Pediarix is a brand-name intramuscular injection. It’s prescribed to help prevent certain infections in children. Pediarix belongs to the vaccine drug class.
Doctors recommend Pediarix to help prevent certain conditions in children ages 6 weeks through 6 years.
Specifically, Pediarix is FDA approved to help prevent:
- diphtheria, tetanus, and pertussis (DTaP)
- infection from the hepatitis B virus
- polio
Drug details
You’ll find key information about Pediarix below.
- Vaccine form: liquid suspension given as an intramuscular injection
- Generic or biosimilar available? no
- Prescription required? yes
- Controlled substance? no
- Year of FDA approval: 2002
Pediarix is available only as a brand-name vaccine. It’s a
Instead of generic forms, biologics have biosimilars. This is because biologics are not made from chemicals. They cannot be copied exactly as traditional drugs can.
Like generics, biosimilars are considered as safe and effective as the original brand-name form of a drug. Also like generics, biosimilars tend to cost less than the brand-name form.
The following information describes the Pediarix vaccine schedule that is commonly used or recommended. However, your child’s doctor will determine the best dosage and schedule to fit their needs.
Vaccine form and strength
Pediarix comes as a 0.5-milliliter (mL) injectable suspension in single-use syringes.
A healthcare professional will give the vaccine as an intramuscular injection. It’s typically given in your child’s thigh or upper arm. Your child may receive Pediarix injections at a doctor’s office or pharmacy.
Dosage for prevention of DTaP, hepatitis B, and polio
Doctors recommend Pediarix to help prevent certain conditions in children ages 6 weeks through 6 years. These include diphtheria, tetanus, and pertussis (DTaP); infection from the hepatitis B virus; and polio.
The usual dose of Pediarix is 0.5 mL per injection. It’s typically given as a series of three doses at ages 2 months, 4 months, and 6 months. However, the vaccine series can be started as early as age 6 weeks and given up until a child’s 7th birthday. Doses are usually given 6 to 8 weeks apart.
Your child’s doctor may adjust their Pediarix schedule if they have already received doses of other vaccines for these conditions. Talk with your child’s doctor to learn more.
About receiving Pediarix
Below you’ll find information about key dosage issues.
- When to receive: Pediarix is typically given as a series of three doses at ages 2 months, 4 months, and 6 months. Talk with your child’s doctor about getting the Pediarix vaccine. They can help you decide whether the vaccine is right for your child and recommend the best time for your child to receive it.
- If your child misses a dose: If your child misses a dose of the Pediarix vaccine, schedule an appointment for them to receive it as soon as possible. It’s important to complete the three-dose series so that the Pediarix vaccine will work effectively.
- Length of use: Pediarix is not used as a long-term treatment. Typically, only three doses are needed to protect against DTaP, hepatitis B, and polio. Your child’s doctor may recommend additional doses of DTaP and polio vaccines later, which will be given using different vaccines. Your child’s doctor can provide more details about their vaccination schedule.
Pediarix can cause mild or serious side effects. The following lists contain some of the key side effects that may occur after your child receives Pediarix. These lists do not include all possible side effects.
For more information about the possible side effects of Pediarix, talk with your child’s doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone by giving doctors and researchers more information about how the drug works in real life. If your child develops a side effect after receiving Pediarix and you want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.
Mild side effects
Below is a partial list of mild side effects of Pediarix. To learn about other mild side effects, talk with your child’s doctor or pharmacist or view Pediarix’s prescribing information.
Mild side effects of Pediarix can include:
- injection site reactions, such as pain, swelling, or changes in skin color around the injection site
- drowsiness
- fever
- fussiness or irritability
- loss of appetite
Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your child’s doctor or pharmacist.
Serious side effects
Serious side effects from Pediarix aren’t common, but they can occur. Call your child’s doctor right away if your child has serious side effects. Call 911 or your local emergency number if your child’s symptoms seem life threatening or you think they’re having a medical emergency.
Serious side effects of Pediarix may include fainting, which can occur with other symptoms such as:
- numbness or tingling
- stiffness or rapid movements of the arms or legs
- vision changes
ALLERGIC REACTIONFor some people, Pediarix can cause an allergic reaction. But it’s not clear whether this side effect occurred in the vaccine’s clinical trials.
In general, symptoms of allergic reaction can be mild or serious.
Ways to manage
For mild allergic reaction symptoms, such as a mild rash, call your child’s doctor right away. They may recommend treatments to help manage symptoms. They’ll also let you know whether your child should continue receiving doses of the vaccine.
For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If your child has had a serious allergic reaction to Pediarix, their doctor may recommend a different vaccine instead.
The Food and Drug Administration (FDA) approves vaccines such as Pediarix for certain uses.
Pediarix for prevention of DTaP, hepatitis B, and polio
Pediarix is FDA approved to help prevent certain condition: diphtheria, tetanus, and pertussis (DTaP); infection from the hepatitis B virus; and polio.
Pediarix may be given to children ages 6 weeks through 6 years. However, it’s approved only for children born to a person who has tested negative for the hepatitis B virus on a blood test.
Below are details about each of the conditions Pediarix protects against:
- Diphtheria is a bacterial infection that releases a toxin, which can damage the skin and respiratory system.
- Tetanus is a bacterial infection that releases a toxin, which can cause muscle stiffness and spasms.
- Pertussis (whooping cough) is a bacterial infection that causes severe coughing episodes and difficulty breathing.
- Hepatitis B is a viral infection that affects the liver.
- Polio is a viral infection that may cause flu-like symptoms but could lead to paralysis.
To learn more about these conditions, talk with your child’s doctor.
Pediarix is not known to interact with other medications, herbs, supplements, foods, or alcohol. The manufacturer did not list any interactions in the vaccine’s prescribing information.
However, this doesn’t mean that interactions won’t be recognized in the future. For example, new drugs could be approved that interact with Pediarix.
Your child can safely receive other vaccines during the same visit when receiving Pediarix. The healthcare professional giving the vaccines will use a different injection site for each one.
Before your child receives Pediarix, talk with their doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs your child takes. Also, tell them about any vitamins, herbs, and supplements your child takes. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect your child, talk with their doctor or pharmacist.
As with all medications, the cost of Pediarix can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.
Drug coupons: You can visit Optum Perks for price estimates of Pediarix. These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with any insurance copays or benefits.
Financial and insurance assistance: If you need financial support to pay for Pediarix or need help understanding your insurance coverage, help is available.
Learn more about saving money on prescriptions.
Generic version: Pediarix is not available in a
Other vaccines are available that can prevent the same conditions as Pediarix. However, they may not protect against all five conditions in a single vaccine. The five conditions are diphtheria, tetanus, and pertussis (DTaP); infection from the hepatitis B virus; and polio.
Some vaccines may be a better fit for your child than others. If you’re interested in finding an alternative to Pediarix, talk with your child’s doctor. They can tell you about other vaccines that may work well.
Vaccines that protect against some of the same conditions as Pediarix include:
- Kinrix and Quadracel, which protect against DTaP and polio
- Infanrix, which protects against DTaP
- Recombivax HB and Engerix-B, which protect against hepatitis B infection
Pediarix is approved to help prevent certain infections in children ages 6 weeks through 6 years. The vaccine is not typically prescribed for people who can become pregnant or breastfeed.
Before your child receives Pediarix, discuss their health history with their doctor. Pediarix may not be right for your child if they have certain medical conditions or other factors affecting their health.
Be sure to talk with your child’s doctor if they’ve had a previous allergic reaction to this or a similar vaccine.
Note: For more information about the potential negative effects of Pediarix, see the “Pediarix side effects” section.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
