Drug Levels and Effects:

Summary of Use during Lactation:

Because of the low levels of saccharin in breastmilk, amounts ingested by the infant after typical maternal intake are small and would not be expected to cause any adverse effects in breastfed infants. No special precautions are required.

Drug Levels:

Maternal Levels.

Six lactating women were given 126 mg of saccharin in the form of a 356 mL (12 fluid ounce) soft drink every 6 hours for 9 doses. Plasma and breastmilk were sampled at 9 time points between 0 and 6 hours after the first and ninth doses. The peak milk concentration occurred 2 hours after both the first and ninth doses. Milk concentrations varied widely, ranging from <0.2 to="" 1.06="" mg/l="" after="" the="" first="" dose="" up="" to="" as="" high="" as="" 1.8="" mg/l="" after="" the="" ninth="" dose.="" the="" area="" under="" the="" milk="" concentration-time="" curve="" increased="" from="" 54%="" to="" 72%="" of="" the="" simultaneous="" serum="" concentration-time="" curve="" between="" the="" first="" and="" ninth="" doses,="" indicating="" some="" accumulation="" in="" milk="" over="" time.="" the="" average="" elimination="" half-life="" from="" milk="" was="" 15="" hours="" on="" day="" 1="" and="" 18="" hours="" on="" day="" 3,="" although="" individual="" values="" varied="" widely.[1]="" using="" the="" highest="" milk="" concentration="" in="" this="" study="" of="" 1.8="" mg/l,="" an="" exclusively="" breastfed="" infant="" would="" receive="" a="" dose="" of="" 0.27="" mg/kg="" daily="" which="" is="" much="" lower="" than="" the="" 5="" mg/kg="" daily="" limit="" suggested="" by="" the="" united="" states="" food="" and="" drug="">

Infant Levels.

Relevant published information was not found as of the revision date.

Effects in Breastfed Infants:

Relevant published information was not found as of the revision date.

Possible Effects on Lactation:

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider:



1. Egan PC, Marx CM, Heyl PS et al. Saccharin excretion in mature human milk. Drug Intell Clin Pharm. 1984;18:511. Abstract.

Substance Identification:

Substance Name:


CAS Registry Number:


Drug Class:

  • Artificial Sweeteners

  • Sweetening Agents

  • Administrative Information:

    LactMed Record Number:


    Last Revision Date:

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