Cromolyn: uses, dosing, side effects & brands
Cromolyn is a mast cell stabilizer sold in the U.S. under 4 brand and generic names, for asthma, bronchial spasm and conjunctivitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Mast Cell Stabilizer
- Treats (across its forms)
- Asthma, Bronchial Spasm and Conjunctivitis
- Available as
- Spray/Inhaler · Solution · Drops · Spray/Inhaler, metered · Liquid · Capsule
- Sold as
- 4 products — Cromolyn Sodium, Opticrom and Gastrocrom, and others
- Prescription?
- Prescription only
- Generic available?
- Yes
- What the pharmacy pays
- about $0.59 per ml — not your price
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How Gastrocrom is dosed
From the FDA label for Gastrocrom (application NDA020479). Other cromolyn products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The usual starting dose is as follows: Adults and Adolescents (13 Years and Older) Two ampules four times daily, taken one-half hour before meals and at bedtime. Children 2-12 Years One ampule four times daily, taken one-half hour before meals and at bedtime. Pediatric Patients Under 2 Years Not recommended. If satisfactory control of symptoms is not achieved within two to three weeks, the dosage may be increased but should not exceed 40 mg/kg/day. Patients should be advised that the effect of GASTROCROM therapy is dependent upon its administration at regular intervals, as directed. Maintenance Dose Once a therapeutic response has been achieved, the dose may be reduced to the minimum required to maintain the patient with a lower degree of symptomatology. To prevent relapses, the dosage should be maintained. Administration GASTROCROM should be administered as a solution at least 1/2 hour before meals and at bedtime after preparation according to the following directions: 1. Break open ampule(s) and squeeze liquid contents of ampule(s) into a glass of water. 2. Stir solution. 3. Drink all of the liquid.
Everything below is the FDA label for Gastrocrom (liquid). Cromolyn is also sold as spray/inhaler, solution, drops, spray/inhaler, metered and capsule, and those are different medicines to take — follow the label for the one you were prescribed.
Gastrocrom side effects
Most of the adverse events reported in mastocytosis patients have been transient and could represent symptoms of the disease. The most frequently reported adverse events in mastocytosis patients who have received GASTROCROM during clinical studies were headache and diarrhea, each of which occurred in 4 of the 87 patients. Pruritus, nausea, and myalgia were each reported in 3 patients and abdominal pain, rash, and irritability in 2 patients each. One report of malaise was also recorded. To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-999-8406 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Other Adverse Events: Additional adverse events have been reported during studies in other clinical conditions and from worldwide postmarketing experience. In most cases the available information is incomplete and attribution to the drug cannot be determined. The majority of these reports involve the gastrointestinal system and include: diarrhea, nausea, abdominal pain, constipation, dyspepsia, flatulence, glossitis, stomatitis, vomiting, dysphagia, esophagospasm. Other less commonly reported events (the majority representing only a single report) include the following: Skin: pruritus, rash, urticaria/angioedema, erythema/ burning, photosensitivity Musculoskeletal: arthralgia, myalgia, stiffness/weakness of legs Neurologic: headache, dizziness,…
Who shouldn’t take Gastrocrom
GASTROCROM is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.
Gastrocrom drug interactions
Drug Interaction During Pregnancy In pregnant mice, cromolyn sodium alone did not cause significant increases in resorptions or major malformations at subcutaneous doses up to 540 mg/kg (approximately equal to the maximum recommended daily oral dose in adults on a mg/m 2 basis). Isoproterenol alone increased both resorptions and major malformations (primarily cleft palate) at a subcutaneous dose of 2.7 mg/kg (approximately 7 times the maximum recommended daily inhalation dose in adults on a mg/m 2 basis). The incidence of major malformations increased further when cromolyn sodium at a subcutaneous dose of 540 mg/kg was added to isoproterenol at a subcutaneous dose of 2.7 mg/kg. No such interaction was observed in rats or rabbits.
Every cromolyn product we track (4)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Spray/Inhaler | Generic | $1 | View → | |
| 2 | 72/100 | Prescription | Drops | Generic | $1 | View → | |
| 3 | Not yet rated | Prescription | Liquid | Generic | $1 | View → | |
| 4 | Not yet rated | Prescription | Solution | Generic | $1 | View → |
How long cromolyn keeps
No cromolyn label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does cromolyn expire? The in-use limits and storage rules from its labelsCromolyn and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for cromolyn: levels in milk, effects in breastfed infants, and the drugs it would consider insteadAlthough no published data exist on the use of cromolyn during lactation, maternal milk levels are likely to be very low and it is expected to be poorly absorbed from the infant's gastrointestinal tract. An expert panel considers use of cromolyn to be acceptable during breastfeeding.
National Institute of Child Health and Human Development, record revised May 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about cromolyn
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 3,225 reports naming cromolyn, and the FDA flagged 35% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- treatment failure1,007 reports
- fatigue183 reports
- nausea169 reports
- headache160 reports
- diarrhoea142 reports
- urticaria137 reports
- dyspnoea114 reports
- malaise112 reports
Read these as a signal, not a rate. A report does not mean cromolyn caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
Related calculators
Frequently asked questions
What is Gastrocrom?
Gastrocrom (Cromolyn Sodium) is a mast cell stabilizer used to treat Asthma, Bronchial Spasm, Conjunctivitis, Food Hypersensitivity.
What kind of drug is cromolyn?
The FDA classifies cromolyn as a mast cell stabilizer. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take cromolyn with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run cromolyn against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is cromolyn sold under?
We track 4 cromolyn-containing products in the U.S.: Cromolyn Sodium, Opticrom, Gastrocrom and Intal. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does cromolyn come in?
Across the brands we track, cromolyn is currently marketed as spray/inhaler, solution, drops, spray/inhaler, metered, liquid and capsule, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic cromolyn?
Yes. Our catalog lists 1 generic cromolyn product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Cromolyn: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/cromolyn
- MLA
- “Cromolyn: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/cromolyn.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for cromolyn on DailyMed (NIH) ↗.