Lidocaine medicated plaster (n=732) | Oral medication (n=732) | ||
Overall | 70 (9.6) | Overall | 451 (61.6) |
Skin and subcutaneous tissue disorders | 52 (7.1) | Nervous system disorders | 201 (27.5) |
Application site erythema | 13 (1.8) | Dizziness | 49 (6.7) |
Administration site pruritus | 8 (1.1) | Headache | 44 (6.0) |
Skin irritation | 7 (1.0) | Tremor | 38 (5.2) |
Eczema | 7 (1.0) | Psychiatric disorders | 172 (23.5) |
Rash pruritic | 6 (0.8) | Somnolence | 108 (14.8) |
Application site eczema | 3 (0.4) | Sleep disorder | 29 (4.0) |
Rash erythematous | 3 (0.4) | Gastrointestinal disorders | 130 (17.8) |
Erythema | 3 (0.4) | Dry mouth | 37 (5.1) |
Pruritus | 1 (0.1) | Nausea | 35 (4.8) |
Application site dermatitis | 1 (0.1) | Constipation | 29 (4.0) |
Immune system disorders | 14 (1.9) | General disorders and administration site conditions | 46 (6.3) |
Urticarial dermatitis | 7 (1.0) | Hyperhidrosis | 30 (4.1) |
Dermatitis allergic | 7 (1.0) | ||
Injury, poisoning and procedural complications | 4 (0.5) | ||
Application site urticaria | 4 (0.5) |
Data are number of patients (%).
For the lidocaine medicated plaster, all events are listed; for OM, the most common events are shown (preferred terms ≥4% of patients in the listed system organ classes).
OM, oral medication.