Methylxanthine Bronchodilator (Asthma / COPD)Conditionally Approved

Theophylline

Brand names: Theo-24, Elixophyllin|Last verified: 2026-03-01

FAA Pathway: May require Special Issuance — narrow therapeutic index

Theophylline has a narrow therapeutic index and can cause significant side effects at supratherapeutic levels. The FAA may require documentation of stable therapeutic levels and absence of CNS side effects such as tremor, insomnia, or seizures.

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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
Therapeutic drug levels, no CNS side effects
Certificate Classes
May require Special Issuance documentation
Monitoring
Serum theophylline levels, PFT documentation
Notes
Narrow therapeutic window — toxicity causes seizures, arrhythmias

Sources

  • FAA AME Guide, Pulmonary

Last verified: 2026-03-01

Frequently Asked Questions

Is Theophylline allowed for pilots?

The FAA considers Theophylline (Theo-24, Elixophyllin) to be "Conditionally Approved" for medical certification purposes. Theophylline has a narrow therapeutic index and can cause significant side effects at supratherapeutic levels. The FAA may require documentation of stable therapeutic levels and absence of CNS side effects such as tremor, insomnia, or seizures.

What is the FAA status of Theophylline?

Theophylline has a status of "Conditionally Approved" under FAA medical certification policy. The certification pathway is: May require Special Issuance — narrow therapeutic index.

Can I fly while taking Theophylline?

Flying while taking Theophylline may be possible through the FAA's Special Issuance process. You will need to meet specific requirements and obtain approval before exercising pilot privileges. Consult an experienced AME for guidance.

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.