HYDROXYUREA

N/A

Manufactured by H2-Pharma LLC

42,593 FDA adverse event reports analyzed

Last updated: 2026-04-14

About HYDROXYUREA

HYDROXYUREA is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by H2-Pharma LLC. The most commonly reported adverse reactions for HYDROXYUREA include OFF LABEL USE, FATIGUE, SICKLE CELL ANAEMIA WITH CRISIS, DIARRHOEA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HYDROXYUREA.

Top Adverse Reactions

OFF LABEL USE2,068 reports
FATIGUE1,490 reports
SICKLE CELL ANAEMIA WITH CRISIS1,475 reports
DIARRHOEA1,378 reports
NAUSEA1,279 reports
HEADACHE1,045 reports
ANAEMIA1,020 reports
DEATH1,003 reports
HAEMOGLOBIN DECREASED930 reports
PYREXIA906 reports
DRUG INEFFECTIVE869 reports
PAIN850 reports
PRODUCT DOSE OMISSION ISSUE810 reports
DYSPNOEA800 reports
PNEUMONIA757 reports
ASTHENIA727 reports
DIZZINESS710 reports
PLATELET COUNT DECREASED678 reports
VOMITING671 reports
PLATELET COUNT INCREASED630 reports
MALAISE605 reports
THROMBOCYTOPENIA585 reports
WHITE BLOOD CELL COUNT INCREASED580 reports
ARTHRALGIA524 reports
PAIN IN EXTREMITY503 reports
DECREASED APPETITE486 reports
ABDOMINAL PAIN UPPER472 reports
RASH471 reports
ABDOMINAL PAIN470 reports
FALL438 reports
WEIGHT DECREASED436 reports
PRURITUS430 reports
SPLENOMEGALY418 reports
FEBRILE NEUTROPENIA410 reports
COUGH400 reports
BACK PAIN394 reports
ABDOMINAL DISCOMFORT388 reports
CONSTIPATION377 reports
WEIGHT INCREASED356 reports
WHITE BLOOD CELL COUNT DECREASED351 reports
ACUTE MYELOID LEUKAEMIA342 reports
PANCYTOPENIA314 reports
CHEST PAIN296 reports
CONDITION AGGRAVATED296 reports
SEPSIS295 reports
CONTUSION292 reports
SKIN ULCER286 reports
NEUTROPENIA277 reports
INTENTIONAL PRODUCT USE ISSUE274 reports
MYELOFIBROSIS265 reports
FEELING ABNORMAL263 reports
DEHYDRATION259 reports
HYPOTENSION259 reports
OEDEMA PERIPHERAL259 reports
URINARY TRACT INFECTION259 reports
ACUTE KIDNEY INJURY257 reports
DISEASE PROGRESSION255 reports
PRODUCT USE IN UNAPPROVED INDICATION254 reports
HYPERTENSION251 reports
PLEURAL EFFUSION244 reports
PRODUCT DOSE OMISSION242 reports
LEUKOCYTOSIS241 reports
EPISTAXIS240 reports
INFECTION238 reports
RED BLOOD CELL COUNT DECREASED233 reports
INSOMNIA230 reports
SOMNOLENCE223 reports
PERIPHERAL SWELLING222 reports
DRUG DOSE OMISSION220 reports
MALIGNANT NEOPLASM PROGRESSION220 reports
DRUG INTOLERANCE219 reports
MUSCLE SPASMS219 reports
CEREBROVASCULAR ACCIDENT217 reports
HAEMORRHAGE213 reports
RENAL FAILURE208 reports
MYALGIA205 reports
ALOPECIA203 reports
ANXIETY199 reports
CARDIAC FAILURE195 reports
GENERAL PHYSICAL HEALTH DETERIORATION194 reports
MEMORY IMPAIRMENT194 reports
DEPRESSION188 reports
RENAL IMPAIRMENT186 reports
COVID 19183 reports
RESPIRATORY FAILURE182 reports
BLOOD LACTATE DEHYDROGENASE INCREASED181 reports
PULMONARY EMBOLISM180 reports
DRUG INTERACTION179 reports
BLOOD CREATININE INCREASED177 reports
BONE PAIN176 reports
CHILLS176 reports
HAEMATOCRIT DECREASED176 reports
ABDOMINAL DISTENSION173 reports
HOSPITALISATION172 reports
ACUTE CHEST SYNDROME171 reports
GAIT DISTURBANCE169 reports
CONFUSIONAL STATE167 reports
ATRIAL FIBRILLATION165 reports
DYSPHAGIA165 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION165 reports

Report Outcomes

Out of 20,424 classified reports for HYDROXYUREA:

Serious 75.4%Non-Serious 24.6%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female8,626 (52.3%)
Male7,778 (47.2%)
Unknown84 (0.5%)

Reports by Age

Age 74324 reports
Age 73321 reports
Age 75307 reports
Age 78303 reports
Age 77293 reports
Age 71281 reports
Age 65277 reports
Age 76277 reports
Age 72269 reports
Age 69255 reports
Age 70250 reports
Age 67238 reports
Age 80227 reports
Age 66224 reports
Age 68223 reports
Age 64217 reports
Age 79214 reports
Age 81212 reports
Age 60199 reports
Age 83195 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with HYDROXYUREA?

This profile reflects 42,593 FDA FAERS reports that mention HYDROXYUREA. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for HYDROXYUREA?

Frequently reported terms in FAERS include OFF LABEL USE, FATIGUE, SICKLE CELL ANAEMIA WITH CRISIS, DIARRHOEA, NAUSEA, HEADACHE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures HYDROXYUREA?

Labeling and FAERS entries often list H2-Pharma LLC in connection with HYDROXYUREA. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.