Intal Side Effects

Generic Name: cromolyn

Note: This page contains information about the side effects of cromolyn. Some of the dosage forms included on this document may not apply to the brand name Intal.

Not all side effects for Intal may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to cromolyn: oral capsule, oral solution

In addition to its needed effects, some unwanted effects may be caused by cromolyn (the active ingredient contained in Intal). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking cromolyn:

Rare
  • Coughing
  • difficulty in swallowing
  • hives or itching of skin
  • swelling of face, lips, or eyelids
  • wheezing or difficulty in breathing

If any of the following side effects occur while taking cromolyn, check with your doctor or nurse as soon as possible:

Less common
  • Skin rash

Some of the side effects that can occur with cromolyn may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Diarrhea
  • headache
Less common

Note: If the above side effects occur in patients with mastocytosis, they are usually only temporary and could be symptoms of the disease.

  • Abdominal pain
  • irritability
  • muscle pain
  • nausea
  • trouble in sleeping

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.[Ref]

Respiratory

Respiratory side effects have included throat irritation and transient cough and bronchospasm after inhalation of cromolyn (the active ingredient contained in Intal) 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.[Ref]

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.[Ref]

Hematologic

Hematologic side effects have included leukocytosis and eosinophilia.[Ref]

Genitourinary

Genitourinary side effects have included urinary burning and irritation.[Ref]

Dermatologic

Dermatologic side effects have included facial or generalized dermatitis, urticaria, and rarely, vasculitis.[Ref]

Gastrointestinal

Gastrointestinal side effects have been reported with inhaled cromolyn (the active ingredient contained in Intal) including nausea, vomiting, and rarely, esophagitis. Symptoms of lactose intolerance have been reported in a patient with lactase deficiency receiving cromolyn capsules by inhalation.[Ref]

Hepatic

Hepatic side effects have included liver disease, with eosinophilic infiltrates, in association with eosinophilia.[Ref]

Cardiovascular

Cardiovascular side effects have included a single case report of cardiac tamponade associated with eosinophilia.[Ref]

Musculoskeletal

Musculoskeletal system side effects have rarely included myositis, which involved the lower extremities resulting in pain and fatigue.[Ref]

References

1. Kimata H, Nagano T "Effect of cromolyn (disodium cromoglycate) solution on atopic dermatitis: unusual adverse effect in two cases [published erratum appears in Allergy 1991 Oct;46(7):560]." Allergy 46 (1991): 319

2. Mansfield LE "Disappearance of allergic reaction to cromolyn (cromoglycate) by avoidance and then reintroduction." J Asthma 28 (1991): 447-50

3. Settipane GA, Klein DE, Boyd GK, Sturam JH, Freye HB, Weltman JK "Adverse reactions to cromolyn." JAMA 241 (1979): 811-3

4. Shapiro GG, Konig P "Cromolyn sodium: a review." Pharmacotherapy 5 (1985): 156-70

5. Brown LA, Kaplan RA, Benjamin PA, Hoffman LS, Shearer WT "Immunoglobulin E-mediated anaphylaxis with inhaled cromolyn sodium." J Allergy Clin Immunol 68 (1981): 416-20

6. Dykes MH "Evaluation of an antiasthmatic agent cromolyn sodium (Aarane, Intal)." JAMA 227 (1974): 1061-2

7. Skarpaas IJ "An unexpected reaction towards disodium cromoglycate." Allergy 42 (1987): 318-9

8. Menon MP, Das AK "Asthma and urticaria during disodium cromoglycate treatment. A case report." Scand J Respir Dis 58 (1977): 145-50

9. Brogden RN, Speight TM, Avery GS "Sodium cromoglycate (cromolyn sodium): a review of its mode of action, pharmacology, therapeutic efficacy and use." Drugs 7 (1974): 164-282

10. Rosenberg JL, Edlow D, Sneider R "Liver disease and vasculitis in a patient taking cromolyn." Arch Intern Med 138 (1978): 989-91

11. Leynadier F, Pujade-Lauraine MD, Cornaille G, Dry J "Death after cromoglycate ." Allergy 40 (1985): 540-1

12. Repo UK, Nieminen P "Pulmonary infiltrates with eosinophilia and urinary symptoms during disodium cromoglycate treatment. A case report." Scand J Respir Dis 57 (1976): 1-4

13. Lobel H, Machtey I, Eldror MY "Pulmonary infiltrates with eosinophilia in an asthmatic patient treated with disodium cromoglycate." Lancet 2 (1972): 1032

14. Burgher LW, Kass I, Schenken JR "Pulmonary allergic granulomatosis: a possible drug reaction in a patient receiving cromolyn sodium." Chest 66 (1974): 84-6

15. "Product Information. Intal (cromolyn)." Rhone-Poulenc Rorer, Collegeville, PA.

16. Blumenthal MN, Selcow J, Spector S, Zeiger RS, Mellon M "A multicenter evaluation of the clinical benefits of cromolyn sodium aerosol by metered-dose inhaler in the treatment of asthma." J Allergy Clin Immunol 81 (1988): 681-7

17. Block SH "Nasal congestion as a side effect of cromolyn sodium." J Allergy Clin Immunol 53 (1974): 243-4

18. Rao M, Steiner P, Victoria MS "Letter: nasal congestion as a side effect of cromolyn sodium in a pediatric patient." J Pediatr 86 (1975): 804

19. Slater EE "Cardiac tamponade and peripheral eosinophilia in a patient receiving cromolyn sodium." Chest 73 (1978): 878-9

20. Block SH "Letter: Urethral burning as a side effect of cromolyn sodium." Am Rev Respir Dis 109 (1974): 581

21. Brandstetter RD, Conetta R, Glazer B "Lactose intolerance associated with Intal capsules ." N Engl J Med 315 (1986): 1613-4

22. Israel RH, Wood J "Esophagitis related to cromolyn ." JAMA 242 (1979): 2758-9

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