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

Pratt et al. 1999 [78]

Fexofenadine HCl 60, or 80 mg BID;

fexofenadine HCl 240 mg QD;

placebo

3 up to 12 months

• 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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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

• 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

• 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)

• 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

• 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%)