Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
Adverse Reactions Clinical experience with the use of cromolyn sodium suggests that adverse reactions are rare events.
The following adverse reactions have been associated with cromolyn sodium: 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 cromolyn sodium for inhalation capsules.
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 cromolyn sodium for inhalation capsules has been derived from U.S.
postmarketing surveillance experience.
The following adverse reactions attributed to cromolyn sodium, 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.
Warnings Cromolyn sodium inhalation solution has no role in the treatment of status asthmaticus.
Anaphylactic reactions with cromolyn sodium administration have been reported rarely.
Like all medications, Cromolyn Sodium Inhalation Solution can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: