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Adverse Reactions

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are also described elsewhere in the labeling:

Neonatal Hypoglycemia [see Warnings and Precautions (5.1)]
Hyperglycemia and Hyperosmolar Hyperglycemic State [see Warnings and Precautions (5.2)]
Hypersensitivity Reactions [see Warnings and Precautions (5.3)]
Phlebitis and Thrombosis [see Warnings and Precautions (5.4)]
Hyponatremia [see Warnings and Precautions (5.5)]
Electrolyte Imbalance, Fluid Overload and Hypervolemia [see Warnings and Precautions (5.6)]
Refeeding Syndrome [see Warnings and Precautions (5.7)]

The following adverse reactions associated with the use of Dextrose Injection (5%) were identified in clinical trials or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Administration site conditions: blister, erythema, extravasation, pain, phlebitis, vein damage, thrombosis

Immune system disorders: anaphylaxis, angioedema, bronchospasm, chills, hypotension, pruritus, pyrexia, rash

Cardiovascular disorders: cyanosis, volume overload

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