Adverse events (69 events in 56 patients)
| Event | Number of patients |
|---|---|
| Reported infections (n = 20) | |
| Bronchitis, prolonged | 2 |
| Infection, prolonged or with fever | 5 |
| Herpes simplex labialis | 2 |
| Varicella zoster virus infection | 1 |
| Zoster | 1 |
| Multiple mollusca contagiosa | 1 |
| Stomatitis | 1 |
| Rotavirus enteritis | 1 |
| Septic arthritis following joint puncture | 1 |
| Urinary tract infection | 1 |
| Impetigo contagiosa | 2 |
| Cellulitis | 1 |
| Pneumonia | 1 |
| Non-infectious reports (n = 49) | |
| Local skin reaction | 7 |
| Eczema | 1 |
| Raised liver enzymes | 7 |
| Itching, exanthemata, urticaria | 6 |
| Allergic conjunctivitis | 1 |
| Scarring skin lesions | 1 |
| Nausea, vomiting | 2 |
| Leucocytopenia +/− thrombocytopenia | 4 |
| Abdominal pain and/or headache | 6 |
| Dizziness | 2 |
| Sleeplessness | 1 |
| Hair loss | 4 |
| Toxic epidermal necrolysis (contraceptiva) | 1 |
| Oesophagitis | 1 |
| Cholecystitis (sterile) | 1 |
| Carcinoma of the thyroid | 1 |
| Febrile seizure (during rotavirus enteritis) | 1 |
| Demyelination, seizures | 1 |
| Lymph node enlargement | 1 |