Astemizole Side Effects

Not all side effects for astemizole 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 astemizole: oral tablet

If you experience any of the following serious side effects, stop taking astemizole and call your doctor immediately or seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

  • an irregular heartbeat;

  • fainting; or

  • seizures.

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

  • drowsiness or dizziness;

  • headache;

  • nervousness;

  • nausea, diarrhea, or abdominal discomfort;

  • dry mouth; or

  • dry skin or itchiness.

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 astemizole: oral tablet

Cardiovascular

Astemizole and its predominant metabolite, desmethylastemizole, have been associated with prolongation of the QT interval. Most cardiovascular events related to astemizole occur in patients with higher than normal astemizole serum concentrations (either due to ingesting more than the recommended dose of 10 mg once daily or due to reduced elimination) or in patients at risk for cardiac events. Macrolide antibiotic and azole antifungal agents may inhibit the metabolism of astemizole, resulting in QT interval prolongation. Patients with liver dysfunction are also at risk due to decreased metabolism of the drug. Other predisposing factors include congenital forms of QT interval prolongation, coronary artery disease, and electrolyte disorders including hypokalemia and hypomagnesemia. Although rare, arrhythmias have been reported in patients on recommended doses without apparent risk factors[Ref]

Cardiovascular system adverse effects have been associated with the use of astemizole. Adverse effects reported include dizziness, syncopal episodes, palpitations, ventricular arrhythmias (including torsades de pointes), cardiac arrest, and cardiac death.[Ref]

Nervous system

Nervous system adverse effects associated with astemizole are rare. Headaches may occur in approximately 7% of treated patients. Astemizole has not been shown to cause significant drowsiness, sedation, or impair psychomotor skills. Increased appetite and weight gain has been reported in approximately 4% of patients.[Ref]

Gastrointestinal

Gastrointestinal effects of astemizole are rare and include nausea and dry mouth.[Ref]

Hypersensitivity

Rare cases of anaphylaxis, including anaphylactic shock, have been reported.[Ref]

References

1. "Safety of terfenadine and astemizole." Med Lett Drugs Ther 34 (1992): 9-10

2. Goss JE, Ramo BW, Blake K "Torsades de pointes associated with astemizole (hismanal) therapy." Arch Intern Med 153 (1993): 2705

3. Saviuc P, Danel V, Dixmerias F "Prolonged QT interval and torsade de pointes following astemizole overdose." J Toxicol Clin Toxicol 31 (1993): 121-5

4. Kessler DA, Scheman C, Nightingale SL, et al "New boxed warnings added for seldane, hismanal." FDA Med Bull 22 (1992): 2-3

5. Craft TM "Torsade de pointes after astemizole overdose." Br Med J 292 (1986): 660

6. Heidemann SM, Sarnaik AP "Arrhythmias after astemizole overdose." Pediatr Emerg Care 12 (1996): 102-4

7. Snook J, Boothman-Burrell D, Watkins J, Colin-Jones D "Torsade de pointes ventricular tachycardia associated with astemizole overdose." Br J Clin Pract 42 (1988): 257-9

8. Desager JP, Horsmans Y "Pharmacokinetic pharmacodynamic relationships of h-1-antihistamines." Clin Pharmacokinet 28 (1995): 419-32

9. Salata JJ, Jurkiewicz NK, Wallace AA, Stupienski RF, Guinosso PJ, Lynch JJ "Cardiac electrophysiological actions of the histamine h-1-receptor antagonists astemizole and terfenadine compared with chlorpheniramine and pyrilamine." Circ Res 76 (1995): 110-9

10. "Product Information. Hismanal (astemizole)." Janssen Pharmaceutica, Titusville, NJ.

11. Sakemi H, VanNatta B "Torsade de pointes induced by astemizole in a patient with prolongation of the QT interval." Am Heart J 125 (1993): 1436-8

12. Smith SJ "Cardiovascular toxicity of antihistamines." Otolaryngol Head Neck Surg 111 Suppl (1994): 348-54

13. Rao KA, Adlakha A, Vermaansil B, Meloy TD, Stanton MS "Torsades de pointes ventricular tachycardia associated with overdose of astemizole." Mayo Clin Proc 69 (1994): 589-93

14. Broadhurst P, Nathan AW "Cardiac arrest in a young woman with the long QT syndrome and concomitant astemizole ingestion." Br Heart J 70 (1993): 469-70

15. Vorperian VR, Zhou ZF, Mohammad S, Hoon TJ, Studenik C, January CT "Torsade de pointes with an antihistamine metabolite: potassium channel blockade with desmethylastemizole." J Am Coll Cardiol 28 (1996): 1556-61

16. Kemp JP "Antihistamines--is there anything safe to prescribe?" Ann Allergy 69 (1992): 276-80

17. Simons FE, Kesselman MS, Giddins NG, Pelech AN, Simons KJ "Astemizole-induced torsade de pointes." Lancet 2 (1988): 624

18. Berul CI, Morad M "Regulation of potassium channels by nonsedating antihistamines." Circulation 91 (1995): 2220-5

19. Woosley RL "Cardiac actions of antihistamines." Annu Rev Pharmacol Toxicol 36 (1996): 233-52

20. Simons FER, Fraser TG, Reggin JD, Simons KJ "Comparison of the central nervous system effects produced by six h-1-receptor antagonists." Clin Exp Allergy 26 (1996): 1092-7

21. Krause LB, Shuster S "A comparison of astemizole and chlorpheniramine in dermographic urticaria." Br J Dermatol 112 (1985): 447-53

22. Bunnag C, Jareoncharsri P, Wong EC "A double-blind comparison of nasal budesonide and oral astemizole for the treatment of perennial rhinitis." Allergy 47 (1992): 313-7

23. Richards DM, Brogden RN, Heel RC, Speight TM, Avery GS "Astemizole. A review of its pharmacodynamic properties and therapeutic efficacy." Drugs 28 (1984): 38-61

24. Juniper EF, White J, Dolovich J "Efficacy of continuous treatment with astemizole (Hismanal) and terfenadine (Seldane) in ragweed pollen-induced rhinoconjunctivitis." J Allergy Clin Immunol 82 (1988): 670-5

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