"Today the U.S. Food and Drug Administration allowed marketing of the NephroCheck test, a first-of-a-kind laboratory test to help determine if certain critically ill hospitalized patients are at risk of developing moderate to severe acute kidney i"...
The following adverse reactions are discussed elsewhere in the label:
Clinical Trials Experience
There are no data available on adverse reactions from controlled clinical trials conducted to evaluate the safety of DIANEAL.
The following adverse experiences have been identified during post-approval use of DIANEAL or in conjunction with performing the peritoneal dialysis procedure. Because these experiences are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship during drug exposure. Most of these adverse experiences are believed to be consequences of peritoneal dialysis.
Infections And Infestations: Fungal peritonitis, Peritonitis bacterial, Catheter related infection
Respiratory, Thoracic, And Mediastinal Disorders: Dyspnea
Gastrointestinal Disorders: Sclerosing encapsulating peritonitis, Peritonitis, Peritoneal cloudy effluent, Vomiting, Diarrhea, Nausea, Constipation, Abdominal pain, Abdominal distension, Abdominal discomfort
Musculoskeletal, Connective Tissue Disorders: Myalgia, Muscle spasms, Musculoskeletal pain
Read the Dianeal PD-1 (peritoneal dialysis solution) Side Effects Center for a complete guide to possible side effects
As with other dialysis solutions, blood concentrations of dialyzable drugs may be reduced by dialysis. Dosage adjustment of concomitant medications may be necessary.
Last reviewed on RxList: 9/2/2016
Additional Dianeal PD-1 Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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