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Medications and Drugs

Brand Names: Pediarix

Generic Name: diphtheria, hepatitis B, pertussis (acellular), polio, and tetanus vaccine (Pronunciation: dif THEER ee a, hep a TYE tis B, per TUS iss, POE lee oh, and TET a nus)

What is diphtheria, hepatitis B, pertussis acellular, polio, and tetanus vaccine (Pediarix)?

Diphtheria, pertussis, and tetanus are serious diseases caused by bacteria.

Diphtheria causes a thick coating in the nose, throat, and airways. It can lead to breathing problems, paralysis, heart failure, or death.

Pertussis (whooping cough) causes coughing so severe that it interferes with eating, drinking, or breathing. These spells can last for weeks and can lead to pneumonia, seizures (convulsions), brain damage, and death.

Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open the mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

Hepatitis B and polio are serious diseases caused by virus.

Hepatitis B is a disease of the liver that is spread through blood or bodily fluids, sexual contact or sharing IV drug needles with an infected person, or during childbirth when the mother is infected. Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

Polio affects the central nervous system and spinal cord. It can cause muscle weakness and paralysis. Polio is a life-threatening condition because it can paralyze the muscles that help you breathe.

Diphtheria, hepatitis B, pertussis, and polio are spread from person to person. Tetanus enters the body through a cut or wound.

The diphtheria, hepatitis B, pertussis acellular, polio, and tetanus vaccine is used to help prevent these diseases in children who are ages 6 weeks to 6 years old, before the child has reached his or her 7th birthday.

This vaccine works by exposing your child to a small dose of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Like any vaccine, the diphtheria, hepatitis B, pertussis acellular, polio, and tetanus vaccine may not provide protection from disease in every person.

What are the possible side effects of this vaccine (Pediarix)?

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with diphtheria, hepatitis B, pertussis, polio, or tetanus is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if the child has any of these serious side effects:

  • extreme drowsiness, fainting;
  • fussiness, irritability, crying for an hour or longer;
  • seizure (black-out or convulsions); or
  • high fever (can occur for up to 4 days after the vaccine).

Less serious side effects include:

  • redness, pain, tenderness, or swelling where the shot was given;
  • mild fever;
  • mild fussiness or crying;
  • joint pain, body aches;
  • loss of appetite; or
  • nausea, vomiting, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What is the most important information I should know about this vaccine (Pediarix)?

The diphtheria, hepatitis B, pertussis, polio, and tetanus vaccine is given in a series of shots. The first shot is usually given when the child is 2 months old. The booster shots are then given at 4 months and 6 months of age. Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with diphtheria, hepatitis B, pertussis, polio, or tetanus is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.



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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