FDA label 87d08fea-99ec-4c02-87d8-dfa745d3fc45

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
80777407-830d-4285-1b94-203d2d0a0f42
SPL ID
87d08fea-99ec-4c02-87d8-dfa745d3fc45
Version
3
Effective date
2016-10-21
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:12:28

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Intal Inhaler has no role in the treatment of an acute attack of asthma, especially status asthmaticus. Severe anaphylactic reactions can occur after cromolyn sodium administration. The recommended dosage should be decreased in patients with decreased renal or hepatic function. Intal Inhaler should be discontinued if the patient develops eosinophilic pneumonia (or pulmonary infiltrates with eosinophilia). Because of the propellants in this preparation, it should be used with caution in patients with coronary artery disease or a history of cardiac arrhythmias.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

Adverse Reactions In controlled clinical studies of Intal Inhaler, the most frequently reported adverse reactions attributed to cromolyn sodium treatment were: Throat irritation or dryness Bad taste Cough Wheeze Nausea The most frequently reported adverse reactions attributed to other forms of cromolyn sodium (on the basis of reoccurrence following readministration) involve the respiratory tract and are: bronchospasm [sometimes severe, associated with a precipitous fall in pulmonary function (FEV 1 )], cough, laryngeal edema (rare), nasal congestion (sometimes severe), pharyngeal irritation, and wheezing. Adverse reactions which occur infrequently and are associated with administration of the drug are: anaphylaxis, angioedema, dizziness, dysuria and urinary frequency, joint swelling and pain, lacrimation, nausea and headache, rash, swollen parotid gland, urticaria, pulmonary infiltrates with eosinophilia, substernal burning, and myopathy. The following adverse reactions have been reported as rare events and it is unclear whether they are attributable to the drug: anemia, exfoliative dermatitis, hemoptysis, hoarseness, myalgia, nephrosis, periarteritic vasculitis, pericarditis, peripheral neuritis, photodermatitis, sneezing, drowsiness, nasal itching, nasal bleeding, nasal burning, serum sickness, stomachache, polymyositis, vertigo, and liver disease.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.