Initial U.S. Approval: 2005
Adacel is a vaccine indicated for active booster immunization against tetanus, diphtheria and pertussis. Adacel is approved for use in persons 10 through 64 years of age.
Serious Adverse Events
SAEs were reported in 1.5% of Adacel recipients… one severe migraine with unilateral facial paralysis…
Postmarketing Experience
– Anaphylactic reaction, hypersensitivity reaction (angioedema, edema, rash, hypotension)
– Paresthesia, hypoesthesia, Guillain-Barré syndrome, brachial neuritis, facial palsy, convulsion, syncope, myelitis
– Myocarditis
– Pruritus, urticaria
– Myositis, muscle spasm
– Large injection site reactions (>50 mm), extensive limb swelling from the injection site beyond one or both joints, injection site bruising, sterile abscess, Arthus hypersensitivity
Each 0.5 mL dose contains… 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant…
Adacel has not been evaluated for carcinogenic or mutagenic potential, or impairment of male fertility.