Gastrocrom Side Effects

Generic Name: cromolyn,cromolyn sodium

Please note - some side effects for Gastrocrom may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Gastrocrom - for the Consumer

Gastrocrom Concentrate

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 Gastrocrom Concentrate:

Diarrhea; headache; nausea.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fast or irregular heartbeat; hoarseness; mental or mood changes; seizures.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Gastrocrom Side Effects - for the Professional

Gastrocrom

Most of the adverse events reported in mastocytosis patients have been transient and could represent symptoms of the disease. The most frequently reported adverse events in mastocytosis patients who have received Gastrocrom during clinical studies were headache and diarrhea, each of which occurred in 4 of the 87 patients. Pruritus, nausea, and myalgia were each reported in 3 patients and abdominal pain, rash, and irritability in 2 patients each. One report of malaise was also recorded.

Other Adverse Events

Additional adverse events have been reported during studies in other clinical conditions and from worldwide postmarketing experience. In most cases the available information is incomplete and attribution to the drug cannot be determined. The majority of these reports involve the gastrointestinal system and include: diarrhea, nausea, abdominal pain, constipation, dyspepsia, flatulence, glossitis, stomatitis, vomiting, dysphagia, esophagospasm.

Other less commonly reported events (the majority representing only a single report) include the following:

• Skin: pruritus, rash, urticaria/angioedema, erythema/ burning, photosensitivity
• Musculoskeletal: arthralgia, myalgia, stiffness/weakness of legs
• Neurologic: headache, dizziness, hypoesthesia, paresthesia, migraine, convulsions, flushing
• Psychiatric: psychosis, anxiety, depression, hallucinations, behavior change, insomnia, nervousness
• Heart Rate: tachycardia, premature ventricular contractions (PVCs), palpitations
• Respiratory: pharyngitis, dyspnea
• Miscellaneous: fatigue, edema, unpleasant taste, chest pain, postprandial lightheadedness and lethargy, dysuria, urinary frequency, purpura, hepatic function test abnormal, polycythemia, neutropenia, pancytopenia, tinnitus, lupus erythematosus (LE) syndrome

Side Effects by Body System - for Healthcare Professionals

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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