Drug · FAERS side-effect profile with label screen
Cromolyn side effects: what 3,585 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Cromolyn Sodium (Gastrocrom)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
3,585 reports · 37% serious · 48 with death outcome · 73% female
openFDA FAERS counts, all years, deduplication not applied
Used for
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.
FDA label, Indications and Usage
What it is
DESCRIPTION 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.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 3Labeled (related wording) 1Likely indication confounding 2Reporting / coding artifact 5Not in label — unassessed 29
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 158 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Treatment failure | 1,005 | 72.5 68.8–76.4ROR 100.4 · χ² 70,193 / p <1e-300 | 71.5 EB05 67.9 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 · 79% consumer | no trial data cached |
| Hereditary angioedema | 33 | 18.4 13.1–25.9ROR 18.6 · χ² 525 / p 1e-116 | 18.2 EB05 13.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 28.5 · ♀ 100% (drug 73%) · 76% consumer | no trial data cached |
| Pharyngeal swelling | 25 | 15.3 10.4–22.6ROR 15.4 · χ² 320 / p 9e-72 | 14.9 EB05 10.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=14 · 88% consumer | no trial data cached |
| Brain fog | 34 | 13.7 9.8–19.1ROR 13.8 · χ² 386 / p 4e-86 | 13.3 EB05 9.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 26.1 · 73% consumer | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 123 | 13.1 11.0–15.6ROR 13.6 · χ² 1,366 / p 2e-299 | 13.0 EB05 11.2 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.5 | no trial data cached |
| Product taste abnormal | 20 | 8.7 5.6–13.5ROR 8.8 · χ² 129 / p 4e-30 | 7.7 EB05 5.1 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious n=5 | no trial data cached |
| Sinus congestion | 20 | 8.7 5.6–13.4ROR 8.7 · χ² 128 / p 6e-30 | 7.6 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Aphonia | 20 | 8.4 5.4–13.0ROR 8.4 · χ² 123 / p 7e-29 | 7.4 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 19.2 | no trial data cached |
| Sleep apnoea syndrome | 26 | 8.0 5.4–11.7ROR 8.0 · χ² 151 / p 5e-35 | 7.2 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 | no trial data cached |
| Dermatitis contact | 15 | 7.7 4.7–12.8ROR 7.8 · χ² 81 / p 1e-19 | 6.5 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Scratch | 13 | 7.4 4.3–12.7ROR 7.4 · χ² 65 / p 4e-16 | 6.1 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Rotator cuff syndrome | 16 | 7.3 4.5–11.9ROR 7.3 · χ² 80 / p 2e-19 | 6.2 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 | no trial data cached |
| Throat tightness | 33 | 7.2 5.1–10.0ROR 7.2 · χ² 169 / p 8e-39 | 6.6 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 | no trial data cached |
| Product packaging issue | 11 | 6.9 3.8–12.5ROR 7.0 · χ² 50 / p 7e-13 | 5.6 EB05 3.3 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious n=3 | no trial data cached |
| Infusion site pain | 15 | 6.9 4.1–11.4ROR 6.9 · χ² 70 / p 4e-17 | 5.8 EB05 3.7 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=11 | no trial data cached |
| Weight fluctuation | 12 | 6.7 3.8–11.9ROR 6.8 · χ² 53 / p 2e-13 | 5.5 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Product odour abnormal | 11 | 6.2 3.4–11.2ROR 6.2 · χ² 43 / p 3e-11 | 5.0 EB05 3.0 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Skin reaction | 14 | 5.8 3.5–9.8ROR 5.8 · χ² 51 / p 4e-13 | 5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.2 | no trial data cached |
| Seasonal allergy | 14 | 5.8 3.4–9.8ROR 5.8 · χ² 51 / p 5e-13 | 4.9 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Muscle tightness | 16 | 5.8 3.5–9.4ROR 5.8 · χ² 59 / p 9e-15 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | no trial data cached |
| Product availability issue | 22 | 5.7 3.8–8.7ROR 5.8 · χ² 82 / p 9e-20 | 5.2 EB05 3.6 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 · ♀ 95% (drug 73%) · 82% consumer | no trial data cached |
| Insurance issue | 14 | 5.5 3.3–9.3ROR 5.5 · χ² 47 / p 3e-12 | 4.7 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 | no trial data cached |
| Asthma | 102 | 5.3 4.4–6.4ROR 5.5 · χ² 356 / p 1e-79 | 5.2 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Paraesthesia oral | 13 | 5.3 3.1–9.1ROR 5.3 · χ² 41 / p 7e-11 | 4.5 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 | no trial data cached |
| Obesity | 14 | 5.1 3.0–8.7ROR 5.2 · χ² 43 / p 3e-11 | 4.4 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Urticaria (hives) | 146 | 5.1 4.4–6.0ROR 5.3 · χ² 485 / p 7e-108 | 5.1 EB05 4.4 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.8 | no trial data cached |
| Throat irritation | 38 | 5.0 3.6–6.8ROR 5.0 · χ² 117 / p 2e-27 | 4.7 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · 76% consumer | no trial data cached |
| Bursitis | 10 | 4.9 2.6–9.0ROR 4.9 · χ² 27 / p 1e-7 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Eye haemorrhage | 11 | 4.8 2.7–8.7ROR 4.8 · χ² 30 / p 3e-8 | 4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Viral infection | 26 | 4.6 3.1–6.7ROR 4.6 · χ² 69 / p 4e-17 | 4.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Migraine | 74 | 4.6 3.6–5.7ROR 4.6 · χ² 203 / p 2e-46 | 4.4 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.0 · ♀ 93% (drug 73%) | no trial data cached |
| Gastroenteritis viral | 14 | 4.5 2.7–7.6ROR 4.5 · χ² 35 / p 2e-9 | 4.0 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Oral candidiasis (oral thrush) | 10 | 4.5 2.4–8.4ROR 4.5 · χ² 24 / p 5e-7 | 3.8 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Impaired quality of life | 11 | 4.5 2.5–8.1ROR 4.5 · χ² 26 / p 1e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Irritable bowel syndrome | 16 | 4.4 2.7–7.1ROR 4.4 · χ² 38 / p 3e-10 | 3.9 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Eye swelling | 27 | 4.3 2.9–6.2ROR 4.3 · χ² 65 / p 5e-16 | 4.0 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Hypersensitivity (allergic reaction) | 135 | 4.3 3.6–5.0ROR 4.4 · χ² 337 / p 2e-75 | 4.2 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 | no trial data cached |
| Candida infection (yeast infection) | 12 | 4.2 2.4–7.4ROR 4.2 · χ² 26 / p 2e-7 | 3.7 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Ear infection | 19 | 4.2 2.7–6.6ROR 4.2 · χ² 43 / p 3e-11 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Sinusitis | 72 | 4.1 3.3–5.2ROR 4.2 · χ² 166 / p 2e-38 | 4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Treatment failure | 1,005 | 72.5 68.8–76.4ROR 100.4 · χ² 70,193 / p <1e-300 | 71.5 EB05 67.9 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 · 79% consumer | no trial data cached |
| Urticaria (hives) | 146 | 5.1 4.4–6.0ROR 5.3 · χ² 485 / p 7e-108 | 5.1 EB05 4.4 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.8 | no trial data cached |
| Hypersensitivity (allergic reaction) | 135 | 4.3 3.6–5.0ROR 4.4 · χ² 337 / p 2e-75 | 4.2 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 123 | 13.1 11.0–15.6ROR 13.6 · χ² 1,366 / p 2e-299 | 13.0 EB05 11.2 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.5 | no trial data cached |
| Product dose omission issue | 105 | 2.2 1.8–2.6ROR 2.2 · χ² 65 / p 4e-16 | 2.1 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 8.3 · 71% consumer | no trial data cached |
| Asthma | 102 | 5.3 4.4–6.4ROR 5.5 · χ² 356 / p 1e-79 | 5.2 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Feeling abnormal | 87 | 2.1 1.7–2.6ROR 2.1 · χ² 51 / p 6e-13 | 2.1 EB05 1.8 · IC025 +0.7 | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Migraine | 74 | 4.6 3.6–5.7ROR 4.6 · χ² 203 / p 2e-46 | 4.4 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.0 · ♀ 93% (drug 73%) | no trial data cached |
| Sinusitis | 72 | 4.1 3.3–5.2ROR 4.2 · χ² 166 / p 2e-38 | 4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Flushing | 70 | 4.0 3.2–5.1ROR 4.1 · χ² 156 / p 4e-36 | 3.9 EB05 3.2 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 11.5 | no trial data cached |
| Inappropriate schedule of product administration | 58 | 1.9 1.5–2.5ROR 1.9 · χ² 25 / p 3e-7 | 1.9 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 5.6 · 71% consumer | no trial data cached |
| Swelling | 53 | 3.3 2.5–4.3ROR 3.4 · χ² 84 / p 2e-20 | 3.2 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Illness | 48 | 2.8 2.1–3.7ROR 2.8 · χ² 54 / p 1e-13 | 2.7 EB05 2.2 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.6 | no trial data cached |
| Epistaxis (nosebleed) | 46 | 3.6 2.7–4.8ROR 3.6 · χ² 84 / p 3e-20 | 3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Swelling face | 45 | 4.0 3.0–5.4ROR 4.1 · χ² 101 / p 6e-24 | 3.9 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Hereditary angioedema — n=33, PRR 18.4
- Pharyngeal swelling — n=25, PRR 15.3
- Brain fog — n=34, PRR 13.7
- Sinus congestion — n=20, PRR 8.7
- Aphonia — n=20, PRR 8.4
- Sleep apnoea syndrome — n=26, PRR 8.0
- Throat tightness — n=33, PRR 7.2
- Asthma — n=102, PRR 5.3
- Throat irritation — n=38, PRR 5.0
- Viral infection — n=26, PRR 4.6
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Cromolyn?
In FDA FAERS, the most frequently co-reported reaction terms for Cromolyn are urticaria, hypersensitivity, anaphylactic reaction, asthma, feeling abnormal, migraine. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Cromolyn have an FDA boxed warning?
No. The FDA label retrieved for Cromolyn has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cromolyn causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 00623958-a8fe-47d1-a0d2-0aa4e2f7966e, effective 20240626; matched on
openfda.generic_name.exact:"CROMOLYN SODIUM") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 198 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.