ADVERSE REACTIONS
ALLEGRA-D
In one clinical trial (n=651) in which 215 patients with seasonal allergic rhinitis received the 60 mg fexofenadine hydrochloride/120 mg pseudoephedrine hydrochloride combination tablet twice daily for up to 2 weeks, adverse events were similar to those reported either in patients receiving fexofenadine hydrochloride 60 mg alone (n=218 patients) or in patients receiving pseudoephedrine hydrochloride 120 mg alone (n=218). A placebo group was not included in this study.
The percent of patients who withdrew prematurely because of adverse events was 3.7% for the fexofenadine hydrochloride/pseudoephedrine hydrochloride combination group, 0.5% for the fexofenadine hydrochloride group, and 4.1% for the pseudoephedrine hydrochloride group. All adverse events that were reported by greater than 1% of patients who received the recommended daily dose of the fexofenadine hydrochloride/pseudoephedrine hydrochloride combination are listed in the following table.
Adverse Experiences Reported
in One Active-Controlled Seasonal Allergic Rhinitis Clinical Trial at Rates of Greater than 1%
|
Adverse Experience
|
60 mg Fexofenadine
Hydrochloride/120 mg
Pseudoephedrine
Hydrochloride
Combination Tablet
Twice Daily
(n=215) |
Fexofenadine
Hydrochloride
60 mg Twice Daily
(n=218) |
Pseudoephedrine
Hydrochloride
120 mg Twice Daily
(n=218) |
|
Headache
|
13.0%
|
11.5%
|
17.4%
|
|
Insomnia
|
12.6%
|
3.2%
|
13.3%
|
|
Nausea
|
7.4%
|
0.5%
|
5.0%
|
|
Dry Mouth
|
2.8%
|
0.5%
|
5.5%
|
|
Dyspepsia
|
2.8%
|
0.5%
|
0.9%
|
|
Throat Irritation
|
2.3%
|
1.8%
|
0.5%
|
|
Dizziness
|
1.9%
|
0.0%
|
3.2%
|
|
Agitation
|
1.9%
|
0.0%
|
1.4%
|
|
Back Pain
|
1.9%
|
0.5%
|
0.5%
|
|
Palpitation
|
1.9%
|
0.0%
|
0.9%
|
|
Nervousness
|
1.4%
|
0.5%
|
1.8%
|
|
Anxiety
|
1.4%
|
0.0%
|
1.4%
|
|
Upper Respiratory Infection
|
1.4%
|
0.9%
|
0.9%
|
|
Abdominal Pain
|
1.4%
|
0.5%
|
0.5%
|
|
Many of the adverse events occurring in the fexofenadine hydrochloride/pseudoephedrine hydrochloride combination group were adverse events also reported predominately in the pseudoephedrine hydrochloride group, such as insomnia, headache, nausea, dry mouth, dizziness, agitation, nervousness, anxiety, and palpitation.
FEXOFENADINE HYDROCHLORIDE
In placebo-controlled clinical trials, which included 2461 patients receiving fexofenadine hydrochloride at doses of 20 mg to 240 mg twice daily, adverse events were similar in fexofenadine hydrochloride and placebo-treated patients. The incidence of adverse events, including drowsiness, was not dose related and was similar across subgroups defined by age, gender, and race. The percent of patients who withdrew prematurely because of adverse events was 2.2% with fexofenadine hydrochloride vs 3.3% with placebo.
Events that have been reported during controlled clinical trials involving seasonal allergic rhinitis and chronic idiopathic urticaria patients with incidences less than 1% and similar to placebo and have been rarely reported during postmarketing surveillance include: insomnia, nervousness, and sleep disorders or paroniria. In rare cases, rash, urticaria, pruritus and hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported.
PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine hydrochloride may cause mild CNS stimulation in hypersensitive patients. Nervousness, excitability, restlessness, dizziness, weakness, or insomnia may occur. Headache, drowsiness, tachycardia, palpitation, pressor activity, and cardiac arrhythmias have been reported. Sympathomimetic drugs have also been associated with other untoward effects such as fear, anxiety, tenseness, tremor, hallucinations, seizures, pallor, respiratory difficulty, dysuria, and cardiovascular collapse.
|
