Nebenwirkungen · Adcirca (previously Tadalafil Lilly)
ADCIRCA 2 mg/mL oral suspension · Abschnitt 4.8 · PDF-Seite 28
HOS-210165 · Präparat HOS-154449
Post-marketing study in paediatric patients (H6D-JE-TD01) Safety data were collected during an observational post-marketing study in Japan including 391 paediatric PAH patients (2 years maximum observational period). The mean age of patients in the study was 5.7 ± 5.3 years, including 79 patients aged < 1year, 41 aged1 to < 2years, 122 aged 2 to 6 years, 110 aged 7 to 14 years, and 39 aged 15 to 17 years. AEs were reported in 123 patients (31.5 %). The incidences of AEs (≥ 5 patients) were pulmonary hypertension (3.6 %); headache (2.8 %); heart failure and decreased platelet count (2.0 % each); epistaxis and upper respiratory tract infection (1.8 % each); bronchitis, diarrhoea, and abnormal hepatic function (1.5 % each); and gastroenteritis, protein losing gastroenteropathy, and increased aspartate aminotransferase (1.3 % each). The incidence of SAEs was 12.0 % (≥ 3 patients), including pulmonary hypertension (3.6 %), heart failure (1.5 %), and pneumonia (0.8 %). Sixteen deaths (4.1 %) were reported; none were related to tadalafil.
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Version 2026-01-27T15:17:00Z · SHA-256 f45503711a580d9fd5973be63b2c67b7830a1e53d77892c603581b2f6ee084ab · Passage 2af972fddc63da10dbe647704f851391eccef039d05dd3be5e6c822cae3d89a2 · Zeichen 9433–10480 im Abschnitt