April 30, 2017
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Included as part of the PRECAUTIONS section.


Guillain-Barré Syndrome

If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including KINRIX, should be based on careful consideration of the potential benefits and possible risks. When a decision is made to withhold tetanus toxoid, other available vaccines should be given, as indicated.


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 KINRIX. 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 pertussis-containing vaccine, the decision to give any pertussis-containing vaccine, including KINRIX, 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.

When a decision is made to withhold pertussis vaccination, other available vaccines should be given, as indicated.

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 pertussis-containing vaccine, including KINRIX, and for the ensuing 24 hours to reduce the possibility of post-vaccination fever.

Preventing And Managing Allergic Vaccine Reactions

Prior to administration, the healthcare provider should review the patient's 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

KINRIX 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 KINRIX. It is also not known whether KINRIX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Pediatric Use

Safety and effectiveness of KINRIX in children younger than 4 years of age and children 7 to 16 years of age have not been evaluated. KINRIX is not approved for use in persons in these age groups.

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

Last reviewed on RxList: 10/19/2015


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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