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Important Safety Information

Adacel vaccine (Tdapa) provides a safety profile similar to Tdb vaccine

  • Serious adverse events were uncommon and comparable in number to Td vaccine19
  • Injection site pain and fever were common and more frequent in adolescents receiving Tdap compared with Td19

Indication

Adacel vaccine is indicated for active booster immunization for the prevention of tetanus, diphtheria, and pertussis as a single dose in persons 11 through 64 years of age.

Safety Information

The most common local and systemic adverse reactions to Adacel vaccine include injection site pain, erythema, and swelling; headache, body ache, tiredness, and fever. Other adverse reactions may occur. A severe allergic reaction after a previous dose of Adacel vaccine or any other tetanus toxoid, diphtheria toxoid or pertussis containing vaccine, or to any component, or encephalopathy within 7 days of a previous dose of a pertussis containing vaccine, is a contraindication.

The decision to give Adacel vaccine should be based on the potential benefits and risks; especially if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid; if progressive or unstable neurologic disorders exist; or if adverse events have occurred in temporal relation to receipt of pertussis-containing vaccine. Persons who experienced Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid-containing vaccine should not receive Adacel vaccine less than 10 years since the last dose of tetanus toxoid-containing vaccine. The tip caps of the prefilled syringes may contain natural rubber latex, which may cause allergic reactions in latex sensitive individuals. Vaccination with Adacel vaccine may not protect all individuals. Tdap vaccines are classified as Pregnancy Category C. Adacel vaccine is not indicated for use in pregnant women.

Before administering Adacel vaccine, please see accompanying full Prescribing Information.

Adacel vaccine is manufactured by Sanofi Pasteur Limited and distributed by Sanofi Pasteur Inc.

a Tdap = Tetanus, diphtheria, and acellular pertussis.
b Td = Tetanus and diphtheria.