Posaconazole Dr. Reddy's Adverse Reactions

Safety data mainly derive from data with the oral suspension.
The tablet formulation was investigated in AML and MDS patients and those after HSCT with or at risk for Graft versus Host Disease (GvHD) only. Maximum duration of exposure to the tablet formulation was shorter than with the oral suspension. Plasma exposure resulting from the tablet formulation was higher than observed with the oral suspension. A higher incidence of adverse reactions cannot be ruled out.
Summary of the safety profile: Posaconazole tablet and oral suspension safety: The most frequently reported serious related adverse reactions included nausea, vomiting, diarrhoea, pyrexia, and increased bilirubin. The safety profile of tablets was similar to that of the oral suspension.
Tabulated list of adverse reactions: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common; common; uncommon; rare; very rare; not known. (See table.)

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Description of selected adverse reactions: Hepatobiliary disorders: During post-marketing surveillance of posaconazole oral suspension, severe hepatic injury with fatal outcome has been reported (see Precautions).