Drug Safety Information for HYDROXYUREA (Hydroxyurea)

Safety-related Labeling Changes for DROXIA (HYDROXYUREA) Rx Drug: FDA Link

Safety-related Labeling Changes for HYDREA (HYDROXYUREA) Rx Drug: FDA Link

Adverse Drug Reactions for HYDROXYUREA* (Hydroxyurea)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with HYDROXYUREA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia278
2Nausea*242
3Anaemia241
4Fatigue*218
5Death215
6Diarrhoea*206
7Haemoglobin decreased205
8Thrombocytopenia202
9Dyspnoea198
10Pneumonia181
11Vomiting172
12Pain*162
13Asthenia159
14Sickle cell anaemia with crisis159
15Drug ineffective156
16Neoplasm malignant150
17Headache*149
18Platelet count decreased146
19White blood cell count increased133
20Dizziness*124

* This side effect also appears in "Top 10 Side Effects of HYDROXYUREA " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking HYDROXYUREA
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Chronic myeloid leukaemia1342
2Product used for unknown indication1085
3Essential thrombocythaemia*921
4Polycythaemia vera*599
5Sickle cell anaemia549
6Acute myeloid leukaemia378
7Thrombocytosis*374
8Glioblastoma multiforme300
9Platelet count increased277
10Polycythaemia*166

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for HYDROXYUREA

Total Reports Filed with FDA: 19903


Number of FDA Adverse Event Reports by Patient Age for HYDROXYUREA

Total Reports Filed with FDA: 19903*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Hydroxyurea (Hydrea, Hydroxyurea, Droxia)

Charts are based on 19903 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and HYDROXYUREA Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.