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Hydrea Side Effects

PatientsVille

Common Hydrea Side Effects


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

Pyrexia (32)
Skin Ulcer (25)
Death (24)
Anaemia (23)
Interstitial Lung Disease (22)
Thrombocytopenia (19)
Renal Failure (17)
Pancytopenia (15)
Cytolytic Hepatitis (14)
Platelet Count Increased (14)
Renal Failure Acute (13)
Pain (13)
Off Label Use (13)
Malignant Neoplasm Progression (13)
Fatigue (12)
Cough (11)
Vomiting (11)
Nausea (11)
Squamous Cell Carcinoma (11)
Erythema (10)

➢ 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.

Hydrea Side Effects Reported to FDA



Hydrea Side Effect Report#8866164
Pancytopenia

on Oct 25, 2012 a 84-year-old male patient from ES was diagnosed with and and was treated with Hydrea on 2001. Directly after treatment started, patient experienced the unwanted or unexpected Hydrea side effects: pancytopenia. Hydrea dosage: NA.
Associated medications used:
  • Mesalazine
  • Seguril
  • Tebetane Compuesto
  • Trangorex
The patient was hospitalized.

Hydrea Side Effect Report#8861947
Cerebral Haemorrhage

This cerebral haemorrhage side effect was reported by a consumer or non-health professional from RU. A male patient was taking Hydrea. Patient felt the following Hydrea side effects: cerebral haemorrhage. Additional patient health information: , weighting 200.6 lb, was diagnosed with and. Hydrea dosage: NA. Concurrently used drugs: NA.. The patient was hospitalized.

Hydrea Side Effect Report#8846073
Diabetes Mellitus, Pruritus, Depression, Haemoglobin Increased

An diabetes mellitus adverse event was reported by a consumer or non-health professional on Oct 17, 2012 from BR. A 73-year-old female patient , weighting 160.9 lb, took Hydrea Caps 500 Mg (dosage: On Monday Dosage:2 Dosage Form) and had the following health condition(s): was diagnosed with and. After Hydrea was administered, patient encountered several Hydrea side effects: diabetes mellitus, pruritus, depression, haemoglobin increased. Concurrently used drugs:
  • Metformin
  • Diovan
  • Amlodipine
  • Escitalopram Oxalate
  • Ticlopidine
.

Hydrea Side Effect Report#8838200
Rash Maculo-papular, Pyrexia, Malaise, Blood Pressure Decreased

This rash maculo-papular side effect was reported by a consumer or non-health professional from FR. on Oct 12, 2012 a 84-year-old male patient from FR , suffering from was diagnosed with and, was treated with Hydrea Caps 500 Mg. Directly after treatment started, patient experienced the unwanted or unexpected Hydrea side effects: rash maculo-papular, pyrexia, malaise, blood pressure decreased. Hydrea Caps 500 Mg dosage: 1df = 1 Caps. Concurrently used drugs:
  • Venofer
  • Lovenox
  • Lantus
  • Triatec
  • Tardyferon
.

Hydrea Side Effect Report#8838173
Platelet Count Increased, Tablet Physical Issue

on Oct 12, 2012 a 43-year-old male patient from BR , weighting 185.2 lb, was diagnosed with and and was treated with Hydrea Caps 500 Mg on Jun 06, 2012. Patient felt the following Hydrea side effects: platelet count increased, tablet physical issue. Hydrea Caps 500 Mg dosage: 1df: 1 Capsule.

Hydrea Side Effect Report#8815597
Myocarditis, Hepatocellular Injury, Cholestasis, Morganella Infection, Thrombocytopenia, Lymphopenia

This myocarditis side effect was reported by a consumer or non-health professional from FR. A 65-year-old male patient was taking Hydrea Caps 500 Mg. After Hydrea was administered, patient encountered several Hydrea side effects: myocarditis, hepatocellular injury, cholestasis, morganella infection, thrombocytopenia, lymphopenia. Additional patient health information: was diagnosed with and. Hydrea Caps 500 Mg dosage: NA. Concurrently used drugs:
  • Novatrex (Novatrex 2.5 Mg Tablet)
  • Methotrexate (10mg Tabs)
  • Cortancyl (Cortancyl 20 Mg Tablet)
  • Mabthera
  • Augmentin
. The patient was hospitalized.

Hydrea Side Effect Report#8811437
Infarction, Haemoglobin Decreased

An infarction adverse event was reported by a consumer or non-health professional on Sep 27, 2012 from BR. A 75-year-old male patient , weighting 154.3 lb, took Hydrea Caps 500 Mg (dosage: NA) and had the following health condition(s): was diagnosed with and. Directly after treatment started, patient experienced the unwanted or unexpected Hydrea side effects: infarction, haemoglobin decreased. Concurrently used drugs:
  • Simvastatin
.

Hydrea Side Effect Report#8796213
Vasculitis, Nephritis

This vasculitis side effect was reported by a consumer or non-health professional from SE. on Nov 16, 2012 a 71-year-old male patient from SE , suffering from was diagnosed with and, was treated with Hydrea. Patient felt the following Hydrea side effects: vasculitis, nephritis. Hydrea dosage: NA. Concurrently used drugs:
  • Omeprazole
  • Ramipril
  • Amlodipine
  • Warfarin
  • Etalpha
  • Furix
  • Emconcor
  • Alfadil
. The patient was hospitalized.

Hydrea Side Effect Report#8779623
Pancytopenia, Bone Marrow Failure, Hip Fracture

on Sep 12, 2012 a 82-year-old female patient from FR was diagnosed with and and was treated with Hydrea Caps 500 Mg on NS. After Hydrea was administered, patient encountered several Hydrea side effects: pancytopenia, bone marrow failure, hip fracture. Hydrea Caps 500 Mg dosage: NA.
Multiple concurrent drugs taken:
  • Allopurinol
  • Plaquenil
  • Kardegic
  • Solupred
  • Doliprane
  • Eupantol
  • Imovane
  • Lasilix
The patient was hospitalized.

Hydrea Side Effect Report#8771142
Bone Marrow Failure, Off Label Use, Discomfort, Overdose, Loss Of Consciousness

This bone marrow failure side effect was reported by a physician from FR. A 13-year-old male patient was taking Hydrea Caps 500 Mg. Directly after treatment started, patient experienced the unwanted or unexpected Hydrea side effects: bone marrow failure, off label use, discomfort, overdose, loss of consciousness. Additional patient health information: , weighting 63.93 lb, . Hydrea Caps 500 Mg dosage: 20 Mg/kilogram. Concurrently used drugs: NA.. The patient was hospitalized.

Hydrea Side Effect Report#8764136
Intentional Overdose, Intentional Self-injury, White Blood Cell Count Decreased

An intentional overdose adverse event was reported by a consumer or non-health professional on Aug 31, 2012 from GB. A 48-year-old female patient took Hydrea (dosage: Prescribed Dose:1g And 1.5g) and had the following health condition(s): was diagnosed with and. Patient felt the following Hydrea side effects: intentional overdose, intentional self-injury, white blood cell count decreased. Concurrently used drugs: NA.. The patient was hospitalized.

Hydrea Side Effect Report#8756926
Pancytopenia, Renal Failure Acute, Infection, Overdose

This pancytopenia side effect was reported by a consumer or non-health professional from FR. on Aug 28, 2012 a 66-year-old female patient from FR , suffering from , was treated with Hydrea. After Hydrea was administered, patient encountered several Hydrea side effects: pancytopenia, renal failure acute, infection, overdose. Hydrea dosage: On The Following Day 2/day. Concurrently used drugs:
  • Lasilix
  • Humalog
  • Claforan (Powder For Solution)
  • Metoject (1df:10 Mg/ml Solution For Injection In Prefilled Syringe)
  • Kardegic
  • Micardis
  • Cortancyl (Tabs)
  • Avlocardyl
. The patient was hospitalized.

Hydrea Side Effect Report#8756925
Pneumonia Legionella, Septic Shock, Renal Failure Acute

on Aug 28, 2012 a 66-year-old female patient from FR was diagnosed with and and was treated with Hydrea on NS. Directly after treatment started, patient experienced the unwanted or unexpected Hydrea side effects: pneumonia legionella, septic shock, renal failure acute. Hydrea dosage: Also Taken 2/day (the Following Day).
Associated medications used:
  • Metoject (1df: 10 Mg/ml Solution Formulation: Injection In Prefilled Syringe)
  • Cortancyl (Formulation: Tab)
  • Kardegic
  • Micardis
  • Avlocardyl
  • Aldactazine (Formulation: Film-coated And Scored Tablet)
  • Laroxyl
  • Inexium


Hydrea Side Effect Report#8618471
Platelet Count Increased, Anaemia, Nail Discolouration, Suspected Counterfeit Product

This platelet count increased side effect was reported by a physician from BR. A 67-year-old female patient was taking Hydrea Caps 500 Mg. Patient felt the following Hydrea side effects: platelet count increased, anaemia, nail discolouration, suspected counterfeit product. Additional patient health information: , weighting 134.5 lb, was diagnosed with and. Hydrea Caps 500 Mg dosage: 1df: 3caps, 2caps And 3 Caps On Tuesdays. Concurrently used drugs: NA..

Hydrea Side Effect Report#8578925-5
Sickle Cell Anaemia With Crisis

An sickle cell anaemia with crisis adverse event was reported by a physician on Jul 09, 2010 from United States. A 26-year-old male patient , weighting 134.0 lb, took Hydrea (dosage: NA) and had the following health condition(s): . After Hydrea was administered, patient encountered several Hydrea side effects: sickle cell anaemia with crisis. Concurrently used drugs:
  • Exjade (1250 Mg/day, Oral)
  • Hydrocodone Bitartrate
  • Folic Acid
. The patient was hospitalized.

Hydrea Side Effect Report#8572674-5
Non-cardiac Chest Pain, Sickle Cell Anaemia With Crisis, Cough, Upper Respiratory Tract Infection

This non-cardiac chest pain side effect was reported by a physician from United States. on Mar 23, 2010 a 48-year-old male patient from United States , weighting 134.0 lb, suffering from , was treated with Hydrea. Directly after treatment started, patient experienced the unwanted or unexpected Hydrea side effects: non-cardiac chest pain, sickle cell anaemia with crisis, cough, upper respiratory tract infection. Hydrea dosage: NA. Concurrently used drugs:
  • Lorcet-hd
  • Oxycontin
  • Exjade (1250 Mg Daily, Oral)
  • Folic Acid
. The patient was hospitalized.

Hydrea Side Effect Report#8572193-6
Sickle Cell Anaemia With Crisis, Nausea, Vomiting, Stress, Pain In Extremity

on Aug 19, 2010 a 53-year-old female patient from United States , weighting 131.0 lb, and was treated with Hydrea on Jul 15, 2010. Patient felt the following Hydrea side effects: sickle cell anaemia with crisis, nausea, vomiting, stress, pain in extremity. Hydrea dosage: NA.
Multiple prescriptions taken:
  • Exjade (1125 Mg, Daily, Oral)
  • Desferal
  • Ms Contin
  • Compazine
  • Ms Contin
  • Folic Acid
The patient was hospitalized.

Hydrea Side Effect Report#8519984-5
Rash, Cough

This rash side effect was reported by a consumer or non-health professional from United States. A 54-year-old female patient was taking Hydrea. After Hydrea was administered, patient encountered several Hydrea side effects: rash, cough. Additional patient health information: . Hydrea dosage: NA. Concurrently used drugs:
  • Azithromycin (250 Mg)
  • Estrogens (no Ingredients/substances)
  • Tasigna (150 Mg, Four Time A Day)
. The patient was hospitalized.

Hydrea Side Effect Report#8516444
Skin Ulcer, Pancytopenia, Syncope, Heart Rate Irregular

An skin ulcer adverse event was reported by a physician on Sep 04, 2012 from US. A 87-year-old female patient , weighting 101.4 lb, took Hydrea (dosage: 1990-unknw, 29nov11-20dec11) and had the following health condition(s): was diagnosed with and. Directly after treatment started, patient experienced the unwanted or unexpected Hydrea side effects: skin ulcer, pancytopenia, syncope, heart rate irregular. Concurrently used drugs:
  • Acetylsalicylic Acid
  • Levothyroxine (Tab)
  • Aspirin (Enteric Coated Tab)
  • Metoprolol Succinate (Extended Release Tab)
.

Hydrea Side Effect Report#8462396-3
Renal Failure, Cholestasis, Cytolytic Hepatitis

This renal failure side effect was reported by a physician from France. on Jun 19, 2012 a 75-year-old male patient from France , suffering from was diagnosed with and, was treated with Hydrea. Patient felt the following Hydrea side effects: renal failure, cholestasis, cytolytic hepatitis. Hydrea dosage: NA. Concurrently used drugs:
  • Sutent (Unk)
  • Oxycontin (Unk)
. The patient was hospitalized.

Hydrea Side Effect Report#8446185-1
Bone Marrow Failure, Fatigue, Deep Vein Thrombosis

on Nov 17, 2011 a 84-year-old male patient from United States , weighting 172.0 lb, and was treated with Hydrea on Mar 23, 2011. After Hydrea was administered, patient encountered several Hydrea side effects: bone marrow failure, fatigue, deep vein thrombosis. Hydrea dosage: NA.
Multiple concurrent drugs taken:
  • Aspirin
  • Cyclobenzaprine
  • Bisoprolol/hctz (biselect)
  • Dexamethasone (dexamethasone)
  • Revlimid (25 Mg, Daily For 21 Days, Po)
  • Amlodipine/benazepril (amlodipine Besylate
  • Zometa
  • Levothyroxine Sodium
The patient was hospitalized.

Hydrea Side Effect Report#8443284-5
Anaemia, Nail Discolouration, Product Counterfeit, Platelet Count Increased

This anaemia side effect was reported by a consumer or non-health professional from Brazil. A 67-year-old female patient was taking Hydrea. Directly after treatment started, patient experienced the unwanted or unexpected Hydrea side effects: anaemia, nail discolouration, product counterfeit, platelet count increased. Additional patient health information: , weighting 134.5 lb, was diagnosed with and. Hydrea dosage: 1df: 3caps, 2caps And 3 Caps On Tuesdays. Concurrently used drugs: NA..

Hydrea Side Effect Report#8435355-4
Cytolytic Hepatitis, Renal Failure, Cholestasis

An cytolytic hepatitis adverse event was reported by a physician on Jun 07, 2012 from France. A 75-year-old male patient took Hydrea (dosage: NA) and had the following health condition(s): was diagnosed with and. Patient felt the following Hydrea side effects: cytolytic hepatitis, renal failure, cholestasis. Concurrently used drugs:
  • Sutent (Unk)
  • Oxycontin (Unk)
. The patient was hospitalized.

Hydrea Side Effect Report#8425640-4
Bone Pain

This bone pain side effect was reported by a consumer or non-health professional from Brazil. on Jun 04, 2012 a male patient from Brazil , weighting 154.3 lb, suffering from , was treated with Hydrea. After Hydrea was administered, patient encountered several Hydrea side effects: bone pain. Hydrea dosage: NA. Concurrently used drugs:
  • Exjade (1500 Mg A Day)
.

Hydrea Side Effect Report#8419000-X
Haemoglobin Decreased, Pallor, Sickle Cell Anaemia With Crisis, Pneumonia, Abdominal Pain, Blood Bilirubin Abnormal

on Jun 04, 2012 a female patient from United States , weighting 116.2 lb, and was treated with Hydrea on Oct 30, 2007. Directly after treatment started, patient experienced the unwanted or unexpected Hydrea side effects: haemoglobin decreased, pallor, sickle cell anaemia with crisis, pneumonia, abdominal pain, blood bilirubin abnormal. Hydrea dosage: NA.
Associated medications used:
  • Folic Acid
  • Megace
  • Exelon
  • Meloxicam (15 Mg, Unk)
  • Lasix
  • Zoloft
  • Phenergan
  • Vicodin (705 Mg, Unk)
The patient was hospitalized.



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The appearance of Hydrea 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.

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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.

    Hydrea 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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    Hydrea Safety Alerts, Active Ingredients, Usage Information

    NDC0003-0830
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameHYDREA
    NameHYDROXYUREA
    Dosage FormCAPSULE
    RouteORAL
    On market since20090601
    LabelerE.R. Squibb & Sons, L.L.C.
    Active Ingredient(s)HYDROXYUREA
    Strength(s)500
    Unit(s)mg/1
    Pharma ClassAntimetabolite [EPC],Urea [Chemical/Ingredient]

    More About Hydrea

    Side Effects reported to FDA: 496

    Hydrea safety alerts: 2006

    Reported deaths: 97

    Reported hospitalizations: 212

    Latest Hydrea clinical trials