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Pirfenidone axunio (previously Pirfenidone AET) · 4.8 Undesirable effects · 1
Eintrag öffnenPirfenidone axunio (previously Pirfenidone AET) · 4.8 · 7 Table 1 Adverse reactions by SOC and MedDRA frequency Infections and infestations Very Common Upper respirat
Eintrag öffnenPirfenidone axunio (previously Pirfenidone AET) · 4.8 · 8 1 Identified through post-marketing surveillance (see section 4.4) 2 Cases of severe drug-induced liver inju
Eintrag öffnenPirfenidone axunio (previously Pirfenidone AET) · 4.8 · Decreased appetite During the pivotal clinical trials, cases of decreased appetite were readily manageable and
Eintrag öffnenPirfenidone axunio (previously Pirfenidone AET) · 4.8 · Description of selected adverse reactions
Eintrag öffnenPirfenidone axunio (previously Pirfenidone AET) · 4.8 · Exposure-adjusted analyses of pooled clinical trials in IPF confirmed that the safety and tolerability profile
Eintrag öffnenPirfenidone axunio (previously Pirfenidone AET) · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenPirfenidone axunio (previously Pirfenidone AET) · 4.8 · Summary of the safety profile The most frequently reported adverse reactions during clinical study experience
Eintrag öffnenPirfenidone axunio (previously Pirfenidone AET) · 4.8 · Table 1 shows the adverse reactions reported at a frequency of ≥2% in 623 patients receiving pirfenidone at th
Eintrag öffnenPirfenidone axunio (previously Pirfenidone AET) · 4.8 · Tabulated list of adverse reactions The safety of pirfenidone has been evaluated in clinical studies including
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