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Adacel

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Adacel

Adacel

Adacel Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) is a "booster" vaccine given to maintain protection (immunity) against diphtheria, tetanus (lockjaw), and pertussis (whooping cough) in children and adults aged 11 to 64 years who have been vaccinated for these diseases in the past. Common side effects include headache, tiredness, body aches, nausea, diarrhea, fever, chills, vomiting, pain/swelling/redness at the injection site, or sore/swollen joints.

Adacel vaccine should be administered as a single injection of one dose (0.5 mL) given intramuscularly (under the skin). Before receiving this vaccine, tell the doctor about all vaccines you have recently received. Adacel may interact with oral, nasal, inhaled, or injectable 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 you use. During pregnancy, Adacel should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine 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.

Adacel in Detail - Patient Information: Side Effects

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

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

Becoming infected with diphtheria, pertussis, or tetanus 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 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 within 7 days after receiving this vaccine:

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

Less serious side effects include:

  • mild fever or chills;
  • redness, pain, tenderness, or swelling where the shot was given;
  • headache or tiredness;
  • joint pain, body aches; or
  • mild nausea, diarrhea, or 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 Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Adacel Overview - Patient Information: Side Effects

SIDE EFFECTS: Pain, swelling, or redness at the injection site may occur. Headache, tiredness, body aches, nausea, diarrhea, fever, chills, vomiting, or sore/swollen joints may also occur. Acetaminophen or ibuprofen (non-aspirin) may be used to reduce soreness. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: high fever (higher than 104 degrees F/40 degrees C), numbness/tingling, muscle weakness, difficulty breathing.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed)»

What is Prescribing information?

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

Adacel FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The safety of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine was evaluated in 4 clinical studies. A total of 5,841 individuals 11-64 years of age inclusive (3,393 adolescents 11-17 years of age and 2,448 adults 18-64 years) received a single dose of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine.

The principal safety study was a randomized, observer-blind, active controlled trial that enrolled participants 11-17 years of age (Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine N = 1,184; Td vaccine N = 792) and 18-64 years of age (Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine N = 1,752; Td vaccine N = 573). Study participants had not received tetanus or diphtheria containing vaccines within the previous 5 years. Solicited local and systemic reactions and unsolicited adverse events were monitored daily for 14 days post-vaccination using a diary card. From days 14-28 post-vaccination, information on adverse events necessitating a medical contact, such as a telephone call, visit to an emergency room, physician's office or hospitalization, was obtained via telephone interview or at an interim clinic visit. From days 28 to 6 months post-vaccination, participants were monitored for unexpected visits to a physician's office or to an emergency room, onset of serious illness and hospitalizations. Information regarding adverse events that occurred in the 6 month post-vaccination time period was obtained from the participant via telephone. Approximately 96% of participants completed the 6-month follow-up evaluation.

In the concomitant vaccination study with Adacel and Hepatitis B vaccines (see Clinical Studies for description of study design and number of participants), local and systemic adverse events were monitored daily for 14 days post-vaccination using a diary card. Local adverse events were only monitored at site/arm of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine administration. Unsolicited reactions (including immediate reactions, serious adverse events and events that elicited seeking medical attention) were collected at a clinic visit or via telephone interview for the duration of the trial, i.e., up to six months post-vaccination.

In the concomitant vaccination study with Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine and trivalent inactivated influenza vaccine (see Clinical Studies for description of study design and number of participants), local and systemic adverse events were monitored for 14 days post-vaccination using a diary card. All unsolicited reactions occurring through day 14 were collected. From day 14 to the end of the trial, i.e., up to 84 days, only events that elicited seeking medical attention were collected.

In all the studies, participants were monitored for serious adverse events throughout the duration ofthe study.

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.

Serious Adverse Events in All Safety Studies

Throughout the 6-month follow-up period in the principal safety study, serious adverse events were reported in 1.5% of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine recipients and 1.4% in Td vaccine recipients. Two serious adverse events in adults were neuropathic events that occurred within 28 days of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine administration; one severe migraine with unilateral facial paralysis and one diagnosis of nerve compression in neck and left arm. Similar or lower rates of serious adverse events were reported in the other trials and there were no additional neuropathic events reported.

Solicited Adverse Events in the Principal Safety Study

The frequency of selected solicited adverse events (erythema, swelling, pain and fever) occurring during Days 0-14 following one dose of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine or Td vaccine are presented in Table 5. Most of these events were reported at a similar frequency in recipients of both Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine and Td vaccine. Few participants ( < 1%) sought medical attention for these reactions. Pain at the injection site was the most common adverse reaction occurring in 63 to 78% of all vaccinees. In addition, overall rates of pain were higher in adolescent recipients of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine compared to Td vaccine recipients. Rates of moderate and severe pain in adolescents did not significantly differ between the Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine and Td vaccine groups. Among adults the rates of pain, after receipt of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine or Td vaccine, did not significantly differ. Fever of 38°C and higher was uncommon, although in the adolescent age group, it occurred significantly more frequently in Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine recipients than Td vaccine recipients. (9)

Table 5: Frequencies of Solicited Injection Site Reactions and Fever for Adolescents and Adults, Days 0-14, Following a Single Dose of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) Vaccine or Td Vaccine

Adverse Event* Adolescents 11-17 years Adults 18-64years
Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed)
N = 1,170-1,175
(%)
Td
N = 783-787
(%)
Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed)
N =1,688-1,698
(%)
Td
N = 551-561
(%)
Injectiton
Site
Pain
Any 77.8§ 71.0 65.7 62.9
Moderate** 18.0 15.6 15.1 10.2
Severe 1.5 0.6 1.1 0.9
Any 20.9 18.3 21.0 17.3
Injection
Site
Swelling
Moderate**  
  1.0 to 3.4 cm 6.5 5.7 7.6 5.4
Severe  
   ≥ 3.5 cm 6.4 5.5 5.8 5.5
   ≥ 5 cm (2 inches) 2.8 3.6 3.2 2.7
Injection
Site
Erythema
Any 20.8 19.7 24.7 21.6
Moderate**  
  1.0 to 3.4 cm 5.9 4.6 8.0 8.4
Severe  
   ≥ 3.5 cm 6.0 5.3 6.2 4.8
   ≥ 5 cm (2 inches) 2.7 2.9 4.0 3.0
Fever ≥ 38.0°C
( ≥ 100.4°F)
5.0§ 2.7 1.4 1.1
≥ 38.8°C to =39.4°C
( ≥ 102.0°F to =103.0°F)
0.9 0.6 0.4 0.2
≥ 39.5°C
( ≥ 103.1°F)
0.2 0.1 0.0 0.2
*Sample size was designed to detect > 10% differences between Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) and Td vaccines for events of 'Any' intensity.
N = number of participants with available data.
Tetanus and Diphtheria Toxoids Adsorbed For Adult Use manufactured by Sanofi Pasteur Inc., Swiftwater, PA.
§Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine did not meet the non-inferiority criterion for rates of 'Any' Pain in adolescents compared to Td vaccine rates (upper limit of the 95% CI on the difference for Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine minus Td vaccine was 10.7% whereas the criterion was < 10%). For 'Any' Fever the non-inferiority criteria was met, however, 'Any' Fever was statistically higher in adolescents receiving Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine.
**Interfered with activities, but did not necessitate medical care or absenteeism.
Incapacitating, prevented the performance of usual activities, may have/or did necessitate medical care or absenteeism.

The frequency of other solicited adverse events (Days 0-14) are presented in Table 6. The rates of these events following Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine were comparable with those observed with Td vaccine. Headache was the most frequent systemic reaction and was usually of mild to moderate intensity.

Table 6: Frequencies of Other Solicited Adverse Events for Adolescents and Adults, Days 0-14, Following a Single Dose of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) Vaccine or Td Vaccine

Adverse Event Adolescents 11-17 years Adults 18-64 years
Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed)
N* =1,174-1,175
(%)
Td N* = 787
(%)
Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed)
N* =1,697-1,698
(%)
Td
N* = 560-561
(%)
Headache Any 43.7 40.4 33.9 34.1
Moderate 14.2 11.1 11.4 10.5
Severe§ 2.0 1.5 2.8 2.1
Body Ache or Muscle Weakness Any 30.4 29.9 21.9 18.8
Moderate 8.5 6.9 6.1 5.7
Severe§ 1.3 0.9 1.2 0.9
Tiredness Any 30.2 27.3 24.3 20.7
Moderate 9.8 7.5 6.9 6.1
Severe§ 1.2 1.0 1.3 0.5
Chills Any 15.1 12.6 8.1 6.6
Moderate 3.2 2.5 1.3 1.6
Severe§ 0.5 0.1 0.7 0.5
Sore and Swollen Joints Any 11.3 11.7 9.1 7.0
Moderate 2.6 2.5 2.5 2.1
Severe§ 0.3 0.1 0.5 0.5
Nausea Any 13.3 12.3 9.2 7.9
Moderate 3.2 3.2 2.5 1.8
Severe§ 1.0 0.6 0.8 0.5
Lymph Node Swelling Any 6.6 5.3 6.5 4.1
Moderate 1.0 0.5 1.2 0.5
Severe§ 0.1 0.0 0.1 0.0
Diarrhea Any 10.3 10.2 10.3 11.3
Moderate 1.9 2.0 2.2 2.7
Severe§ 0.3 0.0 0.5 0.5
Vomiting Any 4.6 2.8 3.0 1.8
Moderate 1.2 1.1 1.0 0.9
Severe§ 0.5 0.3 0.5 0.2
Rash Any 2.7 2.0 2.0 2.3
*N = number of participants with available data.
Tetanus and Diphtheria Toxoids Adsorbed For Adult Use manufactured by Sanofi Pasteur Inc., Swiftwater, PA.
Interfered with activities, but did not necessitate medical care or absenteeism.
§Incapacitating, prevented the performance of usual activities, may have/or did necessitate medical care or absenteeism.

Local and systemic solicited reactions occurred at similar rates in Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine and Td vaccine recipients in the 3 day post-vaccination period. Most local reactions occurred within the first 3 days after vaccination (with a mean duration of less than 3 days).

The rates of unsolicited adverse events reported from days 14-28 post-vaccination were comparable between the two groups, as were the rates of unsolicited adverse events from day 28 through 6 months.

There were no spontaneous reports of whole-arm swelling of the injected limb in this study, nor in the other three studies which contributed to the safety database for Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine.

Adverse Events in the Concomitant Vaccine Studies

Local and Systemic Reactions when Given with Hepatitis B Vaccine

The rates reported for fever and injection site pain (at the Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine administration site) were similar when Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) and Hep B vaccines were given concurrently or separately. However, the rates of injection site erythema (23.4% for concomitant vaccination and 21.4% for separate administration) and swelling (23.9% for concomitant vaccination and 17.9% for separate administration) at the Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine administration site were increased when co-administered. Swollen and/or sore joints were reported by 22.5% for concomitant vaccination and 17.9% for separate administration. The rates of generalized body aches in the individuals who reported swollen and/or sore joints were 86.7% for concomitant vaccination and 72.2% for separate administration. Most joint complaints were mild in intensity with a mean duration of 1.8 days. The incidence of other solicited and unsolicited adverse events were not different between the 2 study groups. (9)

Local and Systemic Reactions when Given with Trivalent Inactivated Influenza Vaccine

The rates of fever and injection site erythema and swelling were similar for recipients of concurrent and separate administration of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine and TIV. However, pain at the Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine injection site occurred at statistically higher rates following concurrent administration (66.6%) versus separate administration (60.8%). The rates of sore and/or swollen joints were 13% for concurrent administration and 9% for separate administration. Most joint complaints were mild in intensity with a mean duration of 2.0 days. The incidence of other solicited and unsolicited adverse events were similar between the 2 study groups. (9)

Additional Studies

An additional 1,806 adolescents received Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine as part of the lot consistency study used to support Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine licensure. This study was a randomized, double-blind, multi-center trial designed to assess lot consistency as measured by the safety and immunogenicity of 3 lots of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine when given as a booster dose to adolescents 11-17 years of age inclusive. Local and systemic adverse events were monitored for 14 days post-vaccination using a diary card. Unsolicited adverse events and serious adverse events were collected for 28 days post-vaccination. Pain was the most frequently reported local adverse event occurring in approximately 80% of all participants. Headache was the most frequently reported systemic event occurring in approximately 44% of all participants. Sore and/or swollen joints were reported by approximately 14% of participants. Most joint complaints were mild in intensity with a mean duration of 2.0 days. (9)

An additional 962 adolescents and adults received Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine in three supportive Canadian studies used as the basis for licensure in other countries. Within these clinical trials, the rates of local and systemic reactions following Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine were similar to those reported in the four principal trials in the US with the exception of a higher rate (86%) of adults experiencing 'any' local injection site pain. The rate of severe pain (0.8%), however, was comparable to the rates reported in four principal trials conducted in the US. (9) There was one spontaneous report of whole-arm swelling of the injected limb among the 277 Td vaccine recipients, and two spontaneous reports among the 962 Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine recipients in the supportive Canadian studies.

Postmarketing Reports

The following adverse events have been spontaneously reported during the post-marketing use of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine in the US and other countries. Because these events are reported voluntarily from a population of uncertain size, it is not 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 Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine.

General disorders and administration site conditions:

Large injection site reactions ( > 50 mm), extensive limb swelling from the injection site beyond one or both joints.
Injection site bruising, sterile abscess

Nervous system disorders:

Paraesthesia, hypoesthesia, Guillain-Barré syndrome, facial palsy, convulsion, syncope, myelitis

Immune system disorders:

Anaphylactic reaction, hypersensitivity reaction (angioedema, edema, rash, hypotension)

Skin and subcutaneous tissue disorders:

Pruritus, urticaria

Musculoskeletal and connective tissue disorders:

Myositis, muscle spasm

Cardiac disorders:

Myocarditis

Additional Adverse Events

Additional adverse events, included in this section, have been reported in conjunction with receipt of vaccines containing diphtheria, tetanus toxoids and/or pertussis antigens.

Arthus-type hypersensitivity reactions, characterized by severe local reactions (generally starting 2-8 hours after an injection), may follow receipt of tetanus toxoid. Such reactions may be associated with high levels of circulating antitoxin in persons who have had overly frequent injections of tetanus toxoid. (14) (See WARNINGS.)

Persistent nodules at the site of injection have been reported following the use ofadsorbed products. (12)

Certain neurological conditions have been reported in temporal association with some tetanus toxoid containing vaccines or tetanus and diphtheria toxoid containing vaccines. A review by the Institute of Medicine (IOM) concluded that the evidence favors acceptance of a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. Other neurological conditions that have been reported include: demyelinating diseases of the central nervous system, peripheral mononeuropathies, and cranial mononeuropathies. The IOM has concluded that the evidence is inadequate to accept or reject a causal relation between these conditions and vaccines containing tetanus and/or diphtheria toxoids.

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 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. The Act further requires the health-care professional to report to the US Department of Health and Human Services the occurrence following immunization of any event set forth in the Vaccine Injury Table. These include anaphylaxis or anaphylactic shock within 7 days; brachial neuritis within 28 days; an acute complication or sequelae (including death) of an illness, disability, injury, or condition referred to above, or any events that would contraindicate further doses of vaccine, according to this Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine package insert. (15) (16) (17)

The US Department of Health and Human Services has established the Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine. Reporting of all adverse events occurring after vaccine administration is encouraged from vaccine recipients, parents/guardians and the health-care provider. Adverse events following immunization should be reported to 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 or visit the VAERS website at www.vaers.hhs.gov. (15) (16) (17)

Health-care providers should also report these events to Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463 (1-800-VACCINE).

Read the entire FDA prescribing information for Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed) »

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Adacel - User Reviews

Adacel User Reviews

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