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- Clinician Information:
Tetanus Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Tetanus (tetanus toxoid) Booster Injection is a vaccine used to prevent tetanus. Common side effects of the tetanus booster include redness, warmth, swelling, hives, and rash near the injection site, fever, pain, and nausea.
The recommended dose of the tetanus booster is a 0.5 mL injection every 10 years. Immunosuppressive drugs like corticosteroids, antimetabolites, alkylating agents, cytotoxic drugs and radiation may interact with the tetanus booster. Tell your doctor all medications you use. Exercise caution if you get the tetanus booster and have had Guillain-Barre syndrome, have thrombocytopenia, or are prone to blood clots. If you are pregnant and have not received the tetanus booster it is recommended to receive the vaccine after the second trimester. You may receive the tetanus booster if you are breastfeeding.
Our Tetanus (tetanus toxoid) 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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Tetanus FDA Prescribing Information: Side Effects
BODY SYSTEM AS A WHOLE
Adverse reactions may be local and include redness, warmth, edema, induration with or without tenderness as well as urticaria, and rash. Malaise, transient fever, pain, hypotension, nausea and arthralgia may develop in some patients after the injection. Arthus-type hypersensitivity reactions, characterized by severe local reactions (generally starting 2 to 8 hours after an injection) may occur, particularly in persons who have received multiple prior boosters.2 On rare occasions, anaphylaxis has been reported following administration of products containing tetanus (tetanus toxoid) toxoid. Upon review, a report by the Institute of Medicine (IOM) concluded the evidence established a causal relationship between tetanus toxoid (tetanus (tetanus toxoid) toxoid) and anaphylaxis.17 Deaths have been reported in temporal association with the administration of tetanus toxoid (tetanus (tetanus toxoid) toxoid) -containing vaccines.
The following neurologic illnesses have been reported as temporally associated with vaccines containing tetanus toxoid (tetanus (tetanus toxoid) toxoid) : neurological complications 18,19 including cochlear lesion, 20 brachial plexus neuropathies, 20,21 paralysis of the radial nerve, 22 paralysis of the recurrent nerve, 20 accommodation paresis, Guillain-Barré syndrome, and EEG disturbances with encephalopathy. The IOM, following review of the reports of neurologic events following vaccination with tetanus toxoid (tetanus (tetanus toxoid) toxoid) , DT or Td, concluded the evidence favored acceptance of a causal relationship between tetanus toxoid (tetanus (tetanus toxoid) toxoid) and brachial neuritis and GBS.17,23
Reporting of Adverse Events
The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine Injury Act of 1986, requires physicians and other health-care providers who administer vaccines to maintain permanent vaccination records and to report occurrences of certain adverse events to the US Department of Health and Human Services.11-13 Reportable events include those listed in the Act for each vaccine and events such as anaphylaxis or anaphylactic shock within 7 days, brachial neuritis within 28 days; any acute complication or sequela (including death) of an illness, 5 disability, injury, or condition referred to above, or any events that would contraindicate further doses of vaccine, according to this Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) for Booster Use Only package insert.
Adverse events following immunization with vaccine should be reported by health-care providers to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967.11-13
Health-care providers also should report these events to the Pharmacovigilance Department, Aventis Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463.
Read the entire FDA prescribing information for Tetanus (Tetanus Toxoid) »
Additional Tetanus Information
- Tetanus Drug Interactions Center: tetanus toxoid fluid inj
- Tetanus Side Effects Center
- Tetanus FDA Approved Prescribing Information including Dosage
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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