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Table 5 Summaries of the studies investigating the safety of fexofenadine HCl in pediatric and adult populations

From: Insights into urticaria in pediatric and adult populations and its management with fexofenadine hydrochloride

Study Treatment and dosage Treatment duration/ time of analysis post administration Patient population, N Fexofenadine HCl outcomes
Pratt et al. 1999 [78] Fexofenadine HCl 60, or 80 mg BID;
fexofenadine HCl 240 mg QD;
placebo
3 up to 12 months Adults, N = 930 • No significant increases in QTc between fexofenadine and placebo (p ≥ 0.188)
Bernstein et al. 1997 [89] Fexofenadine HCl 60, 120, or 240 mg BID; or placebo 14 days Adults, N = 570 • No significant difference in treatment-related AEs were noted between fexofenadine (10.9%) and placebo (9.2%)
• No sedative effects or ECGs abnormalities, including prolongations in QTc
Hindmarch et al. 1999 [79] Fexofenadine HCl 80, 120 and 180 mg, loratadine 10 mg, promethazine 30 mg, and placebo Up to 24 h (post administration) Adults (healthy), N = 24 • No disruptive effects on aspects of psychomotor and cognitive function
Hindmarch et al. 2002 [80] Fexofenadine HCl 360 mg, promethazine 30 mg and placebo 7 h (post administration) Adults (healthy), N = 15 • No disruptive effects on aspects of psychomotor and cognitive function
Hampel et al. 2003 [90] Fexofenadine HCl 180 mg, cetirizine 10 mg 2 weeks (post administration) Adults, N = 495 • Fexofenadine resulted in significantly less overall drowsiness vs baseline than those receiving cetirizine (− 2.33 [95% CI, − 3.80 to 0.86] vs. 0.37 [95% CI, − 1.10 to 1.84]; p = 0.0110)
Inami et al. 2016 [84] Fexofenadine HCl 60 mg; levocetirizine 5 mg; diphenhydramine 50 mg; placebo 90 and 180 min (post-administration) Adults, N = 20 • No significant difference compared with placebo on psychomotor performance (p > 0.03)
Bower et al. 2003 [85] Fexofenadine HCl 180 mg; diphenhydramine 50 mg or placebo 90 min (post-administration) Adults, N = 42 • Effects of fexofenadine on psychomotor performance were similar to placebo. No AE reported with fexofenadine 180 mg
Milgrom et al. 2007 [88] Fexofenadine HCl 30 mg BID, or placebo 2 weeks Children (2–5 years old), N = 453 • AEs possibly related to treatment were experienced by 19 (8.2%) and 21 (9.5%) of participants receiving placebo and fexofenadine, respectively. No clinically relevant differences were found in ECGs, laboratory measures, vital signs, or physical examination results compared to placebo
• No prolongation in QT interval was observed (fexofenadine: − 0.8 [17.2]; placebo: 4.1 [19.9])
Meltzer et al. 2004 [91] Fexofenadine HCl 15; 30 or 60 mg BID; or placebo 2 weeks Children (6–11 years old), N = 1810 • Most common reported AE was headache (4.3% placebo; 7.2% fexofenadine [any dose])
• Adverse events were similar across treatment groups (24.4% placebo; 24.1% fexofenadine [30 mg BID]; 28.4% fexofenadine [any dose])
Segall et al. 2008 [92] Fexofenadine HCl 30 mg; placebo Up to 24 h (post administration) Children (2–5 years old), N = 50 • No trends or clinically meaningful changes in mean ECG, vital sign, or clinical laboratory test data occurred
Maciel-Guerra et al. 2018 [65] Dexchlorpheniramine 2 mg, hydroxyzine 25 mg,
levocetirizine 5 mg,
fexofenadine HCl 180 mg,
cetirizine 10 mg,
loratadine 10 mg,
ebastine 10 mg,
desloratadine 5 mg,
epinastine 20 mg,
rupatadine 10 mg
2 h post administration Adults (healthy), N = 10 • Drowsiness was reported with dexchlorpheniramine (60%), hydroxyzine (80%), levocetirizine (30%), cetirizine (40%), loratadine (20%), ebastine (20%), desloratadine (10%), epinastine (20%), and rupatadine (30%), but not with fexofenadine (0%)
  1. AE adverse events, ECG electrocardiogram