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.
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 Failure
Treatment Failure
1,004 reports
- Fatigue 207
Fatigue
207 reports
- Nausea 183
Nausea
183 reports
- Headache 178
Headache
178 reports
- Diarrhoea 153
Diarrhoea
153 reports
- Dyspnoea 149
Dyspnoea
149 reports
- Urticaria 141
Urticaria
141 reports
- Hypersensitivity 132
Hypersensitivity
132 reports
- Dizziness 130
Dizziness
130 reports
- Pruritus 128
Pruritus
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) 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?
What pregnancy or breastfeeding source fields are listed for cromolyn?
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
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 →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for cromolyn: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 3,396.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 1.38%.
- pimecrolimus Δ 0.02 pts · 1,541 reports · Calcineurin Inhibitor (Topical) 1.36%death share
- tazarotene Δ 0.06 pts · 1,132 reports · Retinoid (Topical) 1.33%death share
- guselkumab Δ 0.09 pts · 31,164 reports · Anti-IL-23 Monoclonal Antibody 1.30%death share
- ixekizumab Δ 0.09 pts · 35,897 reports · Anti-IL-17A Monoclonal Antibody 1.47%death share
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
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: June 26, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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