Nebenwirkungen · Adcirca (previously Tadalafil Lilly)
ADCIRCA 20 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10
HOS-210114 · Präparat HOS-154449
A total of 51 paediatric patients aged from 2.5 to 17 years with PAH were treated with tadalafil in clinical trials (H6D-MC-LVHV, H6D-MC-LVIG). A total of 391 paediatric patients with PAH, from new-born to < 18 years, were treated with tadalafil in an observational post-marketing study (H6D-JE- TD01). Following tadalafil administration, the frequency, type and severity of adverse reactions in children and adolescents were similar to that seen for adults. Due to differences in study design, sample size, gender, age range, and doses, safety findings from these trials are detailed separately below.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-01-27T15:17:00Z · SHA-256 f45503711a580d9fd5973be63b2c67b7830a1e53d77892c603581b2f6ee084ab · Passage 02e1387588529f7827d8e2bdf5c67508f8932ce962e892e42ea098b1c9779e6a · Zeichen 7056–7658 im Abschnitt