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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