Cromolyn Side Effects

Some side effects of cromolyn may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to cromolyn: oral capsule, oral solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking cromolyn: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• white patches or sores inside your mouth or on your lips;

• swelling of your tongue;

• trouble swallowing; or

• tight feeling in the chest.

Less serious side effects of cromolyn may include:

• headache;

• mild stomach pain, indigestion, nausea, vomiting;

• diarrhea, constipation, gas;

• skin itching;

• muscle pain; or

• feeling tired or irritable.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to cromolyn: compounding powder, inhalation aerosol with adapter, inhalation solution, nasal spray, oral capsule, oral solution

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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