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Decavac

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Decavac

Decavac

Decavac Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Decavac (tetanus and diphtheria toxoids adsorbed) vaccine (also called Td) is used to help prevent tetanus (lockjaw) and diphtheria in adults and children who are at least 7 years old. It is an immunization. This medication is available in generic form. Common side effects include pain/redness/warmth/bruising/swelling at the injection site, tiredness, fever, or headache.

Decavac vaccine may be used in persons 7 years of age and older who have not been immunized previously against tetanus and diphtheria, as a primary immunization series of three 0.5 mL doses. The first two doses are administered 4-8 weeks apart and the third dose is administered 6-12 months after the second dose. Decavac may interact with steroids, medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, or medicines to treat or prevent organ transplant rejection. Tell your doctor all medications and supplements you use, and all other vaccines you have recently received. During pregnancy, Decavac should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Decavac (tetanus and diphtheria toxoids adsorbed) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Decavac in Detail - Patient Information: Side Effects

You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot.

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

Becoming infected with tetanus or diphtheria is much more dangerous to your 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 you have 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 you have any of these serious side effects:

  • extreme drowsiness, fainting;
  • severe headache or vomiting;
  • confusion, seizure (black-out or convulsions); or
  • high fever.

Less serious side effects include:

  • redness, pain, tenderness, swelling, or a hard lump where the shot was given;
  • mild fever;
  • joint pain, body aches;
  • mild drowsiness; or
  • mild vomiting.

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.

Read the entire detailed patient monograph for Decavac (Tetanus and Diphtheria Toxoids Adsorbed) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Decavac FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates.

In a clinical study involving 58 individuals 6-58 years of age, 19% of the individuals noted local reactions consisting of erythema, tenderness and induration at the injection site and 2% systemic reactions consisting of headache, malaise and temperature elevations.5

Data from Post-Marketing Experience

The following adverse events have been spontaneously reported during the post-marketing use of Td manufactured by Sanofi Pasteur Inc. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccination. The following adverse events were included based on severity, frequency of reporting or the strength of causal association to DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine.

Blood and lymphatic system disorders

Lymphadenopathy.

Immune system disorders

Allergic reactions (such as rash, urticaria, pruritus, and face edema), including anaphylactoid reactions.

Nervous system disorders

Headache, paresthesia, dizziness, syncope, and convulsions.

Gastrointestinal disorders

Nausea, vomiting.

Musculoskeletal, connective tissue and bone disorders

Myalgia, arthralgia, pain in extremities, musculoskeletal stiffness.

General disorders and administration site conditions

Injection site reactions (including swelling, redness, warmth, induration, cellulitis, and nodules).

Pyrexia, chills, pain, malaise, asthenia, fatigue, edema peripheral.

Reporting of Adverse Events

The National Childhood Vaccine Injury Act of 1986 requires physicians and other health-care providers who administer vaccines to maintain permanent vaccination records of the manufacturer and lot number of the vaccine administered in the vaccine recipient's permanent medical record, along with the date of administration of the vaccine, and the name, address, and title of the person administering the vaccine.8 The Act further requires the health-care professional to report to the US Department of Health and Human Services the occurrence of certain adverse events following vaccination.8 For Td, events required to be reported are anaphylaxis or anaphylactic shock within 7 days; brachial neuritis within 28 days; any acute complication or sequelae (including death) of the above events; or any events that would contraindicate further doses of vaccine according to the manufacturer's package insert.9 These events and other suspected adverse reactions should be reported to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov. Health-care providers should also report adverse events following DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine to Sanofi Pasteur Inc. at 1-800-822-2463.

Read the entire FDA prescribing information for Decavac (Tetanus and Diphtheria Toxoids Adsorbed) »

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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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