Menactra
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Menactra
Menactra Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Menactra (polysaccharide diphtheria toxoid conjugate vaccine) is used to prevent infection caused by meningococcal bacteria. The vaccine contains four of the most common types of meningococcal bacteria. It is an immunization that causes the body to produce its own protection (antibodies) against the bacteria. Common side effects include pain/redness/swelling at the injection site, headache, tiredness, joint pain, loss of appetite, chills, fever, and diarrhea.
Menactra vaccine should be administered as a single 0.5 mL dose injection by the intramuscular route, preferably in the deltoid region. Menactra may interact with blood thinners, 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 other vaccines you have recently received. During pregnancy, Menactra vaccine should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding. Our Menactra (polysaccharide diphtheria toxoid conjugate vaccine) 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.
Menactra in Detail - Patient Information: Side Effects
Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shot caused any side effects. Your child should not receive a booster vaccine if he or she had a life threatening allergic reaction after the first shot.
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.
You may feel faint after receiving this vaccine. Some people have had seizure-like reactions after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection.
Call your doctor at once if you have a serious side effect such as:
- severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine);
- high fever; or
- unusual bleeding.
Less serious side effects may include:
- low fever;
- redness, pain, swelling, or a lump where the vaccine was injected;
- headache, tired feeling;
- joint or muscle pain;
- diarrhea;
- nausea, vomiting, loss of appetite; or
- fussiness, irritability, crying for an hour or longer.
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 Menactra (Polysaccharide Diphtheria Toxoid Conjugate Vaccine) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Menactra Overview - Patient Information: Side Effects
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 immediately if any of these rare but serious side effects occur: numbness/tingling of arms/legs, muscle weakness.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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 Menactra (Polysaccharide Diphtheria Toxoid Conjugate Vaccine)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Menactra FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The safety of Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine was evaluated in 8 clinical studies that enrolled 10,057 participants aged 2-55 years who received Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine and 5266 participants who received Menomune-A/C/Y/W-135 vaccine. There were no substantive differences in demographic characteristics between the vaccine groups. Among Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine recipients of all ages, 24.0%, 16.2%, 40.4% and 19.4% were in the 2-10 year age range, 11-14, 15-25 and 26-55-year age groups, respectively. Among Menomune-A/C/Y/W-135 vaccine recipients of all ages, 42.3%, 9.3%, 30.0% and 18.5% were in the 2-10 year age range, 11-14, 15-25 and 26-55-year age groups, respectively.
The three primary safety studies were randomized, active-controlled trials that enrolled participants 2-10 years of age (Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine, N=1713; Menomune-A/C/Y/W-135 vaccine, N=1519), 11-18 years of age (Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine, N=2270; Menomune-A/C/Y/W-135 vaccine, N=972) and 18-55 years of age (Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine, N=1384; Menomune-A/C/Y/W-135 vaccine, N=1170), respectively. Of the 3232 children 2-10 years old, 68% of participants (Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine, n=1164; Menomune-A/C/Y/W-135 vaccine, n=1031) were enrolled at US sites, and 32% of participants at a Chilean site. The median ages in the Chilean and US subpopulations were 5 and 6 years old, respectively. All adolescents and adults were enrolled at US sites. As the route of administration differed for the two vaccines (Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine given intramuscularly, Menomune-A/C/Y/W-135 vaccine given subcutaneously), study personnel collecting the safety data differed from personnel administering the vaccine. Solicited local and systemic reactions were monitored daily for 7 days post- vaccination using a diary card. Participants were monitored for 28 days for unsolicited adverse events and for 6 months post-vaccination for visits to an emergency room, unexpected visits to an office physician, and serious adverse events. Unsolicited adverse event information was obtained either by telephone interview or at an interim clinic visit. Information regarding adverse events that occurred in the 6-month post-vaccination time period was obtained via a scripted telephone interview. At least 94% of participants from the three primary studies completed the 6-month follow-up evaluation.
In the two concomitant vaccination studies with Menactra (polysaccharide diphtheria toxoid conjugate vaccine) and either Typhim Vi or Td vaccines, local and systemic adverse events were monitored for 7 days post-vaccination using a diary card. Serious adverse events occurring within 1 month after each vaccination were reported and recorded.
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
Serious adverse events reported within a 6-month time period following vaccination in children 2-10 years old occurred at a rate of 0.6% following Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine and at a rate of 0.7% following Menomune-A/C/Y/W-135 vaccine. Serious adverse events reported within a 6-month time period following vaccination in adolescents and adults occurred at a rate of 1.0% following Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine and at a rate of 1.3% following Menomune-A/C/Y/W-135 vaccine.
Solicited Adverse Events in the Primary Safety Studies
The most frequently reported solicited local and systemic adverse reactions in US children aged 2-10 years (Table 7) were injection site pain and irritability. Diarrhea, drowsiness, and anorexia were also common.
The most commonly reported solicited local and systemic adverse reactions in adolescents, ages 11-18 years (Table 8), and adults, ages 18-55 years (Table 9), were injection site pain, headache and fatigue. Except for redness in adults, local reactions were more frequently reported after Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccination than after Menomune-A/C/Y/W-135 vaccination. The majority of local and systemic reactions following Menactra (polysaccharide diphtheria toxoid conjugate vaccine) or Menomune-A/C/Y/W-135 vaccination were reported as mild in intensity. Between the vaccine groups, differences in rates of malaise, diarrhea, anorexia, vomiting, or rash, including urticaria were not statistically significant.
Table 7: Percentage of US Participants 2-10 Years of Age Reporting Solicited Adverse ReactionsWithin 7 Days Following Vaccine Administration
| Menactra vaccine *N=1157 |
Menomune - A/C/Y/W-135 vaccine *N=1027 |
|||||
| Reaction | Any | Moderate | Severe | Any | Moderate | Severe |
| Redness | 21.8 | 4.6 | 3.9 | 7.9 | 0.5 | 0.0 |
| Swelling | 17.4 | 3.9 | 1.9 | 2.8 | 0.3 | 0.0 |
| Induration | 18.9 | 3.4 | 1.4 | 4.2 | 0.6 | 0.0 |
| Pain? | 45.0 | 4.9 | 0.3 | 26.1 | 2.5 | 0.0 |
| Drowsiness | 10.8 | 2.7 | 0.3 | 11.2 | 2.5 | 0.5 |
| Irritability|| | 12.4 | 3.0 | 0.3 | 12.2 | 2.6 | 0.6 |
| Arthralgia¶ | 6.8 | 0.5 | 0.2 | 5.3 | 0.7 | 0.0 |
| Diarrhea# | 11.1 | 2.1 | 0.2 | 11.8 | 2.5 | 0.3 |
| Anorexia** | 8.2 | 1.7 | 0.4 | 8.7 | 1.3 | 0.8 |
| Fever?? | 5.2 | 1.7 | 0.3 | 5.2 | 1.7 | 0.2 |
| Vomiting?? | 3.0 | 0.7 | 0.3 | 2.7 | 0.7 | 0.6 |
| Rash§§ | 3.4 | 3.0 | ||||
| Seizure§§ | 0.0 | 0.0 | ||||
| * N = The total number of subjects reporting
at least one solicited reaction. The median age of participants was 6
years in both vaccine groups. ? Moderate: 1.0-2.0 inches, Severe: > 2.0 inches. ‡ Moderate: interferes with normal activities, Severe: disabling, unwilling to move arm. § Moderate: interferes with normal activities, Severe: disabling, unwilling to engage in play or interact with others. || Moderate: 1-3 hours duration, Severe: > 3 hours duration. ¶ Moderate: Decreased range of motion due to pain or discomfort, Severe: unable to move major joints due to pain. # Moderate: 3-4 episodes, Severe: ≥ 5 episodes .** Moderate: Skipped 2 meals, Severe: skipped =3 meals. †† Oral equivalent temperature; Moderate: 38.4-39.4ºC, Severe: =39.5ºC. ‡‡ Moderate: 2 episodes, Severe: =3 episodes. §§ These solicited adverse events were reported as present or absent only. |
||||||
Table 8: Percentage of Participants 11-18 Years of Age Reporting Solicited Adverse Reactions Within 7 Days Following Vaccine Administration
| Menactra vaccine N*=2264 |
Menomune - A/C/Y/W-135 vaccine N*=970 |
|||||
| Reaction | Any | Moderate | Severe | Any | Moderate | Severe |
| Redness? | 10.9? | 1.6? | 0.6? | 5.7 | 0.4 | 0.0 |
| Swelling? | 10.8? | 1.9? | 0.5? | 3.6 | 0.3 | 0.0 |
| Induration? | 15.7? | 2.5? | 0.3 | 5.2 | 0.5 | 0.0 |
| Pain§ | 59.2? | 12.8? | 0.3 | 28.7 | 2.6 | 0.0 |
| Headache|| | 35.6? | 9.6? | 1.1 | 29.3 | 6.5 | 0.4 |
| Fatigue|| | 30.0? | 7.5 | 1.1? | 25.1 | 6.2 | 0.2 |
| Malaise|| | 21.9? | 5.8? | 1.1 | 16.8 | 3.4 | 0.4 |
| Arthralgia|| | 17.4? | 3.6? | 0.4 | 10.2 | 2.1 | 0.1 |
| Diarrhea¶ | 12.0 | 1.6 | 0.3 | 10.2 | 1.3 | 0.0 |
| Anorexia# | 10.7? | 2.0 | 0.3 | 7.7 | 1.1 | 0.2 |
| Chills|| | 7.0? | 1.7? | 0.2 | 3.5 | 0.4 | 0.1 |
| Fever** | 5.1? | 0.6 | 0.0 | 3.0 | 0.3 | 0.1 |
| Vomiting?? | 1.9 | 0.4 | 0.3 | 1.4 | 0.5 | 0.3 |
| Rash?? | 1.6 | 1.4 | ||||
| Seizure?? | 0.0 | 0.0 | ||||
| * N = The number of subjects with available
data. ? Denotes p < 0.05 level of significance. The p values were calculated for each category and severity using Chi Square test. ? Moderate: 1.0-2.0 inches, Severe: > 2.0 inches. § Moderate: Interferes with or limits usual arm movement, Severe: Disabling, unable to move arm. || Moderate: Interferes with normal activities, Severe: Requiring bed rest. ¶ Moderate: 3-4 episodes, Severe: ≥ 5 episodes. # Moderate: Skipped 2 meals, Severe: Skipped ≥ 3 meals. ** Oral equivalent temperature; Moderate: 38.5-39.4ºC, Severe: ≥ 39.5ºC. ?? Moderate: 2 episodes, Severe: ≥ 3 episodes. ?? These solicited adverse events were reported as present or absent only. |
||||||
Table 9: Percentage of Participants 18-55 Years of Age Reporting Solicited Adverse Reactions Within 7 Days Following Vaccine Administration
| Menactra vaccine N*=1371 | Menomune - A/C/Y/W-135 vaccine N*=1159 | |||||
| Reaction | Any | Moderate | Severe | Any | Moderate | Severe |
| Redness? | 14.4 | 2.9 | 1.1? | 16.0 | 1.9 | 0.1 |
| Swelling? | 12.6? | 2.3? | 0.9? | 7.6 | 0.7 | 0.0 |
| Induration? | 17.1? | 3.4? | 0.7? | 11.0 | 1.0 | 0.0 |
| Pain§ | 53.9? | 11.3? | 0.2 | 48.1 | 3.3 | 0.1 |
| Headache|| | 41.4 | 10.1 | 1.2 | 41.8 | 8.9 | 0.9 |
| Fatigue|| | 34.7 | 8.3 | 0.9 | 32.3 | 6.6 | 0.4 |
| Malaise|| | 23.6 | 6.6? | 1.1 | 22.3 | 4.7 | 0.9 |
| Arthralgia|| | 19.8? | 4.7? | 0.3 | 16.0 | 2.6 | 0.1 |
| Diarrhea¶ | 16.0 | 2.6 | 0.4 | 14.0 | 2.9 | 0.3 |
| Anorexia# | 11.8 | 2.3 | 0.4 | 9.9 | 1.6 | 0.4 |
| Chills|| | 9.7? | 2.1? | 0.6? | 5.6 | 1.0 | 0.0 |
| Fever** | 1.5? | 0.3 | 0.0 | 0.5 | 0.1 | 0.0 |
| Vomiting?? | 2.3 | 0.4 | 0.2 | 1.5 | 0.2 | 0.4 |
| Rash?? | 1.4 | 0.8 | ||||
| Seizure?? | 0.0 | 0.0 | ||||
| * N = The number of subjects with available data. † Denotes . <0.05 level of significance. The p values were calculated for each category and severity using Chi Square test. ‡ Moderate: 1.0-2.0 inches, Severe: >2.0 inches. § Moderate: Interferes with or limits usual arm movement, Severe: Disabling, unable to move arm. || Moderate: Interferes with normal activities, Severe: Requiring bed rest. ¶ Moderate: 3-4 episodes, Severe: =5 episodes. # Moderate, Skipped 2 meals, Severe: Skipped =3 meals. ** Oral equivalent temperature; Moderate: 39.0-39.9ºC, Severe: = 40.0ºC. †† Moderate: 2 episodes, Severe: =3 episodes. ‡‡ These solicited adverse events were reported as present or absent only. |
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Adverse Events in Concomitant Vaccine Studies
Local and Systemic Reactions when Given with Td Vaccine
See Concomitant Vaccine Administration section for a description of the study design and number of participants. The two vaccine groups reported similar frequencies of pain, induration, redness and swelling at the Menactra (polysaccharide diphtheria toxoid conjugate vaccine) injection site, as well as, at the Td injection site. Pain was the most frequent local reaction reported at both the Menactra (polysaccharide diphtheria toxoid conjugate vaccine) and Td injection sites. More participants experienced pain after Td vaccination than after Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccination (71% versus 53%). The majority (66%-77%) of local solicited reactions for both groups at either injection site were reported as mild and resolved within 3 days post-vaccination.
The overall rate of systemic adverse events was higher when Menactra (polysaccharide diphtheria toxoid conjugate vaccine) and Td vaccines were given concomitantly than when Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine was administered 28 days after Td. In both groups, the most common reactions were headache (Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine + Td, 36%; Td + Placebo, 34%; Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine alone, 22%) and fatigue (Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine + Td, 32%; Td + Placebo, 29%; Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine alone, 17%). Between the groups, differences in rates of malaise, diarrhea, anorexia, vomiting, or rash were not statistically significant. Fever ≥ 40.0ºC occurred at ≤ 0.5% in all groups. No seizures occurred in either group.
Local and Systemic Reactions when Given with Typhim Vi Vaccine
See Concomitant Vaccine Administration section for a description of the study design and number of participants. The two vaccine groups reported similar frequencies of pain, induration, redness and swelling at the Menactra (polysaccharide diphtheria toxoid conjugate vaccine) injection site, as well as, at the Typhim Vi injection site. Pain was the most frequent local reaction reported at both the Menactra (polysaccharide diphtheria toxoid conjugate vaccine) and Typhim Vi injection sites. More participants experienced pain after Typhim Vi vaccination than after Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccination (76% versus 47%). The majority (70%-77%) of local solicited reactions for both groups at either injection site were reported as mild and resolved within 3 days post-vaccination. In both groups, the most common systemic reaction was headache (Menactra (polysaccharide diphtheria toxoid conjugate vaccine) + Typhim Vi vaccine, 41%; Typhim Vi vaccine + Placebo, 42%; Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine alone, 33%) and fatigue (Menactra (polysaccharide diphtheria toxoid conjugate vaccine) + Typhim Vi vaccine, 38%; Typhim Vi vaccine + Placebo, 35%; Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine alone, 27%). Between the groups, differences in rates of malaise, diarrhea, anorexia, or vomiting were not statistically significant. Fever ≥ 40.0ºC and seizures were not reported in either group.
Post-Marketing Reports
The following adverse events have been reported during post-approval use of Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine. Because these events were reported voluntarily from a population of uncertain size, it is not always possible to reliably calculate their frequency or to establish a causal relationship to Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine exposure.
Nervous system disorders - Guillain-Barre syndrome, vasovagal syncope, facial palsy, transverse myelitis, acute disseminated encephalomyelitis Skin and subcutaneous tissue disorders - Urticaria Musculoskeletal and connective tissue disorders - Myalgia
Reporting of Adverse Events
Vaccine Adverse Event Reporting System (VAERS) was established by the US Department of Health and Human Services to accept all reports of suspected adverse events after the administration of any vaccine. 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 through http://vaers.hhs.gov.18 Reporting to VAERS of all adverse events after vaccination by parents, guardians or adult patients should be encouraged.
Health-care providers should also report these events to Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1- 800-822-2463.
Read the entire FDA prescribing information for Menactra (Polysaccharide Diphtheria Toxoid Conjugate Vaccine) »
Additional Menactra Information
Menactra - User Reviews
Menactra User Reviews
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