hydroxycarbamide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
1399 127-07-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • xromi
  • siklos
  • hydroxyurea
  • biosupressin
  • carbamohydroxamic acid
  • carbamohydroximic acid
  • carbamoyl oxime
  • oxyrea
  • oxyurea
  • hydroxycarbamide
An antineoplastic agent that inhibits DNA synthesis through the inhibition of ribonucleoside diphosphate reductase.
  • Molecular weight: 76.06
  • Formula: CH4N2O2
  • CLOGP: -1.80
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 3
  • TPSA: 75.35
  • ALOGS: 0.55
  • ROTB: 0

Drug dosage:

DoseUnitRoute
1.40 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 50 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 80 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1502.57 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 79 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.52 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.50 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 1 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 3.40 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,ACVRL1,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,ITK,JAK1,JAK2,MAP2K6,MAP3K14,MAP3K21,MAP3K7,MAP4K1,MAPK7,MTOR,NTRK1,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIK3CD,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ULK1 50
kinase-selectivity-class ACVR2A,ACVR2B,AXL,BMX,BRAF,CAMK2B,CAMK2D,CDK1,CDK9,DDR1,DYRK1B,EIF2AK3,GRK2,IKBKB,IRAK1,JAK1,JAK2,MAP2K3,MAP2K6,MAP3K10,MAP3K14,MAP3K21,MAPK7,SIK2,SIK3,STK33,TEK,TGFBR1,TTK,ULK1 30
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1

Approvals:

DateAgencyCompanyOrphan
July 1, 2019 EMA NOVA LABORATORIES IRELAND LIMITED
Dec. 7, 1967 FDA BRISTOL MYERS SQUIBB

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Sickle cell anaemia with crisis 899.43 14.50 227 19753 7070 90601397
Platelet count increased 309.43 14.50 130 19850 20729 90587738
Acute chest syndrome 246.70 14.50 56 19924 1092 90607375
Acute myeloid leukaemia 223.11 14.50 103 19877 20537 90587930
Splenomegaly 170.00 14.50 74 19906 12850 90595617
Myelofibrosis 150.46 14.50 40 19940 1527 90606940
Thrombocytopenia 146.43 14.50 204 19776 208521 90399946
Anaemia 134.83 14.50 262 19718 352540 90255927
Haemoglobin decreased 133.02 14.50 171 19809 161785 90446682
Tumour lysis syndrome 127.87 14.50 58 19922 11094 90597373
Thrombocytosis 125.50 14.50 50 19930 6951 90601516
Pancytopenia 121.47 14.50 141 19839 120122 90488345
Leukocytosis 118.90 14.50 78 19902 30912 90577555
Differentiation syndrome 113.78 14.50 31 19949 1300 90607167
White blood cell count increased 113.63 14.50 104 19876 67137 90541330
Blast crisis in myelogenous leukaemia 108.95 14.50 26 19954 635 90607832
Platelet count decreased 100.66 14.50 137 19843 136832 90471635
Febrile neutropenia 96.69 14.50 145 19835 158204 90450263
Blood lactate dehydrogenase increased 96.39 14.50 64 19916 25868 90582599
Chronic myeloid leukaemia 92.56 14.50 31 19949 2633 90605834
Serum ferritin increased 89.74 14.50 40 19940 7341 90601126
Skin ulcer 87.62 14.50 79 19901 49996 90558471
Drug resistance 76.02 14.50 59 19921 30390 90578077
Angiodermatitis 61.30 14.50 13 19967 182 90608285
Systemic lupus erythematosus 61.08 14.50 5 19975 361891 90246576
Philadelphia chromosome positive 59.12 14.50 15 19965 475 90607992
Joint swelling 55.20 14.50 21 19959 503279 90105188
Myeloproliferative neoplasm 54.64 14.50 15 19965 647 90607820
Sinusitis 54.55 14.50 6 19974 343082 90265385
Nail pigmentation 52.90 14.50 12 19968 233 90608234
Glossodynia 50.23 14.50 6 19974 321773 90286694
Arthropathy 49.98 14.50 10 19970 366232 90242235
Drug hypersensitivity 49.75 14.50 20 19960 463589 90144878
Erythromelalgia 48.95 14.50 12 19968 329 90608138
Infusion related reaction 48.06 14.50 16 19964 416764 90191703
Angiokeratoma 48.06 14.50 10 19970 127 90608340
Contraindicated product administered 47.50 14.50 7 19973 320132 90288335
Trisomy 21 45.44 14.50 12 19968 446 90608021
Haematocrit increased 45.00 14.50 19 19961 3059 90605408
Cytogenetic analysis abnormal 44.20 14.50 14 19966 996 90607471
Wound 44.10 14.50 7 19973 302973 90305494
Cytopenia 43.96 14.50 34 19946 17415 90591052
Essential thrombocythaemia 43.80 14.50 10 19970 200 90608267
Discomfort 43.09 14.50 5 19975 274330 90334137
Blood iron increased 42.23 14.50 16 19964 1943 90606524
Transformation to acute myeloid leukaemia 42.21 14.50 11 19969 388 90608079
Squamous cell carcinoma of skin 42.02 14.50 24 19956 7425 90601042
Hypersensitivity 40.66 14.50 25 19955 454652 90153815
Myelodysplastic syndrome 40.59 14.50 35 19945 20868 90587599
Haemoglobin increased 39.27 14.50 23 19957 7458 90601009
Platelet count abnormal 38.77 14.50 19 19961 4316 90604151
Polycythaemia vera 38.65 14.50 9 19971 197 90608270
Nasopharyngitis 36.93 14.50 22 19958 407082 90201385
Pleural effusion 36.49 14.50 78 19902 111913 90496554
Bone marrow failure 36.26 14.50 40 19940 32181 90576286
Lower respiratory tract infection 36.00 14.50 6 19974 250653 90357814
Blood bilirubin increased 35.77 14.50 46 19934 43424 90565043
Leukostasis syndrome 35.74 14.50 7 19973 64 90608403
Neutropenia 34.89 14.50 119 19861 224785 90383682
Primary myelofibrosis 34.82 14.50 7 19973 74 90608393
Graft versus host disease in skin 34.80 14.50 17 19963 3836 90604631
Tonsillitis bacterial 34.58 14.50 8 19972 170 90608297
Mucosal inflammation 34.03 14.50 52 19928 57573 90550894
Off label use 33.83 14.50 381 19599 1101871 89506596
Aquagenic pruritus 33.78 14.50 6 19974 30 90608437
Therapeutic product effect decreased 33.15 14.50 10 19970 277561 90330906
Squamous cell carcinoma 32.94 14.50 23 19957 10078 90598389
Sickle cell anaemia 32.72 14.50 10 19970 632 90607835
Urticaria 32.70 14.50 14 19966 312720 90295747
Sleep disorder 32.67 14.50 3 19977 198027 90410440
Blood cholesterol increased 32.15 14.50 4 19976 208008 90400459
Hepatic enzyme increased 32.01 14.50 20 19960 360716 90247751
Mobility decreased 31.87 14.50 8 19972 250726 90357741
Acute myeloid leukaemia recurrent 31.08 14.50 13 19967 2044 90606423
Posterior reversible encephalopathy syndrome 30.97 14.50 31 19949 22308 90586159
Chronic myeloid leukaemia transformation 30.95 14.50 7 19973 134 90608333
Blister 30.79 14.50 9 19971 254989 90353478
Leukaemia 30.64 14.50 17 19963 4975 90603492
Alpha haemolytic streptococcal infection 29.61 14.50 12 19968 1742 90606725
Acute graft versus host disease 29.20 14.50 17 19963 5451 90603016
Red blood cell count decreased 29.04 14.50 43 19937 46308 90562159
Type 2 diabetes mellitus 28.88 14.50 5 19975 203239 90405228
Varicella zoster virus infection 28.84 14.50 15 19965 3862 90604605
Mixed liver injury 28.77 14.50 19 19961 7604 90600863
Hypersplenism 28.71 14.50 8 19972 365 90608102
Cytomegalovirus infection reactivation 28.37 14.50 19 19961 7781 90600686
Musculoskeletal stiffness 28.36 14.50 15 19965 296517 90311950
Haematocrit decreased 27.94 14.50 40 19940 41792 90566675
Injury 27.73 14.50 5 19975 197344 90411123
Ovarian failure 26.91 14.50 11 19969 1632 90606835
Pericarditis 26.83 14.50 13 19967 270138 90338329
Subdural haematoma 26.65 14.50 25 19955 16620 90591847
Death 26.63 14.50 182 19798 456369 90152098
Paraesthesia 26.50 14.50 11 19969 250315 90358152
Heavy chain disease 26.44 14.50 4 19976 5 90608462
Rheumatoid arthritis 25.96 14.50 25 19955 362589 90245878
Blast cell count increased 25.94 14.50 8 19972 521 90607946
Laryngeal inflammation 25.61 14.50 6 19974 135 90608332
Malignant neoplasm progression 25.59 14.50 66 19914 106804 90501663
Swelling 25.50 14.50 33 19947 419025 90189442
Injection site pain 25.29 14.50 4 19976 173695 90434772
Foetal growth restriction 25.22 14.50 19 19961 9361 90599106
Gene mutation identification test positive 25.16 14.50 6 19974 146 90608321
Chronic graft versus host disease 25.15 14.50 14 19966 4125 90604342
Neoplasm malignant 25.02 14.50 34 19946 33846 90574621
Dermatomyositis 24.95 14.50 13 19967 3357 90605110
Disseminated intravascular coagulation 24.69 14.50 27 19953 21511 90586956
Hyperbilirubinaemia 24.39 14.50 22 19958 13914 90594553
White blood cell count decreased 23.81 14.50 86 19894 167023 90441444
Blood disorder 23.69 14.50 17 19963 7773 90600694
Haemorrhage 23.38 14.50 49 19931 69320 90539147
Acute graft versus host disease in skin 23.34 14.50 14 19966 4742 90603725
Haemorrhagic thyroid cyst 23.25 14.50 4 19976 16 90608451
Graft versus host disease 23.02 14.50 17 19963 8127 90600340
Skin maceration 23.01 14.50 6 19974 212 90608255
Pneumonia cryptococcal 22.79 14.50 9 19971 1222 90607245
Soft tissue necrosis 22.70 14.50 8 19972 792 90607675
Liver injury 22.54 14.50 5 19975 170562 90437905
Tyrosine kinase mutation 22.36 14.50 4 19976 21 90608446
Bronchopulmonary aspergillosis 21.96 14.50 19 19961 11379 90597088
Post cardiac arrest syndrome 21.90 14.50 4 19976 24 90608443
Transient acantholytic dermatosis 21.90 14.50 5 19975 100 90608367
Splenic rupture 21.85 14.50 9 19971 1362 90607105
Peripheral swelling 21.74 14.50 36 19944 413070 90195397
Blast cells present 21.49 14.50 7 19973 545 90607922
Anaemia macrocytic 21.25 14.50 13 19967 4559 90603908
Intentional product use issue 20.93 14.50 99 19881 216793 90391674
Uterine atony 20.23 14.50 6 19974 342 90608125
Psoriasis 20.21 14.50 4 19976 147750 90460717
Actinic keratosis 19.96 14.50 11 19969 3177 90605290
Viral infection 19.85 14.50 34 19946 41380 90567087
Ill-defined disorder 19.76 14.50 8 19972 184883 90423584
Insomnia 19.53 14.50 27 19953 333447 90275020
Ventricular hypokinesia 19.40 14.50 13 19967 5328 90603139
Multiple organ dysfunction syndrome 19.33 14.50 45 19935 68291 90540176
Anxiety 19.24 14.50 24 19956 309748 90298719
Serum ferritin decreased 19.12 14.50 10 19970 2604 90605863
Palmar erythema 18.98 14.50 9 19971 1902 90606565
Hypoaesthesia 18.84 14.50 25 19955 314185 90294282
Alopecia 18.67 14.50 52 19928 495019 90113448
Sleep disorder due to general medical condition, insomnia type 18.65 14.50 3 19977 128691 90479776
Vasculitis 18.65 14.50 24 19956 22669 90585798
Red blood cell count increased 18.59 14.50 11 19969 3632 90604835
Osteoarthritis 18.56 14.50 10 19970 195720 90412747
Acute respiratory distress syndrome 18.52 14.50 27 19953 28659 90579808
Transfusion 18.46 14.50 21 19959 17467 90591000
Pharyngeal haematoma 18.42 14.50 4 19976 63 90608404
Bone marrow reticulin fibrosis 18.39 14.50 5 19975 208 90608259
Renal failure 18.30 14.50 67 19913 130940 90477527
Abdominal discomfort 18.10 14.50 50 19930 477278 90131189
Retinopathy sickle cell 18.08 14.50 4 19976 69 90608398
Abortion spontaneous 18.00 14.50 38 19942 54018 90554449
Leukaemia recurrent 17.99 14.50 8 19972 1459 90607008
Extramedullary haemopoiesis 17.99 14.50 5 19975 226 90608241
Adenocarcinoma metastatic 17.99 14.50 5 19975 226 90608241
Left ventricular dysfunction 17.88 14.50 19 19961 14650 90593817
Bone pain 17.73 14.50 41 19939 61942 90546525
Acute respiratory failure 17.70 14.50 33 19947 42885 90565582
Migraine 17.66 14.50 10 19970 190382 90418085
Thyroid haemorrhage 17.62 14.50 4 19976 78 90608389
Hepatomegaly 17.57 14.50 18 19962 13308 90595159
Reticulocyte count abnormal 17.52 14.50 4 19976 80 90608387
Dermatitis bullous 17.49 14.50 16 19964 10300 90598167
Cytogenetic abnormality 17.45 14.50 6 19974 552 90607915
Monocyte percentage decreased 17.20 14.50 5 19975 266 90608201
Septic shock 17.16 14.50 49 19931 84111 90524356
Inflammation 17.11 14.50 9 19971 178583 90429884
Nail discolouration 17.10 14.50 10 19970 3232 90605235
Dry gangrene 16.60 14.50 6 19974 639 90607828
Confusional state 16.54 14.50 38 19942 386167 90222300
Hypoperfusion 16.50 14.50 8 19972 1776 90606691
Basophil count increased 16.48 14.50 7 19973 1144 90607323
Acute febrile neutrophilic dermatosis 16.27 14.50 10 19970 3535 90604932
Disease progression 16.22 14.50 73 19907 156542 90451925
Hepatosplenic candidiasis 16.19 14.50 5 19975 327 90608140
Rash 16.18 14.50 106 19874 795994 89812473
Sickle cell disease 16.13 14.50 4 19976 115 90608352
Haemolysis 16.02 14.50 14 19966 8496 90599971
Pulmonary toxicity 15.98 14.50 16 19964 11515 90596952
Basophil percentage increased 15.88 14.50 4 19976 123 90608344
Dry mouth 15.24 14.50 11 19969 184048 90424419
Toxicity to various agents 15.21 14.50 25 19955 287821 90320646
Blood uric acid increased 15.16 14.50 13 19967 7691 90600776
Pyelonephritis 15.15 14.50 21 19959 21295 90587172
Leukaemia cutis 15.11 14.50 4 19976 150 90608317
Tissue infiltration 14.85 14.50 6 19974 864 90607603
Neutropenic colitis 14.85 14.50 10 19970 4133 90604334
Dementia 14.75 14.50 22 19958 23839 90584628
Hyperleukocytosis 14.74 14.50 6 19974 881 90607586
Impaired healing 14.69 14.50 18 19962 234181 90374286
Electrocardiogram QT prolonged 14.59 14.50 42 19938 72414 90536053
Road traffic accident 14.53 14.50 3 19977 107623 90500844

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Sickle cell anaemia with crisis 776.14 14.43 216 19139 4674 42597306
Acute chest syndrome 201.19 14.43 54 19301 1011 42600969
Differentiation syndrome 189.69 14.43 58 19297 1755 42600225
Acute myeloid leukaemia 179.93 14.43 117 19238 22139 42579841
Myelofibrosis 167.65 14.43 53 19302 1794 42600186
Splenomegaly 156.18 14.43 97 19258 16950 42585030
White blood cell count increased 136.67 14.43 133 19222 44954 42557026
Chronic myeloid leukaemia 133.07 14.43 48 19307 2444 42599536
Tumour lysis syndrome 128.25 14.43 95 19260 22136 42579844
Blast crisis in myelogenous leukaemia 126.89 14.43 34 19321 632 42601348
Platelet count increased 111.12 14.43 66 19289 10637 42591343
Leukocytosis 110.01 14.43 98 19257 29610 42572370
Thrombocytopenia 99.50 14.43 247 19108 190032 42411948
Anaemia 83.55 14.43 298 19057 279980 42322000
Cytogenetic analysis abnormal 77.70 14.43 24 19331 751 42601229
Haemoglobin decreased 76.71 14.43 179 19176 132292 42469688
Hyperleukocytosis 74.70 14.43 32 19323 2576 42599404
Febrile neutropenia 72.89 14.43 217 19138 185486 42416494
Blast cell count increased 71.52 14.43 25 19330 1160 42600820
Philadelphia chromosome positive 69.15 14.43 21 19334 620 42601360
Serum ferritin increased 60.89 14.43 39 19316 7180 42594800
Skin ulcer 60.31 14.43 66 19289 25535 42576445
Endocarditis noninfective 54.19 14.43 13 19342 151 42601829
Increased viscosity of upper respiratory secretion 53.08 14.43 15 19340 342 42601638
Actinic keratosis 51.33 14.43 31 19324 5145 42596835
Graft versus host disease in skin 51.13 14.43 31 19324 5181 42596799
Splenic infarction 51.02 14.43 24 19331 2407 42599573
Blood lactate dehydrogenase increased 50.89 14.43 61 19294 26020 42575960
Granulomatous rosacea 48.99 14.43 12 19343 153 42601827
Mucosal inflammation 48.15 14.43 83 19272 49291 42552689
Myeloproliferative neoplasm 44.99 14.43 16 19339 781 42601199
Pyrexia 41.99 14.43 314 19041 393728 42208252
Pancytopenia 41.83 14.43 133 19222 117610 42484370
Marrow hyperplasia 40.89 14.43 17 19338 1270 42600710
Idiopathic intracranial hypertension 40.64 14.43 15 19340 815 42601165
Extremity necrosis 39.94 14.43 20 19335 2299 42599681
Toxicity to various agents 38.15 14.43 29 19326 229107 42372873
Drug resistance 37.97 14.43 61 19294 34187 42567793
Platelet count decreased 36.65 14.43 142 19213 138439 42463541
Myeloid leukaemia 36.13 14.43 12 19343 476 42601504
Chronic myelomonocytic leukaemia 34.47 14.43 13 19342 750 42601230
Squamous cell carcinoma 33.26 14.43 35 19320 12947 42589033
Sickle cell disease 33.20 14.43 9 19346 175 42601805
Transformation to acute myeloid leukaemia 33.11 14.43 14 19341 1091 42600889
Toxic epidermal necrolysis 31.52 14.43 49 19306 26701 42575279
Thrombocytosis 31.15 14.43 22 19333 4753 42597227
Night sweats 29.96 14.43 41 19314 19928 42582052
Differential white blood cell count abnormal 29.92 14.43 15 19340 1729 42600251
Pleural effusion 29.38 14.43 104 19251 97062 42504918
Azoospermia 27.44 14.43 10 19345 524 42601456
Posterior reversible encephalopathy syndrome 26.68 14.43 31 19324 12790 42589190
Myelodysplastic syndrome 25.88 14.43 41 19314 22704 42579276
Haematocrit decreased 25.66 14.43 52 19303 34856 42567124
Spermatogenesis abnormal 25.65 14.43 6 19349 62 42601918
Subacute combined cord degeneration 25.27 14.43 7 19348 148 42601832
Sticky platelet syndrome 25.26 14.43 5 19350 21 42601959
Varicophlebitis 25.07 14.43 5 19350 22 42601958
Rhabdomyolysis 25.05 14.43 3 19352 78016 42523964
Full blood count abnormal 24.99 14.43 47 19308 29829 42572151
Cytomegalovirus infection reactivation 24.90 14.43 28 19327 11150 42590830
Essential thrombocythaemia 24.31 14.43 7 19348 171 42601809
Parainfluenzae virus infection 24.27 14.43 17 19338 3626 42598354
Antineutrophil cytoplasmic antibody positive 23.70 14.43 18 19337 4347 42597633
Polyarteritis nodosa 23.42 14.43 8 19347 346 42601634
Nasal polyps 23.42 14.43 17 19338 3834 42598146
Chronic myeloid leukaemia transformation 23.20 14.43 7 19348 202 42601778
Second primary malignancy 23.09 14.43 25 19330 9550 42592430
Drug interaction 22.88 14.43 55 19300 266944 42335036
Intentional product use issue 22.67 14.43 78 19277 71755 42530225
Acute myeloid leukaemia recurrent 22.49 14.43 16 19339 3496 42598484
Completed suicide 22.24 14.43 8 19347 96457 42505523
Red blood cell count decreased 22.01 14.43 47 19308 32668 42569312
Chronic myeloid leukaemia recurrent 21.70 14.43 7 19348 253 42601727
Capillary fragility 21.61 14.43 5 19350 49 42601931
Leukaemic infiltration pulmonary 21.25 14.43 4 19351 12 42601968
Gangrene 21.15 14.43 18 19337 5108 42596872
Disseminated intravascular coagulation 20.73 14.43 39 19316 24755 42577225
Bone marrow failure 20.51 14.43 46 19309 33047 42568933
Leukostasis syndrome 20.45 14.43 6 19349 157 42601823
Squamous cell carcinoma of skin 20.41 14.43 27 19328 12699 42589281
Hypersplenism 20.14 14.43 8 19347 531 42601449
Drug hypersensitivity 20.10 14.43 10 19345 99379 42502601
Erdheim-Chester disease 20.09 14.43 3 19352 0 42601980
Anaemia macrocytic 20.06 14.43 15 19340 3540 42598440
Erythropoiesis abnormal 19.79 14.43 7 19348 336 42601644
Therapeutic drug monitoring analysis not performed 19.55 14.43 8 19347 574 42601406
Dermatomyositis 19.35 14.43 11 19344 1632 42600348
Janus kinase 2 mutation 19.02 14.43 4 19351 24 42601956
Loss of therapeutic response 18.95 14.43 10 19345 1281 42600699
Gene mutation 18.52 14.43 11 19344 1770 42600210
Hepatosplenomegaly 18.49 14.43 16 19339 4644 42597336
Acute respiratory failure 17.70 14.43 48 19307 38810 42563170
Cerebral haemorrhage 17.62 14.43 48 19307 38918 42563062
Hip deformity 17.57 14.43 5 19350 117 42601863
Acinetobacter sepsis 17.57 14.43 5 19350 117 42601863
Ureterolithiasis 17.16 14.43 12 19343 2552 42599428
Rectal neoplasm 17.00 14.43 5 19350 132 42601848
Sickle cell anaemia 16.99 14.43 6 19349 287 42601693
Vasoconstriction 16.97 14.43 6 19349 288 42601692
Pleuroparenchymal fibroelastosis 16.45 14.43 5 19350 148 42601832
Anaemia vitamin B12 deficiency 16.43 14.43 7 19348 556 42601424
Leukoerythroblastosis 16.26 14.43 4 19351 52 42601928
Pneumatosis 16.00 14.43 7 19348 593 42601387
Spermatozoa morphology abnormal 15.70 14.43 3 19352 10 42601970
Myocardial infarction 15.64 14.43 20 19335 123989 42477991
Somnolence 15.59 14.43 25 19330 141080 42460900
Embolism venous 15.34 14.43 10 19345 1896 42600084
Blood bilirubin increased 15.22 14.43 48 19307 42204 42559776
Aplastic anaemia 15.03 14.43 23 19332 12361 42589619
Interstitial lung disease 15.03 14.43 73 19282 78389 42523591
Bone marrow disorder 14.96 14.43 10 19345 1976 42600004
Polycythaemia vera 14.83 14.43 6 19349 418 42601562
White blood cell count decreased 14.65 14.43 93 19262 110303 42491677

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Sickle cell anaemia with crisis 1310.91 13.40 345 33005 9200 110546749
Acute chest syndrome 416.99 13.40 102 33248 2001 110553948
Acute myeloid leukaemia 349.37 13.40 188 33162 37922 110518027
Differentiation syndrome 319.14 13.40 89 33261 2955 110552994
Platelet count increased 272.82 13.40 141 33209 26193 110529756
Splenomegaly 270.70 13.40 137 33213 24361 110531588
Myelofibrosis 247.28 13.40 73 33277 2978 110552971
Thrombocytopenia 244.76 13.40 403 32947 348482 110207467
Tumour lysis syndrome 225.19 13.40 131 33219 30670 110525279
Febrile neutropenia 200.99 13.40 350 33000 316417 110239532
Leukocytosis 200.04 13.40 150 33200 53678 110502271
Anaemia 196.95 13.40 478 32872 546608 110009341
Blast crisis in myelogenous leukaemia 190.26 13.40 47 33303 961 110554988
Chronic myeloid leukaemia 179.51 13.40 62 33288 4211 110551738
Haemoglobin decreased 177.87 13.40 290 33060 248437 110307512
White blood cell count increased 164.28 13.40 173 33177 96669 110459280
Pancytopenia 147.91 13.40 243 33107 209370 110346579
Skin ulcer 136.15 13.40 129 33221 63516 110492433
Thrombocytosis 134.97 13.40 65 33285 10379 110545570
Platelet count decreased 118.78 13.40 233 33117 230210 110325739
Philadelphia chromosome positive 111.44 13.40 30 33320 870 110555079
Blood lactate dehydrogenase increased 110.69 13.40 98 33252 44236 110511713
Hyperleukocytosis 96.31 13.40 37 33313 3402 110552547
Myeloproliferative neoplasm 89.78 13.40 28 33322 1377 110554572
Serum ferritin increased 88.19 13.40 51 33299 11796 110544153
Mucosal inflammation 85.33 13.40 124 33226 96017 110459932
Squamous cell carcinoma 83.53 13.40 58 33292 18405 110537544
Graft versus host disease in skin 82.03 13.40 43 33307 8211 110547738
Actinic keratosis 79.73 13.40 40 33310 6973 110548976
Transformation to acute myeloid leukaemia 79.41 13.40 26 33324 1497 110554452
Drug hypersensitivity 71.34 13.40 24 33326 454066 110101883
Squamous cell carcinoma of skin 70.78 13.40 51 33299 17152 110538797
Drug resistance 70.49 13.40 86 33264 56288 110499661
Joint swelling 68.53 13.40 24 33326 442821 110113128
Blast cell count increased 65.85 13.40 23 33327 1614 110554335
Cytogenetic analysis abnormal 63.50 13.40 21 33329 1248 110554701
Angiodermatitis 62.26 13.40 14 33336 187 110555762
Systemic lupus erythematosus 60.97 13.40 4 33346 254334 110301615
Contraindicated product administered 59.23 13.40 4 33346 248263 110307686
Cytomegalovirus infection reactivation 59.14 13.40 47 33303 18286 110537663
Splenic infarction 58.88 13.40 28 33322 4346 110551603
Infusion related reaction 58.38 13.40 21 33329 381141 110174808
Posterior reversible encephalopathy syndrome 58.28 13.40 61 33289 33800 110522149
Arthropathy 57.41 13.40 9 33341 287513 110268436
Essential thrombocythaemia 57.18 13.40 15 33335 393 110555556
Pleural effusion 57.09 13.40 149 33201 177560 110378389
Myelodysplastic syndrome 54.87 13.40 62 33288 37422 110518527
Acute myeloid leukaemia recurrent 54.60 13.40 28 33322 5111 110550838
Toxicity to various agents 52.32 13.40 41 33309 480514 110075435
Pyrexia 51.84 13.40 454 32896 897811 109658138
Endocarditis noninfective 51.46 13.40 13 33337 292 110555657
Increased viscosity of upper respiratory secretion 50.68 13.40 15 33335 617 110555332
Granulomatous rosacea 50.12 13.40 12 33338 214 110555735
Marrow hyperplasia 49.14 13.40 19 33331 1777 110554172
Glossodynia 49.03 13.40 5 33345 221999 110333950
Bone marrow failure 48.98 13.40 73 33277 57775 110498174
Cytopenia 47.85 13.40 52 33298 30064 110525885
Hypersplenism 47.84 13.40 15 33335 751 110555198
Erythromelalgia 46.65 13.40 13 33337 430 110555519
Sinusitis 46.01 13.40 16 33334 296672 110259277
Therapeutic product effect decreased 45.82 13.40 9 33341 244307 110311642
Leukostasis syndrome 44.43 13.40 11 33339 227 110555722
Dermatomyositis 43.92 13.40 23 33327 4383 110551566
Graft versus host disease 43.83 13.40 40 33310 18766 110537183
Disseminated intravascular coagulation 43.73 13.40 58 33292 41228 110514721
Nail pigmentation 43.62 13.40 12 33338 378 110555571
Idiopathic intracranial hypertension 43.34 13.40 22 33328 3930 110552019
Completed suicide 43.26 13.40 10 33340 242371 110313578
Nasopharyngitis 42.46 13.40 34 33316 394327 110161622
Drug abuse 41.90 13.40 3 33347 177408 110378541
Chronic myeloid leukaemia transformation 41.09 13.40 11 33339 312 110555637
Hypersensitivity 40.85 13.40 37 33313 403961 110151988
Death 40.65 13.40 354 32996 698515 109857434
Red blood cell count decreased 40.58 13.40 72 33278 65851 110490098
Blood bilirubin increased 40.52 13.40 78 33272 75894 110480055
Anaemia macrocytic 40.39 13.40 26 33324 7277 110548672
Angiokeratoma 40.36 13.40 10 33340 207 110555742
Mobility decreased 40.05 13.40 11 33339 237411 110318538
Swelling 39.40 13.40 29 33321 351012 110204937
Malignant neoplasm progression 39.35 13.40 129 33221 174438 110381511
Injection site pain 39.31 13.40 4 33346 177918 110378031
Sickle cell anaemia 38.96 13.40 13 33337 794 110555155
Azoospermia 38.64 13.40 10 33340 248 110555701
Musculoskeletal stiffness 38.64 13.40 18 33332 279804 110276145
Sleep disorder 37.92 13.40 7 33343 198637 110357312
Haematocrit decreased 37.89 13.40 70 33280 66047 110489902
Myeloid leukaemia 37.50 13.40 13 33337 892 110555057
Acute respiratory failure 37.39 13.40 75 33275 75185 110480764
Sickle cell disease 36.11 13.40 9 33341 191 110555758
Haematocrit increased 35.99 13.40 21 33329 4938 110551011
Polycythaemia vera 35.81 13.40 11 33339 514 110555435
Wound 35.73 13.40 13 33337 234424 110321525
Rheumatoid arthritis 34.60 13.40 24 33326 299589 110256360
Lower respiratory tract infection 34.56 13.40 15 33335 243091 110312858
Intentional product use issue 34.35 13.40 157 33193 247749 110308200
Discomfort 34.29 13.40 11 33339 214696 110341253
Blood cholesterol increased 34.24 13.40 7 33343 184778 110371171
Folliculitis 34.02 13.40 5 33345 167648 110388301
Cerebral haemorrhage 32.58 13.40 65 33285 64903 110491046
Tongue neoplasm malignant stage unspecified 32.54 13.40 13 33337 1326 110554623
Hyperbilirubinaemia 32.34 13.40 43 33307 30628 110525321
Interstitial lung disease 32.33 13.40 104 33246 139230 110416719
Type 2 diabetes mellitus 32.25 13.40 7 33343 177225 110378724
Peripheral swelling 32.11 13.40 45 33305 403989 110151960
Differential white blood cell count abnormal 31.91 13.40 15 33335 2269 110553680
Chronic myelomonocytic leukaemia 31.79 13.40 12 33338 1051 110554898
White blood cell count decreased 31.57 13.40 145 33205 229245 110326704
Psoriasis 31.31 13.40 3 33347 139990 110415959
Injury 30.29 13.40 8 33342 177257 110378692
Tonsillitis bacterial 29.49 13.40 8 33342 239 110555710
Parainfluenzae virus infection 29.43 13.40 21 33329 6953 110548996
Liver injury 29.36 13.40 5 33345 150408 110405541
Gene mutation 28.86 13.40 16 33334 3413 110552536
Osteoarthritis 28.04 13.40 10 33340 182613 110373336
Leukaemic infiltration pulmonary 27.91 13.40 5 33345 18 110555931
Blister 27.90 13.40 17 33333 227359 110328590
Antineutrophil cytoplasmic antibody positive 27.90 13.40 18 33332 5058 110550891
Electrocardiogram QT prolonged 27.74 13.40 84 33266 108876 110447073
Sticky platelet syndrome 27.49 13.40 5 33345 20 110555929
Leukaemia recurrent 27.43 13.40 15 33335 3116 110552833
Neoplasm malignant 27.42 13.40 44 33306 37099 110518850
Neutropenia 26.75 13.40 199 33151 374421 110181528
Neutropenic colitis 26.71 13.40 21 33329 8044 110547905
Platelet count abnormal 26.70 13.40 19 33331 6263 110549686
Joint range of motion decreased 26.24 13.40 3 33347 121829 110434120
Hepatic enzyme increased 26.23 13.40 35 33315 320857 110235092
Off label use 26.02 13.40 613 32737 1499572 109056377
Primary myelofibrosis 25.90 13.40 7 33343 206 110555743
Dry mouth 25.89 13.40 14 33336 199934 110356015
Jaundice 25.87 13.40 56 33294 59180 110496769
Urticaria 25.84 13.40 35 33315 318822 110237127
Alopecia 25.75 13.40 44 33306 364709 110191240
Ovarian failure 25.55 13.40 10 33340 966 110554983
Haemorrhage 25.08 13.40 80 33270 106612 110449337
Hepatosplenomegaly 25.06 13.40 19 33331 6900 110549049
Subdural haematoma 23.98 13.40 41 33309 36413 110519536
Reticulocyte count increased 23.84 13.40 11 33339 1595 110554354
Paraesthesia 23.80 13.40 29 33321 276492 110279457
Leukaemia 23.66 13.40 19 33331 7499 110548450
Acute febrile neutrophilic dermatosis 23.49 13.40 16 33334 4920 110551029
Blood iron increased 23.42 13.40 12 33338 2186 110553763
Varicophlebitis 22.96 13.40 5 33345 57 110555892
Heavy chain disease 22.89 13.40 4 33346 12 110555937
Sepsis 22.86 13.40 173 33177 327173 110228776
Cardiac failure 22.49 13.40 114 33236 187512 110368437
Blood uric acid increased 22.42 13.40 30 33320 21499 110534450
Haemoglobin increased 22.38 13.40 20 33330 9127 110546822
Extremity necrosis 22.18 13.40 14 33336 3788 110552161
Subacute combined cord degeneration 22.12 13.40 7 33343 361 110555588
Hypoaesthesia 22.09 13.40 38 33312 314185 110241764
Blast cells present 22.06 13.40 9 33341 969 110554980
Polyarteritis nodosa 22.05 13.40 8 33342 627 110555322
Haemorrhagic thyroid cyst 22.00 13.40 4 33346 16 110555933
Acute graft versus host disease 21.80 13.40 23 33327 12858 110543091
Acute respiratory distress syndrome 21.77 13.40 49 33301 53149 110502800
Second primary malignancy 21.67 13.40 27 33323 18041 110537908
Cholestasis 21.63 13.40 55 33295 64463 110491486
Bronchopulmonary aspergillosis 21.53 13.40 35 33315 29828 110526121
Retinopathy sickle cell 21.51 13.40 5 33345 78 110555871
Abdominal discomfort 21.49 13.40 55 33295 393803 110162146
Anxiety 21.39 13.40 45 33305 345033 110210916
Gastrointestinal disorder 21.22 13.40 25 33325 241927 110314022
Intentional product misuse 20.88 13.40 7 33343 132897 110423052
Disease progression 20.56 13.40 135 33215 243899 110312050
Respiratory failure 20.56 13.40 123 33227 215209 110340740
Pericardial effusion 20.47 13.40 50 33300 57167 110498782
Blood pressure increased 20.29 13.40 29 33321 258344 110297605
Bursitis 20.14 13.40 7 33343 129911 110426038
Rash 20.12 13.40 155 33195 820809 109735140
Full blood count abnormal 20.07 13.40 49 33301 56003 110499946
Anaphylactic reaction 19.83 13.40 5 33345 114295 110441654
Budd-Chiari syndrome 19.81 13.40 5 33345 112 110555837
Haemolysis 19.77 13.40 24 33326 15615 110540334
Chromosome analysis abnormal 19.56 13.40 6 33344 279 110555670
Transplant failure 19.37 13.40 15 33335 5620 110550329
Vasculitis 19.33 13.40 37 33313 35836 110520113
Rectal neoplasm 19.17 13.40 5 33345 128 110555821
Reticulocyte count abnormal 19.13 13.40 5 33345 129 110555820
Enterococcal infection 19.13 13.40 27 33323 20339 110535610
Pneumonia cryptococcal 19.07 13.40 11 33339 2531 110553418
Acinetobacter sepsis 18.71 13.40 5 33345 141 110555808
Injection site erythema 18.67 13.40 3 33347 94173 110461776
Arthritis 18.59 13.40 14 33336 167572 110388377
Laryngeal inflammation 18.57 13.40 6 33344 331 110555618
Extramedullary haemopoiesis 18.40 13.40 6 33344 341 110555608
Erythropoiesis abnormal 18.28 13.40 7 33343 638 110555311
Post cardiac arrest syndrome 18.26 13.40 4 33346 47 110555902
Sciatica 18.19 13.40 3 33347 92396 110463553
Road traffic accident 18.06 13.40 5 33345 107393 110448556
Mutagenic effect 18.03 13.40 3 33347 6 110555943
Ureterolithiasis 17.99 13.40 13 33337 4389 110551560
Alpha haemolytic streptococcal infection 17.94 13.40 12 33338 3581 110552368
Rhabdomyolysis 17.80 13.40 7 33343 120394 110435555
Hypercholesterolaemia 17.77 13.40 3 33347 90834 110465115
Basal cell carcinoma 17.75 13.40 41 33309 45229 110510720
Impaired healing 17.60 13.40 20 33330 196697 110359252
Ill-defined disorder 17.53 13.40 13 33337 156840 110399109
Adenovirus infection 17.49 13.40 19 33331 10975 110544974
Skin mass 17.46 13.40 18 33332 9798 110546151
Subdural haemorrhage 17.37 13.40 15 33335 6543 110549406
Pseudohyperkalaemia 17.16 13.40 3 33347 9 110555940
Soft tissue necrosis 17.14 13.40 8 33342 1190 110554759
Bone marrow necrosis 17.12 13.40 6 33344 425 110555524
Tyrosine kinase mutation 17.06 13.40 4 33346 65 110555884
Suicide attempt 17.04 13.40 5 33345 103389 110452560
Radiation interaction 17.00 13.40 4 33346 66 110555883
Migraine 17.00 13.40 16 33334 171636 110384313
Graft versus host disease in gastrointestinal tract 16.96 13.40 17 33333 8951 110546998
Erdheim-Chester disease 16.93 13.40 3 33347 10 110555939
Skin maceration 16.70 13.40 5 33345 214 110555735
Limbal stem cell deficiency 16.62 13.40 4 33346 73 110555876
Portal vein thrombosis 16.42 13.40 15 33335 7043 110548906
Leukoerythroblastic anaemia 16.30 13.40 3 33347 13 110555936
Intentional overdose 16.12 13.40 10 33340 132491 110423458
Acute graft versus host disease in skin 16.12 13.40 18 33332 10722 110545227
Splenic rupture 16.11 13.40 10 33340 2627 110553322
Mixed liver injury 16.03 13.40 19 33331 12060 110543889
Basophil percentage increased 15.97 13.40 5 33345 249 110555700
Remission not achieved 15.95 13.40 6 33344 521 110555428
Inflammation 15.86 13.40 21 33329 193217 110362732
Cytomegalovirus infection 15.80 13.40 44 33306 54400 110501549
Haematoma 15.75 13.40 46 33304 58430 110497519
Weight increased 15.75 13.40 69 33281 419575 110136374
Capillary fragility 15.67 13.40 5 33345 265 110555684
Toxic epidermal necrolysis 15.64 13.40 45 33305 56682 110499267
Uterine atony 15.63 13.40 5 33345 267 110555682
Hip deformity 15.56 13.40 5 33345 271 110555678
Nail discolouration 15.46 13.40 11 33339 3624 110552325
Thyroid haemorrhage 15.31 13.40 4 33346 103 110555846
Pneumatosis 15.31 13.40 7 33343 994 110554955
Central nervous system leukaemia 15.28 13.40 6 33344 585 110555364
Wheezing 15.22 13.40 34 33316 255196 110300753
Penile erosion 15.22 13.40 3 33347 20 110555929
Therapy non-responder 15.10 13.40 90 33260 157217 110398732
Janus kinase 2 mutation 15.09 13.40 3 33347 21 110555928
Gene mutation identification test positive 14.99 13.40 5 33345 305 110555644
Pericarditis 14.94 13.40 27 33323 219087 110336862
Musculoskeletal pain 14.91 13.40 20 33330 183003 110372946
Gastroenteritis staphylococcal 14.85 13.40 5 33345 314 110555635
Epistaxis 14.78 13.40 78 33272 130294 110425655
Prostatism 14.76 13.40 4 33346 119 110555830
Hyperuricaemia 14.75 13.40 20 33330 14511 110541438
Respiratory distress 14.71 13.40 50 33300 68824 110487125
Transient acantholytic dermatosis 14.70 13.40 5 33345 324 110555625
Multiple organ dysfunction syndrome 14.69 13.40 87 33263 151623 110404326
Reticulocytopenia 14.64 13.40 5 33345 328 110555621
Monocyte percentage decreased 14.63 13.40 5 33345 329 110555620
Splenic haematoma 14.58 13.40 5 33345 332 110555617
Bone marrow reticulin fibrosis 14.45 13.40 5 33345 341 110555608
Amyotrophy 14.31 13.40 6 33344 692 110555257
Aplastic anaemia 14.25 13.40 26 33324 24282 110531667
Periarticular disorder 14.23 13.40 3 33347 29 110555920
Pleuroparenchymal fibroelastosis 14.22 13.40 5 33345 358 110555591
Pruritus 14.13 13.40 110 33240 581450 109974499
Lung infiltration 14.01 13.40 26 33324 24602 110531347
Bone marrow disorder 13.99 13.40 11 33339 4212 110551737
Peripheral venous disease 13.99 13.40 4 33346 84113 110471836
Anaemia vitamin B12 deficiency 13.95 13.40 7 33343 1220 110554729
Acute erythroid leukaemia 13.91 13.40 5 33345 382 110555567
Acute leukaemia 13.87 13.40 8 33342 1841 110554108
Ventricular hypokinesia 13.84 13.40 17 33333 11197 110544752
Varicella zoster virus infection 13.78 13.40 13 33337 6355 110549594
Adenocarcinoma metastatic 13.74 13.40 5 33345 395 110555554
Tremor 13.71 13.40 25 33325 202207 110353742
Jugular vein thrombosis 13.70 13.40 12 33338 5333 110550616
Blood pressure systolic increased 13.70 13.40 4 33346 82987 110472962
Confusional state 13.68 13.40 84 33266 468596 110087353
Bone pain 13.66 13.40 47 33303 65086 110490863
Lower limb fracture 13.65 13.40 3 33347 75345 110480604
Asthma 13.61 13.40 35 33315 250256 110305693
Gait disturbance 13.57 13.40 41 33309 278167 110277782
Therapeutic drug monitoring analysis not performed 13.55 13.40 8 33342 1923 110554026
Hypercreatininaemia 13.52 13.40 7 33343 1302 110554647
Venous pressure increased 13.49 13.40 3 33347 38 110555911
Pharyngeal haematoma 13.43 13.40 4 33346 168 110555781

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01XX05 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Other antineoplastic agents
FDA CS M0022315 Urea
MeSH PA D000970 Antineoplastic Agents
MeSH PA D000986 Antisickling Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D006401 Hematologic Agents
MeSH PA D019384 Nucleic Acid Synthesis Inhibitors
FDA EPC N0000180853 Antimetabolite
CHEBI has role CHEBI:35221 antimetabolite
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:48578 radical scavenger
CHEBI has role CHEBI:50846 immunomodulator
CHEBI has role CHEBI:50902 genotoxin
CHEBI has role CHEBI:50905 teratogenic agent
CHEBI has role CHEBI:59517 DNA synthesis inhibitor
CHEBI has role CHEBI:64911 antimitotic
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:74213 EC 1.17.4.1 (ribonucleoside-diphosphate reductase) inhibitor
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

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Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Chronic myeloid leukemia indication 92818009 DOID:8552
Hb SS disease indication 127040003 DOID:10923
Malignant tumor of head and/or neck indication 255056009
Malignant tumor of ovary indication 363443007 DOID:2394
Malignant melanoma indication 372244006
Sickling disorder due to hemoglobin S indication 417357006
Hemoglobin SS disease with crisis indication 417425009
Polycythemia vera off-label use 109992005
Essential thrombocythemia off-label use 109994006 DOID:2224
Vasculitis of the skin contraindication 53312001
Leukopenia contraindication 84828003 DOID:615
Kidney disease contraindication 90708001 DOID:557
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Breastfeeding (mother) contraindication 413712001
Severe Bone Marrow Depression contraindication
Postirradiation Erythema contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.38 acidic
pKa2 12.5 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG/ML XROMI NOVA LABS LTD N216593 April 4, 2024 RX SOLUTION ORAL April 4, 2027 NEW PRODUCT
100MG/ML XROMI NOVA LABS LTD N216593 April 4, 2024 RX SOLUTION ORAL April 4, 2031 TO REDUCE THE FREQUENCY OF PAINFUL CRISES AND REDUCE THE NEED FOR BLOOD TRANSFUSIONS IN PEDIATRIC PATIENTS AGED 6 MONTHS OF AGE TO LESS THAN 2 YEARS, WITH SICKLE CELL ANEMIA WITH RECURRENT MODERATE TO SEVERE PAINFUL CRISES

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Ribonucleoside-diphosphate reductase large subunit Enzyme INHIBITOR WOMBAT-PK CHEMBL
Ribonucleoside-diphosphate reductase subunit M2 Enzyme INHIBITOR WOMBAT-PK CHEMBL
Carbonic anhydrase 2 Enzyme Ki 4.55 CHEMBL
Carbonic anhydrase 9 Enzyme Ki 4.64 CHEMBL
Carbonic anhydrase 5A, mitochondrial Enzyme Ki 4.51 CHEMBL

External reference:

IDSource
4017733 VUID
N0000146101 NUI
D00341 KEGG_DRUG
4017733 VANDF
CHEBI:44423 CHEBI
CHEMBL467 ChEMBL_ID
DB01005 DRUGBANK_ID
1999309 RXNORM
148307 MMSL
1763 MMSL
321531 MMSL
4856 MMSL
d01373 MMSL
002635 NDDF
387314007 SNOMEDCT_US
56602009 SNOMEDCT_US
C0020402 UMLSCUI
D006918 MESH_DESCRIPTOR_UI
NHY PDB_CHEM_ID
1991 INN_ID
3657 PUBCHEM_CID
6822 IUPHAR_LIGAND_ID
X6Q56QN5QC UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
HYDROXYUREA HUMAN PRESCRIPTION DRUG LABEL 1 0555-0882 CAPSULE 500 mg ORAL ANDA 23 sections
Hydroxyurea HUMAN PRESCRIPTION DRUG LABEL 1 0904-6939 CAPSULE 500 mg ORAL ANDA 24 sections
Hydroxyurea HUMAN PRESCRIPTION DRUG LABEL 1 10135-702 CAPSULE 500 mg ORAL ANDA 30 sections
HYDROXYUREA HUMAN PRESCRIPTION DRUG LABEL 1 42291-321 CAPSULE 500 mg ORAL ANDA 22 sections
HYDROXYUREA HUMAN PRESCRIPTION DRUG LABEL 1 42291-321 CAPSULE 500 mg ORAL ANDA 22 sections
Hydroxyurea HUMAN PRESCRIPTION DRUG LABEL 1 49884-724 CAPSULE 500 mg ORAL ANDA 24 sections
HYDROXYUREA HUMAN PRESCRIPTION DRUG LABEL 1 51407-909 CAPSULE 500 mg ORAL ANDA 17 sections
HYDROXYUREA HUMAN PRESCRIPTION DRUG LABEL 1 54868-4773 CAPSULE 500 mg ORAL ANDA 19 sections
DROXIA HUMAN PRESCRIPTION DRUG LABEL 1 61269-402 CAPSULE 200 mg ORAL NDA 29 sections
DROXIA HUMAN PRESCRIPTION DRUG LABEL 1 61269-403 CAPSULE 300 mg ORAL NDA 29 sections
DROXIA HUMAN PRESCRIPTION DRUG LABEL 1 61269-404 CAPSULE 400 mg ORAL NDA 29 sections
HYDREA HUMAN PRESCRIPTION DRUG LABEL 1 61269-835 CAPSULE 500 mg ORAL NDA 27 sections
XROMI HUMAN PRESCRIPTION DRUG LABEL 1 62484-0015 SOLUTION 100 mg ORAL NDA 34 sections
HYDROXYUREA HUMAN PRESCRIPTION DRUG LABEL 1 67046-1619 CAPSULE 500 mg ORAL ANDA 26 sections
HYDROXYUREA HUMAN PRESCRIPTION DRUG LABEL 1 67184-0607 CAPSULE 500 mg ORAL ANDA 27 sections
Hydroxyurea HUMAN PRESCRIPTION DRUG LABEL 1 68084-284 CAPSULE 500 mg ORAL ANDA 26 sections
HYDROXYUREA HUMAN PRESCRIPTION DRUG LABEL 1 69315-164 CAPSULE 500 mg ORAL ANDA 17 sections
HYDROXYUREA HUMAN PRESCRIPTION DRUG LABEL 1 70069-820 CAPSULE 500 mg ORAL ANDA 27 sections
Siklos HUMAN PRESCRIPTION DRUG LABEL 1 71770-105 TABLET, FILM COATED 100 mg ORAL NDA 35 sections
Siklos HUMAN PRESCRIPTION DRUG LABEL 1 71770-120 TABLET, FILM COATED 1000 mg ORAL NDA 35 sections
HYDREA HUMAN PRESCRIPTION DRUG LABEL 1 80725-810 CAPSULE 500 mg ORAL NDA 30 sections
DROXIA HUMAN PRESCRIPTION DRUG LABEL 1 80725-820 CAPSULE 200 mg ORAL NDA 34 sections
DROXIA HUMAN PRESCRIPTION DRUG LABEL 1 80725-830 CAPSULE 300 mg ORAL NDA 34 sections
DROXIA HUMAN PRESCRIPTION DRUG LABEL 1 80725-840 CAPSULE 400 mg ORAL NDA 34 sections
SCEDAMIN HUMAN PRESCRIPTION DRUG LABEL 1 87500-100 TABLET, FILM COATED 100 mg ORAL Export only 1 sections
SCEDAMIN HUMAN PRESCRIPTION DRUG LABEL 1 87500-101 TABLET, FILM COATED 500 mg ORAL Export only 1 sections