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Fluarix Tetra safety information

What you need to know before you or your child are given Fluarix Tetra:

Fluarix Tetra is suitable for use in adults and children from six months of age.

To make sure that Fluarix Tetra is suitable for you or your child, it is important to tell your doctor or pharmacist if any of the points below apply to you or your child. If there is anything you do not understand, ask your doctor or pharmacist to explain.

Do not use Fluarix Tetra if:

  • you or your child are allergic to the active substances or any of the other ingredients of this medicine (listed in section six of Fluarix Tetra patient information leaflet) or any components that may be present in very small amounts such as eggs (ovalbumin or chicken proteins), formaldehyde, gentamycin sulphate or sodium deoxycholate.
  • you or your child have an illness with a high temperature or acute infection, the vaccination should be postponed until after you or your child has recovered.

Warnings and precautions

Talk to your doctor or pharmacist before you or your child receive Fluarix Tetra:

  • if you or your child have a poor immune response (immunodeficiency or taking medicines affecting the immune system)
  • if, for any reason, you or your child have a blood test within a few days following a flu vaccination. This is because false positive blood test results have been observed in a few patients who had recently been vaccinated.
  • if you or your child have a bleeding problem or bruise easily.

Your doctor will decide if you or your child should receive the vaccine.

Fainting can occur (mostly in adolescents) following, or even before, any needle injection; therefore tell the doctor or nurse if you or your child fainted with a previous injection. 

As with all vaccines, Fluarix Tetra may not fully protect all persons who are vaccinated.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Your doctor/pharmacist will be able to decide if you should receive Fluarix Tetra. Ask your doctor or pharmacist for advice before taking any medicine.

Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

These are some of the side effects observed during clinical trials.

For the full list, please refer to the Fluarix Tetra Patient Information Leaflet (PIL).

If you have any further questions or concerns on the use of his product, please speak to your doctor, pharmacist or nurse.

Very Common (these may occur with more than 1 in 10 doses of the vaccine):

  • Injection-site reactions: pain
  • Fatigue
  • Muscular pain (myalgia)
  • Irritability

Common (these may occur with up to 1 in 10 doses of the vaccine):

  • Headache
  • Feeling sick, diarrhoea, vomiting, stomach pain
  • Joint pain (arthralgia)
  • Fever, shivering
  • Injection-site reactions: redness, swelling
  • Appetite loss
  • Drowsiness

Uncommon (these may occur with up to 1 in 100 doses of the vaccine):

  • Bruising (hematoma), itching (pruritus) around the area where the vaccine is injected
  • Dizziness
  • Rash

For further information on Fluarix Tetra, please refer to the information provided in the Fluarix Tetra Patient Information Leaflet (PIL) before vaccination:

Fluarix Tetra Patient Information Leaflet (PIL)

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at
By reporting side effects you can help provide more information on the safety of this medicine.

Fluarix Tetra is a registered trademark of the GlaxoSmithKline group of companies