Intal Side Effects

Generic Name: cromolyn

Please note - some side effects for Intal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Intal - for the Consumer

Intal Aerosol Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Intal Aerosol Solution:

Bad taste; cough; drowsiness; hoarseness; nausea; throat irritation or dryness; tightness in the lungs; wheezing.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breathing problems; severe nasal congestion.

Intal Nebulizer Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Intal Nebulizer Solution:

Bad taste; cough; drowsiness; hoarseness; nausea; sneezing; throat irritation; tightness in the lungs; wheezing.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breathing problems; severe nasal congestion.

Intal Side Effects - for the Professional

Intal

In controlled clinical studies of Intal Inhaler, the most frequently reported adverse reactions attributed to cromolyn sodium treatment were:

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 (FEV1)], 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.

Intal Nebulizer Solution

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.

Side Effects by Body System

Hypersensitivity

Hypersensitivity reactions have included anaphylaxis. Hypersensitivity side effects have been reported to develop after weeks to years of use.

Respiratory

Respiratory side effects have included throat irritation and transient cough and bronchospasm after inhalation of cromolyn powder by Spinhaler. Nasal congestion has been associated with cromolyn use. Pulmonary infiltrates and pulmonary granulomatosis have been rarely reported. Wheezing and chest tightness following cromolyn use have preceded more serious allergic reactions.

Throat irritation may be relieved by drinking water before and after inhalation of cromolyn. Use of a beta-2 agonist prior to cromolyn inhalation may relieve cough and bronchospasm.

Hematologic

Hematologic side effects have included leukocytosis and eosinophilia.

Genitourinary

Genitourinary side effects have included urinary burning and irritation.

Dermatologic

Dermatologic side effects have included facial or generalized dermatitis, urticaria, and rarely, vasculitis.

Gastrointestinal

Gastrointestinal side effects have been reported with inhaled cromolyn, including nausea, vomiting, and rarely, esophagitis. Symptoms of lactose intolerance have been reported in a patient with lactase deficiency receiving cromolyn capsules by inhalation.

Hepatic

Hepatic side effects have included liver disease, with eosinophilic infiltrates, in association with eosinophilia.

Cardiovascular

Cardiovascular side effects have included a single case report of cardiac tamponade associated with eosinophilia.

Musculoskeletal

Musculoskeletal system side effects have rarely included myositis, which involved the lower extremities resulting in pain and fatigue.

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