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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

Does HYDROXYUREA Cause Off label use? 519 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 519 reports of Off label use have been filed in association with HYDROXYUREA (Hydroxyurea). This represents 8.7% of all adverse event reports for HYDROXYUREA.

519
Reports of Off label use with HYDROXYUREA
8.7%
of all HYDROXYUREA reports
63
Deaths
189
Hospitalizations

How Dangerous Is Off label use From HYDROXYUREA?

Of the 519 reports, 63 (12.1%) resulted in death, 189 (36.4%) required hospitalization, and 29 (5.6%) 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 HYDROXYUREA. However, 519 reports have been filed with the FAERS database.

What Other Side Effects Does HYDROXYUREA Cause?

Anaemia (358) Drug ineffective (356) Fatigue (291) Thrombocytopenia (253) Nausea (247) Pyrexia (243) Diarrhoea (222) Febrile neutropenia (202) Intentional product use issue (201) Dyspnoea (184)

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 HYDROXYUREA Alternatives Have Lower Off label use Risk?

HYDROXYUREA vs HYDROXYZINE HYDROXYUREA vs HYDROXYZINE\HYDROXYZINE HYDROXYUREA vs HYOSCYAMINE HYDROXYUREA vs HYPROMELLOSE 2910 HYDROXYUREA vs IBALIZUMAB-UIYK

Related Pages

HYDROXYUREA Full Profile All Off label use Reports All Drugs Causing Off label use HYDROXYUREA Demographics