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6 ADVERSE REACTIONS

6 ADVERSE REACTIONS

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

Aluminum Toxicity [see Warnings and Precautions (5.5)]
Hypomagnesemia [see Warnings and Precautions (5.6)]
Vein Damage and Thrombosis [see Warnings and Precautions (5.7)]

The following adverse reactions in Table 5 have been reported in clinical studies or postmarketing reports in patients receiving intravenously administered potassium phosphates. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

TABLE 5: Adverse Reactions Reported in Clinical Studies or Postmarketing Reports with Intravenous Potassium Phosphates

System Organ Class

Adverse Reactions

Metabolism and Nutrition Disorders

pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.2)], hyperkalemia [see Warnings and Precautions (5.3)], hyperphosphatemia [see Warnings and Precautions (5.4)], hypocalcemia [see Warnings and Precautions (5.5)], hypovolemia, and osmotic diuresis

Cardiac Disorders

hypotension, arrhythmia, heart block, cardiac arrest, bradycardia, chest pain, ECG changes [see Warnings and Precautions (5.1)], and edema

Respiratory, Thoracic, and Mediastinal Disorders

dyspnea [see Warnings and Precautions (5.2)]

Renal and Urinary Disorders

acute phosphate nephropathy (i.e., nephrocalcinosis with acute kidney injury), decreased urine output, and transition to chronic kidney disease [see Warnings and Precautions (5.4)]

Gastrointestinal Disorders

diarrhea, stomach pain

Musculoskeletal and Connective Tissue Disorders

weakness

Nervous System Disorders

confusion, lethargy, paralysis, paresthesia

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