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Seldane Side Effects

Generic name: terfenadine

Note: This document contains side effect information about terfenadine. Some dosage forms listed on this page may not apply to the brand name Seldane.

Applies to terfenadine: oral tablet.

Warning

Terfenadine was withdrawn from the U.S. market in 1998.

Do not take terfenadine with any of the following medicines: the antifungal drugs ketoconazole (Nizoral) or itraconazole (Sporanox); the antibiotics erythromycin (E.E.S., E-Mycin, Ery-Tab), clarithromycin (Biaxin), or azithromycin (Zithromax); or the ulcer drug cimetidine (Tagamet, Tagamet HB). A dangerous drug interaction could occur.

If you experience any of the following serious side effects, stop taking terfenadine (the active ingredient contained in Seldane) and call your doctor immediately or seek emergency medical attention.

If you experience any of the following less serious side effects, continue taking terfenadine and talk to your doctor:

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 terfenadine: oral tablet.

Cardiovascular

Terfenadine use may cause prolongation of the QT interval. Most cardiovascular events related to terfenadine (the active ingredient contained in Seldane) occur in patients taking more than the recommended dose of 60 mg twice a day, in patients with higher-than-normal terfenadine serum concentrations, and in patients who are at risk for cardiac events. Patients with liver disease are also at risk of cardiovascular toxicity due to potential accumulation of the drug. Other predisposing factors for cardiovascular toxicity 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 toxicity has been associated with the use of terfenadine. Reported effects include dizziness, syncopal episodes, palpitations, ventricular arrhythmias (including torsades de pointes), cardiac arrest, and cardiac death.[Ref]

Nervous system

Headaches have been reported in approximately 6% of treated patients. Terfenadine (the active ingredient contained in Seldane) has not been demonstrated to cause significant drowsiness, sedation, or impaired psychomotor skills.[Ref]

Gastrointestinal

Gastrointestinal effects of terfenadine (the active ingredient contained in Seldane) are rare and include nausea and dry mouth.[Ref]

Genitourinary

A study of the effects of terfenadine (the active ingredient contained in Seldane) on the urination of eight healthy male volunteers and 11 males with benign prostatic hypertrophy was not able to confirm a consistent effect on voiding characteristics.[Ref]

Urinary retention has been reported rarely.[Ref]

Hepatic

Acute hepatitis, cholestatic hepatitis, and jaundice have been reported rarely in patients taking terfenadine (the active ingredient contained in Seldane) Hepatic dysfunction has been reversible upon discontinuation of the drug.[Ref]

References

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

2. Kemp JP. Antihistamines--is there anything safe to prescribe? Ann Allergy. 1992;69:276-80.

3. Woosley RL, Chen Y, Freiman JP, Gillis RA. Mechanism of the cardiotoxic actions of terfenadine. JAMA. 1993;269:1532-6.

4. Safety of terfenadine and astemizole. Med Lett Drugs Ther. 1992;34:9-10.

5. Smith SJ. Cardiovascular toxicity of antihistamines. Otolaryngol Head Neck Surg. 1994;111 Suppl:348-54.

6. 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. 1995;76:110-9.

7. Berul CI, Morad M. Regulation of potassium channels by nonsedating antihistamines. Circulation. 1995;91:2220-5.

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

9. Woosley RL. Cardiac actions of antihistamines. Annu Rev Pharmacol Toxicol. 1996;36:233-52.

10. June RA, Nasr I. Torsades de pointes with terfenadine ingestion. Am J Emerg Med. 1997;15:542-3.

11. Carter CA, Wojciechowski NJ, Hayes JM, Skoutakis VA, Rickman LA. Terfenadine, a nonsedating antihistamine. Drug Intell Clin Pharm. 1985;19:812-7.

12. Connell JT. Pharmacology and clinical efficacy of terfenadine, a new H1-receptor antagonist. Pharmacotherapy. 1985;5:201-8.

13. Moser L, Huther KJ, Koch-Weser J, Lundt PV. Effects of terfenadine and diphenhydramine alone or in combination with diazepam or alcohol on psychomotor performance and subjective feelings. Eur J Clin Pharmacol. 1978;14:417-23.

14. Berkowitz RB, Tinkelman DG. Evaluation of oral terfenadine for treatment of the common cold. Ann Allergy. 1991;67:593-7.

15. Lockey RF, Findley S, Mitchell DQ, Woehler T, Lieberman P, Nicodemus CF. Effects of cetirizine versus terfenadine in seasonal allergic rhinitis. Ann Allergy. 1993;70:311-5.

16. Soto J, Sacristan JA, Alsar MJ, Sainz C. Terfenadine-induced tremor . Ann Neurol. 1993;33:226.

17. Ramaekers JG, Ohanlon JF. Acrivastine, terfenadine and diphenhydramine effects on driving performance as a function of dose and time after dosing. Eur J Clin Pharmacol. 1994;47:261-6.

18. 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. 1996;26:1092-7.

19. Adelsberg BR. Sedation and performance issues in the treatment of allergic conditions. Arch Intern Med. 1997;157:494-500.

20. 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. 1988;82:670-5.

21. Spaulding HS, Sutherland RS, Sklarew PR, Punja MK, Thrasher JB, Vaughan TR, Donatucci CF. Effect of terfenadine on urination. Ann Allergy. 1994;72:441-5.

22. Seggev JS, Fink JN. Urinary retention as a result of administration of terfenadine. J Allergy Clin Immunol. 1994;93:1071-2.

23. Sahai A, Villeneuve JP. Terfenadine-induced cholestatic hepatitis. Lancet. 1996;348:552-3.

24. Larrey D, Palazzo L, Benhamou JP. Terfenadine and hepatitis. Ann Intern Med. 1985;103:634.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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