cromolyn
Brand names: Intal
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.
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.
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.
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.
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.
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 2,604 FDA adverse event reports.
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
Death-Related Reports
47
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 |
| 2 | DRUG INEFFECTIVE | 314 |
| 3 | FATIGUE | 207 |
| 4 | NAUSEA | 183 |
| 5 | HEADACHE | 178 |
| 6 | DIARRHOEA | 153 |
| 7 | DYSPNOEA | 149 |
| 8 | OFF LABEL USE | 142 |
| 9 | URTICARIA | 141 |
| 10 | HYPERSENSITIVITY | 132 |
| 11 | DIZZINESS | 130 |
| 12 | PRURITUS | 128 |
| 13 | PAIN | 119 |
| 14 | ANAPHYLACTIC REACTION | 117 |
| 15 | MALAISE | 114 |
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.
Related Medications in Mast Cell Stabilizer
Other drugs grouped near cromolyn — same-class peers and common alternatives.
aclidinium
Tudorza Pressair
Duaklir Pressair is a combination medicine used to help people with COPD breathe better.
Compare with cromolyn →
albuterol
Ventolin, ProAir
Albuterol is a drug that helps you breathe easier.
Compare with cromolyn →
albuterol/ipratropium
Combivent Respimat, DuoNeb
Combivent Respimat is a combination medicine that helps open your airways.
Compare with cromolyn →
beclomethasone
Qvar
Qvar Redihaler is an inhaled medicine that helps control asthma symptoms.
Compare with cromolyn →
benralizumab
Fasenra
Fasenra is a medicine that can help treat severe asthma and EGPA.
Compare with cromolyn →
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Related Health & Safety Data
🩺 Find a Doctor
Search prescribers for Mast Cell Stabilizer
🏨 Hospital Quality
CMS hospital ratings, safety scores & patient outcomes
💊 Supplement Data
NIH DSLD — check supplement ingredients & label claims
🍽️ Food Safety Alerts
FDA recalls, inspections & outbreak investigations
⚠️ Product Recalls
FDA, CPSC & NHTSA recall search
💉 Procedure Costs
Medicare procedure pricing for 9,297 procedures
Save on cromolyn
Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.
Disclosure: This link may earn us a commission at no extra cost to you. See our terms.
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 2,604 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.
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