Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 17 April 2017


• Adacel is a vaccine indicated for active booster immunization against tetanus, diphtheria and pertussis. Adacel is approved for use as a single
dose in persons 10 through 64 years of age. (1)

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Advisory information

• Severe allergic reaction (eg, anaphylaxis) to any component of Adacel or any other diphtheria toxoid, tetanus toxoid and pertussis antigencontaining vaccine. (4.1)
• Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous pertussis antigen-containing vaccine. (4.2)
Special warnings and precautions
• The tip caps of the Adacel prefilled syringes may contain natural rubber latex, which may cause allergic reactions in latex sensitive
individuals. (5.2, 17)
• If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré
syndrome may be increased following a subsequent dose of Adacel vaccine. (5.3)
• Progressive or unstable neurologic conditions are reasons to defer Adacel vaccination. (5.4)
• Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine should
not receive Adacel unless at least 10 years have elapsed since the last dose of a tetanus toxoid-containing vaccine. (5.5)
• Syncope (fainting) can occur in association with administration of injectable vaccines, including Adacel. Procedures should be in place to prevent falling injury and manage syncopal reactions. (5.7)
Adverse reactions
• The most common solicited injection site reactions occurring within 0-14 days following vaccination with Adacel were:
- For Adolescents 11-17 years of age: pain (77.8%), swelling (20.9%), erythema (20.8%).
- For Adults 18-64 years of age: pain (65.7%), swelling (21.0%), erythema (24.7%) (6.1).

• The most common solicited systemic reactions occurring within 0-14 days following vaccination with Adacel were:
- For Adolescents 11-17 years of age: headache (43.7%), body ache or muscle weakness (30.4%), tiredness (15.1%).
- For Adults 18-64 years of age: headache (33.9%), body ache or muscle weakness (21.9%) (6.1).

Usage information

Dosing and administration
• Single-dose vials and prefilled syringes containing a 0.5-mL suspension for injection. (3)
Use in special populations
• Safety and effectiveness of Adacel vaccine have not been established in pregnant women. (8.1)
• Pregnancy Surveillance Registry: contact Sanofi Pasteur Inc. at 1-800-822-2463 (1-800-VACCINE). (8.1)


• When Adacel vaccine was administered concomitantly with trivalent inactivated influenza vaccine (TIV) to adults 19-64 years of age, a lower antibody response was observed for pertactin antigen as compared to Adacel vaccine administered alone. (7.1, 14.3)
• Immunosuppressive therapies may reduce the immune response to Adacel. (7.2)
• Do not mix Adacel vaccine with any other vaccine in the same syringe or vial.

More information

Category Value
Authorisation number BLA125111
Orphan designation No
Product NDC 49281-400
Date First Approved 10-06-2005
Marketing authorisation holder Sanofi Pasteur Limited