tranexamic acid 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 2713 | 1197-18-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Antifibrinolytic hemostatic used in severe hemorrhage.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 2 | g | O |
| 2 | g | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Hosey CM, Chan R, Benet LZ |
| BA (Bioavailability) | 34 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 0.38 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 2.40 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.97 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 2.30 hours | Lombardo F, Berellini G, Obach RS |
| S (Water solubility) | 31 mg/mL | Bocci G, Oprea TI, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 30, 1986 | FDA | PHARMACIA AND UPJOHN |
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 |
|---|---|---|---|---|---|---|
| Purpura | 88.77 | 15.85 | 42 | 10884 | 11343 | 63466753 |
| Wrong product administered | 85.12 | 15.85 | 34 | 10892 | 6107 | 63471989 |
| Melaena | 82.16 | 15.85 | 56 | 10870 | 30309 | 63447787 |
| Aplastic anaemia | 73.68 | 15.85 | 35 | 10891 | 9534 | 63468562 |
| Pulmonary embolism | 72.98 | 15.85 | 95 | 10831 | 116589 | 63361507 |
| Renal cortical necrosis | 69.77 | 15.85 | 13 | 10913 | 117 | 63477979 |
| Vaginal haemorrhage | 68.04 | 15.85 | 48 | 10878 | 27439 | 63450657 |
| Status epilepticus | 63.62 | 15.85 | 37 | 10889 | 15196 | 63462900 |
| Heavy menstrual bleeding | 60.86 | 15.85 | 38 | 10888 | 17735 | 63460361 |
| Hereditary angioedema | 59.26 | 15.85 | 28 | 10898 | 7534 | 63470562 |
| Generalised tonic-clonic seizure | 56.81 | 15.85 | 44 | 10882 | 28972 | 63449124 |
| Haemorrhage | 55.18 | 15.85 | 60 | 10866 | 60962 | 63417134 |
| Myoclonus | 54.52 | 15.85 | 34 | 10892 | 15834 | 63462262 |
| Rash maculo-papular | 51.07 | 15.85 | 43 | 10883 | 31853 | 63446243 |
| Vasodilatation | 50.41 | 15.85 | 18 | 10908 | 2377 | 63475719 |
| Thrombocytopenia | 45.44 | 15.85 | 88 | 10838 | 151069 | 63327027 |
| Platelet count decreased | 44.32 | 15.85 | 75 | 10851 | 116047 | 63362049 |
| Rash erythematous | 44.13 | 15.85 | 45 | 10881 | 42465 | 63435631 |
| Cerebral infarction | 44.11 | 15.85 | 35 | 10891 | 23858 | 63454238 |
| Anaphylactic reaction | 43.14 | 15.85 | 55 | 10871 | 66045 | 63412051 |
| Deep vein thrombosis | 42.95 | 15.85 | 62 | 10864 | 83738 | 63394358 |
| Biliary sepsis | 39.96 | 15.85 | 12 | 10914 | 919 | 63477177 |
| Rectal haemorrhage | 37.16 | 15.85 | 44 | 10882 | 48986 | 63429110 |
| Joint swelling | 37.06 | 15.85 | 6 | 10920 | 327660 | 63150436 |
| Shock haemorrhagic | 36.01 | 15.85 | 22 | 10904 | 9873 | 63468223 |
| Maternal exposure during delivery | 34.33 | 15.85 | 12 | 10914 | 1488 | 63476608 |
| Retinal artery occlusion | 33.20 | 15.85 | 12 | 10914 | 1641 | 63476455 |
| Sepsis | 33.12 | 15.85 | 78 | 10848 | 153045 | 63325051 |
| Fatigue | 32.61 | 15.85 | 65 | 10861 | 887963 | 62590133 |
| Neutropenic sepsis | 32.33 | 15.85 | 25 | 10901 | 16413 | 63461683 |
| Febrile neutropenia | 32.02 | 15.85 | 66 | 10860 | 118383 | 63359713 |
| Tri-iodothyronine free decreased | 31.79 | 15.85 | 8 | 10918 | 316 | 63477780 |
| Ureteric perforation | 31.67 | 15.85 | 5 | 10921 | 14 | 63478082 |
| Brain oedema | 31.04 | 15.85 | 23 | 10903 | 14172 | 63463924 |
| Drug intolerance | 30.07 | 15.85 | 8 | 10918 | 308653 | 63169443 |
| Abdominal discomfort | 29.99 | 15.85 | 9 | 10917 | 320876 | 63157220 |
| Acute left ventricular failure | 29.87 | 15.85 | 10 | 10916 | 1089 | 63477007 |
| Transfusion | 29.61 | 15.85 | 23 | 10903 | 15194 | 63462902 |
| Haemoglobin decreased | 29.19 | 15.85 | 72 | 10854 | 145413 | 63332683 |
| Perforation | 29.15 | 15.85 | 10 | 10916 | 1173 | 63476923 |
| Uterine haemorrhage | 28.74 | 15.85 | 14 | 10912 | 4027 | 63474069 |
| Myoclonic epilepsy | 28.58 | 15.85 | 10 | 10916 | 1244 | 63476852 |
| Drug hypersensitivity | 28.52 | 15.85 | 9 | 10917 | 310678 | 63167418 |
| Toxic epidermal necrolysis | 28.46 | 15.85 | 28 | 10898 | 25306 | 63452790 |
| Ischaemic stroke | 28.31 | 15.85 | 24 | 10902 | 17933 | 63460163 |
| Alanine aminotransferase increased | 28.26 | 15.85 | 58 | 10868 | 103712 | 63374384 |
| Pain | 28.21 | 15.85 | 53 | 10873 | 740575 | 62737521 |
| Seizure | 28.06 | 15.85 | 67 | 10859 | 132567 | 63345529 |
| Infusion site scar | 27.98 | 15.85 | 8 | 10918 | 516 | 63477580 |
| Epistaxis | 27.76 | 15.85 | 47 | 10879 | 72678 | 63405418 |
| Off label use | 27.47 | 15.85 | 204 | 10722 | 674258 | 62803838 |
| Enterococcal sepsis | 27.38 | 15.85 | 10 | 10916 | 1408 | 63476688 |
| Alopecia | 27.26 | 15.85 | 12 | 10914 | 337524 | 63140572 |
| Basophil count increased | 27.18 | 15.85 | 9 | 10917 | 948 | 63477148 |
| Rheumatoid arthritis | 25.84 | 15.85 | 6 | 10920 | 253813 | 63224283 |
| Product packaging confusion | 25.73 | 15.85 | 6 | 10920 | 171 | 63477925 |
| Ovarian vein thrombosis | 25.37 | 15.85 | 5 | 10921 | 62 | 63478034 |
| Hepatic function abnormal | 24.37 | 15.85 | 31 | 10895 | 37111 | 63440985 |
| Circulatory collapse | 24.18 | 15.85 | 24 | 10902 | 21914 | 63456182 |
| Haemoptysis | 23.81 | 15.85 | 27 | 10899 | 28699 | 63449397 |
| Embolic stroke | 23.65 | 15.85 | 12 | 10914 | 3764 | 63474332 |
| Tonic clonic movements | 23.61 | 15.85 | 9 | 10917 | 1426 | 63476670 |
| Incorrect route of product administration | 23.09 | 15.85 | 26 | 10900 | 27426 | 63450670 |
| Product dose omission issue | 22.95 | 15.85 | 6 | 10920 | 234307 | 63243789 |
| Anaphylactic shock | 22.69 | 15.85 | 24 | 10902 | 23609 | 63454487 |
| Uterine disorder | 22.60 | 15.85 | 11 | 10915 | 3158 | 63474938 |
| Cancer pain | 22.48 | 15.85 | 11 | 10915 | 3194 | 63474902 |
| Blood pressure decreased | 22.18 | 15.85 | 40 | 10886 | 64982 | 63413114 |
| Multiple organ dysfunction syndrome | 22.08 | 15.85 | 37 | 10889 | 56715 | 63421381 |
| Urine ketone body present | 21.88 | 15.85 | 10 | 10916 | 2493 | 63475603 |
| Infusion site warmth | 21.55 | 15.85 | 9 | 10917 | 1809 | 63476287 |
| Hypoventilation | 21.05 | 15.85 | 12 | 10914 | 4742 | 63473354 |
| Meningitis aseptic | 20.89 | 15.85 | 12 | 10914 | 4811 | 63473285 |
| Uterine leiomyoma | 20.32 | 15.85 | 15 | 10911 | 9183 | 63468913 |
| Arterial thrombosis | 20.03 | 15.85 | 8 | 10918 | 1435 | 63476661 |
| Infusion site discomfort | 20.01 | 15.85 | 8 | 10918 | 1438 | 63476658 |
| Acute generalised exanthematous pustulosis | 19.93 | 15.85 | 16 | 10910 | 11083 | 63467013 |
| Stevens-Johnson syndrome | 19.91 | 15.85 | 23 | 10903 | 24927 | 63453169 |
| Acute myocardial infarction | 19.80 | 15.85 | 26 | 10900 | 32098 | 63445998 |
| PCO2 abnormal | 19.59 | 15.85 | 4 | 10922 | 60 | 63478036 |
| White blood cell count increased | 19.35 | 15.85 | 32 | 10894 | 48529 | 63429567 |
| Platelet count increased | 18.83 | 15.85 | 19 | 10907 | 17692 | 63460404 |
| Nosocomial infection | 18.67 | 15.85 | 8 | 10918 | 1713 | 63476383 |
| Pyrexia | 18.35 | 15.85 | 141 | 10785 | 470337 | 63007759 |
| Angioedema | 18.30 | 15.85 | 31 | 10895 | 47934 | 63430162 |
| Atrial thrombosis | 18.25 | 15.85 | 8 | 10918 | 1810 | 63476286 |
| Gastrointestinal haemorrhage | 18.24 | 15.85 | 42 | 10884 | 81134 | 63396962 |
| Hyperaesthesia | 17.89 | 15.85 | 14 | 10912 | 9344 | 63468752 |
| Amylase increased | 17.86 | 15.85 | 12 | 10914 | 6333 | 63471763 |
| Cerebral venous sinus thrombosis | 17.62 | 15.85 | 8 | 10918 | 1964 | 63476132 |
| Infusion site rash | 17.54 | 15.85 | 8 | 10918 | 1986 | 63476110 |
| HER2 positive breast cancer | 16.80 | 15.85 | 5 | 10921 | 371 | 63477725 |
| Fibroma | 16.52 | 15.85 | 6 | 10920 | 831 | 63477265 |
| False negative investigation result | 16.50 | 15.85 | 4 | 10922 | 135 | 63477961 |
| Thoracotomy | 16.42 | 15.85 | 3 | 10923 | 24 | 63478072 |
| Tachycardia | 16.27 | 15.85 | 51 | 10875 | 118105 | 63359991 |
| Product use in unapproved indication | 15.91 | 15.85 | 67 | 10859 | 179013 | 63299083 |
| Adnexal torsion | 15.87 | 15.85 | 5 | 10921 | 449 | 63477647 |
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 |
|---|---|---|---|---|---|---|
| Myoclonus | 94.18 | 16.19 | 52 | 7888 | 14673 | 34934318 |
| Factor VIII inhibition | 80.98 | 16.19 | 18 | 7922 | 308 | 34948683 |
| Febrile neutropenia | 70.98 | 16.19 | 118 | 7822 | 136731 | 34812260 |
| Anaphylactic reaction | 61.26 | 16.19 | 54 | 7886 | 32247 | 34916744 |
| Haemorrhage | 58.49 | 16.19 | 65 | 7875 | 51305 | 34897686 |
| Generalised tonic-clonic seizure | 58.31 | 16.19 | 44 | 7896 | 21130 | 34927861 |
| Vasodilatation | 54.24 | 16.19 | 17 | 7923 | 1135 | 34947856 |
| Post procedural hypotension | 47.45 | 16.19 | 9 | 7931 | 66 | 34948925 |
| Platelet count decreased | 42.77 | 16.19 | 88 | 7852 | 119629 | 34829362 |
| Haemophilia | 39.26 | 16.19 | 6 | 7934 | 8 | 34948983 |
| Cerebral infarction | 38.80 | 16.19 | 39 | 7901 | 27416 | 34921575 |
| Haemoptysis | 37.61 | 16.19 | 43 | 7897 | 34963 | 34914028 |
| Haemarthrosis | 37.04 | 16.19 | 17 | 7923 | 3242 | 34945749 |
| Interstitial lung disease | 34.69 | 16.19 | 57 | 7883 | 65225 | 34883766 |
| Wrong product administered | 34.53 | 16.19 | 19 | 7921 | 5315 | 34943676 |
| Post procedural haemorrhage | 33.99 | 16.19 | 22 | 7918 | 8267 | 34940724 |
| Upper respiratory tract inflammation | 32.79 | 16.19 | 13 | 7927 | 1731 | 34947260 |
| Mesenteric vascular insufficiency | 31.93 | 16.19 | 7 | 7933 | 112 | 34948879 |
| Muscle haemorrhage | 29.01 | 16.19 | 15 | 7925 | 3703 | 34945288 |
| Haemoglobin increased | 27.31 | 16.19 | 14 | 7926 | 3395 | 34945596 |
| Aplastic anaemia | 26.31 | 16.19 | 20 | 7920 | 9696 | 34939295 |
| Hepatic function abnormal | 25.28 | 16.19 | 40 | 7900 | 44323 | 34904668 |
| Vascular stent thrombosis | 23.36 | 16.19 | 12 | 7928 | 2923 | 34946068 |
| Myoclonic epilepsy | 23.07 | 16.19 | 9 | 7931 | 1148 | 34947843 |
| Pneumonia | 22.58 | 16.19 | 150 | 7790 | 362477 | 34586514 |
| Toxicity to various agents | 22.01 | 16.19 | 9 | 7931 | 200353 | 34748638 |
| Cerebral haemorrhage | 22.01 | 16.19 | 33 | 7907 | 34904 | 34914087 |
| Platelet transfusion | 20.66 | 16.19 | 9 | 7931 | 1517 | 34947474 |
| Nystagmus | 20.53 | 16.19 | 13 | 7927 | 4702 | 34944289 |
| Chronic pulmonary histoplasmosis | 20.09 | 16.19 | 3 | 7937 | 3 | 34948988 |
| Cholestasis | 19.22 | 16.19 | 27 | 7913 | 26921 | 34922070 |
| Pulmonary haemorrhage | 19.06 | 16.19 | 17 | 7923 | 10287 | 34938704 |
| Hepatic cyst ruptured | 18.88 | 16.19 | 3 | 7937 | 6 | 34948985 |
| Oesophageal haemorrhage | 18.59 | 16.19 | 8 | 7932 | 1310 | 34947681 |
| Haemorrhagic diathesis | 18.14 | 16.19 | 10 | 7930 | 2806 | 34946185 |
| Myelodysplastic syndrome | 17.98 | 16.19 | 22 | 7918 | 19186 | 34929805 |
| Anaphylactic shock | 17.82 | 16.19 | 20 | 7920 | 15921 | 34933070 |
| Fatigue | 17.75 | 16.19 | 36 | 7904 | 370617 | 34578374 |
| Mucosal inflammation | 16.94 | 16.19 | 31 | 7909 | 38591 | 34910400 |
| Hyporesponsive to stimuli | 16.53 | 16.19 | 7 | 7933 | 1101 | 34947890 |
| Neutrophil count decreased | 16.39 | 16.19 | 36 | 7904 | 51068 | 34897923 |
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 |
|---|---|---|---|---|---|---|
| Myoclonus | 143.37 | 13.99 | 85 | 17914 | 27575 | 79698814 |
| Wrong product administered | 115.41 | 13.99 | 51 | 17948 | 8961 | 79717428 |
| Generalised tonic-clonic seizure | 114.25 | 13.99 | 88 | 17911 | 43822 | 79682567 |
| Vasodilatation | 101.68 | 13.99 | 35 | 17964 | 3156 | 79723233 |
| Anaphylactic reaction | 95.88 | 13.99 | 106 | 17893 | 83637 | 79642752 |
| Haemorrhage | 93.56 | 13.99 | 109 | 17890 | 91009 | 79635380 |
| Aplastic anaemia | 90.10 | 13.99 | 54 | 17945 | 17851 | 79708538 |
| Platelet count decreased | 77.20 | 13.99 | 149 | 17850 | 194515 | 79531874 |
| Febrile neutropenia | 73.00 | 13.99 | 161 | 17838 | 230838 | 79495551 |
| Factor VIII inhibition | 69.62 | 13.99 | 16 | 17983 | 322 | 79726067 |
| Cerebral infarction | 66.93 | 13.99 | 66 | 17933 | 45610 | 79680779 |
| Melaena | 64.42 | 13.99 | 74 | 17925 | 60816 | 79665573 |
| Status epilepticus | 62.54 | 13.99 | 49 | 17950 | 24992 | 79701397 |
| Vaginal haemorrhage | 59.53 | 13.99 | 45 | 17954 | 21772 | 79704617 |
| Purpura | 59.40 | 13.99 | 43 | 17956 | 19484 | 79706905 |
| Post procedural hypotension | 58.38 | 13.99 | 11 | 17988 | 78 | 79726311 |
| Renal cortical necrosis | 53.06 | 13.99 | 13 | 17986 | 347 | 79726042 |
| Myoclonic epilepsy | 52.80 | 13.99 | 19 | 17980 | 1951 | 79724438 |
| Haemoptysis | 52.53 | 13.99 | 64 | 17935 | 55935 | 79670454 |
| Pulmonary embolism | 52.34 | 13.99 | 118 | 17881 | 171536 | 79554853 |
| Heavy menstrual bleeding | 49.94 | 13.99 | 34 | 17965 | 13977 | 79712412 |
| Fatigue | 46.67 | 13.99 | 87 | 17912 | 929640 | 78796749 |
| Rash maculo-papular | 46.09 | 13.99 | 60 | 17939 | 56018 | 79670371 |
| Hereditary angioedema | 43.13 | 13.99 | 22 | 17977 | 5313 | 79721076 |
| Hepatic function abnormal | 42.06 | 13.99 | 66 | 17933 | 73041 | 79653348 |
| Product dose omission issue | 38.88 | 13.99 | 5 | 17994 | 247532 | 79478857 |
| Deep vein thrombosis | 37.82 | 13.99 | 84 | 17915 | 120835 | 79605554 |
| Upper respiratory tract inflammation | 36.63 | 13.99 | 18 | 17981 | 4017 | 79722372 |
| Joint swelling | 36.49 | 13.99 | 10 | 17989 | 288636 | 79437753 |
| Rash erythematous | 35.82 | 13.99 | 54 | 17945 | 57715 | 79668674 |
| Haemarthrosis | 35.81 | 13.99 | 20 | 17979 | 5792 | 79720597 |
| Drug intolerance | 35.62 | 13.99 | 8 | 17991 | 264111 | 79462278 |
| Seizure | 35.16 | 13.99 | 108 | 17891 | 188726 | 79537663 |
| Anaphylactic shock | 35.15 | 13.99 | 42 | 17957 | 35954 | 79690435 |
| Haemoglobin increased | 34.81 | 13.99 | 20 | 17979 | 6112 | 79720277 |
| Post procedural haemorrhage | 32.39 | 13.99 | 26 | 17973 | 13718 | 79712671 |
| Toxicity to various agents | 31.81 | 13.99 | 29 | 17970 | 421511 | 79304878 |
| Cerebral haemorrhage | 31.70 | 13.99 | 51 | 17948 | 57622 | 79668767 |
| Thrombocytopenia | 31.59 | 13.99 | 131 | 17868 | 265128 | 79461261 |
| Product packaging confusion | 31.47 | 13.99 | 8 | 17991 | 249 | 79726140 |
| Retinal artery occlusion | 30.82 | 13.99 | 15 | 17984 | 3279 | 79723110 |
| Acute myocardial infarction | 30.52 | 13.99 | 59 | 17940 | 76977 | 79649412 |
| Mesenteric vascular insufficiency | 30.31 | 13.99 | 7 | 17992 | 144 | 79726245 |
| Biliary sepsis | 30.28 | 13.99 | 12 | 17987 | 1605 | 79724784 |
| Rectal haemorrhage | 29.70 | 13.99 | 58 | 17941 | 76242 | 79650147 |
| Tonic clonic movements | 29.59 | 13.99 | 13 | 17986 | 2251 | 79724138 |
| Ureteric perforation | 29.58 | 13.99 | 5 | 17994 | 17 | 79726372 |
| Uterine haemorrhage | 29.53 | 13.99 | 14 | 17985 | 2889 | 79723500 |
| Arthropathy | 29.25 | 13.99 | 3 | 17996 | 177108 | 79549281 |
| Muscle haemorrhage | 29.12 | 13.99 | 18 | 17981 | 6282 | 79720107 |
| Neutropenic sepsis | 28.79 | 13.99 | 33 | 17966 | 27031 | 79699358 |
| Maternal exposure during delivery | 28.79 | 13.99 | 11 | 17988 | 1335 | 79725054 |
| Infusion site scar | 28.73 | 13.99 | 8 | 17991 | 355 | 79726034 |
| Pain | 28.53 | 13.99 | 74 | 17925 | 703728 | 79022661 |
| Tri-iodothyronine free decreased | 28.37 | 13.99 | 8 | 17991 | 372 | 79726017 |
| Blood pressure decreased | 27.67 | 13.99 | 66 | 17933 | 99400 | 79626989 |
| Shock haemorrhagic | 27.56 | 13.99 | 28 | 17971 | 20032 | 79706357 |
| Acute generalised exanthematous pustulosis | 27.27 | 13.99 | 26 | 17973 | 17228 | 79709161 |
| Brain oedema | 27.21 | 13.99 | 31 | 17968 | 25232 | 79701157 |
| Epistaxis | 26.83 | 13.99 | 70 | 17929 | 111445 | 79614944 |
| Rheumatoid arthritis | 26.76 | 13.99 | 7 | 17992 | 208463 | 79517926 |
| Incorrect route of product administration | 26.58 | 13.99 | 36 | 17963 | 34893 | 79691496 |
| Immune thrombocytopenia | 26.58 | 13.99 | 26 | 17973 | 17779 | 79708610 |
| Platelet transfusion | 26.00 | 13.99 | 12 | 17987 | 2330 | 79724059 |
| Circulatory collapse | 25.94 | 13.99 | 37 | 17962 | 37631 | 79688758 |
| Coronary artery thrombosis | 25.67 | 13.99 | 13 | 17986 | 3093 | 79723296 |
| Perforation | 24.69 | 13.99 | 10 | 17989 | 1416 | 79724973 |
| Haemorrhagic diathesis | 24.67 | 13.99 | 16 | 17983 | 6068 | 79720321 |
| Haemoglobin decreased | 24.34 | 13.99 | 107 | 17892 | 222012 | 79504377 |
| Enterococcal sepsis | 24.27 | 13.99 | 12 | 17987 | 2714 | 79723675 |
| Mucosal inflammation | 24.18 | 13.99 | 53 | 17946 | 75527 | 79650862 |
| Embolic stroke | 23.27 | 13.99 | 17 | 17982 | 7809 | 79718580 |
| Cholestasis | 23.25 | 13.99 | 42 | 17957 | 52067 | 79674322 |
| Alanine aminotransferase increased | 23.16 | 13.99 | 85 | 17914 | 162485 | 79563904 |
| Interstitial lung disease | 22.45 | 13.99 | 66 | 17933 | 112534 | 79613855 |
| Acute left ventricular failure | 22.32 | 13.99 | 10 | 17989 | 1814 | 79724575 |
| Drug hypersensitivity | 22.02 | 13.99 | 21 | 17978 | 298895 | 79427494 |
| Drug eruption | 21.66 | 13.99 | 37 | 17962 | 43898 | 79682491 |
| Platelet count increased | 21.64 | 13.99 | 26 | 17973 | 22380 | 79704009 |
| Haemodynamic instability | 21.61 | 13.99 | 23 | 17976 | 17359 | 79709030 |
| Haemophilia | 21.37 | 13.99 | 5 | 17994 | 109 | 79726280 |
| Alopecia | 21.19 | 13.99 | 13 | 17986 | 231342 | 79495047 |
| Infusion site warmth | 21.13 | 13.99 | 9 | 17990 | 1446 | 79724943 |
| Thoracotomy | 21.04 | 13.99 | 5 | 17994 | 117 | 79726272 |
| Basophil count increased | 20.85 | 13.99 | 9 | 17990 | 1494 | 79724895 |
| Uterine disorder | 20.50 | 13.99 | 10 | 17989 | 2197 | 79724192 |
| Thrombotic microangiopathy | 20.46 | 13.99 | 24 | 17975 | 20145 | 79706244 |
| Pyrexia | 20.25 | 13.99 | 238 | 17761 | 678471 | 79047918 |
| Haemophilic arthropathy | 20.14 | 13.99 | 5 | 17994 | 141 | 79726248 |
| Chronic pulmonary histoplasmosis | 20.11 | 13.99 | 3 | 17996 | 3 | 79726386 |
| Acute myeloid leukaemia | 19.33 | 13.99 | 29 | 17970 | 30856 | 79695533 |
| Pulmonary haemorrhage | 19.23 | 13.99 | 20 | 17979 | 14697 | 79711692 |
| Off label use | 19.21 | 13.99 | 299 | 17700 | 906916 | 78819473 |
| Abdominal discomfort | 19.19 | 13.99 | 17 | 17982 | 250710 | 79475679 |
| Ovarian vein thrombosis | 19.04 | 13.99 | 4 | 17995 | 52 | 79726337 |
| Multiple organ dysfunction syndrome | 18.95 | 13.99 | 65 | 17934 | 120181 | 79606208 |
| Hepatic cyst ruptured | 18.90 | 13.99 | 3 | 17996 | 6 | 79726383 |
| PCO2 abnormal | 18.33 | 13.99 | 4 | 17995 | 63 | 79726326 |
| Myelodysplastic syndrome | 18.32 | 13.99 | 28 | 17971 | 30273 | 79696116 |
| Infusion site discomfort | 18.24 | 13.99 | 8 | 17991 | 1379 | 79725010 |
| Vascular stent thrombosis | 18.17 | 13.99 | 11 | 17988 | 3699 | 79722690 |
| Procedural haemorrhage | 18.16 | 13.99 | 12 | 17987 | 4694 | 79721695 |
| Transfusion | 17.79 | 13.99 | 23 | 17976 | 21307 | 79705082 |
| Systemic lupus erythematosus | 17.73 | 13.99 | 3 | 17996 | 121146 | 79605243 |
| Sepsis | 17.29 | 13.99 | 112 | 17887 | 269316 | 79457073 |
| Infusion related reaction | 17.15 | 13.99 | 16 | 17983 | 230221 | 79496168 |
| Intentional self-injury | 16.90 | 13.99 | 28 | 17971 | 32391 | 79693998 |
| Gastrointestinal haemorrhage | 16.81 | 13.99 | 72 | 17927 | 147647 | 79578742 |
| Intracardiac thrombus | 16.70 | 13.99 | 11 | 17988 | 4282 | 79722107 |
| Infusion site rash | 16.68 | 13.99 | 8 | 17991 | 1694 | 79724695 |
| Angioedema | 16.54 | 13.99 | 46 | 17953 | 75989 | 79650400 |
| Asthma | 16.47 | 13.99 | 5 | 17994 | 135090 | 79591299 |
| Oesophageal haemorrhage | 16.39 | 13.99 | 8 | 17991 | 1759 | 79724630 |
| Fall | 16.31 | 13.99 | 56 | 17943 | 487573 | 79238816 |
| Bronchial artery embolisation | 16.22 | 13.99 | 3 | 17996 | 19 | 79726370 |
| Cardiac failure congestive | 16.09 | 13.99 | 6 | 17993 | 142396 | 79583993 |
| Pneumonia | 16.06 | 13.99 | 223 | 17776 | 660023 | 79066366 |
| Urine ketone body present | 16.01 | 13.99 | 10 | 17989 | 3555 | 79722834 |
| HER2 positive breast cancer | 15.99 | 13.99 | 5 | 17994 | 333 | 79726056 |
| Arterial thrombosis | 15.93 | 13.99 | 9 | 17990 | 2665 | 79723724 |
| Memory impairment | 15.85 | 13.99 | 3 | 17996 | 111731 | 79614658 |
| Atrial thrombosis | 15.78 | 13.99 | 10 | 17989 | 3646 | 79722743 |
| Contraindicated product administered | 15.65 | 13.99 | 8 | 17991 | 157530 | 79568859 |
| Weight decreased | 15.40 | 13.99 | 36 | 17963 | 355162 | 79371227 |
| Adnexal torsion | 15.38 | 13.99 | 5 | 17994 | 378 | 79726011 |
| Aphasia | 15.20 | 13.99 | 33 | 17966 | 46699 | 79679690 |
| White blood cell count increased | 15.11 | 13.99 | 44 | 17955 | 74589 | 79651800 |
| Asthenia | 15.00 | 13.99 | 62 | 17937 | 511627 | 79214762 |
| Hyperaesthesia | 14.89 | 13.99 | 16 | 17983 | 12206 | 79714183 |
| Disseminated intravascular coagulation | 14.87 | 13.99 | 28 | 17971 | 35814 | 79690575 |
| Weight increased | 14.70 | 13.99 | 25 | 17974 | 277361 | 79449028 |
| Peripheral swelling | 14.56 | 13.99 | 24 | 17975 | 269593 | 79456796 |
| Fibroma | 14.55 | 13.99 | 6 | 17993 | 889 | 79725500 |
| Pericarditis | 14.36 | 13.99 | 3 | 17996 | 104233 | 79622156 |
| Stevens-Johnson syndrome | 14.30 | 13.99 | 29 | 17970 | 39137 | 79687252 |
| Mobility decreased | 14.05 | 13.99 | 5 | 17994 | 122170 | 79604219 |
| Transaminases increased | 14.02 | 13.99 | 34 | 17965 | 51709 | 79674680 |
| Meningitis aseptic | 14.02 | 13.99 | 12 | 17987 | 6916 | 79719473 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | B02AA02 | BLOOD AND BLOOD FORMING ORGANS ANTIHEMORRHAGICS ANTIFIBRINOLYTICS Amino acids |
| FDA PE | N0000175632 | Decreased Fibrinolysis |
| FDA EPC | N0000175634 | Antifibrinolytic Agent |
| MeSH PA | D000933 | Antifibrinolytic Agents |
| MeSH PA | D003029 | Coagulants |
| MeSH PA | D006401 | Hematologic Agents |
| MeSH PA | D006490 | Hemostatics |
| CHEBI has role | CHEBI:48675 | antifibrinolytic agent |
| CHEBI has role | CHEBI:50248 | hematologic agents |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Contraception | indication | 13197004 | |
| Female hypogonadism syndrome | indication | 16041008 | |
| Endometriosis | indication | 129103003 | |
| Menorrhagia | indication | 386692008 | |
| Hemorrhaging in Hemophilia | indication | ||
| Refractory melasma | off-label use | 36209000 | |
| Epistaxis | off-label use | 249366005 | |
| Hyperfibrinolysis Induced Hemorrhage | off-label use | ||
| Prevention of Hemorrhage with Cardiovascular Instability from Cardiopulmonary Bypass - CABG | off-label use | ||
| Postsurgical Hemorrhage | off-label use | ||
| Heart valve disorder | contraindication | 368009 | DOID:4079 |
| Cerebral edema | contraindication | 2032001 | |
| Hypercholesterolemia | contraindication | 13644009 | |
| Subarachnoid intracranial hemorrhage | contraindication | 21454007 | |
| Myocardial infarction | contraindication | 22298006 | DOID:5844 |
| Depressive disorder | contraindication | 35489007 | |
| Migraine | contraindication | 37796009 | DOID:6364 |
| Hypertensive disorder | contraindication | 38341003 | DOID:10763 |
| Disorder of gallbladder | contraindication | 39621005 | DOID:0060262 |
| Body fluid retention | contraindication | 43498006 | |
| Thrombosis of retinal vein | contraindication | 46085004 | |
| Hyperlipidemia | contraindication | 55822004 | DOID:1168 |
| Benign mammary dysplasia | contraindication | 57993004 | |
| Obstructive hyperbilirubinemia | contraindication | 59848001 | |
| Thrombophlebitis | contraindication | 64156001 | DOID:3875 |
| Intermenstrual bleeding - irregular | contraindication | 64996003 | |
| Cerebral arterial thrombosis | contraindication | 71444005 | |
| Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
| Hyperglycemia | contraindication | 80394007 | DOID:4195 |
| Malignant neoplasm of liver | contraindication | 93870000 | DOID:3571 |
| Deep venous thrombosis | contraindication | 128053003 | |
| Angina pectoris | contraindication | 194828000 | |
| Impaired renal function disorder | contraindication | 197663003 | |
| Cerebrovascular accident | contraindication | 230690007 | |
| Pulmonary thromboembolism | contraindication | 233935004 | |
| Thrombophilia | contraindication | 234467004 | DOID:2452 |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Cholestasis of pregnancy | contraindication | 235888006 | |
| Endometrial carcinoma | contraindication | 254878006 | DOID:2871 |
| Pregnancy, function | contraindication | 289908002 | |
| Hypertriglyceridemia | contraindication | 302870006 | |
| Malignant tumor of cervix | contraindication | 363354003 | DOID:4362 |
| Thromboembolic disorder | contraindication | 371039008 | |
| Cardiovascular event risk | contraindication | 395112001 | |
| Ligneous conjunctivitis | contraindication | 403435005 | |
| Disorder of coronary artery | contraindication | 414024009 | |
| Obesity | contraindication | 414916001 | DOID:9970 |
| Estrogen receptor positive tumor | contraindication | 416053008 | |
| Porphyria | contraindication | 418470004 | |
| Thrombosis | contraindication | 439127006 | |
| Hypertensive urgency | contraindication | 443482000 | |
| Carcinoma of female breast | contraindication | 447782002 | |
| Smokes tobacco daily | contraindication | 449868002 | |
| Major Surgery with Prolonged Post-Operative Immobilization | contraindication | ||
| Nonspecific Abnormal Papanicolaou Smear of Cervix | 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 | 4.31 | acidic |
| pKa2 | 10.7 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 650MG | LYSTEDA | AMRING PHARMS | N022430 | Nov. 13, 2009 | RX | TABLET | ORAL | 8022106 | March 4, 2025 | TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING |
| 650MG | LYSTEDA | AMRING PHARMS | N022430 | Nov. 13, 2009 | RX | TABLET | ORAL | 8273795 | March 4, 2025 | TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING |
| 650MG | LYSTEDA | AMRING PHARMS | N022430 | Nov. 13, 2009 | RX | TABLET | ORAL | 8487005 | March 4, 2025 | TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING |
| 650MG | LYSTEDA | AMRING PHARMS | N022430 | Nov. 13, 2009 | RX | TABLET | ORAL | 8791160 | March 4, 2025 | TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING |
| 650MG | LYSTEDA | AMRING PHARMS | N022430 | Nov. 13, 2009 | RX | TABLET | ORAL | 8809394 | March 4, 2025 | TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING |
| 650MG | LYSTEDA | AMRING PHARMS | N022430 | Nov. 13, 2009 | RX | TABLET | ORAL | 8957113 | March 4, 2025 | TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Plasminogen | Enzyme | INHIBITOR | Kd | 5.96 | CHEMBL | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4020569 | VUID |
| N0000148271 | NUI |
| D01136 | KEGG_DRUG |
| 4020569 | VANDF |
| C0040613 | UMLSCUI |
| CHEBI:48669 | CHEBI |
| CHEMBL877 | ChEMBL_ID |
| DB00302 | DRUGBANK_ID |
| D014148 | MESH_DESCRIPTOR_UI |
| 5526 | PUBCHEM_CID |
| 2060 | INN_ID |
| 6573 | IUPHAR_LIGAND_ID |
| 6T84R30KC1 | UNII |
| 10691 | RXNORM |
| 5607 | MMSL |
| 80873 | MMSL |
| d00529 | MMSL |
| 002073 | NDDF |
| 109006003 | SNOMEDCT_US |
| 386960009 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Cyklokapron | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0013-1114 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | NDA | 30 sections |
| Tranexamic Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0517-0960 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 30 sections |
| Tranexamic Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-3720 | TABLET, FILM COATED | 650 mg | ORAL | ANDA | 25 sections |
| Tranexamic acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 14789-500 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 20 sections |
| Tranexamic Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17478-017 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 26 sections |
| Tranexamic Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17478-018 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 27 sections |
| Tranexamic Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-166 | INJECTION, SOLUTION | 1 g | INTRAVENOUS | ANDA | 24 sections |
| Tranexamic Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-166 | INJECTION, SOLUTION | 1 g | INTRAVENOUS | ANDA | 24 sections |
| Tranexamic Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-524 | INJECTION, SOLUTION | 1 g | INTRAVENOUS | ANDA | 24 sections |
| Tranexamic Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-524 | INJECTION, SOLUTION | 1 g | INTRAVENOUS | ANDA | 24 sections |
| Tranexamic Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 25021-415 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 28 sections |
| Tranexamic Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 39822-1000 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 35 sections |
| Tranexamic Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 39822-1000 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 35 sections |
| Tranexamic Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42192-605 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 13 sections |
| Tranexamic Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42571-189 | INJECTION | 100 mg | INTRAVENOUS | ANDA | 27 sections |
| TRANEXAMIC ACID | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42571-314 | INJECTION | 100 mg | INTRAVENOUS | ANDA | 27 sections |
| TRANEXAMIC ACID | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43066-008 | INJECTION | 100 mg | INTRAVENOUS | ANDA | 27 sections |
| TRANEXAMIC ACID | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43066-008 | INJECTION | 100 mg | INTRAVENOUS | ANDA | 27 sections |
| Tranexamic Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-4530 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 30 sections |
| tranexamic acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-5072 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 26 sections |
| tranexamic acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-5072 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 26 sections |
| Tranexamic Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50268-772 | TABLET | 650 mg | ORAL | NDA authorized generic | 28 sections |
| TRANEXAMIC ACID | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51662-1532 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 16 sections |
| TRANEXAMIC ACID IN SODIUM CHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51754-0108 | INJECTION, SOLUTION | 10 mg | INTRAVENOUS | NDA | 25 sections |
| Tranexamic Acid | Human Prescription Drug Label | 1 | 55150-188 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 27 sections |
| Lysteda | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55566-2110 | TABLET | 650 mg | ORAL | NDA | 28 sections |
| Tranexamic Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-3638 | TABLET | 650 1 | ORAL | ANDA | 25 sections |
| Tranexamic Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-6169 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 28 sections |
| Tranexamic Acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-6169 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 28 sections |
| tranexamic acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61990-0611 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 27 sections |