Theophylline Shortage: A Provider Briefing for 2026

Theophylline — one of the oldest and most cost-effective bronchodilators still in clinical use — has faced intermittent supply disruptions since 2022. For providers managing patients with asthma, COPD, or other conditions requiring methylxanthine therapy, these shortages create real clinical challenges: treatment gaps, patient anxiety, and the need for therapeutic substitution.

This briefing covers the current state of the Theophylline shortage, its implications for your practice, and practical tools to help your patients maintain access.

Shortage Timeline

The Theophylline supply disruption has evolved over several years:

• 2022: Initial reports of spot shortages for certain extended-release tablet strengths. FDA adds Theophylline ER tablets to the Drug Shortage database.
• 2023: Shortages expand to include the oral solution (Elixophyllin) and additional ER tablet strengths (300 mg, 400 mg). Multiple generic manufacturers reduce or pause production citing raw material constraints and manufacturing economics.
• 2024: Some improvement in 100 mg and 200 mg ER tablet supply. Higher-dose formulations and the oral solution remain constrained. The FDA works with remaining manufacturers to increase output.
• 2025: Intermittent availability continues. Supply is region-dependent, with rural areas disproportionately affected. Some pharmacies report week-to-week fluctuations in stock.
• 2026 (current): Situation remains fluid. Most strengths are available at least intermittently, but consistent nationwide supply has not been fully restored.

Prescribing Implications

The ongoing shortage raises several clinical considerations:

Narrow Therapeutic Index

Theophylline's narrow therapeutic window (target serum concentration 5-15 mcg/mL) means dose changes require careful monitoring. If a patient must switch strengths due to availability, therapeutic drug monitoring (TDM) should be repeated within 3-5 days of any dose adjustment.

Formulation Switching

Not all extended-release Theophylline products are bioequivalent. Switching between manufacturers or formulations may alter pharmacokinetics. The FDA recommends treating Theophylline ER products as non-interchangeable in some cases. When switching formulations is unavoidable, check serum levels and monitor for signs of toxicity or subtherapeutic response.

Patient Non-Adherence Risk

Patients who can't find their medication may self-discontinue, ration doses, or substitute with inappropriate alternatives (including excessive caffeine). Proactive communication about the shortage and clear instructions for what to do if they can't fill their prescription can reduce these risks.

Current Availability Picture

As of early 2026, availability by formulation:

• ER tablets 100 mg, 200 mg: Generally available with occasional spot shortages
• ER tablets 300 mg, 400 mg, 450 mg, 600 mg: Intermittent — check distributor availability before prescribing specific strengths
• Oral solution: Limited availability — consider ER tablets as alternative where clinically appropriate
• ER capsules (Theo-24 type): Very limited — most supply is in tablet form

For real-time pharmacy-level availability data, Medfinder for Providers offers stock-checking tools that your team or patients can use.

Cost and Access Considerations

Theophylline remains highly affordable when available:

• Generic cash price: $10-$40/month for most ER tablet strengths
• With discount cards: $4-$15/month
• Insurance: Typically Tier 1 generic; prior authorization is uncommon

However, during supply gaps, patients may encounter higher prices at pharmacies that have limited stock, or they may need to fill at a non-preferred pharmacy, affecting copay structures. Direct patients to our cost-saving resource guide as needed.

Tools and Resources for Your Practice

Real-Time Stock Checking

Medfinder for Providers allows your staff to quickly identify pharmacies in your patients' area with Theophylline in stock. This can be incorporated into your prescription workflow to avoid sending patients to pharmacies that can't fill the order.

Therapeutic Alternatives

When Theophylline is unavailable and a therapeutic substitution is necessary, consider:

• Dyphylline: Same drug class (methylxanthine); fewer drug interactions but less potent and shorter-acting
• Tiotropium (Spiriva): Long-acting muscarinic antagonist; well-suited for COPD patients; available for asthma maintenance
• Montelukast: Leukotriene receptor antagonist; oral, widely available, but different mechanism — note FDA boxed warning for neuropsychiatric events
• LABA/ICS combinations: For patients who were using Theophylline as add-on therapy, stepping up to or adjusting a LABA/ICS combination may be appropriate

For a patient-facing comparison, you can share: Alternatives to Theophylline.

Patient Communication Templates

Consider proactively reaching out to patients currently on Theophylline to:

1. Inform them of the ongoing supply situation
2. Provide refill timing guidance (refill 7-10 days early)
3. Share Medfinder as a resource for finding stock
4. Offer a backup plan (alternative medication or strength adjustment) if they can't fill

Looking Ahead

The FDA has been actively encouraging additional generic manufacturers to enter the Theophylline market. As market dynamics shift — particularly if new manufacturers begin production — supply should gradually stabilize. However, given the low profit margins for generic Theophylline, the incentive for new market entrants remains limited.

Providers should plan for continued intermittent availability through at least mid-2026 and maintain contingency plans for affected patients.

Final Thoughts

The Theophylline shortage is a manageable challenge, but it requires proactive clinical planning. Ensure your patients know about the supply situation before they're standing at the pharmacy counter. Leverage real-time tools like Medfinder for Providers, have a backup medication strategy ready, and monitor serum levels closely when any formulation changes occur.

For the patient-facing perspective on this shortage, see: Theophylline shortage update for patients.