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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 Product use in unapproved indication? 159 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 159 reports of Product use in unapproved indication have been filed in association with HYDROXYUREA (Hydroxyurea). This represents 2.7% of all adverse event reports for HYDROXYUREA.

159
Reports of Product use in unapproved indication with HYDROXYUREA
2.7%
of all HYDROXYUREA reports
28
Deaths
41
Hospitalizations

How Dangerous Is Product use in unapproved indication From HYDROXYUREA?

Of the 159 reports, 28 (17.6%) resulted in death, 41 (25.8%) required hospitalization, and 10 (6.3%) were considered life-threatening.

Is Product use in unapproved indication Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for HYDROXYUREA. However, 159 reports have been filed with the FAERS database.

What Other Side Effects Does HYDROXYUREA Cause?

Off label use (519) Anaemia (358) Drug ineffective (356) Fatigue (291) Thrombocytopenia (253) Nausea (247) Pyrexia (243) Diarrhoea (222) Febrile neutropenia (202) Intentional product use issue (201)

What Other Drugs Cause Product use in unapproved indication?

DUPILUMAB (33,452) DICLOFENAC (12,197) METHOTREXATE (8,930) PREDNISONE (7,625) RITUXIMAB (7,519) MYCOPHENOLATE MOFETIL (5,910) ACETAMINOPHEN (5,819) CYCLOPHOSPHAMIDE (5,750) RISPERIDONE (5,551) TACROLIMUS (5,057)

Which HYDROXYUREA Alternatives Have Lower Product use in unapproved indication 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 Product use in unapproved indication Reports All Drugs Causing Product use in unapproved indication HYDROXYUREA Demographics