Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety profile of XOFLUZA is based on data from 2 placebo-controlled trials, in which a total of 910 subjects received XOFLUZA: 834 (92%) were adults (18 years and older) and 76 (8%) were adolescents (12 to less than 18 years). Of these, 710 subjects received XOFLUZA at the recommended dose. In Trial 1, adult subjects 20 to 64 years of age received a single oral dose of XOFLUZA or placebo. In Trial 2, adult subjects 20 to 64 years of age received XOFLUZA, placebo as a single oral dose on Day 1, or oseltamivir twice a day for 5 days, and adolescent subjects 12 to less than 20 years of age received XOFLUZA or placebo as a single oral dose.
Table 6 displays the most common adverse events (regardless of causality assessment) reported in at least 1% of adult and adolescent subjects who received XOFLUZA at the recommended dose in Trials 1 and 2. (See Table 6.)
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Postmarketing Experience: The following adverse reactions have been identified during postmarketing use of XOFLUZA. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to XOFLUZA exposure.
Body as a Whole: Swelling of the face, eyelids or tongue, dysphonia, angioedema, anaphylactic reactions, anaphylactic shock, anaphylactoid reactions.
Skin and Subcutaneous Tissue Disorders: Rash, urticaria, erythema multiforme.
Gastrointestinal disorders: Vomiting, bloody diarrhea, melena, colitis.
Psychiatric: Delirium, abnormal behavior, and hallucinations.