serious side effects of Accolate

Along with its needed effects, zafirlukast (the active ingredient contained in Accolate) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking zafirlukast:

Less common


Incidence not known

Other side effects of Accolate

Some side effects of zafirlukast may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Incidence not known

For Healthcare Professionals

Applies to zafirlukast: oral tablet.


The most commons adverse effects may be associated with headache or gastrointestinal disturbances. These symptoms are usually mild.[Ref]

Nervous system

Very common (10% or more): Headache (up to 12.9%)

Common (1% to 10%): Dizziness (1.6%)

Frequency not reported: Neuropathy, neuropsychiatric events[Ref]


Common (1% to 10%): Nausea (up to 3.1%), diarrhea (up to 2.8%), abdominal pain (up to 2.8%), vomiting (up to 1.5%), dyspepsia (1.3%)[Ref]


Common (1% to 10%): SGPT elevation (1.5%), AST (1.4%)

Rare (less than 0.1%): Hyperbilirubinemia without other elevated liver function tests; fulminant hepatitis or progressed to hepatic failure, liver transplantation and death

Postmarketing reports: Symptomatic hepatitis (with or without hyperbilirubinemia) without other attributable cause; hepatic dysfunction[Ref]

In most of the postmarketing reports, the patient's symptoms abated and the liver enzymes returned to normal or near normal after stopping this drug.[Ref]


Common (1% to 10%): Myalgia (1.6%), back pain (1.5%)

Frequency not reported: Arthralgia[Ref]


Common (1% to 10%): Generalized pain (1.9%), asthenia (up to 1.8%), accidental injury (1.6%), fever (1.4%)

Rare (less than 0.1%): Increased theophylline levels with or without clinical signs or symptoms of theophylline toxicity when this drug was added to an existing theophylline regime.

Frequency not reported: Edema, malaise[Ref]


Common (1% to 10%): Respiratory tract infection (3.5%)[Ref]

Infections were usually mild or moderate, predominantly affecting the respiratory tract and not necessitating withdrawal from the therapy.

In clinical trials, an increased proportion of patients over the age of 55 years reported these infections. Infections occurred equally in both sexes and were associated with coadministration of inhaled corticosteroids.[Ref]


Rare (less than 0.1%): Bleeding disorders including menorrhagia, thrombocytopenia[Ref]


Rare (less than 0.1%): Alopecia

Frequency not reported: Bruising, pruritus[Ref]


Rare (0.01% to 0.1%): Granulomatosis

Very rare (less than 0.01%): Agranulocytosis[Ref]


Rare (less than 0.1%): Systemic eosinophilia, eosinophilic pneumonia, or clinical features of vasculitis consistent with Churg-Strauss syndrome[Ref]

Systemic eosinophilia may also involve various body systems including vasculitic rash, worsening pulmonary symptoms, cardiac complications or neuropathy.[Ref]


Frequency not reported: Urticaria, angioedema, rashes (with or without blistering)[Ref]


Frequency not reported: Insomnia, depression[Ref]


1. Product Information. Accolate (zafirlukast). Astra-Zeneca Pharmaceuticals. 2001;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

4. Spector SL, Smith LJ, Glass M. Effects of 6 weeks of therapy with oral doses of ICI 204,219, a leukotriene D4 receptor antagonist, in subjects with bronchial asthma. ACCOLATE Asthma Trialists Group. Am J Respir Crit Care Med. 1994;150:618-23.

5. Smith LJ, Geller S, Ebright L, Glass M, Thyrum PT. Inhibition of leukotriene D4-induced bronchoconstriction in normal subjects by the oral LTD4 receptor antagonist ICI 204,219. Am Rev Respir Dis. 1990;141:988-92.

6. Findlay SR, Barden JM, Easley CB, Glass M. Effect of the oral leukotriene antagonist, ICI 204,219, on antigen- induced bronchoconstriction in subjects with asthma. J Allergy Clin Immunol. 1992;89:1040-5.

7. Spector SL. Leukotriene inhibitors and antagonists in asthma. Ann Allergy Asthma Immunol. 1995;75:463-70,473-4.

8. Kelloway JS. Zafirlukast: the first leukotriente-receptor antagonist approved for the treatment of asthma. Ann Pharmacother. 1997;31:1012-21.

9. Torres M, Reddy KR. Severe liver injury. Ann Intern Med. 2001;135:550.

10. Danese S, De Vitis I, Gasbarrini A. Severe Liver Injury Associated with Zafirlukast. Ann Intern Med. 2001;135:930.

11. Katz RS, Papernik M. Zafirlukast and Churg-Strauss syndrome. JAMA. 1998;279:1949.

12. Honsinger RW. Zafirlukast and Churg-Strauss syndrome. JAMA. 1998;279:1949.

13. Churg J, Churg A. Zafirlukast and Churg-Strauss syndrome. JAMA. 1998;279:1949-50.

14. Wechsler ME, Drazen JM. Zafirlukast and Churg-Strauss syndrome - Reply. JAMA. 1998;279:1950.

15. Knoell DL, Lucas J, Allen JN. Churg-Strauss syndrome associated with zafirlukast. Chest. 1998;114:332-4.

16. Wechsler ME, Garpestad E, Rlier SR, et al. Pulmonary infiltrates, eosinophilia, and cardiomyopathy following corticosteroid withdrawal in patients with asthma receiving zafirlukast. JAMA. 1998;279:455-7.

17. Green RL, Vayonis AG. Churg-Strauss syndrome after zafirlukast in two patients not receiving systemic steroid treatment. Lancet. 1999;353:725-6.

18. Finkel TH, Hunter DJ, Paisley JE, Finkel RS, Larsen GL. Drug-induced lupus in a child after treatment with zafirlukast (Accolate). J Allerg Clin Immunol. 1999;103:533-4.

19. Wechsler M, Drazen JM. Churg-Strauss syndome. Lancet. 1999;353:1999.

20. Wechsler ME, Drazen JM. Zafirlukast and Churg-Strauss syndrome. Chest. 1999;116:266-7.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.