A clinical briefing on the Gastrocrom (Cromolyn Sodium) shortage for providers. Prescribing implications, alternatives, and patient access tools.
Gastrocrom (Cromolyn Sodium oral concentrate, 100 mg/5 mL) continues to face significant supply constraints heading into 2026. For providers managing patients with systemic mastocytosis, mast cell activation syndrome (MCAS), and related conditions, the ongoing shortage presents real clinical challenges — from treatment continuity to patient anxiety and therapeutic substitution decisions.
This briefing covers the current state of the shortage, its clinical implications, available alternatives, and practical tools to help your patients maintain access to care.
The Gastrocrom supply issue is not new. Key milestones include:
The FDA has periodically noted Cromolyn Sodium oral concentrate on its drug shortage list. Providers can check current status at the FDA Drug Shortage Database and the ASHP Drug Shortage Resource Center.
The shortage affects clinical practice in several important ways:
Patients who have been stable on Gastrocrom may face abrupt treatment interruptions when they cannot fill refills. For patients with systemic mastocytosis, discontinuation can lead to rapid symptom recurrence — including severe GI symptoms, flushing episodes, and in some cases, anaphylactoid reactions.
Many insurance plans require prior authorization for Gastrocrom, adding administrative burden. Some plans also impose step therapy requirements, requiring patients to try (and fail) antihistamines before approving Cromolyn Sodium. When the drug is already hard to find, these hurdles compound patient frustration.
Generic Cromolyn Sodium oral concentrate is available, though it faces similar supply constraints. When writing prescriptions, consider allowing generic substitution (DAW 0) to maximize the chance of filling. Specify "Cromolyn Sodium oral concentrate" rather than brand-only to give pharmacies more options.
As of early 2026, Gastrocrom availability is best characterized as regionally variable and week-to-week inconsistent:
Real-time stock information is available through tools like Medfinder for Providers, which allows you to check pharmacy-level availability and direct patients accordingly.
The financial burden of Gastrocrom is substantial and contributes to adherence challenges:
Providers should proactively discuss cost with patients and consider directing them to resources like savings guides and discount card programs.
When Gastrocrom is unavailable, the following substitutions may be appropriate depending on the clinical scenario:
The most direct substitution. A compounding pharmacy can prepare an oral Cromolyn Sodium solution from USP-grade bulk powder. Dosing can be matched to the patient's current Gastrocrom regimen. Requires a new prescription specifying the compounded formulation.
Ketotifen is both a mast cell stabilizer and H1 antihistamine. While only approved in the US as an ophthalmic solution (Zaditor), oral Ketotifen is widely used internationally for mast cell disorders and is available through US compounding pharmacies. Typical dose: 1-2 mg twice daily. Notable side effects include sedation and weight gain, particularly during initiation.
A combination of an H1 blocker (e.g., Cetirizine 10-20 mg daily or Hydroxyzine 25 mg TID-QID) plus an H2 blocker (e.g., Famotidine 20-40 mg BID) provides broad histamine receptor blockade. This does not replicate Cromolyn's mast cell stabilization but can provide meaningful symptom control.
A leukotriene receptor antagonist that may help patients with prominent respiratory or inflammatory symptoms. Note: The FDA issued a boxed warning regarding neuropsychiatric side effects — discuss risks with patients.
For a patient-facing overview of alternatives, refer patients to: Alternatives to Gastrocrom.
Several tools can streamline the process of helping patients find Gastrocrom:
The Gastrocrom shortage reflects a broader pattern affecting niche medications with limited manufacturer competition. While no new market entrants for oral Cromolyn Sodium have been announced, the growing recognition of mast cell activation disorders may eventually drive increased supply.
In the meantime, proactive patient communication, flexible prescribing strategies, and use of availability tools can help minimize treatment disruptions. Consider discussing backup plans with patients before they run out — having a contingency in place reduces both clinical risk and patient anxiety.
The Gastrocrom shortage presents a challenging but manageable clinical scenario. By staying informed about availability, maintaining alternative therapy options, and leveraging tools like Medfinder for Providers, you can help ensure your patients maintain symptom control even during supply disruptions.
For additional patient-facing resources, consider sharing these guides with your patients:
You focus on staying healthy. We'll handle the rest.
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