Table 2 Adverse events reported during first dose monitoring after fingolimod administration
Adverse event, n (%) | n = 906 |
|---|---|
Cardiac disorders | 18 (2.0) |
Atrioventricular block first degree | 1 (0.1) |
Atrioventricular block second degree | 2 (0.2) |
Bradycardia | 12 (1.3) |
Palpitations | 1 (0.1) |
Ventricular premature beats | 1 (0.1) |
Sinus arrhythmia | 1 (0.1) |
Ear and labyrinth disorders | 2 (0.2) |
Vertigo | 2 (0.2) |
Gastrointestinal disorders | 8 (0.9) |
Diarrhoea | 2 (0.2) |
Nausea | 5 (0.6) |
Vomiting | 1 (0.1) |
General disorders and administration site conditions | 7 (0.8) |
Asthenia | 4 (0.4) |
Chest pain | 1 (0.1) |
Chills | 1 (0.1) |
Hyperpyrexia | 1 (0.1) |
Malaise | 1 (0.1) |
Infections and infestations | 3 (0.3) |
Influenza | 1 (0.1) |
Nasopharyngitis | 1 (0.1) |
Urinary tract infection | 1 (0.1) |
Musculoskeletal and connective tissue disorders | 2 (0.2) |
Pain in extremity | 2 (0.2) |
Nervous system disorders | 11 (1.2) |
Dysgeusia | 1 (0.1) |
Headache | 6 (0.7) |
Paraesthesia | 1 (0.1) |
Dizziness | 1 (0.1) |
Neuralgia | 1 (0.1) |
Somnolence | 2 (0.2) |
Eye disorders | 1 (0.1) |
Vision blurred | 1 (0.1) |