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Hydroxyurea Side Effects

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Common Hydroxyurea Side Effects


The most commonly reported Hydroxyurea side effects (click to view or check a box to report):

Skin Ulcer (24)
Anaemia (17)
Acute Myeloid Leukaemia (15)
Asthenia (14)
Neoplasm Malignant (13)
Pyrexia (12)
Death (12)
Nausea (11)
Dyspnoea (11)
Fatigue (10)
Thrombocytopenia (9)
Dizziness (9)
Pain (9)
Pneumonia (9)
Headache (8)
Haemoglobin Decreased (8)
Chills (8)
Cytogenetic Analysis Abnormal (8)
Pancytopenia (7)
Sickle Cell Anaemia With Crisis (7)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Hydroxyurea Side Effects Reported to FDA



Hydroxyurea Side Effect Report#9913086
Wound, Wound Secretion
This is a report of a 80-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: thrombocytosis, who was treated with Hydroxyurea (dosage: One Tablet Bid Po, start time: NS), combined with:
  • Lisinopril
and developed a serious reaction and side effect(s): Wound, Wound Secretion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Hydroxyurea treatment in female patients, resulting in Wound side effect.
Hydroxyurea Side Effect Report#9913024
Wound
This report suggests a potential Hydroxyurea Wound side effect(s) that can have serious consequences. A 74-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: polycythaemia vera and used Hydroxyurea (dosage: Of Hydoryurea) starting 2006. After starting Hydroxyurea the patient began experiencing various side effects, including: WoundAdditional drugs used concurrently: NA. Although Hydroxyurea demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Wound, may still occur.
Hydroxyurea Side Effect Report#9912715
Wound
This Wound problem was reported by a health professional from US. A 74-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: polycythaemia vera. On 2000 this consumer started treatment with Hydroxyurea (dosage: NA). The following drugs were being taken at the same time: NA. When using Hydroxyurea, the patient experienced the following unwanted symptoms/side effects: WoundAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Wound, may become evident only after a product is in use by the general population.
Hydroxyurea Side Effect Report#9790882
Gastric Ulcer, Upper Gastrointestinal Haemorrhage
This Gastric Ulcer side effect was reported by a physician from PT. A 76-year-old male patient (weight:NA) experienced the following symptoms/conditions: chronic myeloid leukaemia.The patient was prescribed Hydroxyurea (drug dosage: 2002?2006), which was initiated on 2002. Concurrently used drugs: NA..After starting to take Hydroxyurea the consumer reported adverse symptoms, such as: Gastric Ulcer, Upper Gastrointestinal HaemorrhageThese side effects may potentially be related to Hydroxyurea.
Hydroxyurea Side Effect Report#9756800
Plasma Cell Myeloma
This is a report of a 85-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Hydroxyurea (dosage: NA, start time: NS), combined with:
  • Aspirin
and developed a serious reaction and side effect(s): Plasma Cell Myeloma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Hydroxyurea treatment in male patients, resulting in Plasma Cell Myeloma side effect. The patient was hospitalized.
Hydroxyurea Side Effect Report#9756795
Plasma Cell Myeloma
This report suggests a potential Hydroxyurea Plasma Cell Myeloma side effect(s) that can have serious consequences. A 54-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Hydroxyurea (dosage: NA) starting NS. After starting Hydroxyurea the patient began experiencing various side effects, including: Plasma Cell MyelomaAdditional drugs used concurrently: NA. Although Hydroxyurea demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Plasma Cell Myeloma, may still occur.
Hydroxyurea Side Effect Report#9720036
Prostate Cancer, Urinary Incontinence, Off Label Use
This Prostate Cancer problem was reported by a consumer or non-health professional from US. A 63-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: platelet count increased. On NS this consumer started treatment with Hydroxyurea (dosage: 1df: Two 500 Mg Caps Every Night). The following drugs were being taken at the same time:
  • Pravachol
  • Lisinopril
When using Hydroxyurea, the patient experienced the following unwanted symptoms/side effects: Prostate Cancer, Urinary Incontinence, Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Prostate Cancer, may become evident only after a product is in use by the general population.
Hydroxyurea Side Effect Report#9712391
Rash Erythematous, Rash Macular, Pruritus, Skin Exfoliation, Product Colour Issue
This Rash Erythematous side effect was reported by a consumer or non-health professional from US. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: platelet count abnormal.The patient was prescribed Hydroxyurea (drug dosage: 1 Capsule), which was initiated on
Jun 01, 2013. Concurrently used drugs:
  • Amlodipine Besylate
  • Allopurinol
  • Metoprolol Er
  • Omeprazole
  • Losartan
  • Ferrous Sulfate
  • Senokot-s
  • Warfarin
.After starting to take Hydroxyurea the consumer reported adverse symptoms, such as: Rash Erythematous, Rash Macular, Pruritus, Skin Exfoliation, Product Colour IssueThese side effects may potentially be related to Hydroxyurea.
Hydroxyurea Side Effect Report#9680817
Pruritus, Rash Erythematous, Scab, Rash Macular
This is a report of a 70-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: platelet count abnormal, who was treated with Hydroxyurea (dosage: 1 Capsule Per Day, Daily, By Mouth, start time:
Jun 01, 2013), combined with: NA. and developed a serious reaction and side effect(s): Pruritus, Rash Erythematous, Scab, Rash Macular after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Hydroxyurea treatment in male patients, resulting in Pruritus side effect.
Hydroxyurea Side Effect Report#9671999
Red Blood Cell Count Decreased, Haematocrit Decreased, Haemoglobin Decreased, Product Quality Issue, Asthenia, Blood Count Abnormal, Product Substitution Issue
This report suggests a potential Hydroxyurea Red Blood Cell Count Decreased side effect(s) that can have serious consequences. A female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Hydroxyurea (dosage: NA) starting NS. After starting Hydroxyurea the patient began experiencing various side effects, including: Red Blood Cell Count Decreased, Haematocrit Decreased, Haemoglobin Decreased, Product Quality Issue, Asthenia, Blood Count Abnormal, Product Substitution IssueAdditional drugs used concurrently: NA. Although Hydroxyurea demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Red Blood Cell Count Decreased, may still occur.
Hydroxyurea Side Effect Report#9554138
Tumour Lysis Syndrome
This Tumour Lysis Syndrome problem was reported by a health professional from JP. A 44-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic myeloid leukaemia. On NS this consumer started treatment with Hydroxyurea (dosage: Increased To 2000mg/day). The following drugs were being taken at the same time:
  • Nilotinib
When using Hydroxyurea, the patient experienced the following unwanted symptoms/side effects: Tumour Lysis SyndromeAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Tumour Lysis Syndrome, may become evident only after a product is in use by the general population.
Hydroxyurea Side Effect Report#9554136
Tumour Lysis Syndrome
This Tumour Lysis Syndrome side effect was reported by a health professional from JP. A 47-year-old male patient (weight:NA) experienced the following symptoms/conditions: chronic myeloid leukaemia.The patient was prescribed Hydroxyurea (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Nilotinib (Restarted 200mg/d And Increased To 600mg/d)
.After starting to take Hydroxyurea the consumer reported adverse symptoms, such as: Tumour Lysis SyndromeThese side effects may potentially be related to Hydroxyurea. The patient was hospitalized.
Hydroxyurea Side Effect Report#9322032
Bronchopulmonary Aspergillosis, Graft Versus Host Disease In Skin, Cytomegalovirus Test Positive, Oral Candidiasis, Graft Versus Host Disease In Lung, Pseudomonas Infection, Enterobacter Infection
This is a report of a 36-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: chronic myeloid leukaemia,stem cell transplant,prophylaxis against graft versus host disease,oral candidiasis, who was treated with Hydroxyurea (dosage: NA, start time: 200405), combined with:
  • Cyclophosphamide Tablets Usp
  • Methotrexate
  • Fluconazole (100 Mg)
  • Interferon Alpha-2b
  • Busulfan
  • Cyclosporine
  • Itraconazole (100 Mg)
  • Amphotericin B
and developed a serious reaction and side effect(s): Bronchopulmonary Aspergillosis, Graft Versus Host Disease In Skin, Cytomegalovirus Test Positive, Oral Candidiasis, Graft Versus Host Disease In Lung, Pseudomonas Infection, Enterobacter Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Hydroxyurea treatment in female patients, resulting in Death side effect. The patient was hospitalized.
Hydroxyurea Side Effect Report#9300779
Basal Cell Carcinoma
This report suggests a potential Hydroxyurea Basal Cell Carcinoma side effect(s) that can have serious consequences. A 76-year-old female patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: essential thrombocythaemia and used Hydroxyurea (dosage: 500 Mg, 500 Mg To 1500 Mg Per Day - As Required) starting
Dec 13, 2006. After starting Hydroxyurea the patient began experiencing various side effects, including: Basal Cell CarcinomaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Hydroxyurea demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Basal Cell Carcinoma, may still occur.
Hydroxyurea Side Effect Report#9276354
Neuropathy Peripheral, Pain In Extremity
This Neuropathy Peripheral problem was reported by a health professional from US. A 55-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: psoriasis. On
Jun 01, 2012 this consumer started treatment with Hydroxyurea (dosage: NA). The following drugs were being taken at the same time: NA. When using Hydroxyurea, the patient experienced the following unwanted symptoms/side effects: Neuropathy Peripheral, Pain In ExtremityAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Neuropathy Peripheral, may become evident only after a product is in use by the general population.
Hydroxyurea Side Effect Report#9257534
Rash, Ulcer
This Rash side effect was reported by a pharmacist from US. A 85-year-old male patient (weight:NA) experienced the following symptoms/conditions: oncologic complication.The patient was prescribed Hydroxyurea (drug dosage: NA), which was initiated on
Sep 09, 2004. Concurrently used drugs: NA..After starting to take Hydroxyurea the consumer reported adverse symptoms, such as: Rash, UlcerThese side effects may potentially be related to Hydroxyurea.
Hydroxyurea Side Effect Report#9255427
Platelet Count Decreased
This is a report of a 72-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Hydroxyurea (dosage: NA, start time: 201202), combined with:
  • Jakafi (Tablet)
  • Aspirin
and developed a serious reaction and side effect(s): Platelet Count Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Hydroxyurea treatment in female patients, resulting in Platelet Count Decreased side effect.
Hydroxyurea Side Effect Report#9255405
Skin Ulcer
This report suggests a potential Hydroxyurea Skin Ulcer side effect(s) that can have serious consequences. A 59-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: essential thrombocythaemia and used Hydroxyurea (dosage: NA) starting NS. After starting Hydroxyurea the patient began experiencing various side effects, including: Skin UlcerAdditional drugs used concurrently: NA. Although Hydroxyurea demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Skin Ulcer, may still occur.
Hydroxyurea Side Effect Report#9255402
Urticaria, Swelling Face, Eye Swelling
This Urticaria problem was reported by a consumer or non-health professional from US. A 63-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: leukaemia. On 201202 this consumer started treatment with Hydroxyurea (dosage: NA). The following drugs were being taken at the same time:
  • Sprycel
  • Gleevec
When using Hydroxyurea, the patient experienced the following unwanted symptoms/side effects: Urticaria, Swelling Face, Eye SwellingAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Urticaria, may become evident only after a product is in use by the general population.
Hydroxyurea Side Effect Report#9130992
Macrocytosis, White Blood Cell Count Decreased, Suicide Attempt, Overdose
This Macrocytosis side effect was reported by a health professional from PL. A 31-year-old female patient (weight:NA) experienced the following symptoms/conditions: essential thrombocythaemia,insomnia.The patient was prescribed Hydroxyurea (drug dosage: 12 Months Before 500mg/day?15 Tabs?10gm), which was initiated on NS. Concurrently used drugs:
  • Diazepam (1df: 2.5mg-5mg?10 Tabs: 5mg)
  • Paroxetine
  • Alcohol
.After starting to take Hydroxyurea the consumer reported adverse symptoms, such as: Macrocytosis, White Blood Cell Count Decreased, Suicide Attempt, OverdoseThese side effects may potentially be related to Hydroxyurea. The patient was hospitalized.
Hydroxyurea Side Effect Report#8922287
Rib Fracture
This is a report of a 83-year-old patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Hydroxyurea (dosage: 1df:500mg Cap 1 Standered Dose Of 100, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Rib Fracture after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Hydroxyurea treatment in patients, resulting in Rib Fracture side effect.
Hydroxyurea Side Effect Report#8849740
Pulmonary Toxicity
This report suggests a potential Hydroxyurea Pulmonary Toxicity side effect(s) that can have serious consequences. A 43-year-old male patient (weight: NA) from PL was diagnosed with the following symptoms/conditions: essential thrombocythaemia and used Hydroxyurea (dosage: Increased To 1g/d) starting NS. After starting Hydroxyurea the patient began experiencing various side effects, including: Pulmonary ToxicityAdditional drugs used concurrently: NA. Although Hydroxyurea demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pulmonary Toxicity, may still occur.
Hydroxyurea Side Effect Report#8773909
Epistaxis, Rectal Haemorrhage
This Epistaxis problem was reported by a consumer or non-health professional from NO. A 61-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Hydroxyurea (dosage: NA). The following drugs were being taken at the same time: NA. When using Hydroxyurea, the patient experienced the following unwanted symptoms/side effects: Epistaxis, Rectal HaemorrhageAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Epistaxis, may become evident only after a product is in use by the general population.
Hydroxyurea Side Effect Report#8573940-X
Arthralgia, Haemoglobin Decreased, Dyspnoea, Sickle Cell Anaemia With Crisis, Nausea, Back Pain, White Blood Cell Count Increased, Bone Pain, Reticulocyte Count Increased
This Arthralgia side effect was reported by a physician from United States. A 22-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Hydroxyurea (drug dosage: NA), which was initiated on
Jun 10, 2009. Concurrently used drugs:
  • Exjade (500 Mg, Tid, Oral)
  • Folic Acid
.After starting to take Hydroxyurea the consumer reported adverse symptoms, such as: Arthralgia, Haemoglobin Decreased, Dyspnoea, Sickle Cell Anaemia With Crisis, Nausea, Back Pain, White Blood Cell Count Increased, Bone Pain, Reticulocyte Count IncreasedThese side effects may potentially be related to Hydroxyurea. The patient was hospitalized.
Hydroxyurea Side Effect Report#8516440
Malignant Neoplasm Progression
This is a report of a 86-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: chronic myeloid leukaemia, who was treated with Hydroxyurea (dosage: 1df=1500(units Not Specified)., start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Malignant Neoplasm Progression after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Hydroxyurea treatment in male patients, resulting in Malignant Neoplasm Progression side effect.


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The appearance of Hydroxyurea on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Hydroxyurea Side Effects for Women?

Women Side EffectsReports
Skin Ulcer 14
Fatigue 6
Anaemia 5
Platelet Count Decreased 5
Acute Myeloid Leukaemia 4
Asthenia 4
Bladder Cancer 4
Bone Marrow Failure 4
Death 4
Dyspnoea 4

What are common Hydroxyurea Side Effects for Men?

Men Side EffectsReports
Anaemia 12
Acute Myeloid Leukaemia 11
Asthenia 10
Neoplasm Malignant 10
Death 8
Pyrexia 8
Skin Ulcer 8
Cytogenetic Analysis Abnormal 7
Dizziness 7
Dyspnoea 7

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Hydroxyurea reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    How Effective is Hydroxyurea for You?

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    Hydroxyurea Safety Alerts, Active Ingredients, Usage Information

    NDC0555-0882
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameHYDROXYUREA
    NameHydroxyurea
    Dosage FormCAPSULE
    RouteORAL
    On market since19981019
    LabelerBarr Laboratories Inc.
    Active Ingredient(s)HYDROXYUREA
    Strength(s)500
    Unit(s)mg/1
    Pharma ClassAntimetabolite [EPC],Urea [Chemical/Ingredient]

    Hydroxyurea Dosage, Warnings, Usage.

    Side Effects reported to FDA: 320

    Hydroxyurea safety alerts: 2006

    Reported deaths: 75

    Reported hospitalizations: 125

    Droxia (hydroxyurea capsules)

    Hydrea (hydroxyurea capsules)
    Droxia (hydroxyurea capsules)

    Audience: Pharmacists and Oncological healthcare professionals
    [Posted 01/26/2006] Bristol-Myers Squibb notified healthcare professionals about revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information to describe cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, in patients with myeloproliferative disorders during therapy with hydroxyurea, most often reported in patients with a history of or currently receiving interferon therapy. The PRECAUTIONS and DOSING AND ADMINISTRATION sections have been revised to provide updated information on the safe handling of these products.

    The proposed changes are highlighted in the following "Dear Healthcare Provider" letters issued January 2006 by Bristol-Myers Squibb; specific wording of these additions and revisions to the labeling is pending FDA review and approval.

    [January 20, 2006 ?? Hydrea letter ?? Bristol-Myers Squibb]
    [January 20, 2006 ?? Droxia letter ?? Bristol-Myers Squibb]

    Latest Hydroxyurea clinical trials