Safety Information

Safety Information

Prescribing Information [External link]

Please refer to the Summary of Product Characteristics for full prescribing information.

An established safety profile1

Over 220 million doses of Varivax (varicella virus vaccine (live)), distributed worldwide to date

Clinical studies
In healthy children aged 12 months to 12 years (N=5185) given 1 dose of VARIVAX, the most frequent adverse events reported in temporal association with vaccination were:1

FrequencyAdverse event(s)
Very common (≥1/10)● Fever
Common (≥1/100, <1/10)● Upper respiratory infection
● Rash
● Maculopapular rash
● Varicella-like rash (generalised median 5 lesions)
● Injection site erythema
● Pain/tenderness/soreness
● Swelling
● Varicella-like rash (injection site median 2 lesions)
● Irritability

In healthy children aged 12 months to 12 years given 2 doses of VARIVAX (≥3 months apart, N=1102), the rates of systemic clinical adverse events after a second dose were generally similar to, or lower than, those seen with the first dose. The rates of injection-site reactions (primarily erythema and swelling) were higher after a second dose.1

The following serious adverse events temporally associated with the vaccine were reported: diarrhoea, febrile seizure, fever, post-infectious arthritis and vomiting.1

Please refer to the Summary of Product Characteristics for further details on less frequent adverse events reported in people who received VARIVAX.

VARIVAX contraindications1

Special warnings and precautions for use1

Interaction with other medicinal products and other forms
of interaction1

Other injectable vaccines or other medicinal products must be given as separate injections and at different body sites.

Concomitant administration with other vaccines

VARIVAX has been administered to toddlers at the same time as, but at a different injection site from, a combined measles, mumps, and rubella vaccine, Haemophilus influenzae type b conjugate vaccine, hepatitis B vaccine, diphtheria/tetanus/whole-cell pertussis vaccine, and oral polio virus vaccine. There was no evidence of a clinically relevant difference in the immune responses to any of the antigens when co-administered with VARIVAX. If VARIVAX is not given concomitantly with measles, mumps, and rubella virus vaccine live, a 1-month interval between the 2 live virus vaccines should be observed. Concurrent administration of VARIVAX and tetravalent, pentavalent or hexavalent (diphtheria, tetanus, and acellular pertussis [DTaP])-based vaccines has not been evaluated. Vaccination should be deferred for at least 5 months following blood or plasma transfusions, or administration of normal human immune globulin or varicella zoster immune globulin (VZIG). Administration of varicella zoster virus antibody-containing blood products, including VZIG or other immune globulin preparations, within 1 month following a dose of VARIVAX may reduce the immune response to the vaccine and hence reduce its protective efficacy. Therefore, administration of any of these products should be avoided within 1 month after a dose of VARIVAX unless considered to be essential. Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with VARIVAX as Reye syndrome has been reported following use of salicylates during wild-type varicella infection.

Pregnancy and Lactation1


Pregnant women should not be vaccinated with VARIVAX. Studies have not been conducted with VARIVAX in pregnant women, and therefore it is not known whether VARIVAX can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. Pregnancy should be avoided for 1 month following vaccination. Women who intend to become pregnant should be advised to delay.


Due to the theoretical risk of transmission of the vaccine viral strain from mother to infant, VARIVAX is not generally recommended for breastfeeding mothers.

Study design

Galea SA, et al.3
A review describing the 10-year safety profile of VARIVAX using 16,683 spontaneous post-marketing AE reports submitted to MSD between 1 May 1995 and 30 April 2005, together with results from the Varicella Zoster Virus Identification Program (VZVIP). All reported AEs temporally related to the administration of VARIVAX were added to the Worldwide Adverse Experience System database without regard to the likelihood of a causal relationship and coded in the terminology used by the reporter. VZVIP used polymerase chain reaction analysis to distinguish the Oka VZV strain from the wild-type VZV strain circulating in the United States. Clinical specimens were collected from patients with >50 vesicular lesions occurring within 42 days of vaccination, breakthrough cases of varicella, herpes zoster, encephalitis, aseptic meningitis, cerebellar ataxia, pneumonitis, and suspected secondary transmission.


  1. VARIVAX Summary of Product Characteristics.
  2. MSD Data on File. VACC-1246225-0000.
  3. Galea SA, Sweet A, Beninger P, et al. The safety profile of varicella vaccine: a 10-year review. J Infect Dis. 2008;197:S165–S169.

Supporting documentation

Prescribing Information
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