May 24, 2017
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"By Brenda Goodman, MA

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Included as part of the PRECAUTIONS section.



In clinical trials, administration of PEDIARIX in infants was associated with higher rates of fever, relative to separately administered vaccines [see ADVERSE REACTIONS].

Guillain-Barre Syndrome

If Guillain-Barre syndrome occurs within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give PEDIARIX or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.


The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.


Syncope (fainting) can occur in association with administration of injectable vaccines, including PEDIARIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

Adverse Events Following Prior Pertussis Vaccination

If any of the following events occur in temporal relation to receipt of a vaccine containing a pertussis component, the decision to give any pertussis-containing vaccine, including PEDIARIX, should be based on careful consideration of the potential benefits and possible risks:

  • Temperature of ≥ 40.5°C (105°F) within 48 hours not due to another identifiable cause;
  • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours;
  • Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours;
  • Seizures with or without fever occurring within 3 days.

Children At Risk For Seizures

For children at higher risk for seizures than the general population, an appropriate antipyretic may be administered at the time of vaccination with a vaccine containing a pertussis component, including PEDIARIX, and for the ensuing 24 hours to reduce the possibility of post-vaccination fever.

Apnea In Premature Infants

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including PEDIARIX, to infants born prematurely should be based on consideration of the individual infant's medical status, and the potential benefits and possible risks of vaccination.

Preventing And Managing Allergic Vaccine Reactions

Prior to administration, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

PEDIARIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Use In Specific Populations


Pregnancy Category C

Animal reproduction studies have not been conducted with PEDIARIX. It is not known whether PEDIARIX can cause fetal harm when administered to a pregnant woman or if PEDIARIX can affect reproduction capacity.

Pediatric Use

Safety and effectiveness of PEDIARIX were established in the age group 6 weeks through 6 months on the basis of clinical studies [see ADVERSE REACTION and Clinical Studies]. Safety and effectiveness of PEDIARIX in the age group 7 months through 6 years are supported by evidence in infants 6 weeks through 6 months of age. Safety and effectiveness of PEDIARIX in infants younger than 6 weeks of age and children 7 to 16 years of age have not been evaluated.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 11/13/2015


Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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