Nedocromil Side Effects

Some side effects of nedocromil 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 nedocromil: inhalation aerosol with adapter

Serious side effects from nedocromil inhalation are not likely to occur. Seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to use nedocromil inhalation and talk to your doctor if you experience

• a dry mouth,

• an unpleasant taste, or

• mild nausea after use.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to nedocromil: inhalation aerosol with adapter

Gastrointestinal

Gastrointestinal side effects have included unpleasant taste which was reported in approximately 13% of patients receiving nedocromil and resulted in drug withdrawal in up to 3%. Less commonly, nedocromil has caused nausea and vomiting (2% to 4%).

Respiratory

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

Respiratory side effects have included cough and throat irritation in 6% to 7% of patients treated with nedocromil. Bronchospasm has been induced in 5% of patients.

Nervous system

Nervous system side effects have included headache in up to 6% of patients treated. Less commonly dizziness has been reported.

Hepatic

Hepatic side effects have included elevations of liver function tests (SGPT) in approximately 3% of patients treated with nedocromil.

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