"The US Food and Drug Administration (FDA) has approved the long-acting muscarinic antagonist tiotropium bromide (Spiriva Respimat, Boehringer Ingelheim) for long-term maintenance treatment of asthma in people aged 12 years and older, accor"...
Intal Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Intal (cromolyn sodium) is an anti-inflammatory drug indicated in the management of patients with bronchial asthma. Cromolyn sodium is available as a generic drug. Some side effects may include but are not limited to: throat irritation or dryness, bad taste, cough, wheeze, and nausea.
Intal inhaler delivers about 800 mcg per inhalation. For management of bronchial asthma in adults and pediatric patients (5 years of age and over), the usual starting dosage is two metered inhalations four times daily at regular intervals. This dose should not be exceeded. Effective Intal Inhaler therapy is dependent upon its administration at regular intervals, as directed. Intal Inhaler should be used during pregnancy only if clearly needed. Adverse effects of this drug could become apparent only after many years; a benefit/risk consideration of the long-term use of the Intal Inhaler is particularly important in pediatric patients.
Our Intal (cromolyn sodium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Intal in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- severe wheezing or chest tightness just after inhaling the medication;
- skin rash, bruising, severe tingling, numbness, pain, muscle weakness; or
- fever, swollen glands, rash or itching, joint pain, and a general ill feeling.
Less serious side effects may include:
- dry or irritated throat, temporary or occasional cough;
- sneezing, stuffy or itchy nose, watery eyes;
- burning or bleeding of your nose;
- nausea, heartburn, stomach pain;
- urinating more or less than usual;
- dizziness, drowsiness, headache; or
- unusual or unpleasant taste in your mouth.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Intal (Cromolyn Sodium Inhalation Aerosol)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Intal FDA Prescribing Information: Side Effects
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.
Read the entire FDA prescribing information for Intal (Cromolyn Sodium Inhalation Aerosol)
Additional Intal Inhaler Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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