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Pediarix Side Effects

Generic name: diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid

Medically reviewed by Drugs.com. Last updated on Oct 5, 2023.

Note: This document contains side effect information about diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid. Some dosage forms listed on this page may not apply to the brand name Pediarix.

Applies to diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid: intramuscular suspension.

Serious side effects of Pediarix

Along with its needed effects, a vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. It is very important that you tell your doctor about any side effect that occurs after a dose of DTaP-HepB-IPV vaccine, even if the side effect goes away without treatment. Some types of side effects may mean that your child should not receive any more doses of DTaP-HepB-IPV vaccine.

Check with your doctor or nurse immediately if any of the following side effects occur while taking diphtheria toxoid/hepatitis b pediatric vaccine/pertussis, acellular/poliovirus vaccine, inactivated/tetanus toxoid:

Incidence not known

Other side effects of Pediarix

Some side effects of diphtheria toxoid/hepatitis b pediatric vaccine/pertussis, acellular/poliovirus vaccine, inactivated/tetanus toxoid may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Incidence not known

For Healthcare Professionals

Applies to diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid: intramuscular suspension.

Other

Very common (10% or more): Fever 39%

Rare (less than 0.1%): Death

In clinical trials 5 deaths occurred in 8088 vaccinees. Causes of death included 2 cases of sudden infant death syndrome (SIDS), 1 convulsive disorder, 1 congenital immunodeficiency with sepsis, and 1 neuroblastoma. One case of SIDS occurred in the comparator group.

Local

Very common (10% or more): Local redness (40%), local pain (36%), local swelling (29%)[Ref]

Nervous system

Very common (10% or more): Drowsiness (57%)

Uncommon (0.1% to 1%): Pyrexia[Ref]

Immunologic

Uncommon (0.1% to 1%): Culture-negative clinical sepsis[Ref]

Psychiatric

Very common (10% or more): Irritability/fussiness (65%)[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Gastroenteritis[Ref]

Metabolic

Very common (10% or more): Loss of appetite (31%)

More about Pediarix (diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid)

Patient resources

Professional resources

Related treatment guides

References

1. (2022) "Product Information. Pediarix (DTaP-HepB IPV) (diphtheria/hepB/pertussis,acel/polio/tetanus)." GlaxoSmithKline

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.