"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
(Generic versions may still be available.)
Seldane Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Seldane (terfenadine) is used to treat allergies, hives (urticaria), and other allergic inflammatory conditions. It is an antihistamine. The brand name Seldane is discontinued in the U.S. Generic versions may be available. Common side effects include drowsiness or dizziness, headache, nervousness, nausea, diarrhea, abdominal discomfort, dry mouth, dry skin or itchiness.
The dose of terfenadine for adults and pediatric patients 12 years and older is one tablet (60 mg) twice daily. Terfenadine may interact with antifungal drugs, antibiotics, ulcer drugs, beta-blockers, monoamine oxidase inhibitors (MAOIs), antidepressants, caffeine, amphetamines, decongestants, or diet pills. Tell your doctor all medications you use. During pregnancy, terfenadine should be taken only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Our Seldane (terfenadine) 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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Seldane FDA Prescribing Information: Side Effects
Cardiovascular Adverse Events
Rare reports of severe cardiovascular adverse effects have been received which include ventricular tachyarrhythmias (torsades de pointes, ventricular tachycardia, ventricular fibrillation, and cardiac arrest), hypotension, palpitations, syncope, and dizziness. Rare reports of deaths resulting from ventricular tachyarrhythmias have been received (see CONTRAINDICATIONS, WARNINGS, and DRUG INTERACTIONS). Hypotension, palpitations, syncope, and dizziness could reflect undetected ventricular arrhythmia. IN SOME PATIENTS, DEATH, CARDIAC ARREST, OR TORSADES DE POINTES HAVE BEEN PRECEDED BY EPISODES OF SYNCOPE. (See BOXED WARNING). Rare reports of serious cardiovascular adverse events have been received, some involving QT prolongation and torsades de pointes, in apparently normal individuals without identifiable risk factors. There is not conclusive evidence of causal relationship of these events with terfenadine. Although in rare cases there was measurable plasma terfenadine, the implications of this finding with respect to the variability of terfenadine metabolism in the normal population cannot be assessed without further study. In controlled clinical trials in otherwise normal patients with rhinitis, small increases in QTc interval were observed at doses of 60 mg b.i.d. In studies of 300 mg b.i.d. a mean increase in QTc of 10% (range -4% to +30%)(mean increase of 46 msec) was observed.
General Adverse Events
Experience from clinical studies, including both controlled and uncontrolled studies involving more than 2,400 patients who received terfenadine, provides information on adverse experience incidence for periods of a few days up to six months. The usual dose in these studies was 60 mg twice daily, but in a small number of patients, the dose was as low as 20 mg twice a day, or as high as 600 mg daily.
In controlled clinical studies using the recommended dose of 60 mg b.i.d., the incidence of reported adverse effects in patients receiving terfenadine was similar to that reported in patients receiving placebo. (See TABLE 1).
TABLE 1 - ADVERSE EVENTS REPORTED IN CLINICAL STUDIES
Percent of Patients Reporting
All Clinical Studies**
|CENTRAL NERVOUS SYSTEM|
|Gastrointestinal Distress (Abdominal distress, Nausea, Vomiting, Change in bowel habits)||4.6||3.0||2.7||7.6||5.4|
|EYE, EAR NOSE, AND THROAT|
|Eruption (including rash and urticaria) or itching||1.0||1.7||1.4||1.6||2.0|
|* Duration of treatment in "CONTROLLED STUDIES" was usually 7-14 days.|
|** Duration of treatment in "ALL CLINICAL STUDIES" was up to 6 months.|
|*** CONTROL DRUGS: Chlorpheniramine (291 patients), d-Chlorpheniramine (189 patients), Clemastine (146 patients)|
In addition to the more frequent side effects reported in clinical trials, adverse effects have been reported at a lower incidence in clinical trials and/or spontaneously during marketing of terfenadine that warrant listing as possibly associated with drug administration. These include: alopecia (hair loss or thinning), anaphylaxis, angioedema, bronchospasm, confusion, depression, galactorrhea, insomnia, menstrual disorder (including dysmenorrhea), musculoskeletal symptoms, nightmares, paresthesia, photosensitivity, rapid flare of psoriasis, seizures, sinus tachycardia, sweating, thrombocytopenia, tremor, urinary frequency and visual disturbances.
In clinical trials, severe instances of mild, or in one case, moderate transaminase elevations were seen in patients receiving terfenadine. Mild elevations were also seen in placebo treated patients. Marketing experiences include isolated reports of jaundice, cholestatic hepatitis, and hepatitis. In most cases available information is incomplete.
Read the entire FDA prescribing information for Seldane (Terfenadine (Removed from market 1998))
Additional Seldane Information
- Seldane Drug Interactions Center: terfenadine oral
- Seldane Side Effects Center
- Seldane FDA Approved Prescribing Information including Dosage
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.
Find out what women really need.