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Cromolyn Side Effects

The most commonly reported side effects of cromolyn include treatment failure, fatigue, and nausea, based on 5,000 FDA adverse event reports from 2004 to 2025. 8.1% of reports found the drug to be ineffective.

Cromolyn side effects

Percentages show how often each reaction appears relative to total reports for cromolyn.

1
Treatment Failure20.7%1,036
2
Drug Ineffective8.1%407
3
Fatigue5.8%291
4
Nausea5.1%253
5
Headache4.5%226
6
Off Label Use4.3%217
7
Dyspnoea4.2%208
8
Diarrhoea4.2%208
9
Urticaria3.7%183
10
Dizziness3.6%181
11
Pruritus3.4%172
12
Malaise3.4%170
13
Hypersensitivity3.3%164
14
Pain3.3%163
15
Anaphylactic Reaction3.1%156

These are voluntary reports and do not establish that cromolyn caused these reactions.

Report severity

44.8%Serious2,238 reports
16.3%Hospitalizations817 reports
2.1%Fatal106 reports

Seriousness is determined by the reporter, not by OpenClaim.

Cromolyn drug interactions

Other drugs that appear in adverse event reports alongside cromolyn. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Ketotifen-fumarate19.1%956
2
Azelastine11.9%596
3
Olopatadine-hydrochloride10.6%531
4
Omalizumab7.3%364
5
Epinastine-hydrochloride5.1%256
6
Montelukast-sodium4.6%230
7
Avapritinib4.3%217
8
Sodium-oxybate3.6%179
9
Ketorolac-tromethamine3.2%159
10
Dupilumab3.1%155
11
Cetirizine-hydrochloride2.1%107
12
Prednisone1.9%95
13
Fluticasone1.8%89
14
Budesonide1.5%74
15
Albuterol1.4%69

Taken alongside

1
Albuterol19.7%986
2
Montelukast-sodium17.7%886
3
Cetirizine-hydrochloride14.8%738
4
Fluticasone14.5%724
5
Famotidine12.5%627
6
Ergocalciferol11.8%591
7
Acetaminophen11.7%586
8
Epinephrine11.6%582
9
Diphenhydramine10.4%519
10
Levothyroxine-sodium9.9%495
11
Fexofenadine-hydrochloride9.6%479
12
Omeprazole9.1%457
13
Prednisone8.3%414
14
Aspirin8.1%406
15
Ondansetron8.0%401

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports cromolyn side effects

65.6% of cromolyn adverse event reports involve female patients and 26.3% involve male patients. The largest age group is adult at 60%. These figures reflect who reports side effects, not underlying risk.

Sex

Female65.6%
Male26.3%
Unknown8.1%

Age group

< 21.6%
2–115.6%
12–173.9%
18–6460.3%
65+28.5%

What is cromolyn used for

Conditions and purposes for which patients were taking cromolyn when the adverse event was reported.

Abdominal DiscomfortAbdominal PainAdverse EventAllergic KeratitisAllergy ProphylaxisAllergy To ChemicalsAnaphylactic ReactionAnaphylaxis ProphylaxisAsthmaAsthma Exacerbation ProphylaxisAsthma Exercise InducedAtopic KeratoconjunctivitisAutoimmune DisorderAbdominal PainAbdominal Pain Upper

Showing 15 of 214 indications

Cromolyn brand names and reporting trend

Cromolyn is sold under the brand name Opticrom.

Brand names

Opticrom3,987

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking cromolyn with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.