Adacel

Adacel is a vaccine used for active booster immunization against tetanus (lockjaw), diphtheria and pertussis (whooping cough).

Adacel is given as a single shot in the upper arm. 

Common side effects of Adacel include pain, redness, and swelling at the injection site.

Adacel is a vaccine used for active booster immunization against tetanus (lockjaw), diphtheria and pertussis (whooping cough). Adacel vaccine is approved for use as a single dose in individuals 10 through 64 years of age.

The safety and effectiveness of Adacel vaccine in those who have not been previously vaccinated for diphtheria, tetanus, or pertussis or who have not completed the series has not been demonstrated.

If tetanus prevention is needed for wound management, Adacel may be given if no previous dose of any Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap) has been administered.

Adacel vaccine is given by a healthcare provider as a single 0.5 mL injection into the upper arm.

There are no data to support repeat administration of Adacel vaccine.

Five years should have elapsed since the recipient's last dose of tetanus toxoid, diphtheria toxoid and/or pertussis containing vaccine and the administration of Adacel vaccine.

• Allergic reactions. Tell your healthcare provider about any signs or symptoms of  allergic reactions, which include the following:
  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing or swallowing
  • rash
• Latex. The tip caps of the Adacel prefilled syringes may contain natural rubber latex, which may cause allergic reactions in latex sensitive individuals.
• 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 Adacel vaccine more frequently than every 10 years, even for tetanus prevention as part of wound management.
• Guillain-Barré Syndrome and Brachial Neuritis. There is a causal relationship between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. Guillain-Barré Syndrome is a condition in which the immune system attacks the nerves.  Brachial neuritis is a term used to describe an inflammation of a network of nerves that originate near the neck and shoulder (brachial plexus) that causes sudden-onset shoulder and arm pain, followed by weakness and/or numbness.
• Altered immunocompetence. If Adacel vaccine is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained.
• Progressive or unstable neurologic conditions. Progressive or unstable neurologic conditions (i.e. cerebrovascular events and acute encephalopathic conditions) are reasons to defer vaccination.
• Fainting. Fainting can occur in association with administration of Adacel. 

Do not get Adacel if you or your child:

• had a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine or any component of this vaccine.
• had encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis antigen-containing vaccine that is not attributable to another identifiable cause

Side effects reported with Adacel include:

• pain, redness, and swelling at the injection site
• fever
• headache
• body ache or muscle weakness
• tiredness
• chills
• nausea
• sore or swollen joints
• swollen lymph nodes
• diarrhea
• vomiting
• rash

Tell your healthcare provider if you have any new or unusual symptoms after you receive Adacel. For a complete list of side effects, ask your health care provider.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you use:

• immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids

This is not a complete list of Adacel drug interactions. Ask your doctor or pharmacist for more information. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Adacel falls into category C. No studies have been conducted in animals, and no well-controlled studies have been done in pregnant women. Adacel should only be given to a pregnant woman if clearly needed. 

Sanofi Pasteur Inc. maintains a surveillance registry to collect data on pregnancy outcomes and newborn health status outcomes following vaccination with Adacel vaccine during pregnancy. Women who receive Adacel vaccine during pregnancy are encouraged to contact directly or have their health-care professional contact Sanofi Pasteur Inc. at 1-800-822-2463 (1-800-VACCINE).

Tell your doctor is you are breastfeeding or plan to breastfeed. 

It is not known if Adacel crosses into human milk. Because some vaccines can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this vaccine, a choice should be made whether to stop nursing or stop the use of this vaccine. Your doctor and you will decide if the benefits outweigh the risk of using Adacel.