May 24, 2016
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Varivax

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Varivax




Varivax Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 9/18/2015

Varivax (varicella virus vaccine live) is a live vaccine used to help prevent varicella virus infection (commonly known as chickenpox). Chickenpox is a common childhood illness, but can cause more serious illnesses in people who have not yet had either chickenpox or this vaccine. Common side effects of Varivax include pain/redness/bruising/swelling at the injection site, fever, mild chickenpox-like skin rash, runny or stuffy nose, cough, sore throat, headache, tired feeling, sleep problems (insomnia), joint or muscle pain, nausea, vomiting, stomach pain, or diarrhea.

Children 12 months to 12 years of age should receive a 0.5-mL dose of Varivax administered subcutaneously. Adolescents and adults 13 years of age and older should receive a 0.5-mL dose administered subcutaneously at an elected date and a second 0.5-mL dose 4 to 8 weeks later. Varivax may interact with aspirin or other salicylates, drugs or treatments that can weaken the immune system, including: oral, nasal, inhaled, or injectable steroid medicine, 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, and all other vaccines you recently received. Varivax must not be used during pregnancy. There is some risk it may harm a fetus. If you have been vaccinated with varicella virus vaccine, you should not become pregnant for at least 3 months after the vaccination. It is unknown if the varicella virus in this vaccine passes into breast milk. Consult your doctor before breastfeeding.

Our Varivax (varicella virus vaccine live) 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.

Varivax 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. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with chickenpox is much more dangerous to your health than receiving the vaccine to protect against it. 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:

  • cough, tight feeling in your chest, breathing problems;
  • seizure (black-out or convulsions);
  • easy bruising or bleeding, unusual weakness;
  • behavior changes; or
  • high fever (within a few hours or a few weeks after the vaccine).

Less serious side effects include:

  • redness, pain, or swelling where the shot was given;
  • low fever;
  • mild skin rash;
  • runny or stuffy nose, cough, sore throat;
  • headache, tired feeling;
  • sleep problems (insomnia);
  • joint or muscle pain; or
  • nausea, vomiting, stomach pain, diarrhea.

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 Varivax (Varicella Virus Vaccine Live)

What is Patient Information Overview?

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

Varivax Overview - Patient Information: Side Effects

SIDE EFFECTS: Pain/redness/bruising/swelling at the injection site, fever, or mild chickenpox-like rash may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your health care professional 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.

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 the 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 call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018.

Read the entire patient information overview for Varivax (Varicella Virus Vaccine Live)

What is Prescribing information?

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

Varivax FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 clinical practice. Vaccine-related adverse reactions reported during clinical trials were assessed by the study investigators to be possibly, probably, or definitely vaccine-related and are summarized below.

In clinical trials2-9, VARIVAX was administered to over 11,000 healthy children, adolescents, and adults.

In a double-blind, placebo-controlled study among 914 healthy children and adolescents who were serologically confirmed to be susceptible to varicella, the only adverse reactions that occurred at a significantly (p < 0.05) greater rate in vaccine recipients than in placebo recipients were pain and redness at the injection site2.

Children 1 to 12 Years of Age

One-Dose Regimen in Children

In clinical trials involving healthy children monitored for up to 42 days after a single dose of VARIVAX, the frequency of fever, injection-site complaints, or rashes were reported as shown in Table 1:

Table 1: Fever, Local Reactions, and Rashes (%) in Children 1 to 12 Years of Age 0 to 42 Days After Receipt of a Single Dose of VARIVAX

Reaction N % Experiencing Reaction Peak Occurrence During Post vaccination Days
Fever ≥ 102.0°F (38.9°C) Oral 8827 14.7% 0 to 42
Injection-site complaints (pain/soreness, swelling and/or erythema, rash, pruritus, hematoma, induration, stiffness) 8916 19.3% 0 to 2
Varicella-like rash (injection site) 8916 3.4% 8 to 19
  Median number of lesions   2  
Varicella-like rash (generalized) 8916 3.8% 5 to 26
  Median number of lesions   5  

In addition, adverse events occurring at a rate of ≥ 1% are listed in decreasing order of frequency: upper respiratory illness, cough, irritability/nervousness, fatigue, disturbed sleep, diarrhea, loss of appetite, vomiting, otitis, diaper rash/contact rash, headache, teething, malaise, abdominal pain, other rash, nausea, eye complaints, chills, lymphadenopathy, myalgia, lower respiratory illness, allergic reactions (including allergic rash, hives), stiff neck, heat rash/prickly heat, arthralgia, eczema/dry skin/dermatitis, constipation, itching.

Pneumonitis has been reported rarely ( < 1%) in children vaccinated with VARIVAX.

Febrile seizures have occurred at a rate of < 0.1% in children vaccinated with VARIVAX.

Two-Dose Regimen in Children

Nine hundred eighty-one (981) subjects in a clinical trial received 2 doses of VARIVAX 3 months apart and were actively followed for 42 days after each dose. The 2-dose regimen of varicella vaccine had a safety profile comparable to that of the 1-dose regimen. The overall incidence of injection-site clinical complaints (primarily erythema and swelling) observed in the first 4 days following vaccination was 25.4% Postdose 2 and 21.7% Postdose 1, whereas the overall incidence of systemic clinical complaints in the 42-day follow-up period was lower Postdose 2 (66.3%) than Postdose 1 (85.8%).

Adolescents (13 Years of Age and Older) and Adults

In clinical trials involving healthy adolescents and adults, the majority of whom received two doses of VARIVAX and were monitored for up to 42 days after any dose, the frequencies of fever, injection-site complaints, or rashes are shown in Table 2.

Table 2: Fever, Local Reactions, and Rashes (%) in Adolescents and Adults 0 to 42 Days After Receipt of VARIVAX

Reaction N % Post Dose 1 Peak Occurrence in Post vaccination Days N % Post Dose 2 Peak Occurrence in Post vaccination Days
Fever ≥ 100.0°F (37.8°C) Oral 1584 10.2% 14 to 27 956 9.5% 0 to 42
Injection-site complaints (soreness, erythema, swelling, rash, pruritus, pyrexia, hematoma, induration, numbness) 1606 24.4% 0 to 2 955 32.5% 0 to 2
Varicella-like rash (injection site) 1606 3% 6 to 20 955 1% 0 to 6
  Median number of lesions   2     2  
Varicella-like rash (generalized) 1606 5.5% 7 to 21 955 0.9% 0 to 23
  Median number of lesions   5     5.5  

In addition, adverse events reported at a rate of ≥ 1% are listed in decreasing order of frequency: upper respiratory illness, headache, fatigue, cough, myalgia, disturbed sleep, nausea, malaise, diarrhea, stiff neck, irritability/nervousness, lymphadenopathy, chills, eye complaints, abdominal pain, loss of appetite, arthralgia, otitis, itching, vomiting, other rashes, constipation, lower respiratory illness, allergic reactions (including allergic rash, hives), contact rash, cold/canker sore.

Post-Marketing Experience

Broad use of VARIVAX could reveal adverse events not observed in clinical trials.

The following additional adverse events, regardless of causality, have been reported during post-marketing use of VARIVAX:

Body as a Whole

Anaphylaxis (including anaphylactic shock) and related phenomena such as angioneurotic edema, facial edema, and peripheral edema.

Eye Disorders

Necrotizing retinitis (in immunocompromised individuals).

Hemic and Lymphatic System

Aplastic anemia; thrombocytopenia (including idiopathic thrombocytopenic purpura (ITP)).

Infections and Infestations

Varicella (vaccine strain).

Nervous/Psychiatric

Encephalitis; cerebrovascular accident; transverse myelitis; Guillain-Barré syndrome; Bell's palsy; ataxia; non-febrile seizures; aseptic meningitis; dizziness; paresthesia.

Respiratory

Pharyngitis; pneumonia/pneumonitis.

Skin

Stevens-Johnson syndrome; erythema multiforme; Henoch-Schönlein purpura; secondary bacterial infections of skin and soft tissue, including impetigo and cellulitis; herpes zoster.

Read the entire FDA prescribing information for Varivax (Varicella Virus Vaccine Live)

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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