hydroxycarbamide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 1399 | 127-07-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
An antineoplastic agent that inhibits DNA synthesis through the inhibition of ribonucleoside diphosphate reductase.
|
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 1, 2019 | EMA | NOVA LABORATORIES IRELAND LIMITED | |
| Dec. 7, 1967 | FDA | BRISTOL MYERS SQUIBB |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | 710.26 | 14.09 | 187 | 16348 | 5816 | 63466671 |
| Platelet count increased | 276.06 | 14.09 | 120 | 16415 | 17591 | 63454896 |
| Acute myeloid leukaemia | 176.02 | 14.09 | 87 | 16448 | 17060 | 63455427 |
| Acute chest syndrome | 164.30 | 14.09 | 39 | 16496 | 782 | 63471705 |
| Splenomegaly | 155.77 | 14.09 | 70 | 16465 | 11087 | 63461400 |
| Myelofibrosis | 125.72 | 14.09 | 35 | 16500 | 1342 | 63471145 |
| White blood cell count increased | 117.58 | 14.09 | 99 | 16436 | 48462 | 63424025 |
| Thrombocytopenia | 105.58 | 14.09 | 161 | 16374 | 150996 | 63321491 |
| Haemoglobin decreased | 104.51 | 14.09 | 157 | 16378 | 145328 | 63327159 |
| Blast crisis in myelogenous leukaemia | 98.77 | 14.09 | 24 | 16511 | 533 | 63471954 |
| Pancytopenia | 97.31 | 14.09 | 123 | 16412 | 96810 | 63375677 |
| Thrombocytosis | 95.78 | 14.09 | 41 | 16494 | 5777 | 63466710 |
| Anaemia | 93.97 | 14.09 | 224 | 16311 | 293206 | 63179281 |
| Chronic myeloid leukaemia | 87.81 | 14.09 | 30 | 16505 | 2288 | 63470199 |
| Serum ferritin increased | 86.96 | 14.09 | 39 | 16496 | 6143 | 63466344 |
| Leukocytosis | 86.77 | 14.09 | 64 | 16471 | 25871 | 63446616 |
| Differentiation syndrome | 78.11 | 14.09 | 23 | 16512 | 1080 | 63471407 |
| Blood lactate dehydrogenase increased | 74.99 | 14.09 | 56 | 16479 | 23060 | 63449427 |
| Platelet count decreased | 74.50 | 14.09 | 119 | 16416 | 116003 | 63356484 |
| Tumour lysis syndrome | 62.04 | 14.09 | 35 | 16500 | 8955 | 63463532 |
| Philadelphia chromosome positive | 54.51 | 14.09 | 14 | 16521 | 392 | 63472095 |
| Drug resistance | 51.90 | 14.09 | 45 | 16490 | 22888 | 63449599 |
| Erythromelalgia | 51.16 | 14.09 | 11 | 16524 | 138 | 63472349 |
| Haemoglobin increased | 48.11 | 14.09 | 22 | 16513 | 3624 | 63468863 |
| Febrile neutropenia | 46.26 | 14.09 | 98 | 16437 | 118351 | 63354136 |
| Angiokeratoma | 45.49 | 14.09 | 10 | 16525 | 140 | 63472347 |
| Haematocrit increased | 43.66 | 14.09 | 18 | 16517 | 2308 | 63470179 |
| Blood iron increased | 43.37 | 14.09 | 16 | 16519 | 1526 | 63470961 |
| Sinusitis | 41.78 | 14.09 | 5 | 16530 | 226648 | 63245839 |
| Myeloproliferative neoplasm | 41.48 | 14.09 | 12 | 16523 | 529 | 63471958 |
| Arthropathy | 41.31 | 14.09 | 6 | 16529 | 234786 | 63237701 |
| Skin ulcer | 40.60 | 14.09 | 53 | 16482 | 42992 | 63429495 |
| Intentional product use issue | 40.12 | 14.09 | 97 | 16438 | 127795 | 63344692 |
| Joint swelling | 39.46 | 14.09 | 18 | 16517 | 327648 | 63144839 |
| Nail pigmentation | 37.79 | 14.09 | 9 | 16526 | 183 | 63472304 |
| Drug hypersensitivity | 37.52 | 14.09 | 17 | 16518 | 310670 | 63161817 |
| Glossodynia | 35.42 | 14.09 | 3 | 16532 | 178873 | 63293614 |
| Cytogenetic analysis abnormal | 35.21 | 14.09 | 12 | 16523 | 908 | 63471579 |
| Contraindicated product administered | 35.12 | 14.09 | 7 | 16528 | 217641 | 63254846 |
| Transformation to acute myeloid leukaemia | 34.98 | 14.09 | 9 | 16526 | 254 | 63472233 |
| Platelet count abnormal | 34.30 | 14.09 | 17 | 16518 | 3347 | 63469140 |
| Essential thrombocythaemia | 33.76 | 14.09 | 8 | 16527 | 159 | 63472328 |
| Primary myelofibrosis | 33.66 | 14.09 | 7 | 16528 | 74 | 63472413 |
| Blood bilirubin increased | 32.36 | 14.09 | 44 | 16491 | 37096 | 63435391 |
| Aquagenic pruritus | 32.30 | 14.09 | 6 | 16529 | 33 | 63472454 |
| Leukaemia | 30.71 | 14.09 | 17 | 16518 | 4191 | 63468296 |
| Leukostasis syndrome | 30.58 | 14.09 | 6 | 16529 | 46 | 63472441 |
| Chronic myeloid leukaemia transformation | 30.46 | 14.09 | 7 | 16528 | 121 | 63472366 |
| Squamous cell carcinoma | 30.44 | 14.09 | 22 | 16513 | 8610 | 63463877 |
| Laryngitis | 30.00 | 14.09 | 29 | 16506 | 16938 | 63455549 |
| Toxicity to various agents | 29.11 | 14.09 | 14 | 16521 | 247236 | 63225251 |
| Polycythaemia vera | 28.09 | 14.09 | 7 | 16528 | 173 | 63472314 |
| Discomfort | 27.81 | 14.09 | 5 | 16530 | 167369 | 63305118 |
| Malignant neoplasm progression | 27.59 | 14.09 | 64 | 16471 | 82057 | 63390430 |
| Red blood cell count decreased | 26.50 | 14.09 | 42 | 16493 | 40603 | 63431884 |
| Pleural effusion | 26.38 | 14.09 | 68 | 16467 | 93142 | 63379345 |
| Bone marrow failure | 25.97 | 14.09 | 35 | 16500 | 29255 | 63443232 |
| Infusion related reaction | 25.85 | 14.09 | 16 | 16519 | 245505 | 63226982 |
| Hypersensitivity | 25.75 | 14.09 | 23 | 16512 | 292662 | 63179825 |
| Immunodeficiency | 25.72 | 14.09 | 29 | 16506 | 20225 | 63452262 |
| Neoplasm malignant | 25.45 | 14.09 | 35 | 16500 | 29826 | 63442661 |
| Wound | 24.81 | 14.09 | 6 | 16529 | 163257 | 63309230 |
| Myelodysplastic syndrome | 24.78 | 14.09 | 26 | 16509 | 16728 | 63455759 |
| Gene mutation identification test positive | 24.57 | 14.09 | 6 | 16529 | 136 | 63472351 |
| Laryngeal inflammation | 24.53 | 14.09 | 6 | 16529 | 137 | 63472350 |
| Therapeutic product effect decreased | 24.21 | 14.09 | 10 | 16525 | 193177 | 63279310 |
| Lower respiratory tract infection | 24.16 | 14.09 | 3 | 16532 | 132304 | 63340183 |
| Haematocrit decreased | 23.40 | 14.09 | 39 | 16496 | 39301 | 63433186 |
| Blood disorder | 23.29 | 14.09 | 17 | 16518 | 6754 | 63465733 |
| Cytopenia | 22.75 | 14.09 | 21 | 16514 | 11580 | 63460907 |
| Haemorrhagic thyroid cyst | 22.58 | 14.09 | 4 | 16531 | 16 | 63472471 |
| Transient acantholytic dermatosis | 22.55 | 14.09 | 5 | 16530 | 73 | 63472414 |
| Decreased appetite | 22.15 | 14.09 | 126 | 16409 | 250926 | 63221561 |
| Tyrosine kinase mutation | 21.69 | 14.09 | 4 | 16531 | 21 | 63472466 |
| Hepatic enzyme increased | 21.55 | 14.09 | 13 | 16522 | 202315 | 63270172 |
| Blast cells present | 21.30 | 14.09 | 7 | 16528 | 473 | 63472014 |
| Injection site pain | 21.30 | 14.09 | 4 | 16531 | 129796 | 63342691 |
| Post cardiac arrest syndrome | 21.24 | 14.09 | 4 | 16531 | 24 | 63472463 |
| Adenocarcinoma metastatic | 20.93 | 14.09 | 5 | 16530 | 103 | 63472384 |
| Splenic rupture | 20.61 | 14.09 | 9 | 16526 | 1329 | 63471158 |
| Sickle cell anaemia | 20.33 | 14.09 | 7 | 16528 | 546 | 63471941 |
| Nasopharyngitis | 20.04 | 14.09 | 22 | 16513 | 254235 | 63218252 |
| Tonsillitis bacterial | 19.86 | 14.09 | 5 | 16530 | 129 | 63472358 |
| Serum ferritin decreased | 19.75 | 14.09 | 10 | 16525 | 2060 | 63470427 |
| Viral infection | 19.43 | 14.09 | 34 | 16501 | 35629 | 63436858 |
| Drug ineffective | 19.26 | 14.09 | 177 | 16358 | 1044588 | 62427899 |
| Anxiety | 19.24 | 14.09 | 17 | 16518 | 217524 | 63254963 |
| Ventricular hypokinesia | 19.09 | 14.09 | 13 | 16522 | 4631 | 63467856 |
| Posterior reversible encephalopathy syndrome | 18.96 | 14.09 | 23 | 16512 | 17322 | 63455165 |
| Red blood cell count increased | 18.50 | 14.09 | 11 | 16524 | 3101 | 63469386 |
| Left ventricular dysfunction | 18.44 | 14.09 | 19 | 16516 | 11969 | 63460518 |
| Extramedullary haemopoiesis | 18.33 | 14.09 | 4 | 16531 | 54 | 63472433 |
| Palmar erythema | 18.22 | 14.09 | 9 | 16526 | 1758 | 63470729 |
| Pharyngeal haematoma | 17.88 | 14.09 | 4 | 16531 | 61 | 63472426 |
| Blast cell count increased | 17.79 | 14.09 | 6 | 16529 | 440 | 63472047 |
| Uterine atony | 17.78 | 14.09 | 5 | 16530 | 199 | 63472288 |
| Anaemia macrocytic | 17.44 | 14.09 | 11 | 16524 | 3443 | 63469044 |
| Leukaemia recurrent | 17.42 | 14.09 | 8 | 16527 | 1330 | 63471157 |
| Retinopathy sickle cell | 17.42 | 14.09 | 4 | 16531 | 69 | 63472418 |
| Bone marrow reticulin fibrosis | 17.38 | 14.09 | 5 | 16530 | 216 | 63472271 |
| Subdural haematoma | 17.32 | 14.09 | 20 | 16515 | 14308 | 63458179 |
| Thyroid haemorrhage | 16.90 | 14.09 | 4 | 16531 | 79 | 63472408 |
| Cytogenetic abnormality | 16.89 | 14.09 | 6 | 16529 | 513 | 63471974 |
| Rheumatoid arthritis | 16.85 | 14.09 | 25 | 16510 | 253794 | 63218693 |
| Paraesthesia | 16.83 | 14.09 | 10 | 16525 | 156956 | 63315531 |
| Monocyte percentage decreased | 16.79 | 14.09 | 5 | 16530 | 244 | 63472243 |
| Hypoperfusion | 16.72 | 14.09 | 8 | 16527 | 1459 | 63471028 |
| Basophil count increased | 16.60 | 14.09 | 7 | 16528 | 950 | 63471537 |
| Alopecia | 16.48 | 14.09 | 40 | 16495 | 337496 | 63134991 |
| Acute febrile neutrophilic dermatosis | 16.36 | 14.09 | 10 | 16525 | 2964 | 63469523 |
| Transfusion | 16.35 | 14.09 | 20 | 16515 | 15197 | 63457290 |
| Normal newborn | 16.16 | 14.09 | 15 | 16520 | 8326 | 63464161 |
| Hypersplenism | 16.14 | 14.09 | 5 | 16530 | 279 | 63472208 |
| Neutropenic colitis | 15.99 | 14.09 | 10 | 16525 | 3085 | 63469402 |
| Dermatitis bullous | 15.91 | 14.09 | 15 | 16520 | 8493 | 63463994 |
| Blister | 15.81 | 14.09 | 7 | 16528 | 129807 | 63342680 |
| Gene mutation | 15.76 | 14.09 | 8 | 16527 | 1657 | 63470830 |
| Basophil percentage increased | 15.71 | 14.09 | 4 | 16531 | 108 | 63472379 |
| Musculoskeletal stiffness | 15.64 | 14.09 | 15 | 16520 | 184603 | 63287884 |
| Mobility decreased | 15.62 | 14.09 | 6 | 16529 | 121153 | 63351334 |
| Blood cholesterol increased | 15.21 | 14.09 | 3 | 16532 | 94029 | 63378458 |
| Abortion spontaneous | 15.00 | 14.09 | 36 | 16499 | 47159 | 63425328 |
| Actinic keratosis | 14.95 | 14.09 | 9 | 16526 | 2595 | 63469892 |
| Graft versus host disease | 14.75 | 14.09 | 13 | 16522 | 6750 | 63465737 |
| Pericarditis | 14.65 | 14.09 | 8 | 16527 | 131571 | 63340916 |
| Nail discolouration | 14.50 | 14.09 | 9 | 16526 | 2741 | 63469746 |
| Hepatic vein thrombosis | 14.48 | 14.09 | 4 | 16531 | 149 | 63472338 |
| Tracheal deviation | 14.25 | 14.09 | 4 | 16531 | 158 | 63472329 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | 635.07 | 14.25 | 178 | 16015 | 3875 | 34936863 |
| Acute myeloid leukaemia | 158.15 | 14.25 | 101 | 16092 | 18169 | 34922569 |
| Myelofibrosis | 148.53 | 14.25 | 47 | 16146 | 1564 | 34939174 |
| Differentiation syndrome | 145.31 | 14.25 | 45 | 16148 | 1393 | 34939345 |
| Acute chest syndrome | 137.12 | 14.25 | 38 | 16155 | 789 | 34939949 |
| Splenomegaly | 126.93 | 14.25 | 82 | 16111 | 15035 | 34925703 |
| Blast crisis in myelogenous leukaemia | 124.73 | 14.25 | 33 | 16160 | 571 | 34940167 |
| Chronic myeloid leukaemia | 114.81 | 14.25 | 42 | 16151 | 2182 | 34938556 |
| White blood cell count increased | 112.84 | 14.25 | 116 | 16077 | 41035 | 34899703 |
| Tumour lysis syndrome | 104.08 | 14.25 | 76 | 16117 | 16983 | 34923755 |
| Platelet count increased | 90.78 | 14.25 | 56 | 16137 | 9470 | 34931268 |
| Leukocytosis | 85.03 | 14.25 | 78 | 16115 | 23987 | 34916751 |
| Cytogenetic analysis abnormal | 82.63 | 14.25 | 25 | 16168 | 714 | 34940024 |
| Philadelphia chromosome positive | 70.34 | 14.25 | 19 | 16174 | 357 | 34940381 |
| Anaemia | 70.05 | 14.25 | 252 | 15941 | 233083 | 34707655 |
| Thrombocytopenia | 69.12 | 14.25 | 193 | 16000 | 156054 | 34784684 |
| Haemoglobin decreased | 67.61 | 14.25 | 163 | 16030 | 120609 | 34820129 |
| Serum ferritin increased | 65.96 | 14.25 | 39 | 16154 | 6107 | 34934631 |
| Blast cell count increased | 65.60 | 14.25 | 23 | 16170 | 1055 | 34939683 |
| Hyperleukocytosis | 61.62 | 14.25 | 26 | 16167 | 1976 | 34938762 |
| Antineutrophil cytoplasmic antibody positive | 56.56 | 14.25 | 19 | 16174 | 765 | 34939973 |
| Endocarditis noninfective | 55.98 | 14.25 | 13 | 16180 | 127 | 34940611 |
| Myeloproliferative neoplasm | 53.84 | 14.25 | 17 | 16176 | 561 | 34940177 |
| Skin ulcer | 52.65 | 14.25 | 58 | 16135 | 22158 | 34918580 |
| Granulomatous rosacea | 49.43 | 14.25 | 12 | 16181 | 144 | 34940594 |
| Splenic infarction | 47.85 | 14.25 | 22 | 16171 | 2053 | 34938685 |
| Blood lactate dehydrogenase increased | 46.01 | 14.25 | 55 | 16138 | 22935 | 34917803 |
| Drug resistance | 45.41 | 14.25 | 58 | 16135 | 25869 | 34914869 |
| Actinic keratosis | 43.89 | 14.25 | 27 | 16166 | 4540 | 34936198 |
| Idiopathic intracranial hypertension | 42.82 | 14.25 | 15 | 16178 | 686 | 34940052 |
| Full blood count abnormal | 41.26 | 14.25 | 47 | 16146 | 18621 | 34922117 |
| Marrow hyperplasia | 38.80 | 14.25 | 16 | 16177 | 1147 | 34939591 |
| Chronic myelomonocytic leukaemia | 36.18 | 14.25 | 13 | 16180 | 641 | 34940097 |
| Toxic epidermal necrolysis | 35.68 | 14.25 | 47 | 16146 | 21599 | 34919139 |
| Toxicity to various agents | 33.87 | 14.25 | 26 | 16167 | 200336 | 34740402 |
| Extremity necrosis | 33.62 | 14.25 | 17 | 16176 | 1955 | 34938783 |
| Nasal polyps | 32.53 | 14.25 | 18 | 16175 | 2485 | 34938253 |
| Graft versus host disease in skin | 32.21 | 14.25 | 21 | 16172 | 3904 | 34936834 |
| Platelet count decreased | 32.20 | 14.25 | 125 | 16068 | 119592 | 34821146 |
| Differential white blood cell count abnormal | 32.18 | 14.25 | 15 | 16178 | 1444 | 34939294 |
| Posterior reversible encephalopathy syndrome | 30.81 | 14.25 | 30 | 16163 | 9924 | 34930814 |
| Loss of therapeutic response | 29.50 | 14.25 | 11 | 16182 | 603 | 34940135 |
| Pleural effusion | 28.66 | 14.25 | 93 | 16100 | 81453 | 34859285 |
| Intentional product use issue | 28.46 | 14.25 | 76 | 16117 | 59740 | 34880998 |
| Essential thrombocythaemia | 27.74 | 14.25 | 6 | 16187 | 41 | 34940697 |
| Second primary malignancy | 26.75 | 14.25 | 25 | 16168 | 7861 | 34932877 |
| Pyrexia | 26.74 | 14.25 | 253 | 15940 | 332760 | 34607978 |
| Spermatogenesis abnormal | 26.08 | 14.25 | 6 | 16187 | 56 | 34940682 |
| Parainfluenzae virus infection | 25.35 | 14.25 | 16 | 16177 | 2814 | 34937924 |
| Azoospermia | 25.28 | 14.25 | 9 | 16184 | 432 | 34940306 |
| Subacute combined cord degeneration | 25.27 | 14.25 | 7 | 16186 | 145 | 34940593 |
| Febrile neutropenia | 24.76 | 14.25 | 127 | 16066 | 136722 | 34804016 |
| Thrombocytosis | 24.34 | 14.25 | 18 | 16175 | 4094 | 34936644 |
| Transformation to acute myeloid leukaemia | 23.64 | 14.25 | 10 | 16183 | 764 | 34939974 |
| Completed suicide | 23.62 | 14.25 | 8 | 16185 | 98160 | 34842578 |
| Chronic myeloid leukaemia recurrent | 23.23 | 14.25 | 7 | 16186 | 197 | 34940541 |
| Leukostasis syndrome | 22.89 | 14.25 | 5 | 16188 | 36 | 34940702 |
| Pancytopenia | 22.89 | 14.25 | 96 | 16097 | 95061 | 34845677 |
| Erythropoiesis abnormal | 22.71 | 14.25 | 7 | 16186 | 213 | 34940525 |
| Haematocrit decreased | 21.88 | 14.25 | 47 | 16146 | 32169 | 34908569 |
| Night sweats | 21.66 | 14.25 | 33 | 16160 | 17319 | 34923419 |
| Capillary fragility | 21.61 | 14.25 | 5 | 16188 | 48 | 34940690 |
| Red blood cell count decreased | 21.57 | 14.25 | 44 | 16149 | 29046 | 34911692 |
| Acinetobacter sepsis | 21.52 | 14.25 | 5 | 16188 | 49 | 34940689 |
| Hypersplenism | 21.43 | 14.25 | 8 | 16185 | 440 | 34940298 |
| Mucosal inflammation | 21.41 | 14.25 | 52 | 16141 | 38570 | 34902168 |
| Sickle cell disease | 21.19 | 14.25 | 6 | 16187 | 135 | 34940603 |
| Blood uric acid increased | 20.87 | 14.25 | 24 | 16169 | 9600 | 34931138 |
| Gene mutation | 20.73 | 14.25 | 11 | 16182 | 1397 | 34939341 |
| Squamous cell carcinoma | 20.60 | 14.25 | 26 | 16167 | 11449 | 34929289 |
| Sleep disorder due to a general medical condition | 20.56 | 14.25 | 18 | 16175 | 5203 | 34935535 |
| Gangrene | 20.49 | 14.25 | 17 | 16176 | 4569 | 34936169 |
| Chronic myeloid leukaemia transformation | 20.37 | 14.25 | 6 | 16187 | 156 | 34940582 |
| Erdheim-Chester disease | 20.03 | 14.25 | 3 | 16190 | 0 | 34940738 |
| Stenotrophomonas infection | 19.07 | 14.25 | 12 | 16181 | 2098 | 34938640 |
| Anaemia vitamin B12 deficiency | 18.63 | 14.25 | 7 | 16186 | 392 | 34940346 |
| Drug hypersensitivity | 18.62 | 14.25 | 7 | 16186 | 80522 | 34860216 |
| Sickle cell anaemia | 18.42 | 14.25 | 6 | 16187 | 219 | 34940519 |
| Ureterolithiasis | 18.42 | 14.25 | 12 | 16181 | 2227 | 34938511 |
| Hip deformity | 17.98 | 14.25 | 5 | 16188 | 105 | 34940633 |
| Malignant neoplasm progression | 17.53 | 14.25 | 84 | 16109 | 87962 | 34852776 |
| Anaemia macrocytic | 17.36 | 14.25 | 13 | 16180 | 3013 | 34937725 |
| Embolism venous | 17.27 | 14.25 | 10 | 16183 | 1506 | 34939232 |
| Drug interaction | 17.09 | 14.25 | 51 | 16142 | 225895 | 34714843 |
| Squamous cell carcinoma of skin | 16.97 | 14.25 | 23 | 16170 | 10858 | 34929880 |
| Pneumatosis | 16.91 | 14.25 | 7 | 16186 | 507 | 34940231 |
| Myelodysplastic syndrome | 16.61 | 14.25 | 31 | 16162 | 19177 | 34921561 |
| Myocardial infarction | 16.57 | 14.25 | 19 | 16174 | 121066 | 34819672 |
| Leukoerythroblastosis | 16.55 | 14.25 | 4 | 16189 | 47 | 34940691 |
| Spermatozoa morphology abnormal | 16.43 | 14.25 | 3 | 16190 | 7 | 34940731 |
| Bone marrow disorder | 16.02 | 14.25 | 10 | 16183 | 1725 | 34939013 |
| Leukaemic infiltration pulmonary | 14.84 | 14.25 | 3 | 16190 | 14 | 34940724 |
| Myelodysplastic syndrome transformation | 14.71 | 14.25 | 6 | 16187 | 418 | 34940320 |
| Penile erosion | 14.50 | 14.25 | 3 | 16190 | 16 | 34940722 |
| Cerebral haemorrhage | 14.26 | 14.25 | 42 | 16151 | 34895 | 34905843 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | 1051.58 | 13.18 | 286 | 26907 | 7636 | 79709559 |
| Acute myeloid leukaemia | 280.83 | 13.18 | 158 | 27035 | 30727 | 79686468 |
| Acute chest syndrome | 272.15 | 13.18 | 70 | 27123 | 1491 | 79715704 |
| Platelet count increased | 223.89 | 13.18 | 122 | 27071 | 22284 | 79694911 |
| Differentiation syndrome | 217.02 | 13.18 | 65 | 27128 | 2459 | 79714736 |
| Splenomegaly | 207.35 | 13.18 | 113 | 27080 | 20641 | 79696554 |
| Myelofibrosis | 204.70 | 13.18 | 62 | 27131 | 2438 | 79714757 |
| Blast crisis in myelogenous leukaemia | 176.15 | 13.18 | 44 | 27149 | 829 | 79716366 |
| Thrombocytopenia | 155.80 | 13.18 | 304 | 26889 | 264955 | 79452240 |
| White blood cell count increased | 148.99 | 13.18 | 154 | 27039 | 74479 | 79642716 |
| Chronic myeloid leukaemia | 146.92 | 13.18 | 53 | 27140 | 3611 | 79713584 |
| Tumour lysis syndrome | 141.56 | 13.18 | 93 | 27100 | 23846 | 79693349 |
| Leukocytosis | 135.65 | 13.18 | 115 | 27078 | 43340 | 79673855 |
| Anaemia | 129.98 | 13.18 | 389 | 26804 | 444626 | 79272569 |
| Haemoglobin decreased | 128.45 | 13.18 | 253 | 26940 | 221866 | 79495329 |
| Philadelphia chromosome positive | 106.07 | 13.18 | 28 | 27165 | 662 | 79716533 |
| Pancytopenia | 97.21 | 13.18 | 190 | 27003 | 165555 | 79551640 |
| Thrombocytosis | 92.35 | 13.18 | 49 | 27144 | 8477 | 79708718 |
| Serum ferritin increased | 88.43 | 13.18 | 50 | 27143 | 9797 | 79707398 |
| Platelet count decreased | 88.40 | 13.18 | 201 | 26992 | 194463 | 79522732 |
| Blood lactate dehydrogenase increased | 83.91 | 13.18 | 84 | 27109 | 39086 | 79678109 |
| Febrile neutropenia | 83.04 | 13.18 | 218 | 26975 | 230781 | 79486414 |
| Myeloproliferative neoplasm | 82.99 | 13.18 | 25 | 27168 | 964 | 79716231 |
| Skin ulcer | 80.83 | 13.18 | 96 | 27097 | 54054 | 79663141 |
| Hyperleukocytosis | 79.97 | 13.18 | 31 | 27162 | 2579 | 79714616 |
| Toxicity to various agents | 66.98 | 13.18 | 30 | 27163 | 421510 | 79295685 |
| Cytogenetic analysis abnormal | 66.26 | 13.18 | 22 | 27171 | 1168 | 79716027 |
| Actinic keratosis | 66.22 | 13.18 | 35 | 27158 | 6007 | 79711188 |
| Intentional product use issue | 64.56 | 13.18 | 153 | 27040 | 151959 | 79565236 |
| Squamous cell carcinoma | 60.69 | 13.18 | 47 | 27146 | 15575 | 79701620 |
| Drug resistance | 58.36 | 13.18 | 72 | 27121 | 42141 | 79675054 |
| Transformation to acute myeloid leukaemia | 57.79 | 13.18 | 19 | 27174 | 978 | 79716217 |
| Endocarditis noninfective | 53.46 | 13.18 | 13 | 27180 | 218 | 79716977 |
| Drug hypersensitivity | 52.85 | 13.18 | 18 | 27175 | 298898 | 79418297 |
| Completed suicide | 52.65 | 13.18 | 10 | 27183 | 245757 | 79471438 |
| Blast cell count increased | 51.35 | 13.18 | 19 | 27174 | 1391 | 79715804 |
| Splenic infarction | 51.16 | 13.18 | 25 | 27168 | 3639 | 79713556 |
| Erythromelalgia | 49.53 | 13.18 | 12 | 27181 | 198 | 79716997 |
| Granulomatous rosacea | 49.20 | 13.18 | 12 | 27181 | 204 | 79716991 |
| Antineutrophil cytoplasmic antibody positive | 49.04 | 13.18 | 18 | 27175 | 1288 | 79715907 |
| Pleural effusion | 49.02 | 13.18 | 134 | 27059 | 145128 | 79572067 |
| Posterior reversible encephalopathy syndrome | 48.43 | 13.18 | 52 | 27141 | 26229 | 79690966 |
| Essential thrombocythaemia | 46.89 | 13.18 | 11 | 27182 | 157 | 79717038 |
| Joint swelling | 45.10 | 13.18 | 21 | 27172 | 288625 | 79428570 |
| Idiopathic intracranial hypertension | 45.04 | 13.18 | 22 | 27171 | 3200 | 79713995 |
| Drug abuse | 43.78 | 13.18 | 3 | 27190 | 162688 | 79554507 |
| Leukostasis syndrome | 41.68 | 13.18 | 9 | 27184 | 86 | 79717109 |
| Marrow hyperplasia | 41.53 | 13.18 | 17 | 27176 | 1631 | 79715564 |
| Hypersplenism | 41.44 | 13.18 | 13 | 27180 | 575 | 79716620 |
| Arthropathy | 40.60 | 13.18 | 6 | 27187 | 177105 | 79540090 |
| Malignant neoplasm progression | 39.62 | 13.18 | 119 | 27074 | 135871 | 79581324 |
| Contraindicated product administered | 39.38 | 13.18 | 4 | 27189 | 157534 | 79559661 |
| Graft versus host disease in skin | 39.35 | 13.18 | 25 | 27168 | 6048 | 79711147 |
| Angiokeratoma | 38.26 | 13.18 | 10 | 27183 | 227 | 79716968 |
| Chronic myeloid leukaemia transformation | 37.23 | 13.18 | 10 | 27183 | 253 | 79716942 |
| Azoospermia | 36.73 | 13.18 | 9 | 27184 | 156 | 79717039 |
| Pyrexia | 36.35 | 13.18 | 372 | 26821 | 678337 | 79038858 |
| Red blood cell count decreased | 34.97 | 13.18 | 67 | 27126 | 57446 | 79659749 |
| Nail pigmentation | 34.93 | 13.18 | 10 | 27183 | 322 | 79716873 |
| Myelodysplastic syndrome | 34.56 | 13.18 | 47 | 27146 | 30254 | 79686941 |
| Mucosal inflammation | 34.20 | 13.18 | 78 | 27115 | 75502 | 79641693 |
| Squamous cell carcinoma of skin | 33.61 | 13.18 | 32 | 27161 | 14001 | 79703194 |
| Gene mutation | 33.58 | 13.18 | 17 | 27176 | 2669 | 79714526 |
| Injection site pain | 33.23 | 13.18 | 3 | 27190 | 129835 | 79587360 |
| Chronic myelomonocytic leukaemia | 32.75 | 13.18 | 12 | 27181 | 854 | 79716341 |
| Therapeutic product effect decreased | 32.37 | 13.18 | 8 | 27185 | 163855 | 79553340 |
| Haematocrit increased | 32.27 | 13.18 | 19 | 27174 | 4015 | 79713180 |
| Sickle cell anaemia | 31.94 | 13.18 | 11 | 27182 | 653 | 79716542 |
| Differential white blood cell count abnormal | 31.51 | 13.18 | 15 | 27178 | 2062 | 79715133 |
| Anaemia macrocytic | 31.28 | 13.18 | 21 | 27172 | 5576 | 79711619 |
| Bone marrow failure | 30.41 | 13.18 | 59 | 27134 | 51048 | 79666147 |
| Tongue neoplasm malignant stage unspecified | 30.13 | 13.18 | 12 | 27181 | 1072 | 79716123 |
| Infusion related reaction | 29.88 | 13.18 | 21 | 27172 | 230216 | 79486979 |
| Blood bilirubin increased | 29.57 | 13.18 | 68 | 27125 | 66164 | 79651031 |
| Polycythaemia vera | 29.44 | 13.18 | 9 | 27184 | 365 | 79716830 |
| Sinusitis | 29.34 | 13.18 | 15 | 27178 | 195486 | 79521709 |
| Neutropenic colitis | 28.55 | 13.18 | 20 | 27173 | 5687 | 79711508 |
| Cytopenia | 28.54 | 13.18 | 35 | 27158 | 20348 | 79696847 |
| Acute myeloid leukaemia recurrent | 27.23 | 13.18 | 16 | 27177 | 3367 | 79713828 |
| Electrocardiogram QT prolonged | 27.17 | 13.18 | 80 | 27113 | 90306 | 79626889 |
| Neoplasm malignant | 27.09 | 13.18 | 43 | 27150 | 31767 | 79685428 |
| Leukaemia | 25.61 | 13.18 | 19 | 27174 | 5906 | 79711289 |
| Blood iron increased | 25.43 | 13.18 | 12 | 27181 | 1618 | 79715577 |
| Haematocrit decreased | 25.25 | 13.18 | 61 | 27132 | 61251 | 79655944 |
| Acute febrile neutrophilic dermatosis | 25.24 | 13.18 | 16 | 27177 | 3856 | 79713339 |
| Cytomegalovirus infection reactivation | 25.02 | 13.18 | 22 | 27171 | 8694 | 79708501 |
| Glossodynia | 24.87 | 13.18 | 3 | 27190 | 103334 | 79613861 |
| Laryngitis | 24.86 | 13.18 | 29 | 27164 | 16010 | 79701185 |
| Rhabdomyolysis | 24.80 | 13.18 | 3 | 27190 | 103128 | 79614067 |
| Leukaemia recurrent | 24.67 | 13.18 | 14 | 27179 | 2760 | 79714435 |
| Blood uric acid increased | 23.85 | 13.18 | 26 | 27167 | 13334 | 79703861 |
| Hypersensitivity | 23.59 | 13.18 | 33 | 27160 | 262206 | 79454989 |
| Haemoglobin increased | 22.85 | 13.18 | 18 | 27175 | 6114 | 79711081 |
| Death | 22.84 | 13.18 | 294 | 26899 | 566220 | 79150975 |
| Musculoskeletal stiffness | 22.65 | 13.18 | 16 | 27177 | 174992 | 79542203 |
| Therapy non-responder | 22.51 | 13.18 | 76 | 27117 | 92229 | 79624966 |
| Second primary malignancy | 22.33 | 13.18 | 26 | 27167 | 14324 | 79702871 |
| Primary myelofibrosis | 22.26 | 13.18 | 6 | 27187 | 154 | 79717041 |
| Acute respiratory failure | 22.17 | 13.18 | 57 | 27136 | 59484 | 79657711 |
| Platelet count abnormal | 21.93 | 13.18 | 16 | 27177 | 4846 | 79712349 |
| Acinetobacter sepsis | 21.89 | 13.18 | 5 | 27188 | 63 | 79717132 |
| Swelling | 21.85 | 13.18 | 25 | 27168 | 216686 | 79500509 |
| Subacute combined cord degeneration | 21.80 | 13.18 | 7 | 27186 | 334 | 79716861 |
| Nasopharyngitis | 21.80 | 13.18 | 33 | 27160 | 253848 | 79463347 |
| Interstitial lung disease | 21.79 | 13.18 | 86 | 27107 | 112514 | 79604681 |
| Haemorrhagic thyroid cyst | 21.50 | 13.18 | 4 | 27189 | 16 | 79717179 |
| Blast cells present | 21.36 | 13.18 | 9 | 27184 | 928 | 79716267 |
| Graft versus host disease | 21.36 | 13.18 | 26 | 27167 | 15000 | 79702195 |
| White blood cell count decreased | 21.23 | 13.18 | 123 | 27070 | 188165 | 79529030 |
| Retinopathy sickle cell | 21.21 | 13.18 | 5 | 27188 | 73 | 79717122 |
| Rheumatoid arthritis | 21.07 | 13.18 | 24 | 27169 | 208446 | 79508749 |
| Full blood count abnormal | 20.83 | 13.18 | 44 | 27149 | 40430 | 79676765 |
| Leukaemic infiltration pulmonary | 20.78 | 13.18 | 4 | 27189 | 20 | 79717175 |
| Laryngeal inflammation | 20.61 | 13.18 | 6 | 27187 | 205 | 79716990 |
| Extremity necrosis | 20.45 | 13.18 | 13 | 27180 | 3148 | 79714047 |
| Post cardiac arrest syndrome | 20.16 | 13.18 | 4 | 27189 | 24 | 79717171 |
| Discomfort | 19.82 | 13.18 | 9 | 27184 | 125608 | 79591587 |
| Parainfluenzae virus infection | 19.72 | 13.18 | 16 | 27177 | 5666 | 79711529 |
| Disseminated intravascular coagulation | 19.66 | 13.18 | 40 | 27153 | 35802 | 79681393 |
| Tyrosine kinase mutation | 19.63 | 13.18 | 4 | 27189 | 28 | 79717167 |
| Peripheral swelling | 19.55 | 13.18 | 39 | 27154 | 269578 | 79447617 |
| Erythropoiesis abnormal | 19.54 | 13.18 | 7 | 27186 | 467 | 79716728 |
| Pericardial effusion | 19.04 | 13.18 | 46 | 27147 | 46191 | 79671004 |
| Jaundice | 18.76 | 13.18 | 50 | 27143 | 53299 | 79663896 |
| Blood pressure increased | 18.60 | 13.18 | 27 | 27166 | 211333 | 79505862 |
| Skin mass | 18.58 | 13.18 | 18 | 27175 | 8045 | 79709150 |
| Graft versus host disease in gastrointestinal tract | 18.16 | 13.18 | 16 | 27177 | 6340 | 79710855 |
| Nasal polyps | 18.10 | 13.18 | 17 | 27176 | 7310 | 79709885 |
| Sickle cell disease | 18.06 | 13.18 | 5 | 27188 | 142 | 79717053 |
| Haemorrhage | 17.95 | 13.18 | 70 | 27123 | 91048 | 79626147 |
| Immunodeficiency | 17.95 | 13.18 | 29 | 27164 | 21739 | 79695456 |
| Lower respiratory tract infection | 17.82 | 13.18 | 11 | 27182 | 129209 | 79587986 |
| Erdheim-Chester disease | 17.66 | 13.18 | 3 | 27190 | 6 | 79717189 |
| Transient acantholytic dermatosis | 17.58 | 13.18 | 5 | 27188 | 157 | 79717038 |
| Mobility decreased | 17.41 | 13.18 | 10 | 27183 | 122165 | 79595030 |
| Insomnia | 17.31 | 13.18 | 36 | 27157 | 245134 | 79472061 |
| Sleep disorder | 17.27 | 13.18 | 4 | 27189 | 85673 | 79631522 |
| Tonsillitis bacterial | 17.23 | 13.18 | 5 | 27188 | 169 | 79717026 |
| Alopecia | 17.17 | 13.18 | 33 | 27160 | 231322 | 79485873 |
| Gangrene | 16.98 | 13.18 | 18 | 27175 | 8946 | 79708249 |
| Toxic epidermal necrolysis | 16.93 | 13.18 | 43 | 27150 | 44538 | 79672657 |
| Adenocarcinoma metastatic | 16.77 | 13.18 | 5 | 27188 | 186 | 79717009 |
| Basophil percentage increased | 16.67 | 13.18 | 5 | 27188 | 190 | 79717005 |
| Central nervous system leukaemia | 16.47 | 13.18 | 6 | 27187 | 420 | 79716775 |
| Cerebral haemorrhage | 16.34 | 13.18 | 50 | 27143 | 57623 | 79659572 |
| Hip deformity | 16.33 | 13.18 | 5 | 27188 | 204 | 79716991 |
| Capillary fragility | 16.28 | 13.18 | 5 | 27188 | 206 | 79716989 |
| Anaemia vitamin B12 deficiency | 16.09 | 13.18 | 7 | 27186 | 781 | 79716414 |
| Stenotrophomonas infection | 16.08 | 13.18 | 12 | 27181 | 3761 | 79713434 |
| Ureterolithiasis | 15.87 | 13.18 | 12 | 27181 | 3836 | 79713359 |
| Wound | 15.87 | 13.18 | 10 | 27183 | 116169 | 79601026 |
| Splenic rupture | 15.74 | 13.18 | 10 | 27183 | 2419 | 79714776 |
| Penile erosion | 15.42 | 13.18 | 3 | 27190 | 16 | 79717179 |
| Chromosome analysis abnormal | 15.39 | 13.18 | 5 | 27188 | 248 | 79716947 |
| Pneumatosis | 15.28 | 13.18 | 7 | 27186 | 882 | 79716313 |
| Myeloblast count increased | 15.12 | 13.18 | 3 | 27190 | 18 | 79717177 |
| Reticulocyte count increased | 15.11 | 13.18 | 8 | 27185 | 1378 | 79715817 |
| Subdural haemorrhage | 15.08 | 13.18 | 14 | 27179 | 5934 | 79711261 |
| Vasculitis | 14.95 | 13.18 | 29 | 27164 | 25073 | 79692122 |
| Acute erythroid leukaemia | 14.87 | 13.18 | 5 | 27188 | 276 | 79716919 |
| Budd-Chiari syndrome | 14.86 | 13.18 | 4 | 27189 | 102 | 79717093 |
| Anaphylactic reaction | 14.86 | 13.18 | 5 | 27188 | 83738 | 79633457 |
| Bronchopulmonary aspergillosis | 14.83 | 13.18 | 27 | 27166 | 22267 | 79694928 |
| Thyroid haemorrhage | 14.79 | 13.18 | 4 | 27189 | 104 | 79717091 |
| Intentional overdose | 14.64 | 13.18 | 9 | 27184 | 105951 | 79611244 |
| Sleep disorder due to a general medical condition | 14.57 | 13.18 | 21 | 27172 | 14256 | 79702939 |
| Enterococcal infection | 14.49 | 13.18 | 22 | 27171 | 15638 | 79701557 |
| Monocyte percentage decreased | 14.44 | 13.18 | 5 | 27188 | 302 | 79716893 |
| Gastroenteritis staphylococcal | 14.42 | 13.18 | 5 | 27188 | 303 | 79716892 |
| Adenovirus infection | 14.32 | 13.18 | 16 | 27177 | 8431 | 79708764 |
| Amyotrophy | 14.29 | 13.18 | 6 | 27187 | 614 | 79716581 |
| Hypercreatininaemia | 14.15 | 13.18 | 7 | 27186 | 1046 | 79716149 |
| B-cell small lymphocytic lymphoma | 14.12 | 13.18 | 4 | 27189 | 124 | 79717071 |
| Anxiety | 14.01 | 13.18 | 41 | 27152 | 248471 | 79468724 |
| Transplant failure | 13.90 | 13.18 | 12 | 27181 | 4629 | 79712566 |
| Venous pressure increased | 13.86 | 13.18 | 3 | 27190 | 29 | 79717166 |
| Extramedullary haemopoiesis | 13.82 | 13.18 | 4 | 27189 | 134 | 79717061 |
| Bone marrow reticulin fibrosis | 13.80 | 13.18 | 5 | 27188 | 345 | 79716850 |
| Ovarian failure | 13.79 | 13.18 | 6 | 27187 | 670 | 79716525 |
| Periarticular disorder | 13.68 | 13.18 | 3 | 27190 | 31 | 79717164 |
| Cholestasis | 13.68 | 13.18 | 44 | 27149 | 52065 | 79665130 |
| Pharyngeal haematoma | 13.60 | 13.18 | 4 | 27189 | 142 | 79717053 |
| Acute leukaemia | 13.47 | 13.18 | 8 | 27185 | 1718 | 79715477 |
| Paraesthesia | 13.21 | 13.18 | 25 | 27168 | 176298 | 79540897 |
| Blood cholesterol increased | 13.20 | 13.18 | 6 | 27187 | 83714 | 79633481 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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 agents |
| CHEBI has role | CHEBI:48578 | free radical scavengers |
| CHEBI has role | CHEBI:50846 | Immunologic factor |
| CHEBI has role | CHEBI:50902 | genotoxic agent |
| CHEBI has role | CHEBI:50905 | teratogeno |
| CHEBI has role | CHEBI:59517 | DNA synthesis inhibitors |
| CHEBI has role | CHEBI:64911 | mitotic inhibitor |
| CHEBI has role | CHEBI:74213 | EC 1.17.4.1 inhibitor |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 100MG | SIKLOS | ADDMEDICA SAS | N208843 | Dec. 21, 2017 | RX | TABLET | ORAL | Dec. 21, 2024 | TO REDUCE THE FREQUENCY OF PAINFUL CRISES AND TO REDUCE THE NEED FOR BLOOD TRANSFUSIONS IN PEDIATRIC PATIENTS, 2 YEARS OF AGE AND OLDER, WITH SICKLE CELL ANEMIA WITH RECURRENT MODERATE TO SEVERE PAINFUL CRISIS |
| 1GM | SIKLOS | ADDMEDICA SAS | N208843 | Dec. 21, 2017 | RX | TABLET | ORAL | Dec. 21, 2024 | TO REDUCE THE FREQUENCY OF PAINFUL CRISES AND TO REDUCE THE NEED FOR BLOOD TRANSFUSIONS IN PEDIATRIC PATIENTS, 2 YEARS OF AGE AND OLDER, WITH SICKLE CELL ANEMIA WITH RECURRENT MODERATE TO SEVERE PAINFUL CRISIS |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 4017733 | VUID |
| N0000146101 | NUI |
| D00341 | KEGG_DRUG |
| 4017733 | VANDF |
| CHEBI:44423 | CHEBI |
| CHEMBL467 | ChEMBL_ID |
| 6822 | IUPHAR_LIGAND_ID |
| DB01005 | DRUGBANK_ID |
| 1999309 | RXNORM |
| 148307 | MMSL |
| 1763 | 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 |
| X6Q56QN5QC | UNII |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| HYDREA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0003-0830 | CAPSULE | 500 mg | ORAL | NDA | 27 sections |
| HYDREA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0003-0830 | CAPSULE | 500 mg | ORAL | NDA | 27 sections |
| DROXIA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0003-6335 | CAPSULE | 200 mg | ORAL | NDA | 29 sections |
| DROXIA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0003-6335 | CAPSULE | 200 mg | ORAL | NDA | 29 sections |
| DROXIA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0003-6336 | CAPSULE | 300 mg | ORAL | NDA | 29 sections |
| DROXIA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0003-6336 | CAPSULE | 300 mg | ORAL | NDA | 29 sections |
| DROXIA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0003-6337 | CAPSULE | 400 mg | ORAL | NDA | 29 sections |
| DROXIA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0003-6337 | CAPSULE | 400 mg | ORAL | NDA | 29 sections |
| HYDROXYUREA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0555-0882 | CAPSULE | 500 mg | ORAL | ANDA | 23 sections |
| 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 | 49884-724 | CAPSULE | 500 mg | ORAL | ANDA | 23 sections |
| HYDROXYUREA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-4773 | CAPSULE | 500 mg | ORAL | ANDA | 19 sections |
| Hydroxyurea | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55154-3554 | CAPSULE | 500 mg | ORAL | ANDA | 24 sections |
| Hydroxyurea | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55154-7143 | CAPSULE | 500 mg | ORAL | ANDA | 26 sections |
| Hydroxyurea | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55154-7143 | CAPSULE | 500 mg | ORAL | ANDA | 26 sections |
| Hydroxyurea | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60429-265 | CAPSULE | 500 mg | ORAL | ANDA | 23 sections |
| Hydroxyurea | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60429-265 | CAPSULE | 500 mg | ORAL | ANDA | 23 sections |
| DROXIA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61269-402 | CAPSULE | 200 mg | ORAL | NDA | 29 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 | 61269-403 | CAPSULE | 300 mg | ORAL | NDA | 29 sections |
| DROXIA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61269-404 | CAPSULE | 400 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 |
| Hydroxyurea | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68084-284 | CAPSULE | 500 mg | ORAL | ANDA | 26 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 |