FDA label 6214a3ca-93d7-4abf-b59e-f4bddbfe8d79

Warnings INTAL has no role in the treatment of status asthmaticus. Anaphylactic reactions with cromolyn sodium administration have been reported rarely.

Adverse Reactions Clinical experience with the use of INTAL suggests that adverse reactions are rare events. The following adverse reactions have been associated with INTAL Nebulizer Solution: cough, nasal congestion, nausea, sneezing, and wheezing. Other reactions have been reported in clinical trials; however, a causal relationship could not be established: drowsiness, nasal itching, nose bleed, nose burning, serum sickness, and stomachache. In addition, adverse reactions have been reported with INTAL Capsules (cromolyn sodium for inhalation, USP). The most common side effects are associated with inhalation of the powder and include transient cough (1 in 5 patients) and mild wheezing (1 in 25 patients). These effects rarely require treatment or discontinuation of the drug. Information on the incidence of adverse reactions to INTAL Capsules has been derived from U.S. postmarketing surveillance experience. The following adverse reactions attributed to INTAL, based upon recurrence following readministration, have been reported in less than 1 in 10,000 patients: laryngeal edema, swollen parotid gland, angioedema, bronchospasm, joint swelling and pain, dizziness, dysuria and urinary frequency, nausea, cough, wheezing, headache, nasal congestion, rash, urticaria, and lacrimation. Other adverse reactions have been reported in less than 1 in 100,000 patients, and it is unclear whether these are attributable to the drug: anaphylaxis, nephrosis, periarteritic vasculitis, pericarditis, peripheral neuritis, pulmonary infiltrates with eosinophilia, polymyositis, exfoliative dermatitis, hemoptysis, anemia, myalgia, hoarseness, photodermatitis, and vertigo.