Leukotriene Modifier (Asthma)Generally Approved

Zafirlukast

Brand names: Accolate|Last verified: 2026-03-01

FAA Pathway: Standard issuance by AME

Zafirlukast is a leukotriene receptor antagonist acceptable for FAA certification. Same class as montelukast with a similar safety profile for aviation. Report on your application.

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Pilot Tip

Always report all medications on your FAA medical application (Form 8500-8, Item 17a), even OTC medications. Failure to disclose is a far bigger issue than the medication itself.

Certification Details

Key Requirements

No significant side effects, liver function monitoring

Certificate Classes

All classes eligible

Side Effects to Watch

Hepatotoxicity (rare), headache

Notes

Report on Form 8500-8 Item 17a

Sources

FAA AME Guide, Pharmaceuticals

Last verified: 2026-03-01

Frequently Asked Questions

Is Zafirlukast allowed for pilots?

The FAA considers Zafirlukast (Accolate) to be "Generally Approved" for medical certification purposes. Zafirlukast is a leukotriene receptor antagonist acceptable for FAA certification. Same class as montelukast with a similar safety profile for aviation. Report on your application.

What is the FAA status of Zafirlukast?

Zafirlukast has a status of "Generally Approved" under FAA medical certification policy. The certification pathway is: Standard issuance by AME.

Can I fly while taking Zafirlukast?

Zafirlukast is generally compatible with flying. However, you must report it on your FAA medical application (Form 8500-8) and ensure you are not experiencing side effects that could impair flight safety. Always consult your Aviation Medical Examiner (AME).

Important Notice

The FAA does not publish a comprehensive list of “approved” medications. The information on this page represents our interpretation of publicly available FAA guidance and is provided for informational and educational purposes only. It does not constitute medical advice, legal advice, or a guarantee of certification outcome.

The primary issue with the FAA is always whether the underlying medical condition — not just the medication — is compatible with safe flight. You should only start, stop, or change medications after consulting your treating physician. Always consult with a qualified Aviation Medical Examiner (AME) for guidance specific to your situation. FAA policies are subject to change. ClearedMed is not affiliated with or endorsed by the FAA.