Prescription medication · Mast Cell Stabilizer
cromolyn
Also sold as Intal. Cromolyn is used to manage mastocytosis.
Data updated 2026-05-15
- 3,396
- FDA reportsLightly reported
- In shortage
- FDA status
What the data shows
cromolyn (Intal) is a prescription Mast Cell Stabilizer, among the least-reported drugs the FDA tracks (3,396 FDA reports).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
cromolyn (Intal) is a prescription Mast Cell Stabilizer. Cromolyn is used to manage mastocytosis.
Cromolyn (Intal) is a medicine that helps manage mastocytosis, a condition where you have too many mast cells. It can help improve symptoms like diarrhea and flushing.
Verify with FDA → · CMS NADAC pricing →
Drug Shortage Alert
cromolyn is currently listed as in shortage by the FDA. Affected manufacturer: Mylan Specialty, a Viatris Company. Status: Available.
View all drug shortages →Drug Pricing (NADAC)
Generic Price
$0.24/unit
Generic Available
Yes (8 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Cromolyn is used to manage mastocytosis.
Common side effects
Headache, Diarrhea
Key warnings
You should not take this medicine if you are allergic to cromolyn sodium.
The sections below are summarized in plain English from cromolyn's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Cromolyn works by preventing mast cells from releasing substances that cause symptoms. It stabilizes these cells. This helps to reduce the symptoms of mastocytosis.
How to Take It
Take this medicine as a solution by mouth. For adults and teens (13+), the usual starting dose is two ampules four times a day. Children ages 2-12 usually take one ampule four times a day. Take it 30 minutes before meals and at bedtime. Break open the ampule, squeeze the liquid into water, stir, and drink all of it.
This is a plain-language summary of cromolyn's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
In animal studies, cromolyn sodium alone did not cause harm during pregnancy. Talk to your doctor if you are pregnant or breastfeeding before taking this medicine.
This is a plain-language summary of cromolyn's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of cromolyn's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store between 59° and 86°F (15°-30°C) and protect from light. Keep out of the reach of children.
Side Effects (from patient reports)
Based on 3,396 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for cromolyn, by number of reports
- Treatment not working
Treatment not working
1,004 reports
- Tiredness 207
Tiredness
207 reports
- Feeling sick to your stomach 183
Feeling sick to your stomach
183 reports
- Head pain 178
Head pain
178 reports
- Loose, watery stools 153
Loose, watery stools
153 reports
- Difficulty breathing 149
Difficulty breathing
149 reports
- Hives 142
Hives
142 reports
- Allergic reaction 132
Allergic reaction
132 reports
- Feeling lightheaded 130
Feeling lightheaded
130 reports
- Itching 128
Itching
128 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for cromolyn each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where cromolyn sits
cromolyn has more FDA adverse-event reports than 20% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is cromolyn; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 3,396 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
3,396
Reports Mentioning Death
47
1.4% of reports — not proof of cause
Hospitalization Reports
408
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | TREATMENT FAILURE | 1,004 |
| 3 | FATIGUE | 207 |
| 4 | NAUSEA | 183 |
| 5 | HEADACHE | 178 |
| 6 | DIARRHOEA | 153 |
| 7 | DYSPNOEA | 149 |
| 9 | URTICARIA | 141 |
| 10 | HYPERSENSITIVITY | 132 |
| 11 | DIZZINESS | 130 |
| 12 | PRURITUS | 128 |
| 13 | PAIN | 119 |
| 14 | ANAPHYLACTIC REACTION | 117 |
| 15 | MALAISE | 114 |
| 16 | CONDITION AGGRAVATED | 99 |
| 17 | ASTHMA | 93 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
You should not take this medicine if you are allergic to cromolyn sodium.
Common Questions
How should I store GASTROCROM?
What do I do if the solution contains a precipitate or becomes discolored?
How should I administer GASTROCROM?
How do I prepare GASTROCROM for administration?
What is the adult dosage of GASTROCROM?
When should I take GASTROCROM?
What is the pediatric dosage for children 2-12 years?
What should I do if I miss a dose?
Can I use GASTROCROM for inhalation or injection?
What should I do if my symptoms do not improve?
What are the common side effects of cromolyn?
What drug class is cromolyn?
Is cromolyn safe during pregnancy?
Has cromolyn been recalled?
Is cromolyn currently in shortage?
Active Recalls
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn, Inc.
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What the FDA Data Shows for cromolyn
The FDA label for cromolyn (sold under brand names such as Intal) classifies it as a prescription-only medication in the Mast Cell Stabilizer class. Cromolyn is used to manage mastocytosis. Official labeling lists 2 commonly reported side effects, including Headache, Diarrhea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 3,396 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.24.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: June 26, 2024
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages