Incidence of treatment-emergent adverse events by primary system organ class and preferred term at an incidence of ≥2% (safety population)#
| Primary system organ class (preferred term) | Placebo | Fexofenadine HCl |
| Subjects | 126 | 127 |
| Any class | 19 (15.1) | 16 (12.6) |
| Infections and infestations | 3 (2.4) | 2 (1.6) |
| Upper respiratory tract infection | 2 (1.6) | 2 (1.6) |
| Gastroenteritis | 1 (0.8) | 0 (0.0) |
| Immune system disorders | 7 (5.6) | 6 (4.7) |
| Seasonal allergic rhinitis | 7 (5.6) | 6 (4.7) |
| Respiratory, thoracic and mediastinal disorders | 5 (4.0) | 2 (1.6) |
| Nasal dryness | 0 (0.0) | 2 (1.6) |
| Cough | 1 (0.8) | 0 (0.0) |
| Nasal congestion | 1 (0.8) | 0 (0.0) |
| Nasal pruritus | 1 (0.8) | 0 (0.0) |
| Rhinorrhoea | 1 (0.8) | 0 (0.0) |
| Sneezing | 1 (0.8) | 0 (0.0) |
| Upper-airway cough syndrome | 1 (0.8) | 0 (0.0) |
| Gastrointestinal disorders | 0 (0.0) | 3 (2.4) |
| Dry mouth | 0 (0.0) | 1 (0.8) |
| Enlarged uvula | 0 (0.0) | 1 (0.8) |
| Nausea | 0 (0.0) | 1 (0.8) |
Data are presented as n or n (%). HCl: hydrochloride. #: Subjects may have experienced more than one type of adverse event within any primary system organ class.