CROMOLYN SODIUM

N/A

Manufactured by Prestige Brands Holdings, Inc.

7,214 FDA adverse event reports analyzed

Last updated: 2026-04-15

About CROMOLYN SODIUM

CROMOLYN SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Prestige Brands Holdings, Inc.. The most commonly reported adverse reactions for CROMOLYN SODIUM include TREATMENT FAILURE, DRUG INEFFECTIVE, FATIGUE, NAUSEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CROMOLYN SODIUM.

Top Adverse Reactions

TREATMENT FAILURE1,004 reports
DRUG INEFFECTIVE314 reports
FATIGUE207 reports
NAUSEA183 reports
HEADACHE178 reports
DIARRHOEA153 reports
DYSPNOEA149 reports
OFF LABEL USE142 reports
URTICARIA141 reports
HYPERSENSITIVITY132 reports
DIZZINESS130 reports
PRURITUS128 reports
PAIN119 reports
ANAPHYLACTIC REACTION117 reports
MALAISE114 reports
CONDITION AGGRAVATED99 reports
ASTHMA93 reports
PRODUCT DOSE OMISSION ISSUE92 reports
RASH90 reports
FEELING ABNORMAL85 reports
VOMITING85 reports
COUGH82 reports
ARTHRALGIA78 reports
INSOMNIA76 reports
ANXIETY70 reports
PYREXIA70 reports
MIGRAINE69 reports
PRODUCT USE IN UNAPPROVED INDICATION69 reports
ASTHENIA68 reports
FLUSHING67 reports
SINUSITIS67 reports
WEIGHT DECREASED66 reports
MUSCLE SPASMS63 reports
NASOPHARYNGITIS62 reports
DRUG HYPERSENSITIVITY58 reports
ABDOMINAL PAIN UPPER57 reports
BLOOD PRESSURE INCREASED56 reports
MAST CELL ACTIVATION SYNDROME56 reports
ABDOMINAL DISCOMFORT55 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION55 reports
ERYTHEMA54 reports
MYALGIA54 reports
BACK PAIN52 reports
ABDOMINAL PAIN51 reports
CHEST PAIN51 reports
COVID 1951 reports
FALL51 reports
SWELLING50 reports
CONSTIPATION49 reports
DEPRESSION48 reports
ILLNESS46 reports
PAIN IN EXTREMITY46 reports
SOMNOLENCE45 reports
EPISTAXIS43 reports
STRESS43 reports
CHEST DISCOMFORT41 reports
ABDOMINAL DISTENSION40 reports
CONFUSIONAL STATE40 reports
GAIT DISTURBANCE40 reports
SWELLING FACE40 reports
URINARY TRACT INFECTION40 reports
PNEUMONIA39 reports
INFECTION38 reports
BRONCHITIS36 reports
FOOD ALLERGY36 reports
HEART RATE INCREASED36 reports
PRODUCT USE ISSUE36 reports
PALPITATIONS35 reports
PARAESTHESIA35 reports
THROAT IRRITATION35 reports
DECREASED APPETITE34 reports
GASTROOESOPHAGEAL REFLUX DISEASE34 reports
PERIPHERAL SWELLING34 reports
VISION BLURRED34 reports
WHEEZING34 reports
HYPOAESTHESIA33 reports
PRODUCT QUALITY ISSUE33 reports
TREMOR33 reports
WEIGHT INCREASED33 reports
BURNING SENSATION32 reports
CONTUSION32 reports
HYPERTENSION32 reports
ALOPECIA31 reports
INTENTIONAL PRODUCT USE ISSUE31 reports
MEMORY IMPAIRMENT31 reports
THROAT TIGHTNESS31 reports
NASAL CONGESTION30 reports
OROPHARYNGEAL PAIN30 reports
EYE IRRITATION29 reports
BONE PAIN28 reports
CHILLS28 reports
DRUG INTOLERANCE28 reports
DYSPEPSIA28 reports
EYE PAIN28 reports
GASTROINTESTINAL DISORDER28 reports
HEREDITARY ANGIOEDEMA28 reports
DYSGEUSIA27 reports
OEDEMA27 reports
UPPER RESPIRATORY TRACT INFECTION27 reports
BRAIN FOG26 reports

Report Outcomes

Out of 3,396 classified reports for CROMOLYN SODIUM:

Serious 36.9%Non-Serious 63.1%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female2,265 (72.4%)
Male859 (27.5%)
Unknown4 (0.1%)

Reports by Age

Age 5542 reports
Age 6440 reports
Age 6937 reports
Age 4732 reports
Age 6132 reports
Age 4931 reports
Age 6231 reports
Age 6730 reports
Age 5029 reports
Age 7029 reports
Age 4328 reports
Age 4428 reports
Age 5728 reports
Age 5828 reports
Age 6628 reports
Age 7126 reports
Age 4625 reports
Age 5425 reports
Age 5624 reports
Age 6324 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with CROMOLYN SODIUM?

This profile reflects 7,214 FDA FAERS reports that mention CROMOLYN SODIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CROMOLYN SODIUM?

Frequently reported terms in FAERS include TREATMENT FAILURE, DRUG INEFFECTIVE, FATIGUE, NAUSEA, HEADACHE, DIARRHOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CROMOLYN SODIUM?

Labeling and FAERS entries often list Prestige Brands Holdings, Inc. in connection with CROMOLYN SODIUM. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.