Tenivac Side Effects Center

Last updated on RxList: 10/18/2021
Tenivac Side Effects Center

What Is Tenivac?

Tenivac (tetanus and diphtheria toxoids adsorbed) is a vaccine used for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older.

What Are Side Effects of Tenivac?

Common side effects of Tenivac include:

Dosage for Tenivac

In persons who have not been immunized previously against tetanus and diphtheria, primary immunization with Tenivac vaccine consists of three 0.5 mL doses. The first 2 doses are administered 2 months apart and the third dose is administered 6-8 months after the second dose.

What Drugs, Substances, or Supplements Interact with Tenivac?

Tenivac may interact with immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids. Tell your doctor all medications and supplements you use and all vaccines you recently received.

Tenivac During Pregnancy and Breastfeeding

During pregnancy, Tenivac should be administered only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Tenivac (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.

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Tenivac Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; dizziness, weakness; difficult breathing; swelling of your face, lips, tongue, or throat.

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

Keep track of all side effects you have. If you receive a booster dose, tell the vaccination provider if the previous shot caused any side effects.

Becoming infected with tetanus or diphtheria is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is low.

Call your doctor at once if you have:

  • severe pain, itching, swelling, or redness where the shot was given;
  • high fever (over 102 degrees F);
  • a light-headed feeling, like you might pass out;
  • severe joint pain; or
  • nervous system problems--numbness, pain, tingling, weakness, burning or prickly feeling, vision or hearing problems, trouble breathing.

Common side effects include:

  • redness, pain, swelling, or a lump where the shot was given;
  • joint pain, muscle weakness;
  • fever, chills, headache, not feeling well; or
  • nausea, vomiting, stomach pain.

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 Tenivac (Tetanus and Diphtheria Toxoids Adsorbed)

Tenivac Professional Information

SIDE EFFECTS

Clinical Trials Experience

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 of those events.

In a primary immunization study conducted in Canada, 18 participants, 8 of whom were 6 to 9 years of age and 10 of whom were 17 to 56 years of age, received three doses of TENIVAC. In four booster immunization studies conducted in either the US or Canada, TENIVAC was administered to 3,723 participants overall, ranging in age from 11 to 93 years.

In one of these studies, a US multi-center booster immunization study (TDC01), 2,250 adolescents and adults ages 11-59 years of age received TENIVAC in an open-label design and adults 60 years of age and over were randomized to receive either TENIVAC (N = 700) or DECAVAC (Td manufactured by Sanofi Pasteur Inc.) (N = 701). Vaccine assignment for participants ≥60 years of age was unblinded to pharmacists and vaccination nurses, but was blinded to other study personnel and participants. Among participants who received TENIVAC, overall, 80.4% were Caucasian, 3.3% Black, 5.1% Hispanic, 4.5% Asian and 6.6% other races. Among participants ≥60 years of age, the racial distribution was similar for the TENIVAC and DECAVAC groups. Among participants who received TENIVAC, the proportion of participants who were female varied by age group (44.4% of participants 11-18 years of age, 70.1% of participants 19-59 years of age and 62.4% of participants ≥60 years of age). Among participants ≥60 years of age who received DECAVAC, 57.6% were female. Nearly all (99.8%) enrolled participants and all participants in the per-protocol immunogenicity population had a reported or documented history of previous immunization against tetanus and diphtheria and, by report, had not received a vaccine containing tetanus or diphtheria toxoid within 5 years prior to enrollment.

In the US multi-center booster immunization study, solicited injection site reactions and systemic adverse events were monitored on diary cards for a subset of participants 11-59 years of age and for all participants ≥60 years of age. The incidence and severity of solicited injection site reactions and selected solicited systemic adverse events that occurred within 3 days following vaccination are shown in Table 2.

Table 2: Frequency and Severity of Selected Solicited Adverse Events Within 0-3 Days Following TENIVAC or DECAVAC in a US Study

TENIVAC DECAVAC
Adolescents 11 to 18 years
N = 491-492 %
Adults 19 to 59 years
N = 247 %
Adults ≥60 years
N = 688-695 %
Adults ≥60 years
N = 686-693 %
Injection Site Adverse Reactions
Pain
Any 80.1 74.9 35.3 29.4
Moderate* 15.0 18.2 2.9 2.3
Severe† 0.2 0.4 0.6 0.7
Redness
Any 25.6 15.8 18.1 18.0
≥35 mm to <50 mm 1.2 2.4 0.7 1.3
≥50 mm 0.4 0.4 2.3 1.9
Swelling
Any 15.0 17.0 12.1 13.0
≥35 mm to <50 mm 1.2 2.8 1.0 1.3
≥50 mm 1.8 2.8 1.7 1.3
Systemic Adverse Events
Fever
≥37.5°C 4.3 5.7 2.5 3.8
≥38.0°C to <39°C 0.8 1.6 0.6 0.9
≥39°C 0.0 0.0 0.1 0.1
Headache
Any 23.0 25.1 11.7 10.8
Moderate* 4.3 7.3 1.6 1.4
Severe† 0.6 0.8 0.0 0.3
Muscle Weakness
Any 32.3 17.4 4.9 5.9
Moderate* 7.3 3.2 1.3 1.0
Severe† 0.6 0.4 0.1 0.1
Malaise
Any 14.5 17.0 8.9 8.8
Moderate* 3.5 3.2 2.4 1.2
Severe† 0.8 0.4 0.1 0.4
Pain in Joints
Any 15.7 10.9 8.5 7.4
Moderate* 2.8 1.6 2.2 1.4
Severe† 0.6 0.4 0.1 0.0
*Moderate: interfered with activities, but did not require medical care or absenteeism.
†Severe: incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism.

In the US booster immunization study, among participants ≥60 years of age, 7 (1.0%) participants in the TENIVAC group and 10 (1.4%) participants in the DECAVAC group experienced a serious adverse event within 30 days following vaccination. During this period, 2 (0.3%) participants 19-59 years of age and no participants 11-18 years of age experienced a serious adverse event following TENIVAC. Serious adverse events within 30 days following TENIVAC included localized infection, asthma, colonic polyp, cellulitis, angina pectoris, hip and wrist fracture, cholecystitis, chest pain and cerebrovascular accident.

There were five deaths reported during the study. All of the reported deaths were in participants ≥60 years of age and occurred >30 days post-vaccination: three in the TENIVAC group (cardiopulmonary arrest; myocardial infarction and septic shock; and unknown cause) and two in the DECAVAC group (myocardial infarction and congestive heart failure; and liver cancer).

In the primary immunization study (N = 18) in which serious adverse events were monitored for 3 days following each vaccination and in three other booster immunization studies in which serious adverse events were monitored for either four days (N = 347) or one month (N = 426) following vaccination, no serious adverse events were reported.

Postmarketing Experience

The following adverse events have been spontaneously reported during the postmarketing use of TENIVAC. 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 vaccine exposure.

The following adverse events were included based on severity, frequency of reporting or the strength of causal association to TENIVAC:

Blood And Lymphatic System Disorders

Lymphadenopathy

Immune System Disorders

Allergic reactions (such as erythematous rash, maculopapular rash, urticaria and pruritus); anaphylactic reaction (bronchospasm and angioedema).

Nervous System Disorders

Paresthesia, dizziness, syncope

Guillain-Barre syndrome

Gastrointestinal Disorders

Vomiting

Musculoskeletal, Connective Tissue And Bone Disorders

Myalgia, pain in extremities

General Disorders And Administration Site Conditions

Injection site reactions (including inflammation, mass, edema, induration, warmth, pruritus, cellulitis, discomfort)

Fatigue, edema peripheral

DRUG INTERACTIONS

Concomitant Vaccine Administration

No safety and immunogenicity data are available on the concomitant administration of TENIVAC with other US licensed vaccines.

Tetanus Immune Globulin (Human)

If passive protection against tetanus is required, TIG (Human) may be administered according to its prescribing information, concomitantly with TENIVAC at a separate site with a separate needle and syringe. [See DOSAGE AND ADMINISTRATION]

Immunosuppressive Treatments

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to TENIVAC. [See WARNINGS AND PRECAUTIONS]

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

© Tenivac Patient Information is supplied by Cerner Multum, Inc. and Tenivac Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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