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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). 


NDA 17-037/S-158 
Page 19 
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. 
Hypersensitivity 
Generalized hypersensitivity reactions have been reported, with chills, fever and urticaria as the most 
usual manifestations, and asthma, rhinitis, lacrimation, headache, nausea and vomiting, and 
anaphylactoid reactions, including shock, occurring more rarely. Itching and burning, especially on the 
plantar side of the feet, may occur. 
Thrombocytopenia has been reported to occur in patients receiving heparin, with a reported incidence 
of 0 to 30
%. While often mild and of no obvious clinical significance, such thrombocytopenia can be 
accompanied by severe thromboembolic complications such as skin necrosis, gangrene of the 
extremities that may lead to amputation, myocardial infarction, pulmonary embolism, stroke, and 
possibly death. (See WARNINGS and PRECAUTIONS.) 
Certain episodes of painful, ischemic and cyanosed limbs have in the past been attributed to allergic 
vasospastic reactions. Whether these are in fact identical to the thrombocytopenia-associated 
complications remains to be determined. 
OVERDOSAGE 
Symptoms 
Bleeding is the chief sign of heparin overdosage. Nosebleeds, blood in urine or tarry stools may be 
noted as the first sign of bleeding. Easy bruising or petechial formations may precede frank bleeding. 

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