Fexofenadine (Allegra) Adverse Reactions
- anaphylactoid reactions
- angioedema
- back pain
- cough
- dizziness
- drowsiness
- dysmenorrhea
- dyspepsia
- fatigue
- fever
- headache
- infection
- insomnia
- myalgia
- nausea/vomiting
- pharyngitis
- pruritus
- QT prolongation
- rash (unspecified)
- restlessness
- urticaria
Fexofenadine (Allegra) Adverse Reactions
The most common adverse reactions associated with fexofenadine therapy include viral infection (e.g., cold, flu), nausea/vomiting, dysmenorrhea, drowsiness, dyspepsia, and fatigue. These adverse reactions were more common in fexofenadine-treated patients than in placebo-treated patients and occurred in greater than 1% of patients. In a study of 570 patients 12 years of age and older, adverse reactions which were more common in those receiving fexofenadine 120 or 180 mg daily versus placebo, and occurred in greater than 2% of patients included back pain, headache, and upper respiratory infection. Adverse reactions reported in greater than 2% of patients in a placebo controlled pediatric study (age 6 - 11 years) included cough, fever, otitis media, pain (unspecified), and upper respiratory tract infection. Other adverse events which have been reported in clinical trials of patients 12 years of age and older include dizziness, myalgia, pharyngitis (nasal), and unspecified pain in extremity.
Fexofenadine (Allegra) is a metabolite of terfenadine. Terfenadine has been associated with QT prolongation and ventricular tachycardias (torsades de point) and was withdrawn from the U.S. market after ten years of post-marketing experience. Pre-marketing trials with fexofenadine in greater than 900 patients demonstrated no significant prolongation of the QT interval at doses of 60 - 240 mg PO twice daily. One case report documented ventricular tachycardia associated with QT prolongation during therapy with fexofenadine in a patient with a history of prolonged QT interval. No cases of cardiac arrhythmias are reported in the fexofenadine or Allegra-D® product information. No QT prolongation was evident with the maximum fexofenadine dosage studied (400 mg PO twice daily for seven days in healthy subjects).
Events that have been reported during controlled clinical trials involving seasonal allergic rhinitis and chronic idiopathic urticaria patients with frequencies < 1%, similar to placebo, and have been rarely reported during post-marketing surveillance of fexofenadine include: insomnia, nervousness (restlessness), and sleep disorders or paranoia. In rare cases, rash (unspecified), urticaria, pruritus and hypersensitivity reactions (anaphylactoid reactions) with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported.
[ Last revised: 1/4/2006 10:06:00 PM ]
References
. Giraud T. QT lengthening and arrhythmias associated with fexofenadine. Lancet 1999;353:2072 - 3.
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