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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 Stomatitis? 78 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 78 reports of Stomatitis have been filed in association with HYDROXYUREA (Hydroxyurea). This represents 1.3% of all adverse event reports for HYDROXYUREA.

78
Reports of Stomatitis with HYDROXYUREA
1.3%
of all HYDROXYUREA reports
6
Deaths
33
Hospitalizations

How Dangerous Is Stomatitis From HYDROXYUREA?

Of the 78 reports, 6 (7.7%) resulted in death, 33 (42.3%) required hospitalization.

Is Stomatitis Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for HYDROXYUREA. However, 78 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 Stomatitis?

METHOTREXATE (7,245) TOCILIZUMAB (4,761) ADALIMUMAB (4,500) LEFLUNOMIDE (4,492) ABATACEPT (4,481) ETANERCEPT (4,338) RITUXIMAB (4,335) CERTOLIZUMAB PEGOL (3,760) INFLIXIMAB (3,713) PREDNISONE (3,656)

Which HYDROXYUREA Alternatives Have Lower Stomatitis 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 Stomatitis Reports All Drugs Causing Stomatitis HYDROXYUREA Demographics