Description

Carcinogenesis, Mutagenesis, Impairment of Fertility 
No long-term studies in animals have been performed to evaluate the carcinogenic potential of heparin 
sodium. Also, no reproduction studies in animals have been performed concerning mutagenesis or 
impairment of fertility. 
Pregnancy 
Teratogenic Effects—Pregnancy Category C 
Animal reproduction studies have not been conducted with heparin sodium. It is also not known 
whether heparin sodium can cause fetal harm when administered to a pregnant woman or can affect 
reproduction capacity. Heparin sodium should be given to a pregnant woman only if clearly needed. 

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NDA 17-037/S-158 
Page 28 
Nonteratogenic Effects 
Heparin does not cross the placental barrier. 
Nursing Mothers 
Heparin is not excreted in human milk. 
Pediatric Use 
Safety and effectiveness in pediatric patients have not been established (see WARNINGS, Use in 
Neonates and Infants). 
Geriatric Use 
A higher incidence of bleeding has been reported in patients over 60 years of age, especially women 
(see CLINICAL PHARMACOLOGY and PRECAUTIONS, General). 
ADVERSE REACTIONS 
Hemorrhage 
Hemorrhage is the chief complication that may result from heparin use (see WARNINGS, 
Hemorrhage). An overly prolonged clotting time or minor bleeding during therapy can usually be 
controlled by withdrawing the drug (see OVERDOSAGE). 
Thrombocytopenia, Heparin-induced Thrombocytopenia (HIT) and Heparin-induced 
Thrombocytopenia and Thrombosis (HITT) and Delayed Onset of HIT and HITT 
See WARNINGS. 
Local Irritation 
Local irritation and erythema have been reported with the use of Heparin Lock Flush Solution.