May 29, 2017
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Included as part of the PRECAUTIONS section.


Management Of Acute Allergic Reactions

Epinephrine injection (1:1000) and other appropriate agents and equipment must be immediately available should an acute anaphylactic reaction occur.


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

Frequency Of Administration

More frequent administration of DECAVAC vaccine than described in Dosage and Administration [see DOSAGE AND ADMINISTRATION] may be associated with increased incidence and severity of adverse reactions.

Arthus Reactions

Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus-toxoid containing vaccine usually have high serum tetanus antitoxin levels and should not receive DECAVAC vaccine more frequently than every 10 years, even for tetanus prophylaxis as part of wound management [see DOSAGE AND ADMINISTRATION].

GuiNain-Barre Syndrome And Brachial Neuritis

A review by the Institute of Medicine 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 after receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain- Barre syndrome may be increased following DECAVAC vaccine.

Limitations Of Vaccine Effectiveness

Vaccination with DECAVAC vaccine may not protect all individuals.

Altered Immunocompetence

Immune responses to inactivated vaccines and toxoids when given to immunocompromised persons may be suboptimal. The immune response to DECAVAC vaccine administered to immunocompromised individuals (whether from disease or treatment) has not been studied.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No studies have been performed with DECAVAC vaccine to evaluate carcinogenicity, mutagenic potential, or impact on fertility.

Use In Specific Populations


Pregnancy Catergory C

Animal reproduction studies have not been conducted with DECAVAC vaccine. It is also not known whether DECAVAC vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DECAVAC vaccine should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether DECAVAC vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when DECAVAC vaccine is administered to a nursing woman.

Pediatric Use

DECAVAC vaccine is not approved for use in infants and children younger than 7 years of age. Safety and effectiveness of DECAVAC vaccine in this age group have not been established.

Geriatric Use

Clinical studies of DECAVAC vaccine did not include subjects aged 65 years and over to determine whether they respond differently than younger subjects.


3 Institute of Medicine (US). Stratton KR, et al, eds. Adverse events associated with childhood vaccines: evidence bearing on causality. Washington (DC): National Academy Press. 1994:67-117.

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

Last reviewed on RxList: 9/29/2014


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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