Gastrocrom Recall

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Questions & Answers

Side Effects & Adverse Reactions

WARNINGS: The recommended dosage should be decreased in patients with decreased renal or hepatic function. Severe anaphylactic reactions may occur rarely in association with cromolyn sodium administration.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


INDICATIONS AND USAGE: GASTROCROM is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.


There is currently no drug history available for this drug.

Other Information

Each 5 mL ampule of GASTROCROM contains 100 mg cromolyn sodium, USP, in purified water. Cromolyn sodium is a hygroscopic, white powder having little odor. It may leave a slightly bitter aftertaste. GASTROCROM (cromolyn sodium, USP) Oral Concentrate is clear, colorless, and sterile. It is intended for oral use.

Chemically, cromolyn sodium is disodium 5,5’-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]. The empirical formula is C23H14Na2O11; the molecular weight is 512.34. Its chemical structure is:


Pharmacologic Category: Mast cell stabilizer

Therapeutic Category: Antiallergic

Gastrocrom Manufacturers

  • Meda Pharmaceuticals
    Gastrocrom (Cromolyn Sodium) Liquid [Meda Pharmaceuticals]
  • Jazz Pharmaceuticals Commercial Corp.
    Gastrocrom (Cromolyn Sodium) Solution, Concentrate [Jazz Pharmaceuticals Commercial Corp.]

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