Fluarix Tetra Adverse Reactions

Adverse reactions reported for Fluarix Tetra are listed according to the following frequency categories: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000).
Clinical trial data: Adults: A study with Fluarix Tetra in adults has evaluated the incidence of adverse reactions in subjects ≥18 years who received one dose of Fluarix Tetra (N=3,036) or Fluarix (N=1,010).
The following adverse reactions per dose have been reported: (See Table 4.)

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Children aged 6 months to <18 years: Two clinical studies evaluated the reactogenicity and safety of Fluarix Tetra in children who received at least one dose of Fluarix Tetra or a control vaccine.
One study enrolled children 3 to <18 years of age who received Fluarix Tetra (N=915) or Fluarix (N=912). The second study enrolled children 6 to <36 months of age who received Fluarix Tetra (N=6,006) or a non-influenza vaccine control (N=6,012) (see Pharmacology: Pharmacodynamics under Actions).
The following adverse reactions per dose have been reported: (See Table 5.)

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Post-marketing data: The following adverse reactions have been observed for Fluarix and/or Fluarix Tetra during post-marketing surveillance.¹ (See Table 6).

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