Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hemorrhage [see Warnings and Precautions (5.2) ] Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia with Thrombosis [see Warnings and Precautions (5.3) ] Thrombocytopenia [see Warnings and Precautions (5.4) ] Heparin Resistance [see Warnings and Precautions (5.6) ] Hypersensitivity [see Warnings and Precautions (5.7) ] Hyperkalemia [see Warnings and Precautions (5.8) ] Elevations of Serum Aminotransferases [see Warnings and Precautions (5.9) ] Most common adverse reactions are: hemorrhage, thrombocytopenia, HIT or HITT, heparin resistance, hypersensitivity reactions, hyperkalemia, and elevations of aminotransferase levels.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact B.
Braun Medical Inc.
at 1-800-227-2862 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Postmarketing Experience The following adverse reactions have been identified during post-approval use of heparin sodium.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
Hemorrhage – Hemorrhage is the chief complication that may result from heparin therapy [see Warnings and Precautions (5.2) ] .
An overly prolonged clotting time or minor bleeding during therapy can usually be controlled by withdrawing the drug [see Overdosage (10) ] .
Gastrointestinal or urinary tract bleeding during anticoagulant therapy may indicate the presence of an underlying occult lesion.
Bleeding can occur at any site but certain specific hemorrhagic complications may be difficult to detect: Adrenal hemorrhage, with resultant acute adrenal insufficiency, has occurred with heparin therapy, including fatal cases.
5 WARNINGS AND PRECAUTIONS Fatal Medication Errors: Confirm choice of correct strength prior to administration.
( 5.1 ) Hemorrhage: Fatal cases have occurred.
Monitor for signs of bleeding and manage promptly.
( 5.2 ) HIT or HITT: Monitor for signs and symptoms and discontinue if indicative of HIT or HITT.
( 5.3 ) Thrombocytopenia: Monitor platelet count during therapy;
Like all medications, Heparin Sodium In Dextrose can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: