Concerns about safety have focused on formaldehyde in part because high concentrations of formaldehyde can damage DNA (the building block of genes) and cause cancerous changes in cells in the laboratory. Although formaldehyde is diluted during the manufacturing process, residual quantities of formaldehyde may be found in several current vaccines (see table below). However, formaldehyde does not appear to be a cause of cancer in man. Further, animals exposed to large quantities of formaldehyde (a single dose of 25 mg/kg or chronic exposure at doses of 80-100 mg/kg/day) do not develop malignancies. (One kilogram [kg] is equal to 2.2 pounds.)
The average quantity of formaldehyde to which a young infant could be exposed at one time may be as high as 0.2 mg (see table below). This quantity of formaldehyde is considered to be safe for two reasons:
|Vaccine||Trade Name||Quantity (per dose)|
|Td (adult)/ DT||none||≤0.02 mg - 0.1 mg|
|DTaP-Hep B IPV||Pediarix||≤0.1 mg|
|hepatitis A||Havrix||≤0.05mg (pediatric)
≤0.1 mg (adult)
||0.004 mg (pediatric)
0.008 mg (adult)
|hepatitis A - hepatitis B||Twinrix||≤0.1 mg|
|Hib-hepatitis B||Comvax||< 0.0004 mg|
|JE-Vax||< 0.2 mg|
|Tdap||ADACEL||< 0.005 mg|
|Boostrix||< 0.1 mg|
|FluLaval||< 0.025 mg|
|Fluzone - intradermal||< 0.02 mg|
Epidemiology of chronic occupational exposure to formaldehyde: report of the Ad Hoc panel on health aspects of formaldehyde. Toxicol Ind. Health. 1988;4:77-90.
Goldmacher VS, Thilly WG. Formaldehyde is mutagenic for cultured human cells. Mutat. Res. 1983;116:417-422.
Heck H, Casanova-Schmitz M, Dodd PB, et al. Formaldehyde (CH2O) concentrations in the blood of humans and Fischer-344 rats exposed to CH2O under controlled conditions. Am Ind Hyg Assoc J. 1985;46:1-3.
Huennekens FM, Osborne MJ. Folic acid coenzymes and one-carbon metabolism. Adv Enzymol. 1959;21:369-446.
Natarajan AT, Darroudi F, Bussman CJM, van Kesteren-van Leeuwen AC. Evaluation of the mutagenicity of formaldehyde in mammalian cytogenetic assays in vivo and in vitro. Mutat. Res. 1983;122:355-360.
Ragan DL, Boreiko CJ. Initiation of C3H/10T1/2 cell transformation by formaldehyde. Cancer Lett. 198113:325-331.
Til HP, Woutersen RA, Feron VJ, et al. Two-year drinking-water study of formaldehyde in rats. Food Chem Toxicol. 1989;27:77-87.
Reviewed by: Paul A. Offit, MD
Date: April 2013
Materials in this section are updated as new information and vaccines become available. The Vaccine Education Center staff regularly reviews materials for accuracy.You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family's personal health. You should not use it to replace any relationship with a physician or other qualified healthcare professional. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult your physician or, in serious cases, seek immediate assistance from emergency personnel.