Does POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM BICARBONATE\SODIUM Cause Off label use? 156 Reports in FDA Database

Q: Does POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM BICARBONATE\SODIUM cause Off label use?

156 reports of Off label use have been filed with the FDA for POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM BICARBONATE\SODIUM, representing 6.5% of all POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM BICARBONATE\SODIUM adverse event reports.

Q: How dangerous is Off label use from POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM BICARBONATE\SODIUM?

Of 156 reports, 47 (30.1%) resulted in death and 112 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 156 reports of Off label use have been filed in association with POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM BICARBONATE\SODIUM. This represents 6.5% of all adverse event reports for POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM BICARBONATE\SODIUM.

156

Reports of Off label use with POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM BICARBONATE\SODIUM

6.5%

of all POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM BICARBONATE\SODIUM reports

Deaths

112

Hospitalizations

How Dangerous Is Off label use From POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM BICARBONATE\SODIUM?

Of the 156 reports, 47 (30.1%) resulted in death, 112 (71.8%) required hospitalization, and 16 (10.3%) were considered life-threatening.

Is Off label use Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM BICARBONATE\SODIUM. However, 156 reports have been filed with the FAERS database.

What Other Side Effects Does POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM BICARBONATE\SODIUM Cause?

Vomiting (335) Drug ineffective (271) Nausea (245) Constipation (226) Diarrhoea (177) Hyponatraemia (172) Macular degeneration (165) Abdominal pain (159) Dyspnoea (144) General physical health deterioration (131)

What Other Drugs Cause Off label use?

RITUXIMAB (39,751) INFLIXIMAB (34,801) DENOSUMAB (34,612) METHOTREXATE (24,020) VEDOLIZUMAB (21,017) ETANERCEPT (20,178) TOCILIZUMAB (18,256) PREDNISONE (17,867) LENALIDOMIDE (17,017) ADALIMUMAB (16,417)

Which POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM BICARBONATE\SODIUM Alternatives Have Lower Off label use Risk?

POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM BICARBONATE\SODIUM Full Profile All Off label use Reports All Drugs Causing Off label use POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM BICARBONATE\SODIUM Demographics