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Pediarix Warnings and Precautions

To help minimize the risks, warnings and precautions for Pediarix should be reviewed before vaccination occurs. Pediarix (a combination of DTaP, hepatitis B vaccine, and inactivated polio vaccine) is more likely to cause a fever compared to the three vaccines given separately. The combination vaccine may also rarely cause febrile seizures in young children.

Pediarix: What Should I Tell My Healthcare Provider?

You should talk to a healthcare provider before your child receives Pediarix® (DTaP, hepatitis B vaccine, and inactivated polio vaccine) if your child has:
  • An immune-suppressing condition such as HIV or AIDS, diabetes, or cancer
  • A bleeding disorder
  • Had any sort of a reaction to any vaccine in the past
  • A moderate or severe illness
  • A brain or nervous system disorder
  • Any allergies, including allergies to foods, dyes, or preservatives.
Make sure to tell the healthcare provider about any medications your child is taking, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Specific Pediarix Warnings and Precautions

Warnings and precautions to be aware of prior to getting this vaccine include the following:
  • Studies suggest that Pediarix (a combination of DTaP, hepatitis B vaccine, and inactivated polio vaccine) is more likely to cause a fever compared to these three vaccines given separately (at the same time but not in the same injection).
  • Care must be taken when giving any intramuscular injection (including Pediarix) to individuals with bleeding disorders or who are taking anticoagulant medications ("blood thinners"). In some cases, your child's healthcare provider may decide that the risk of the injection is not worth the benefit (see Pediarix Drug Interactions).
  • Febrile seizures (seizures associated with high fevers in young children) have been rarely associated with vaccines, including Pediarix. If your child has a tendency to get febrile seizures, ask your healthcare provider if you should give an anti-fever medication such as acetaminophen (Tylenol®) or ibuprofen (Advil®, Motrin®) to help avoid febrile seizures.
  • Your child can receive Pediarix if he or she has a mild illness (such as the common cold). However, it is usually best to postpone the vaccine in the case of a moderate or severe illness.


  • The currently available Pediarix vaccine is slightly different from the previous version. This new reformulated version now contains no thimerosal (a mercury-containing preservative) or other preservatives. Parents who are concerned about exposing their children to thimerosal can be confident that this vaccine has no thimerosal (not even trace amounts).
  • Some parents are concerned about aluminum content of vaccines; Pediarix contains no more than 0.85 mg of aluminum per dose. This vaccine is not made from human fetal components or animal components, as some vaccines are. However, it is made from bovine (cow) and monkey components. 


  • Make sure your healthcare provider knows if your child has ever had any serious reactions to any vaccines in the past.
  • If you have an immune-suppressing condition, Pediarix may not be as effective as usual.
  • Pediarix comes in vials or prefilled syringes. The vials do not contain latex. There are two different types of prefilled syringes; one definitely contains latex, and the other might contain latex. If your child has a severe latex allergy, it is probably best for your healthcare provider to use Pediarix from a vial, not a prefilled syringe. 


  • Pediarix is considered a pregnancy Category C medication. This means it is unknown if it is safe for use during pregnancy. However, this is a childhood vaccine and should not be given to pregnant women.
  • At this time, it is unknown if Pediarix passes through breast milk. However, this is a childhood vaccine and should not be given to breastfeeding women.
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Pediarix Vaccine Information

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