May 29, 2017
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"Vaccines are an important step in protecting adults against serious, sometimes deadly, diseases. Even if you were vaccinated at a younger age, the protection from some vaccines can wear off or the virus or bacteria that the vaccine protects again"...





Included as part of the PRECAUTIONS section.


Management of Acute Allergic Reactions

Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.

Adverse Reactions Following Prior Pertussis Vaccination

If any of the following events occur within the specified period after administration of a pertussis vaccine, the decision to administer Pentacel vaccine should be based on careful consideration of potential benefits and possible risks.

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

Guillain-Barre Syndrome And Brachial Neuritis

A review by the Institute of Medicine (IOM) found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barre syndrome.3 If Guillain-Barre syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barre syndrome may be increased following Pentacel vaccine.

Infants And Children With A History Of Previous Seizures

For infants or children with a history of previous seizures, an appropriate antipyretic may be administered (in the dosage recommended in its prescribing information) at the time of vaccination with a vaccine containing acellular pertussis antigens (including Pentacel vaccine) and for the following 24 hours, to reduce the possibility of post-vaccination fever.

Limitations Of Vaccine Effectiveness

Vaccination with Pentacel vaccine may not protect all individuals.

Altered Immunocompetence

If Pentacel vaccine is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained. [See DRUG INTERACTIONS.]

Apnea In Premature Infants

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


3. Stratton KR, et al. editors. Adverse events associated with childhood vaccines; evidence bearing on causality. Washington D.C.: National Academy Press. 1994. p. 67-117.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Pentacel vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.

Use In Specific Populations


Pregnancy Category C

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

Pediatric Use

The safety and effectiveness of Pentacel vaccine was established in the age group 6 weeks through 18 months on the basis of clinical studies. [See ADVERSE REACTIONS and Clinical Studies] The safety and effectiveness of Pentacel vaccine in the age group 19 months through 4 years is supported by evidence in children 6 weeks through 18 months. The safety and effectiveness of Pentacel vaccine in infants less than 6 weeks of age and in children 5 to 16 years of age have not been established.


5. Rothstein EP, et al. Comparison of antigenuria after immunization with three Haemophilus influenzae type b conjugate vaccines. Pediatr Infect Dis J 1991;10:311-4.

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

Last reviewed on RxList: 11/13/2015


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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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