Hydroxyurea

Common brands: Hydrea, Siklos, Droxia, Xromi, Jakafi

Top reporter: H2-Pharma Llc

Antimetabolite [EPC]Kinase Inhibitor [EPC]Janus Kinase Inhibitor [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Vitamin C [EPC]
20,706
Total Reports
9,454
Serious Reports
3,092
Death Reports
30
Reported Reactions
Death Report Ratio: High (14.93%)

Patient Demographics

Male
7,875
Female
8,732

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Hydroxyurea.

# Reaction Reports % of Total
1 OFF LABEL USE 2,119
8.3%
2 FATIGUE 1,519
5.9%
3 SICKLE CELL ANAEMIA WITH CRISIS 1,480
5.8%
4 DIARRHOEA 1,390
5.4%
5 NAUSEA 1,291
5.1%
6 HEADACHE 1,054
4.1%
7 ANAEMIA 1,032
4.0%
8 DEATH 1,024
4.0%
9 HAEMOGLOBIN DECREASED 936
3.7%
10 PYREXIA 917
3.6%
11 DRUG INEFFECTIVE 892
3.5%
12 PAIN 857
3.4%
13 PRODUCT DOSE OMISSION ISSUE 817
3.2%
14 DYSPNOEA 815
3.2%
15 PNEUMONIA 761
3.0%
16 ASTHENIA 745
2.9%
17 DIZZINESS 714
2.8%
18 PLATELET COUNT DECREASED 689
2.7%
19 VOMITING 673
2.6%
20 PLATELET COUNT INCREASED 636
2.5%
21 MALAISE 611
2.4%
22 THROMBOCYTOPENIA 592
2.3%
23 WHITE BLOOD CELL COUNT INCREASED 584
2.3%
24 ARTHRALGIA 526
2.1%
25 PAIN IN EXTREMITY 508
2.0%
26 DECREASED APPETITE 495
1.9%
27 RASH 481
1.9%
28 ABDOMINAL PAIN UPPER 474
1.9%
29 ABDOMINAL PAIN 471
1.8%
30 FALL 450
1.8%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.