valsartan Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| angiotensin II receptor antagonists, antihypertensive (non-peptidic) | 2806 | 137862-53-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A tetrazole derivative and ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to treat HYPERTENSION.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 80 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 4 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 0.18 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 13 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 10.50 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 23 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 0.22 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 0.49 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.04 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 9.50 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 23, 1996 | FDA |
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 |
|---|---|---|---|---|---|---|
| Hypotension | 503.80 | 9.84 | 1678 | 137230 | 230911 | 46316243 |
| Blood pressure increased | 353.14 | 9.84 | 999 | 137909 | 125667 | 46421487 |
| Blood pressure inadequately controlled | 344.66 | 9.84 | 195 | 138713 | 4211 | 46542943 |
| Cardiac failure | 325.05 | 9.84 | 728 | 138180 | 79220 | 46467934 |
| Completed suicide | 272.34 | 9.84 | 52 | 138856 | 145868 | 46401286 |
| Hyponatraemia | 243.06 | 9.84 | 758 | 138150 | 100574 | 46446580 |
| Dizziness | 240.91 | 9.84 | 1784 | 137124 | 338630 | 46208524 |
| Hypertension | 222.43 | 9.84 | 1162 | 137746 | 195194 | 46351960 |
| Hyperkalaemia | 204.01 | 9.84 | 460 | 138448 | 50249 | 46496905 |
| Rheumatoid arthritis | 189.53 | 9.84 | 263 | 138645 | 239952 | 46307202 |
| Product prescribing error | 188.50 | 9.84 | 264 | 138644 | 19783 | 46527371 |
| Blood pressure decreased | 183.28 | 9.84 | 475 | 138433 | 56684 | 46490470 |
| Off label use | 174.61 | 9.84 | 565 | 138343 | 379276 | 46167878 |
| Myocardial infarction | 169.73 | 9.84 | 656 | 138252 | 96872 | 46450282 |
| Wrong technique in product usage process | 169.11 | 9.84 | 447 | 138461 | 53975 | 46493179 |
| Acute kidney injury | 153.54 | 9.84 | 1213 | 137695 | 234642 | 46312512 |
| Toxicity to various agents | 149.51 | 9.84 | 250 | 138658 | 211516 | 46335638 |
| Blood creatinine increased | 146.30 | 9.84 | 530 | 138378 | 75873 | 46471281 |
| Diabetes mellitus | 127.84 | 9.84 | 383 | 138525 | 49682 | 46497472 |
| Angioedema | 127.17 | 9.84 | 328 | 138580 | 39014 | 46508140 |
| Cardiac failure congestive | 119.27 | 9.84 | 565 | 138343 | 91185 | 46455969 |
| Oligohydramnios | 114.68 | 9.84 | 109 | 138799 | 5356 | 46541798 |
| Cardiac failure chronic | 113.99 | 9.84 | 90 | 138818 | 3434 | 46543720 |
| Atrial fibrillation | 104.88 | 9.84 | 595 | 138313 | 102995 | 46444159 |
| Oedema peripheral | 104.66 | 9.84 | 823 | 138085 | 158883 | 46388271 |
| Cerebrovascular accident | 102.72 | 9.84 | 581 | 138327 | 100458 | 46446696 |
| Drug ineffective | 102.03 | 9.84 | 1414 | 137494 | 676424 | 45870730 |
| Hypertensive crisis | 101.72 | 9.84 | 161 | 138747 | 13454 | 46533700 |
| Blood potassium increased | 99.38 | 9.84 | 180 | 138728 | 16787 | 46530367 |
| Drug hypersensitivity | 98.88 | 9.84 | 382 | 138526 | 243443 | 46303711 |
| Infusion related reaction | 97.85 | 9.84 | 94 | 138814 | 101114 | 46446040 |
| Renal failure | 97.50 | 9.84 | 625 | 138283 | 112969 | 46434185 |
| Cerebral infarction | 93.96 | 9.84 | 212 | 138696 | 23154 | 46524000 |
| Pemphigus | 91.36 | 9.84 | 13 | 138895 | 45261 | 46501893 |
| Syncope | 88.93 | 9.84 | 575 | 138333 | 104228 | 46442926 |
| Cough | 87.83 | 9.84 | 1059 | 137849 | 229190 | 46317964 |
| Exposure during pregnancy | 86.68 | 9.84 | 117 | 138791 | 108095 | 46439059 |
| Treatment failure | 83.70 | 9.84 | 92 | 138816 | 92995 | 46454159 |
| Maternal exposure during pregnancy | 83.03 | 9.84 | 110 | 138798 | 102439 | 46444715 |
| Dyspnoea | 82.37 | 9.84 | 2060 | 136848 | 513488 | 46033666 |
| Renal impairment | 79.79 | 9.84 | 434 | 138474 | 73938 | 46473216 |
| Colitis microscopic | 79.72 | 9.84 | 98 | 138810 | 6458 | 46540696 |
| Coronary artery disease | 79.43 | 9.84 | 251 | 138657 | 33501 | 46513653 |
| Blood glucose increased | 79.13 | 9.84 | 423 | 138485 | 71590 | 46475564 |
| Glaucoma | 78.54 | 9.84 | 157 | 138751 | 15764 | 46531390 |
| Pain | 76.60 | 9.84 | 981 | 137927 | 475967 | 46071187 |
| Angina pectoris | 76.21 | 9.84 | 213 | 138695 | 26562 | 46520592 |
| Drug abuse | 73.67 | 9.84 | 49 | 138859 | 63359 | 46483795 |
| Neutropenia | 72.75 | 9.84 | 203 | 138705 | 143001 | 46404153 |
| Glossodynia | 72.46 | 9.84 | 21 | 138887 | 44352 | 46502802 |
| Glomerular filtration rate decreased | 69.68 | 9.84 | 125 | 138783 | 11569 | 46535585 |
| Hand deformity | 69.59 | 9.84 | 10 | 138898 | 34564 | 46512590 |
| Ejection fraction decreased | 67.99 | 9.84 | 159 | 138749 | 17778 | 46529376 |
| Blood urea increased | 66.64 | 9.84 | 196 | 138712 | 25156 | 46521998 |
| Febrile neutropenia | 66.41 | 9.84 | 112 | 138796 | 94515 | 46452639 |
| Arrhythmia | 64.37 | 9.84 | 239 | 138669 | 34602 | 46512552 |
| Abortion spontaneous | 63.71 | 9.84 | 25 | 138883 | 43621 | 46503533 |
| Therapeutic product effect decreased | 62.48 | 9.84 | 93 | 138815 | 82508 | 46464646 |
| Malaise | 60.51 | 9.84 | 1349 | 137559 | 329883 | 46217271 |
| Systemic lupus erythematosus | 60.16 | 9.84 | 63 | 138845 | 65117 | 46482037 |
| Cardiac disorder | 55.43 | 9.84 | 268 | 138640 | 43590 | 46503564 |
| Injection site pain | 55.07 | 9.84 | 151 | 138757 | 107001 | 46440153 |
| Blood pressure abnormal | 54.98 | 9.84 | 116 | 138792 | 12101 | 46535053 |
| Thyroid disorder | 54.74 | 9.84 | 115 | 138793 | 11961 | 46535193 |
| Condition aggravated | 53.87 | 9.84 | 468 | 138440 | 244584 | 46302570 |
| Mitral valve incompetence | 53.67 | 9.84 | 150 | 138758 | 18702 | 46528452 |
| Disease progression | 52.88 | 9.84 | 121 | 138787 | 91179 | 46455975 |
| Intentional overdose | 52.21 | 9.84 | 70 | 138838 | 64874 | 46482280 |
| Blood pressure diastolic decreased | 50.65 | 9.84 | 123 | 138785 | 14088 | 46533066 |
| Fall | 50.29 | 9.84 | 1308 | 137600 | 327789 | 46219365 |
| Pregnancy | 49.87 | 9.84 | 10 | 138898 | 27127 | 46520027 |
| Product use issue | 49.67 | 9.84 | 132 | 138776 | 94512 | 46452642 |
| N-terminal prohormone brain natriuretic peptide increased | 49.63 | 9.84 | 41 | 138867 | 1670 | 46545484 |
| Feeling abnormal | 47.93 | 9.84 | 576 | 138332 | 124484 | 46422670 |
| Injection site reaction | 47.92 | 9.84 | 43 | 138865 | 47806 | 46499348 |
| Injection site erythema | 47.82 | 9.84 | 93 | 138815 | 74334 | 46472820 |
| Asthenia | 47.70 | 9.84 | 1237 | 137671 | 309838 | 46237316 |
| Renal disorder | 45.94 | 9.84 | 179 | 138729 | 26507 | 46520647 |
| Product impurity | 44.54 | 9.84 | 14 | 138894 | 59 | 46547095 |
| Joint swelling | 42.59 | 9.84 | 304 | 138604 | 165769 | 46381385 |
| Tachyarrhythmia | 42.05 | 9.84 | 60 | 138848 | 4572 | 46542582 |
| Infection | 41.76 | 9.84 | 230 | 138678 | 133362 | 46413792 |
| Diabetes mellitus inadequate control | 41.48 | 9.84 | 109 | 138799 | 13105 | 46534049 |
| Infarction | 41.04 | 9.84 | 42 | 138866 | 2259 | 46544895 |
| Recalled product administered | 40.95 | 9.84 | 18 | 138890 | 220 | 46546934 |
| Arthropathy | 40.13 | 9.84 | 124 | 138784 | 84576 | 46462578 |
| Hospitalisation | 40.03 | 9.84 | 80 | 138828 | 63305 | 46483849 |
| Migraine | 39.58 | 9.84 | 94 | 138814 | 69932 | 46477222 |
| Ejection fraction abnormal | 39.35 | 9.84 | 24 | 138884 | 598 | 46546556 |
| General physical health deterioration | 39.15 | 9.84 | 521 | 138387 | 115248 | 46431906 |
| Alopecia | 38.92 | 9.84 | 303 | 138605 | 162111 | 46385043 |
| Concomitant disease aggravated | 38.00 | 9.84 | 77 | 138831 | 7805 | 46539349 |
| Pyrexia | 37.65 | 9.84 | 772 | 138136 | 348030 | 46199124 |
| Pulmonary hypoplasia | 37.37 | 9.84 | 18 | 138890 | 275 | 46546879 |
| Total lung capacity increased | 36.92 | 9.84 | 25 | 138883 | 749 | 46546405 |
| Sinusitis | 36.53 | 9.84 | 231 | 138677 | 129537 | 46417617 |
| Blood uric acid increased | 36.07 | 9.84 | 53 | 138855 | 4148 | 46543006 |
| Labile hypertension | 35.77 | 9.84 | 21 | 138887 | 487 | 46546667 |
| Suicidal ideation | 35.74 | 9.84 | 71 | 138837 | 56311 | 46490843 |
| Chest pain | 35.61 | 9.84 | 729 | 138179 | 175595 | 46371559 |
| Fear of disease | 35.56 | 9.84 | 28 | 138880 | 1064 | 46546090 |
| Memory impairment | 35.44 | 9.84 | 369 | 138539 | 76968 | 46470186 |
| Nervousness | 35.26 | 9.84 | 173 | 138735 | 28302 | 46518852 |
| Therapeutic product effect incomplete | 34.54 | 9.84 | 118 | 138790 | 78035 | 46469119 |
| Seizure | 34.15 | 9.84 | 220 | 138688 | 122834 | 46424320 |
| Gout | 33.96 | 9.84 | 92 | 138816 | 11264 | 46535890 |
| Musculoskeletal stiffness | 33.84 | 9.84 | 163 | 138745 | 97830 | 46449324 |
| Macular degeneration | 33.10 | 9.84 | 69 | 138839 | 7136 | 46540018 |
| Cardiomegaly | 32.35 | 9.84 | 120 | 138788 | 17362 | 46529792 |
| Multiple sclerosis relapse | 32.26 | 9.84 | 47 | 138861 | 42078 | 46505076 |
| Basilar artery occlusion | 32.24 | 9.84 | 13 | 138895 | 126 | 46547028 |
| Nausea | 32.15 | 9.84 | 1696 | 137212 | 685758 | 45861396 |
| Cardiac failure acute | 32.14 | 9.84 | 73 | 138835 | 8005 | 46539149 |
| Brain natriuretic peptide increased | 32.02 | 9.84 | 53 | 138855 | 4597 | 46542557 |
| Injection site swelling | 31.87 | 9.84 | 44 | 138864 | 40283 | 46506871 |
| Product dose omission issue | 31.81 | 9.84 | 334 | 138574 | 168186 | 46378968 |
| Arthralgia | 30.71 | 9.84 | 838 | 138070 | 363765 | 46183389 |
| Inappropriate schedule of product administration | 30.64 | 9.84 | 312 | 138596 | 64701 | 46482453 |
| Bone marrow failure | 30.51 | 9.84 | 26 | 138882 | 29643 | 46517511 |
| Psoriatic arthropathy | 30.48 | 9.84 | 38 | 138870 | 36341 | 46510813 |
| Glycosylated haemoglobin increased | 30.43 | 9.84 | 86 | 138822 | 10790 | 46536364 |
| Chronic kidney disease | 30.31 | 9.84 | 217 | 138691 | 40654 | 46506500 |
| Anaphylactic reaction | 30.25 | 9.84 | 71 | 138837 | 53041 | 46494113 |
| Hypoglycaemia | 29.14 | 9.84 | 268 | 138640 | 54081 | 46493073 |
| Loss of personal independence in daily activities | 29.05 | 9.84 | 81 | 138827 | 57102 | 46490052 |
| Pancreatic steatosis | 28.98 | 9.84 | 24 | 138884 | 981 | 46546173 |
| Drug resistance | 28.76 | 9.84 | 8 | 138900 | 17360 | 46529794 |
| Ischaemic stroke | 28.65 | 9.84 | 112 | 138796 | 16610 | 46530544 |
| Diverticulitis | 28.43 | 9.84 | 182 | 138726 | 32857 | 46514297 |
| Blood sodium decreased | 28.34 | 9.84 | 134 | 138774 | 21592 | 46525562 |
| Psychotic disorder | 28.33 | 9.84 | 16 | 138892 | 22605 | 46524549 |
| Blood pressure systolic increased | 28.20 | 9.84 | 164 | 138744 | 28623 | 46518531 |
| Device dislocation | 27.91 | 9.84 | 15 | 138893 | 21787 | 46525367 |
| Rheumatoid factor positive | 27.82 | 9.84 | 13 | 138895 | 20448 | 46526706 |
| Intentional product misuse | 27.65 | 9.84 | 62 | 138846 | 47066 | 46500088 |
| Vascular resistance pulmonary decreased | 27.62 | 9.84 | 10 | 138898 | 70 | 46547084 |
| Blood pressure fluctuation | 27.62 | 9.84 | 170 | 138738 | 30278 | 46516876 |
| Palpitations | 27.51 | 9.84 | 417 | 138491 | 94842 | 46452312 |
| Cardiovascular disorder | 27.18 | 9.84 | 89 | 138819 | 12098 | 46535056 |
| Adverse drug reaction | 27.15 | 9.84 | 57 | 138851 | 44305 | 46502849 |
| Brain stem stroke | 26.53 | 9.84 | 14 | 138894 | 262 | 46546892 |
| Polyuria | 26.42 | 9.84 | 63 | 138845 | 7132 | 46540022 |
| Hyperuricaemia | 26.30 | 9.84 | 49 | 138859 | 4668 | 46542486 |
| Breast cancer | 26.22 | 9.84 | 228 | 138680 | 45290 | 46501864 |
| Therapeutic drug monitoring analysis not performed | 26.21 | 9.84 | 17 | 138891 | 473 | 46546681 |
| Cardiogenic shock | 25.88 | 9.84 | 107 | 138801 | 16277 | 46530877 |
| Transient ischaemic attack | 25.70 | 9.84 | 185 | 138723 | 34718 | 46512436 |
| Malignant neoplasm progression | 25.43 | 9.84 | 103 | 138805 | 64823 | 46482331 |
| Lymphatic fistula | 24.97 | 9.84 | 21 | 138887 | 877 | 46546277 |
| Femoral hernia incarcerated | 24.75 | 9.84 | 21 | 138887 | 888 | 46546266 |
| Pericarditis | 24.56 | 9.84 | 21 | 138887 | 23906 | 46523248 |
| Overdose | 24.53 | 9.84 | 190 | 138718 | 101789 | 46445365 |
| Thrombocytopenia | 24.24 | 9.84 | 250 | 138658 | 126331 | 46420823 |
| Product contamination chemical | 24.10 | 9.84 | 5 | 138903 | 0 | 46547154 |
| Throat clearing | 23.66 | 9.84 | 15 | 138893 | 401 | 46546753 |
| Tricuspid valve incompetence | 23.60 | 9.84 | 92 | 138816 | 13625 | 46533529 |
| Skin reaction | 23.58 | 9.84 | 79 | 138829 | 10867 | 46536287 |
| Diverticulum intestinal | 23.38 | 9.84 | 54 | 138854 | 5987 | 46541167 |
| Device stimulation issue | 23.30 | 9.84 | 9 | 138899 | 77 | 46547077 |
| Cutaneous lymphoma | 23.26 | 9.84 | 11 | 138897 | 161 | 46546993 |
| Left-to-right cardiac shunt | 23.14 | 9.84 | 10 | 138898 | 117 | 46547037 |
| Intentional product use issue | 23.10 | 9.84 | 80 | 138828 | 52700 | 46494454 |
| Arterial haemorrhage | 23.05 | 9.84 | 27 | 138881 | 1691 | 46545463 |
| Hypertensive cardiomyopathy | 22.67 | 9.84 | 12 | 138896 | 226 | 46546928 |
| Antinuclear antibody negative | 22.57 | 9.84 | 12 | 138896 | 228 | 46546926 |
| Hemiplegia | 22.57 | 9.84 | 58 | 138850 | 6880 | 46540274 |
| Thrombotic stroke | 22.54 | 9.84 | 16 | 138892 | 518 | 46546636 |
| Neuropathy peripheral | 22.50 | 9.84 | 168 | 138740 | 90725 | 46456429 |
| Cytomegalovirus infection | 22.48 | 9.84 | 13 | 138895 | 18131 | 46529023 |
| Forced expiratory volume decreased | 22.43 | 9.84 | 48 | 138860 | 5056 | 46542098 |
| Clostridium difficile infection | 22.34 | 9.84 | 25 | 138883 | 25078 | 46522076 |
| Acute myocardial infarction | 22.24 | 9.84 | 167 | 138741 | 31757 | 46515397 |
| Atrioventricular block complete | 22.02 | 9.84 | 61 | 138847 | 7566 | 46539588 |
| Rash | 21.54 | 9.84 | 855 | 138053 | 355657 | 46191497 |
| Lip swelling | 21.30 | 9.84 | 139 | 138769 | 25256 | 46521898 |
| Hypochloraemia | 21.18 | 9.84 | 27 | 138881 | 1846 | 46545308 |
| Acral lentiginous melanoma | 21.18 | 9.84 | 5 | 138903 | 4 | 46547150 |
| Hepatic cyst | 21.15 | 9.84 | 45 | 138863 | 4721 | 46542433 |
| Bronchial haemorrhage | 21.03 | 9.84 | 13 | 138895 | 332 | 46546822 |
| Product odour abnormal | 20.74 | 9.84 | 21 | 138887 | 1115 | 46546039 |
| Pancytopenia | 20.68 | 9.84 | 158 | 138750 | 84900 | 46462254 |
| Impaired work ability | 20.59 | 9.84 | 6 | 138902 | 12630 | 46534524 |
| Renal artery stenosis | 20.57 | 9.84 | 26 | 138882 | 1762 | 46545392 |
| Therapeutic response decreased | 20.54 | 9.84 | 63 | 138845 | 43082 | 46504072 |
| Ventricular extrasystoles | 20.52 | 9.84 | 76 | 138832 | 10987 | 46536167 |
| Angina unstable | 20.45 | 9.84 | 59 | 138849 | 7489 | 46539665 |
| Caesarean section | 20.42 | 9.84 | 12 | 138896 | 16591 | 46530563 |
| Status epilepticus | 20.41 | 9.84 | 8 | 138900 | 13971 | 46533183 |
| Urine albumin/creatinine ratio increased | 20.29 | 9.84 | 10 | 138898 | 161 | 46546993 |
| Transitional cell cancer of the renal pelvis and ureter | 20.18 | 9.84 | 5 | 138903 | 6 | 46547148 |
| Therapy cessation | 20.11 | 9.84 | 30 | 138878 | 26599 | 46520555 |
| Orthopnoea | 20.00 | 9.84 | 50 | 138858 | 5830 | 46541324 |
| Metastatic bronchial carcinoma | 19.98 | 9.84 | 9 | 138899 | 117 | 46547037 |
| Device issue | 19.95 | 9.84 | 18 | 138890 | 19962 | 46527192 |
| Cardio-respiratory arrest | 19.85 | 9.84 | 101 | 138807 | 59768 | 46487386 |
| Hypokalaemia | 19.79 | 9.84 | 370 | 138538 | 87654 | 46459500 |
| Gastritis haemorrhagic | 19.75 | 9.84 | 22 | 138886 | 1304 | 46545850 |
| N-terminal prohormone brain natriuretic peptide abnormal | 19.71 | 9.84 | 7 | 138901 | 46 | 46547108 |
| Ischaemic cardiomyopathy | 19.68 | 9.84 | 31 | 138877 | 2579 | 46544575 |
| Left atrial enlargement | 19.67 | 9.84 | 11 | 138897 | 232 | 46546922 |
| Hypoacusis | 19.60 | 9.84 | 118 | 138790 | 20851 | 46526303 |
| Coombs positive haemolytic anaemia | 19.57 | 9.84 | 13 | 138895 | 377 | 46546777 |
| Apparent death | 19.43 | 9.84 | 22 | 138886 | 1328 | 46545826 |
| Bronchial neoplasm | 19.42 | 9.84 | 11 | 138897 | 238 | 46546916 |
| Prescribed underdose | 19.26 | 9.84 | 79 | 138829 | 11974 | 46535180 |
| Ophthalmic vein thrombosis | 18.89 | 9.84 | 9 | 138899 | 134 | 46547020 |
| Near death experience | 18.73 | 9.84 | 12 | 138896 | 327 | 46546827 |
| Pollakiuria | 18.68 | 9.84 | 130 | 138778 | 24131 | 46523023 |
| White blood cell count decreased | 18.59 | 9.84 | 229 | 138679 | 112002 | 46435152 |
| Hypertensive heart disease | 18.59 | 9.84 | 30 | 138878 | 2548 | 46544606 |
| Premature delivery | 18.54 | 9.84 | 23 | 138885 | 22046 | 46525108 |
| Hip arthroplasty | 18.47 | 9.84 | 16 | 138892 | 18096 | 46529058 |
| Gait disturbance | 18.11 | 9.84 | 563 | 138345 | 144700 | 46402454 |
| Aortic valve stenosis | 18.11 | 9.84 | 33 | 138875 | 3091 | 46544063 |
| Wound infection pseudomonas | 18.10 | 9.84 | 22 | 138886 | 1433 | 46545721 |
| Lymphocyte stimulation test positive | 18.07 | 9.84 | 15 | 138893 | 615 | 46546539 |
| Herpes simplex reactivation | 18.07 | 9.84 | 12 | 138896 | 348 | 46546806 |
| Renin decreased | 18.04 | 9.84 | 8 | 138900 | 100 | 46547054 |
| Wound | 17.98 | 9.84 | 66 | 138842 | 42736 | 46504418 |
| Pneumothorax traumatic | 17.93 | 9.84 | 9 | 138899 | 151 | 46547003 |
| Septic shock | 17.89 | 9.84 | 100 | 138808 | 57793 | 46489361 |
| Orthostatic hypotension | 17.75 | 9.84 | 130 | 138778 | 24528 | 46522626 |
| Multiple sclerosis | 17.70 | 9.84 | 29 | 138879 | 24762 | 46522392 |
| Coronary arterial stent insertion | 17.64 | 9.84 | 31 | 138877 | 2822 | 46544332 |
| Product colour issue | 17.64 | 9.84 | 15 | 138893 | 636 | 46546518 |
| Lipoedema | 17.52 | 9.84 | 9 | 138899 | 159 | 46546995 |
| Herpes zoster | 17.49 | 9.84 | 124 | 138784 | 67748 | 46479406 |
| Ear infection | 17.30 | 9.84 | 26 | 138882 | 22987 | 46524167 |
| Dehydration | 17.24 | 9.84 | 608 | 138300 | 158932 | 46388222 |
| Oedema | 17.24 | 9.84 | 288 | 138620 | 66783 | 46480371 |
| Mydriasis | 17.22 | 9.84 | 5 | 138903 | 10548 | 46536606 |
| Gastric ulcer haemorrhage | 17.20 | 9.84 | 42 | 138866 | 4826 | 46542328 |
| Staphylococcal infection | 17.20 | 9.84 | 52 | 138856 | 35719 | 46511435 |
| Hepatotoxicity | 17.17 | 9.84 | 30 | 138878 | 24979 | 46522175 |
| Drug intolerance | 17.16 | 9.84 | 321 | 138587 | 146728 | 46400426 |
| Frustration tolerance decreased | 17.15 | 9.84 | 44 | 138864 | 5213 | 46541941 |
| Respiratory arrest | 17.10 | 9.84 | 48 | 138860 | 33768 | 46513386 |
| Blood lactate dehydrogenase increased | 17.07 | 9.84 | 112 | 138796 | 20388 | 46526766 |
| Suicide attempt | 17.04 | 9.84 | 95 | 138813 | 54941 | 46492213 |
| Injection site bruising | 16.99 | 9.84 | 52 | 138856 | 35584 | 46511570 |
| Forced vital capacity decreased | 16.99 | 9.84 | 17 | 138891 | 890 | 46546264 |
| Injection site pruritus | 16.88 | 9.84 | 61 | 138847 | 39682 | 46507472 |
| Concomitant disease progression | 16.75 | 9.84 | 26 | 138882 | 2136 | 46545018 |
| Neutrophil function disorder | 16.74 | 9.84 | 5 | 138903 | 17 | 46547137 |
| Live birth | 16.66 | 9.84 | 5 | 138903 | 10325 | 46536829 |
| Swollen tongue | 16.61 | 9.84 | 146 | 138762 | 29086 | 46518068 |
| Bladder transitional cell carcinoma recurrent | 16.52 | 9.84 | 4 | 138904 | 4 | 46547150 |
| Synovitis | 16.52 | 9.84 | 110 | 138798 | 60965 | 46486189 |
| Cardiac pacemaker insertion | 16.50 | 9.84 | 35 | 138873 | 3664 | 46543490 |
| Bradycardia | 16.43 | 9.84 | 283 | 138625 | 66015 | 46481139 |
| Ventricular internal diameter abnormal | 16.33 | 9.84 | 6 | 138902 | 44 | 46547110 |
| Sinus node dysfunction | 16.23 | 9.84 | 38 | 138870 | 4251 | 46542903 |
| Nasal turbinate hypertrophy | 16.17 | 9.84 | 12 | 138896 | 417 | 46546737 |
| Infusion site pain | 16.10 | 9.84 | 5 | 138903 | 10102 | 46537052 |
| Incorrect route of product administration | 16.07 | 9.84 | 15 | 138893 | 16368 | 46530786 |
| Liver function test increased | 16.02 | 9.84 | 27 | 138881 | 22799 | 46524355 |
| Anuria | 16.01 | 9.84 | 72 | 138836 | 11359 | 46535795 |
| Withdrawal hypertension | 16.00 | 9.84 | 8 | 138900 | 133 | 46547021 |
| Metastases to bone | 16.00 | 9.84 | 17 | 138891 | 17459 | 46529695 |
| Coronary artery stenosis | 15.95 | 9.84 | 40 | 138868 | 4673 | 46542481 |
| Diabetic nephropathy | 15.91 | 9.84 | 20 | 138888 | 1348 | 46545806 |
| Gastric cancer | 15.80 | 9.84 | 30 | 138878 | 2899 | 46544255 |
| Progressive multifocal leukoencephalopathy | 15.75 | 9.84 | 7 | 138901 | 11339 | 46535815 |
| Lung diffusion test decreased | 15.68 | 9.84 | 14 | 138894 | 634 | 46546520 |
| Accidental exposure to product | 15.67 | 9.84 | 24 | 138884 | 21057 | 46526097 |
| Altered state of consciousness | 15.62 | 9.84 | 121 | 138787 | 23227 | 46523927 |
| Device related infection | 15.60 | 9.84 | 24 | 138884 | 21017 | 46526137 |
| Sepsis | 15.54 | 9.84 | 298 | 138610 | 135716 | 46411438 |
| Carotid artery disease | 15.39 | 9.84 | 22 | 138886 | 1679 | 46545475 |
| Deafness | 15.39 | 9.84 | 91 | 138817 | 15977 | 46531177 |
| Fluid retention | 15.33 | 9.84 | 225 | 138683 | 50821 | 46496333 |
| Gamma-glutamyltransferase increased | 15.27 | 9.84 | 153 | 138755 | 31587 | 46515567 |
| Neutrophil count decreased | 15.12 | 9.84 | 72 | 138836 | 43354 | 46503800 |
| Sudden cardiac death | 15.09 | 9.84 | 25 | 138883 | 2170 | 46544984 |
| Somnolence | 14.94 | 9.84 | 353 | 138555 | 156168 | 46390986 |
| Intentional self-injury | 14.83 | 9.84 | 31 | 138877 | 24135 | 46523019 |
| Blood pressure systolic decreased | 14.83 | 9.84 | 42 | 138866 | 5276 | 46541878 |
| Adverse reaction | 14.83 | 9.84 | 3 | 138905 | 8087 | 46539067 |
| Myocardial ischaemia | 14.75 | 9.84 | 76 | 138832 | 12673 | 46534481 |
| Dementia Alzheimer's type | 14.75 | 9.84 | 18 | 138890 | 1177 | 46545977 |
| Hypertensive emergency | 14.75 | 9.84 | 21 | 138887 | 1597 | 46545557 |
| Therapeutic drug monitoring analysis incorrectly performed | 14.73 | 9.84 | 8 | 138900 | 159 | 46546995 |
| Vomiting | 14.71 | 9.84 | 1154 | 137754 | 451640 | 46095514 |
| Small intestinal obstruction | 14.50 | 9.84 | 16 | 138892 | 16156 | 46530998 |
| Seroma | 14.49 | 9.84 | 24 | 138884 | 2083 | 46545071 |
| Carcinogenicity | 14.46 | 9.84 | 3 | 138905 | 0 | 46547154 |
| Kidney malrotation | 14.46 | 9.84 | 3 | 138905 | 0 | 46547154 |
| Mouth ulceration | 14.39 | 9.84 | 37 | 138871 | 26795 | 46520359 |
| Retinopathy hypertensive | 14.18 | 9.84 | 9 | 138899 | 241 | 46546913 |
| Nocturia | 14.08 | 9.84 | 50 | 138858 | 7082 | 46540072 |
| Platelet count decreased | 14.07 | 9.84 | 211 | 138697 | 99813 | 46447341 |
| Peak expiratory flow rate decreased | 13.96 | 9.84 | 13 | 138895 | 622 | 46546532 |
| Respiration abnormal | 13.89 | 9.84 | 37 | 138871 | 4484 | 46542670 |
| Aortic arteriosclerosis | 13.87 | 9.84 | 43 | 138865 | 5678 | 46541476 |
| Fear | 13.86 | 9.84 | 89 | 138819 | 16083 | 46531071 |
| Angiotensin converting enzyme inhibitor foetopathy | 13.81 | 9.84 | 5 | 138903 | 35 | 46547119 |
| Neuroleptic malignant syndrome | 13.74 | 9.84 | 8 | 138900 | 11114 | 46536040 |
| Acute myeloid leukaemia | 13.73 | 9.84 | 16 | 138892 | 15762 | 46531392 |
| Hypoxia | 13.70 | 9.84 | 94 | 138814 | 51744 | 46495410 |
| Neutropenic sepsis | 13.68 | 9.84 | 10 | 138898 | 12314 | 46534840 |
| Prerenal failure | 13.62 | 9.84 | 19 | 138889 | 1418 | 46545736 |
| Mood swings | 13.59 | 9.84 | 17 | 138891 | 16235 | 46530919 |
| Post-anoxic myoclonus | 13.57 | 9.84 | 5 | 138903 | 37 | 46547117 |
| Low density lipoprotein increased | 13.55 | 9.84 | 44 | 138864 | 5956 | 46541198 |
| Blood potassium abnormal | 13.45 | 9.84 | 23 | 138885 | 2049 | 46545105 |
| Bronchial disorder | 13.45 | 9.84 | 16 | 138892 | 1019 | 46546135 |
| Arteriosclerosis | 13.41 | 9.84 | 61 | 138847 | 9672 | 46537482 |
| Faecaloma | 13.34 | 9.84 | 52 | 138856 | 7700 | 46539454 |
| Lacunar infarction | 13.32 | 9.84 | 31 | 138877 | 3454 | 46543700 |
| Blood antidiuretic hormone increased | 13.31 | 9.84 | 4 | 138904 | 14 | 46547140 |
| Transplant rejection | 13.19 | 9.84 | 6 | 138902 | 9590 | 46537564 |
| Left ventricular dysfunction | 13.19 | 9.84 | 63 | 138845 | 10192 | 46536962 |
| Amenorrhoea | 13.14 | 9.84 | 5 | 138903 | 8890 | 46538264 |
| Plasma cell myeloma | 13.11 | 9.84 | 78 | 138830 | 44400 | 46502754 |
| Bezold-Jarisch reflex | 13.09 | 9.84 | 4 | 138904 | 15 | 46547139 |
| Loss of consciousness | 13.09 | 9.84 | 418 | 138490 | 107820 | 46439334 |
| Cardiac dysfunction | 13.08 | 9.84 | 19 | 138889 | 1472 | 46545682 |
| Therapy interrupted | 12.99 | 9.84 | 8 | 138900 | 10783 | 46536371 |
| Neurotoxicity | 12.94 | 9.84 | 13 | 138895 | 13704 | 46533450 |
| Liver function test abnormal | 12.94 | 9.84 | 83 | 138825 | 46404 | 46500750 |
| Prohormone brain natriuretic peptide increased | 12.94 | 9.84 | 7 | 138901 | 138 | 46547016 |
| Body height decreased | 12.93 | 9.84 | 60 | 138848 | 9592 | 46537562 |
| Injection site urticaria | 12.91 | 9.84 | 10 | 138898 | 11957 | 46535197 |
| Marasmus | 12.91 | 9.84 | 11 | 138897 | 468 | 46546686 |
| Constipation | 12.89 | 9.84 | 407 | 138501 | 173690 | 46373464 |
| Monocyte count abnormal | 12.85 | 9.84 | 8 | 138900 | 207 | 46546947 |
| Atrioventricular block | 12.81 | 9.84 | 47 | 138861 | 6764 | 46540390 |
| Dementia | 12.69 | 9.84 | 82 | 138826 | 14848 | 46532306 |
| Arterial occlusive disease | 12.49 | 9.84 | 37 | 138871 | 4767 | 46542387 |
| Carotid arteriosclerosis | 12.49 | 9.84 | 15 | 138893 | 965 | 46546189 |
| Glycosylated haemoglobin decreased | 12.42 | 9.84 | 11 | 138897 | 493 | 46546661 |
| Papilloma | 12.39 | 9.84 | 8 | 138900 | 221 | 46546933 |
| Dyschezia | 12.35 | 9.84 | 19 | 138889 | 1549 | 46545605 |
| Duodenal ulcer perforation | 12.19 | 9.84 | 5 | 138903 | 8497 | 46538657 |
| Lower respiratory tract infection | 12.16 | 9.84 | 105 | 138803 | 54984 | 46492170 |
| Ventricular hypokinesia | 12.15 | 9.84 | 33 | 138875 | 4045 | 46543109 |
| Blood creatine phosphokinase increased | 12.09 | 9.84 | 131 | 138777 | 27593 | 46519561 |
| C-reactive protein increased | 12.05 | 9.84 | 243 | 138665 | 58347 | 46488807 |
| Injection site warmth | 11.94 | 9.84 | 14 | 138894 | 13758 | 46533396 |
| Renal cancer | 11.91 | 9.84 | 28 | 138880 | 3140 | 46544014 |
| Drug ineffective for unapproved indication | 11.90 | 9.84 | 19 | 138889 | 16394 | 46530760 |
| Bundle branch block left | 11.90 | 9.84 | 44 | 138864 | 6355 | 46540799 |
| Foetal exposure during pregnancy | 11.90 | 9.84 | 49 | 138859 | 30698 | 46516456 |
| Tooth abscess | 11.89 | 9.84 | 12 | 138896 | 12621 | 46534533 |
| Laboratory test abnormal | 11.87 | 9.84 | 32 | 138876 | 22815 | 46524339 |
| Arrhythmogenic right ventricular dysplasia | 11.86 | 9.84 | 4 | 138904 | 22 | 46547132 |
| Haematotoxicity | 11.85 | 9.84 | 3 | 138905 | 6930 | 46540224 |
| Blood aldosterone increased | 11.82 | 9.84 | 7 | 138901 | 165 | 46546989 |
| Gastroenteritis | 11.77 | 9.84 | 117 | 138791 | 24102 | 46523052 |
| Asthmatic crisis | 11.77 | 9.84 | 18 | 138890 | 1460 | 46545694 |
| Candida infection | 11.67 | 9.84 | 31 | 138877 | 22209 | 46524945 |
| Multiple injuries | 11.67 | 9.84 | 21 | 138887 | 1948 | 46545206 |
| Febrile bone marrow aplasia | 11.67 | 9.84 | 3 | 138905 | 6859 | 46540295 |
| Atrial flutter | 11.62 | 9.84 | 56 | 138852 | 9092 | 46538062 |
| Encephalopathy | 11.51 | 9.84 | 56 | 138852 | 33533 | 46513621 |
| Brain contusion | 11.49 | 9.84 | 11 | 138897 | 545 | 46546609 |
| Heart valve incompetence | 11.48 | 9.84 | 23 | 138885 | 2312 | 46544842 |
| Epstein-Barr virus infection | 11.47 | 9.84 | 3 | 138905 | 6781 | 46540373 |
| Haematoma | 11.41 | 9.84 | 145 | 138763 | 31727 | 46515427 |
| Coronary angioplasty | 11.33 | 9.84 | 6 | 138902 | 113 | 46547041 |
| Colon cancer | 11.25 | 9.84 | 56 | 138852 | 9213 | 46537941 |
| Pneumonia aspiration | 11.24 | 9.84 | 52 | 138856 | 31553 | 46515601 |
| Blood sodium increased | 11.23 | 9.84 | 24 | 138884 | 2525 | 46544629 |
| Multiple organ dysfunction syndrome | 11.22 | 9.84 | 99 | 138809 | 51611 | 46495543 |
| Weight fluctuation | 11.20 | 9.84 | 44 | 138864 | 6540 | 46540614 |
| Pyometra | 11.19 | 9.84 | 6 | 138902 | 116 | 46547038 |
| Lymphostasis | 11.18 | 9.84 | 3 | 138905 | 6 | 46547148 |
| Rhabdomyolysis | 11.15 | 9.84 | 181 | 138727 | 41728 | 46505426 |
| Accident | 11.14 | 9.84 | 37 | 138871 | 5067 | 46542087 |
| Complication associated with device | 11.08 | 9.84 | 18 | 138890 | 15423 | 46531731 |
| Disease recurrence | 11.08 | 9.84 | 24 | 138884 | 18447 | 46528707 |
| Diarrhoea | 11.05 | 9.84 | 1478 | 137430 | 558124 | 45989030 |
| Nodal rhythm | 11.00 | 9.84 | 19 | 138889 | 1706 | 46545448 |
| Ulcer | 10.93 | 9.84 | 22 | 138886 | 17370 | 46529784 |
| Dizziness postural | 10.90 | 9.84 | 43 | 138865 | 6403 | 46540751 |
| Myocardial calcification | 10.87 | 9.84 | 3 | 138905 | 7 | 46547147 |
| Visual acuity reduced | 10.83 | 9.84 | 107 | 138801 | 22006 | 46525148 |
| Nephrogenic anaemia | 10.83 | 9.84 | 20 | 138888 | 1893 | 46545261 |
| Gingival hypertrophy | 10.81 | 9.84 | 17 | 138891 | 1412 | 46545742 |
| Contraindicated product administered | 10.78 | 9.84 | 170 | 138738 | 79777 | 46467377 |
| Upper respiratory tract infection | 10.78 | 9.84 | 129 | 138779 | 63427 | 46483727 |
| Gestational diabetes | 10.76 | 9.84 | 4 | 138904 | 7215 | 46539939 |
| Prosthesis implantation | 10.71 | 9.84 | 5 | 138903 | 71 | 46547083 |
| Visual impairment | 10.70 | 9.84 | 267 | 138641 | 66422 | 46480732 |
| Mucosal inflammation | 10.64 | 9.84 | 70 | 138838 | 38906 | 46508248 |
| Cranial sutures widening | 10.59 | 9.84 | 4 | 138904 | 32 | 46547122 |
| Cerebral arteriosclerosis | 10.53 | 9.84 | 8 | 138900 | 288 | 46546866 |
| Inappropriate antidiuretic hormone secretion | 10.52 | 9.84 | 75 | 138833 | 14027 | 46533127 |
| Glucose tolerance impaired | 10.52 | 9.84 | 35 | 138873 | 4796 | 46542358 |
| Joint range of motion decreased | 10.51 | 9.84 | 18 | 138890 | 15106 | 46532048 |
| Premature baby | 10.48 | 9.84 | 24 | 138884 | 18088 | 46529066 |
| Rash maculo-papular | 10.43 | 9.84 | 45 | 138863 | 27829 | 46519325 |
| Skin infection | 10.41 | 9.84 | 11 | 138897 | 11328 | 46535826 |
| Lymphocyte count decreased | 10.40 | 9.84 | 40 | 138868 | 25549 | 46521605 |
| Perihepatic discomfort | 10.33 | 9.84 | 3 | 138905 | 9 | 46547145 |
| Myelosuppression | 10.31 | 9.84 | 5 | 138903 | 7698 | 46539456 |
| Eructation | 10.26 | 9.84 | 46 | 138862 | 7249 | 46539905 |
| Drug dependence | 10.25 | 9.84 | 28 | 138880 | 19873 | 46527281 |
| Hepatocellular injury | 10.24 | 9.84 | 49 | 138859 | 29473 | 46517681 |
| Hepatic cancer | 10.19 | 9.84 | 26 | 138882 | 3071 | 46544083 |
| Bradyarrhythmia | 10.15 | 9.84 | 20 | 138888 | 1986 | 46545168 |
| Duodenal polyp | 10.12 | 9.84 | 5 | 138903 | 81 | 46547073 |
| Intestinal polyp | 10.09 | 9.84 | 14 | 138894 | 1039 | 46546115 |
| Fabry's disease | 10.09 | 9.84 | 3 | 138905 | 10 | 46547144 |
| Subclavian vein thrombosis | 10.07 | 9.84 | 19 | 138889 | 1827 | 46545327 |
| Cardiac myxoma | 10.04 | 9.84 | 7 | 138901 | 220 | 46546934 |
| Oxygen saturation decreased | 10.04 | 9.84 | 145 | 138763 | 69019 | 46478135 |
| Movement disorder | 10.02 | 9.84 | 85 | 138823 | 16764 | 46530390 |
| Ear pain | 10.00 | 9.84 | 33 | 138875 | 22059 | 46525095 |
| Injection site rash | 9.94 | 9.84 | 20 | 138888 | 15793 | 46531361 |
| Pigmentation disorder | 9.94 | 9.84 | 29 | 138879 | 3704 | 46543450 |
| Renal cell carcinoma | 9.92 | 9.84 | 28 | 138880 | 3510 | 46543644 |
| Coronary artery occlusion | 9.87 | 9.84 | 49 | 138859 | 8053 | 46539101 |
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 |
|---|---|---|---|---|---|---|
| Hypotension | 1121.56 | 10.53 | 2542 | 123114 | 198023 | 29628799 |
| Cardiac failure | 730.73 | 10.53 | 1278 | 124378 | 82140 | 29744682 |
| Dizziness | 498.20 | 10.53 | 1869 | 123787 | 193040 | 29633782 |
| Wrong technique in product usage process | 476.88 | 10.53 | 620 | 125036 | 30535 | 29796287 |
| Ejection fraction decreased | 315.64 | 10.53 | 353 | 125303 | 14822 | 29812000 |
| Product prescribing error | 308.93 | 10.53 | 366 | 125290 | 16367 | 29810455 |
| Blood creatinine increased | 293.16 | 10.53 | 946 | 124710 | 90429 | 29736393 |
| Off label use | 281.87 | 10.53 | 381 | 125275 | 248909 | 29577913 |
| Blood pressure decreased | 276.11 | 10.53 | 610 | 125046 | 46465 | 29780357 |
| Drug abuse | 262.21 | 10.53 | 22 | 125634 | 82050 | 29744772 |
| Toxicity to various agents | 250.51 | 10.53 | 225 | 125431 | 176958 | 29649864 |
| Hyperkalaemia | 243.76 | 10.53 | 718 | 124938 | 65292 | 29761530 |
| Dyspnoea | 222.50 | 10.53 | 2252 | 123404 | 331043 | 29495779 |
| Blood potassium increased | 222.42 | 10.53 | 306 | 125350 | 15907 | 29810915 |
| Cardiac failure chronic | 191.11 | 10.53 | 174 | 125482 | 5689 | 29821133 |
| Prescribed underdose | 184.96 | 10.53 | 194 | 125462 | 7565 | 29819257 |
| Completed suicide | 183.68 | 10.53 | 94 | 125562 | 99398 | 29727424 |
| Blood pressure inadequately controlled | 182.40 | 10.53 | 121 | 125535 | 2449 | 29824373 |
| Angioedema | 182.06 | 10.53 | 428 | 125228 | 33956 | 29792866 |
| Cough | 180.13 | 10.53 | 1018 | 124638 | 124624 | 29702198 |
| Neutropenia | 171.25 | 10.53 | 172 | 125484 | 128368 | 29698454 |
| Blood pressure increased | 165.94 | 10.53 | 669 | 124987 | 71259 | 29755563 |
| Renal impairment | 149.44 | 10.53 | 724 | 124932 | 83460 | 29743362 |
| Febrile neutropenia | 144.10 | 10.53 | 141 | 125515 | 106552 | 29720270 |
| N-terminal prohormone brain natriuretic peptide increased | 140.40 | 10.53 | 81 | 125575 | 1265 | 29825557 |
| Hypoacusis | 134.40 | 10.53 | 225 | 125431 | 13914 | 29812908 |
| Syncope | 134.38 | 10.53 | 707 | 124949 | 84196 | 29742626 |
| Glomerular filtration rate decreased | 130.30 | 10.53 | 197 | 125459 | 11165 | 29815657 |
| Myocardial infarction | 127.00 | 10.53 | 932 | 124724 | 124693 | 29702129 |
| Blood pressure systolic decreased | 118.83 | 10.53 | 109 | 125547 | 3598 | 29823224 |
| Weight increased | 117.96 | 10.53 | 623 | 125033 | 74290 | 29752532 |
| Pyrexia | 117.67 | 10.53 | 739 | 124917 | 293750 | 29533072 |
| Inappropriate schedule of product administration | 110.13 | 10.53 | 392 | 125264 | 39336 | 29787486 |
| Fluid retention | 108.96 | 10.53 | 289 | 125367 | 24709 | 29802113 |
| No adverse event | 106.89 | 10.53 | 230 | 125426 | 17189 | 29809633 |
| Blood urea increased | 100.50 | 10.53 | 325 | 125331 | 31056 | 29795766 |
| Hypertension | 98.38 | 10.53 | 856 | 124800 | 120498 | 29706324 |
| Ventricular tachycardia | 98.11 | 10.53 | 270 | 125386 | 23592 | 29803230 |
| Renal failure | 95.51 | 10.53 | 892 | 124764 | 128074 | 29698748 |
| Cerebrovascular accident | 95.22 | 10.53 | 638 | 125018 | 82839 | 29743983 |
| Drug ineffective | 92.55 | 10.53 | 948 | 124708 | 339439 | 29487383 |
| Concomitant disease aggravated | 91.03 | 10.53 | 110 | 125546 | 5019 | 29821803 |
| Ventricular arrhythmia | 87.85 | 10.53 | 99 | 125557 | 4189 | 29822633 |
| Blood pressure abnormal | 84.03 | 10.53 | 124 | 125532 | 6875 | 29819947 |
| Pancytopenia | 83.24 | 10.53 | 143 | 125513 | 84909 | 29741913 |
| Contraindicated product administered | 83.14 | 10.53 | 207 | 125449 | 17024 | 29809798 |
| Pneumonia | 78.60 | 10.53 | 962 | 124694 | 333344 | 29493478 |
| Sepsis | 76.42 | 10.53 | 335 | 125321 | 146060 | 29680762 |
| Mitral valve incompetence | 75.81 | 10.53 | 170 | 125486 | 13064 | 29813758 |
| Disease progression | 75.71 | 10.53 | 137 | 125519 | 79737 | 29747085 |
| Thrombocytopenia | 74.97 | 10.53 | 308 | 125348 | 136736 | 29690086 |
| Treatment failure | 74.77 | 10.53 | 26 | 125630 | 34653 | 29792169 |
| Ejection fraction abnormal | 74.28 | 10.53 | 43 | 125613 | 676 | 29826146 |
| Hospitalisation | 71.66 | 10.53 | 49 | 125607 | 44270 | 29782552 |
| Cardiac failure acute | 70.09 | 10.53 | 133 | 125523 | 9076 | 29817746 |
| Throat clearing | 69.46 | 10.53 | 29 | 125627 | 211 | 29826611 |
| Acute kidney injury | 68.65 | 10.53 | 1566 | 124090 | 272276 | 29554546 |
| Plasma cell myeloma | 67.22 | 10.53 | 75 | 125581 | 53387 | 29773435 |
| Infusion related reaction | 66.72 | 10.53 | 44 | 125612 | 40520 | 29786302 |
| Arrhythmia | 66.67 | 10.53 | 296 | 125360 | 32873 | 29793949 |
| Angina pectoris | 64.38 | 10.53 | 270 | 125386 | 29248 | 29797574 |
| Malignant neoplasm progression | 64.11 | 10.53 | 129 | 125527 | 72158 | 29754664 |
| Seizure | 63.25 | 10.53 | 207 | 125449 | 98268 | 29728554 |
| Cardiac failure congestive | 61.50 | 10.53 | 582 | 125074 | 83825 | 29742997 |
| Deep vein thrombosis | 58.92 | 10.53 | 102 | 125554 | 60399 | 29766423 |
| Oedema peripheral | 58.89 | 10.53 | 691 | 124965 | 105141 | 29721681 |
| Orthopnoea | 58.24 | 10.53 | 83 | 125573 | 4457 | 29822365 |
| Cerebral infarction | 58.11 | 10.53 | 242 | 125414 | 26131 | 29800691 |
| Left ventricular dilatation | 57.97 | 10.53 | 35 | 125621 | 597 | 29826225 |
| Vomiting | 54.81 | 10.53 | 624 | 125032 | 219194 | 29607628 |
| Atrial fibrillation | 53.26 | 10.53 | 690 | 124966 | 107434 | 29719388 |
| Malaise | 52.97 | 10.53 | 989 | 124667 | 165973 | 29660849 |
| Rheumatoid arthritis | 52.66 | 10.53 | 57 | 125599 | 41140 | 29785682 |
| Intentional overdose | 52.35 | 10.53 | 58 | 125598 | 41423 | 29785399 |
| Brain natriuretic peptide increased | 52.10 | 10.53 | 74 | 125582 | 3961 | 29822861 |
| Drug dependence | 51.30 | 10.53 | 13 | 125643 | 21282 | 29805540 |
| Aggression | 50.66 | 10.53 | 48 | 125608 | 36859 | 29789963 |
| Mucosal inflammation | 50.25 | 10.53 | 33 | 125623 | 30461 | 29796361 |
| Dizziness postural | 48.59 | 10.53 | 85 | 125571 | 5445 | 29821377 |
| Renal disorder | 48.55 | 10.53 | 212 | 125444 | 23372 | 29803450 |
| Neuropathy peripheral | 48.16 | 10.53 | 144 | 125512 | 70331 | 29756491 |
| Foetal exposure during pregnancy | 47.14 | 10.53 | 51 | 125605 | 36820 | 29790002 |
| Diabetes mellitus | 47.09 | 10.53 | 319 | 125337 | 41546 | 29785276 |
| Cardiac disorder | 46.70 | 10.53 | 307 | 125349 | 39586 | 29787236 |
| Agitation | 46.66 | 10.53 | 98 | 125558 | 53975 | 29772847 |
| Leukopenia | 46.62 | 10.53 | 104 | 125552 | 56055 | 29770767 |
| Suicidal ideation | 46.12 | 10.53 | 50 | 125606 | 36064 | 29790758 |
| Feeling abnormal | 45.19 | 10.53 | 399 | 125257 | 56357 | 29770465 |
| Intentional product use issue | 44.84 | 10.53 | 52 | 125604 | 36388 | 29790434 |
| Left ventricular dysfunction | 44.68 | 10.53 | 107 | 125549 | 8584 | 29818238 |
| Blood uric acid increased | 44.62 | 10.53 | 86 | 125570 | 5937 | 29820885 |
| Neutrophil count decreased | 43.72 | 10.53 | 69 | 125587 | 42385 | 29784437 |
| Brain natriuretic peptide abnormal | 43.55 | 10.53 | 19 | 125637 | 156 | 29826666 |
| Product impurity | 42.98 | 10.53 | 14 | 125642 | 44 | 29826778 |
| Hypertensive crisis | 42.01 | 10.53 | 102 | 125554 | 8255 | 29818567 |
| Blood glucose increased | 41.72 | 10.53 | 418 | 125238 | 61112 | 29765710 |
| Sudden cardiac death | 41.52 | 10.53 | 64 | 125592 | 3688 | 29823134 |
| Cardiogenic shock | 41.36 | 10.53 | 160 | 125496 | 16701 | 29810121 |
| Constipation | 41.03 | 10.53 | 291 | 125365 | 112615 | 29714207 |
| Intentional product misuse | 41.03 | 10.53 | 51 | 125605 | 34616 | 29792206 |
| Underdose | 39.99 | 10.53 | 127 | 125529 | 12014 | 29814808 |
| Cytomegalovirus infection | 39.85 | 10.53 | 25 | 125631 | 23649 | 29803173 |
| Jugular vein distension | 39.72 | 10.53 | 26 | 125630 | 514 | 29826308 |
| Nausea | 39.46 | 10.53 | 947 | 124709 | 296010 | 29530812 |
| Oedema | 39.42 | 10.53 | 312 | 125344 | 42681 | 29784141 |
| Blood pressure diastolic decreased | 39.05 | 10.53 | 83 | 125573 | 6148 | 29820674 |
| Weight fluctuation | 38.35 | 10.53 | 62 | 125594 | 3722 | 29823100 |
| Weight decreased | 38.27 | 10.53 | 865 | 124791 | 150056 | 29676766 |
| Abnormal behaviour | 37.97 | 10.53 | 31 | 125625 | 25592 | 29801230 |
| Tricuspid valve incompetence | 37.87 | 10.53 | 100 | 125556 | 8523 | 29818299 |
| Ischaemic cardiomyopathy | 37.31 | 10.53 | 82 | 125574 | 6215 | 29820607 |
| Bone marrow failure | 37.19 | 10.53 | 42 | 125614 | 29743 | 29797079 |
| N-terminal prohormone brain natriuretic peptide abnormal | 37.16 | 10.53 | 15 | 125641 | 99 | 29826723 |
| Drug resistance | 37.13 | 10.53 | 19 | 125637 | 20114 | 29806708 |
| Device inappropriate shock delivery | 36.31 | 10.53 | 12 | 125644 | 40 | 29826782 |
| Fear of disease | 35.20 | 10.53 | 18 | 125638 | 218 | 29826604 |
| White blood cell count decreased | 34.73 | 10.53 | 208 | 125448 | 83739 | 29743083 |
| Lung diffusion disorder | 34.61 | 10.53 | 9 | 125647 | 8 | 29826814 |
| Pulmonary embolism | 34.25 | 10.53 | 190 | 125466 | 77945 | 29748877 |
| Sedation | 34.06 | 10.53 | 13 | 125643 | 16360 | 29810462 |
| Overdose | 33.83 | 10.53 | 211 | 125445 | 84126 | 29742696 |
| Hepatojugular reflux | 33.44 | 10.53 | 20 | 125636 | 335 | 29826487 |
| Bundle branch block left | 33.40 | 10.53 | 70 | 125586 | 5134 | 29821688 |
| Ventricular hypokinesia | 33.39 | 10.53 | 62 | 125594 | 4161 | 29822661 |
| Left ventricular hypertrophy | 33.03 | 10.53 | 78 | 125578 | 6200 | 29820622 |
| Eosinophilic colitis | 32.95 | 10.53 | 16 | 125640 | 172 | 29826650 |
| Left atrial enlargement | 32.74 | 10.53 | 22 | 125634 | 455 | 29826367 |
| Heart rate decreased | 32.58 | 10.53 | 174 | 125482 | 20820 | 29806002 |
| Injection site pain | 32.42 | 10.53 | 48 | 125608 | 30262 | 29796560 |
| Type 2 diabetes mellitus | 32.39 | 10.53 | 128 | 125528 | 13494 | 29813328 |
| Septic shock | 32.26 | 10.53 | 147 | 125509 | 63460 | 29763362 |
| Cardiorenal syndrome | 31.52 | 10.53 | 26 | 125630 | 742 | 29826080 |
| Drug hypersensitivity | 31.48 | 10.53 | 164 | 125492 | 68355 | 29758467 |
| Lip swelling | 31.31 | 10.53 | 121 | 125535 | 12623 | 29814199 |
| Generalised tonic-clonic seizure | 31.08 | 10.53 | 22 | 125634 | 19529 | 29807293 |
| Sudden death | 30.93 | 10.53 | 138 | 125518 | 15354 | 29811468 |
| Respiratory arrest | 30.65 | 10.53 | 47 | 125609 | 29211 | 29797611 |
| Clostridium difficile infection | 30.47 | 10.53 | 14 | 125642 | 15769 | 29811053 |
| Cardiac dysfunction | 30.45 | 10.53 | 31 | 125625 | 1166 | 29825656 |
| Pulmonary oedema | 30.40 | 10.53 | 300 | 125356 | 43675 | 29783147 |
| Hallucination | 30.19 | 10.53 | 105 | 125551 | 48954 | 29777868 |
| Cardio-respiratory arrest | 29.92 | 10.53 | 131 | 125525 | 57175 | 29769647 |
| Neutropenic sepsis | 29.41 | 10.53 | 6 | 125650 | 11403 | 29815419 |
| Fatigue | 29.31 | 10.53 | 1634 | 124022 | 319039 | 29507783 |
| Diastolic dysfunction | 29.24 | 10.53 | 59 | 125597 | 4212 | 29822610 |
| Weight loss poor | 29.03 | 10.53 | 14 | 125642 | 148 | 29826674 |
| Nephrogenic anaemia | 28.76 | 10.53 | 40 | 125616 | 2099 | 29824723 |
| Orthostatic intolerance | 28.59 | 10.53 | 24 | 125632 | 702 | 29826120 |
| Tremor | 28.46 | 10.53 | 192 | 125464 | 75171 | 29751651 |
| Cytokine release syndrome | 28.30 | 10.53 | 4 | 125652 | 9929 | 29816893 |
| Ventricular extrasystoles | 28.24 | 10.53 | 109 | 125547 | 11365 | 29815457 |
| Neurotoxicity | 28.21 | 10.53 | 10 | 125646 | 13172 | 29813650 |
| Status epilepticus | 28.18 | 10.53 | 6 | 125650 | 11066 | 29815756 |
| Therapeutic product effect incomplete | 27.79 | 10.53 | 63 | 125593 | 33771 | 29793051 |
| Synovitis | 27.73 | 10.53 | 4 | 125652 | 9779 | 29817043 |
| Respiratory failure | 27.71 | 10.53 | 279 | 125377 | 100363 | 29726459 |
| Pain | 27.67 | 10.53 | 534 | 125122 | 172107 | 29654715 |
| Sinus arrest | 27.63 | 10.53 | 33 | 125623 | 1487 | 29825335 |
| Immune reconstitution inflammatory syndrome | 27.55 | 10.53 | 3 | 125653 | 9098 | 29817724 |
| Drug ineffective for unapproved indication | 27.48 | 10.53 | 6 | 125650 | 10874 | 29815948 |
| Therapy non-responder | 27.45 | 10.53 | 51 | 125605 | 29402 | 29797420 |
| Memory impairment | 27.37 | 10.53 | 257 | 125399 | 36917 | 29789905 |
| Schizophrenia | 27.35 | 10.53 | 3 | 125653 | 9045 | 29817777 |
| Congestive cardiomyopathy | 27.24 | 10.53 | 75 | 125581 | 6552 | 29820270 |
| Blood lactic acid | 27.23 | 10.53 | 18 | 125638 | 362 | 29826460 |
| Orthostatic hypotension | 27.13 | 10.53 | 183 | 125473 | 23796 | 29803026 |
| Hypoxia | 27.10 | 10.53 | 106 | 125550 | 47748 | 29779074 |
| Graft versus host disease | 26.88 | 10.53 | 5 | 125651 | 10145 | 29816677 |
| Near death experience | 26.75 | 10.53 | 10 | 125646 | 52 | 29826770 |
| Infection | 26.54 | 10.53 | 205 | 125451 | 77869 | 29748953 |
| Hypertensive heart disease | 26.39 | 10.53 | 41 | 125615 | 2379 | 29824443 |
| Left ventricular enlargement | 26.38 | 10.53 | 21 | 125635 | 569 | 29826253 |
| Fractured coccyx | 26.28 | 10.53 | 13 | 125643 | 146 | 29826676 |
| Intentional self-injury | 26.13 | 10.53 | 12 | 125644 | 13520 | 29813302 |
| Blood triglycerides increased | 25.86 | 10.53 | 122 | 125534 | 13895 | 29812927 |
| Blood pressure fluctuation | 25.76 | 10.53 | 143 | 125513 | 17360 | 29809462 |
| Glycosylated haemoglobin increased | 25.72 | 10.53 | 93 | 125563 | 9398 | 29817424 |
| Atrioventricular block | 25.67 | 10.53 | 78 | 125578 | 7204 | 29819618 |
| Palpitations | 25.67 | 10.53 | 234 | 125422 | 33339 | 29793483 |
| Right hemisphere deficit syndrome | 25.61 | 10.53 | 8 | 125648 | 21 | 29826801 |
| Chest pain | 25.50 | 10.53 | 660 | 124996 | 116967 | 29709855 |
| Dystonia | 25.32 | 10.53 | 5 | 125651 | 9722 | 29817100 |
| Blood thyroid stimulating hormone abnormal | 25.17 | 10.53 | 13 | 125643 | 161 | 29826661 |
| Vertigo | 25.16 | 10.53 | 172 | 125484 | 22463 | 29804359 |
| Liver function test abnormal | 25.12 | 10.53 | 58 | 125598 | 30892 | 29795930 |
| Psychotic disorder | 25.09 | 10.53 | 32 | 125624 | 21483 | 29805339 |
| Loss of consciousness | 25.04 | 10.53 | 470 | 125186 | 78905 | 29747917 |
| Pulmonary arterial pressure abnormal | 24.75 | 10.53 | 13 | 125643 | 167 | 29826655 |
| Drug withdrawal syndrome | 24.65 | 10.53 | 28 | 125628 | 19781 | 29807041 |
| Chronic kidney disease | 24.65 | 10.53 | 255 | 125401 | 37583 | 29789239 |
| Chest discomfort | 24.39 | 10.53 | 295 | 125361 | 45185 | 29781637 |
| Mitral valve thickening | 24.30 | 10.53 | 14 | 125642 | 218 | 29826604 |
| Blood creatine increased | 24.23 | 10.53 | 56 | 125600 | 4389 | 29822433 |
| Visual impairment | 24.22 | 10.53 | 214 | 125442 | 30224 | 29796598 |
| Stomatitis | 24.16 | 10.53 | 78 | 125578 | 37201 | 29789621 |
| Loss of personal independence in daily activities | 24.12 | 10.53 | 33 | 125623 | 21502 | 29805320 |
| Pemphigoid | 24.11 | 10.53 | 78 | 125578 | 7450 | 29819372 |
| Peripheral swelling | 24.11 | 10.53 | 375 | 125281 | 60699 | 29766123 |
| Hypochromasia | 23.98 | 10.53 | 16 | 125640 | 327 | 29826495 |
| Therapeutic response unexpected | 23.93 | 10.53 | 87 | 125569 | 8816 | 29818006 |
| Diabetic nephropathy | 23.72 | 10.53 | 34 | 125622 | 1835 | 29824987 |
| Serotonin syndrome | 23.70 | 10.53 | 24 | 125632 | 17867 | 29808955 |
| Confusional state | 23.48 | 10.53 | 411 | 125245 | 134423 | 29692399 |
| Pruritus | 23.27 | 10.53 | 655 | 125001 | 117549 | 29709273 |
| Aspergillus infection | 23.17 | 10.53 | 7 | 125649 | 10207 | 29816615 |
| Condition aggravated | 23.14 | 10.53 | 423 | 125233 | 137443 | 29689379 |
| Hyperuricaemia | 23.13 | 10.53 | 76 | 125580 | 7318 | 29819504 |
| Right atrial enlargement | 23.12 | 10.53 | 14 | 125642 | 240 | 29826582 |
| Exercise tolerance decreased | 22.99 | 10.53 | 50 | 125606 | 3762 | 29823060 |
| Aortic aneurysm | 22.90 | 10.53 | 69 | 125587 | 6344 | 29820478 |
| Bacteraemia | 22.84 | 10.53 | 19 | 125637 | 15541 | 29811281 |
| Drug reaction with eosinophilia and systemic symptoms | 22.63 | 10.53 | 54 | 125602 | 28434 | 29798388 |
| Encephalopathy | 22.57 | 10.53 | 65 | 125591 | 32140 | 29794682 |
| Infarction | 22.56 | 10.53 | 40 | 125616 | 2590 | 29824232 |
| Laziness | 22.50 | 10.53 | 15 | 125641 | 306 | 29826516 |
| Colitis | 22.49 | 10.53 | 61 | 125595 | 30759 | 29796063 |
| Nasal pruritus | 22.48 | 10.53 | 9 | 125647 | 58 | 29826764 |
| Dyspnoea paroxysmal nocturnal | 22.35 | 10.53 | 26 | 125630 | 1139 | 29825683 |
| Oxygen saturation increased | 22.20 | 10.53 | 13 | 125643 | 209 | 29826613 |
| Chest injury | 22.18 | 10.53 | 28 | 125628 | 1336 | 29825486 |
| Extrasystoles | 22.12 | 10.53 | 49 | 125607 | 3733 | 29823089 |
| Low density lipoprotein abnormal | 22.05 | 10.53 | 14 | 125642 | 262 | 29826560 |
| Bronchopulmonary aspergillosis | 22.05 | 10.53 | 12 | 125644 | 12272 | 29814550 |
| Electrocardiogram QRS complex abnormal | 21.73 | 10.53 | 14 | 125642 | 269 | 29826553 |
| Adverse drug reaction | 21.64 | 10.53 | 40 | 125616 | 23105 | 29803717 |
| Therapeutic product effect decreased | 21.63 | 10.53 | 57 | 125599 | 29019 | 29797803 |
| Aortic valve incompetence | 21.52 | 10.53 | 57 | 125599 | 4866 | 29821956 |
| Pneumocystis jirovecii pneumonia | 21.52 | 10.53 | 24 | 125632 | 17096 | 29809726 |
| Transplant rejection | 21.45 | 10.53 | 6 | 125650 | 9200 | 29817622 |
| Blood cholesterol increased | 21.33 | 10.53 | 133 | 125523 | 16837 | 29809985 |
| Pancreatic neoplasm | 21.12 | 10.53 | 23 | 125633 | 936 | 29825886 |
| Pulmonary valve stenosis congenital | 21.10 | 10.53 | 11 | 125645 | 139 | 29826683 |
| Candida infection | 21.05 | 10.53 | 20 | 125636 | 15342 | 29811480 |
| Microalbuminuria | 21.05 | 10.53 | 19 | 125637 | 614 | 29826208 |
| Psoriatic arthropathy | 21.04 | 10.53 | 21 | 125635 | 15740 | 29811082 |
| Gouty arthritis | 21.00 | 10.53 | 24 | 125632 | 1031 | 29825791 |
| Product dose omission issue | 20.89 | 10.53 | 265 | 125391 | 91366 | 29735456 |
| Cardiac aneurysm | 20.71 | 10.53 | 19 | 125637 | 627 | 29826195 |
| Gout | 20.71 | 10.53 | 134 | 125522 | 17181 | 29809641 |
| Epilepsy | 20.55 | 10.53 | 33 | 125623 | 20136 | 29806686 |
| Pathogen resistance | 20.52 | 10.53 | 5 | 125651 | 8405 | 29818417 |
| Urine albumin/creatinine ratio increased | 20.39 | 10.53 | 10 | 125646 | 110 | 29826712 |
| Swollen tongue | 20.24 | 10.53 | 109 | 125547 | 13083 | 29813739 |
| Hallucination, auditory | 19.99 | 10.53 | 8 | 125648 | 9781 | 29817041 |
| Renal artery stenosis | 19.83 | 10.53 | 31 | 125625 | 1808 | 29825014 |
| Mental status changes | 19.82 | 10.53 | 84 | 125572 | 36995 | 29789827 |
| Acute myeloid leukaemia | 19.76 | 10.53 | 28 | 125628 | 17978 | 29808844 |
| Product use issue | 19.56 | 10.53 | 113 | 125543 | 45903 | 29780919 |
| Hemiplegia | 19.54 | 10.53 | 67 | 125589 | 6594 | 29820228 |
| Abdominal pain | 19.51 | 10.53 | 427 | 125229 | 135227 | 29691595 |
| Mean platelet volume increased | 19.44 | 10.53 | 15 | 125641 | 388 | 29826434 |
| Acute myocardial infarction | 19.37 | 10.53 | 321 | 125335 | 52618 | 29774204 |
| Thrombotic microangiopathy | 19.35 | 10.53 | 6 | 125650 | 8604 | 29818218 |
| Respiratory distress | 19.33 | 10.53 | 72 | 125584 | 32900 | 29793922 |
| Hepatotoxicity | 19.14 | 10.53 | 29 | 125627 | 18116 | 29808706 |
| Lymphocyte stimulation test positive | 19.14 | 10.53 | 21 | 125635 | 862 | 29825960 |
| Ventricular hyperkinesia | 19.12 | 10.53 | 12 | 125644 | 220 | 29826602 |
| Cell marker increased | 19.12 | 10.53 | 16 | 125640 | 466 | 29826356 |
| Dyspnoea at rest | 19.04 | 10.53 | 37 | 125619 | 2569 | 29824253 |
| N-terminal prohormone brain natriuretic peptide decreased | 18.95 | 10.53 | 5 | 125651 | 5 | 29826817 |
| Hyponatraemia | 18.86 | 10.53 | 391 | 125265 | 66811 | 29760011 |
| Conduction disorder | 18.47 | 10.53 | 31 | 125625 | 1920 | 29824902 |
| Device malfunction | 18.31 | 10.53 | 75 | 125581 | 8036 | 29818786 |
| Paranoia | 18.22 | 10.53 | 10 | 125646 | 10178 | 29816644 |
| Respiratory depression | 18.21 | 10.53 | 13 | 125643 | 11490 | 29815332 |
| Cerebellar ischaemia | 18.20 | 10.53 | 9 | 125647 | 101 | 29826721 |
| Venoocclusive liver disease | 18.07 | 10.53 | 3 | 125653 | 6610 | 29820212 |
| Cachexia | 18.07 | 10.53 | 3 | 125653 | 6608 | 29820214 |
| Lymphocyte count abnormal | 18.04 | 10.53 | 17 | 125639 | 581 | 29826241 |
| Coronary artery disease | 18.03 | 10.53 | 301 | 125355 | 49411 | 29777411 |
| Suicide attempt | 17.89 | 10.53 | 86 | 125570 | 36611 | 29790211 |
| Poisoning | 17.84 | 10.53 | 13 | 125643 | 11369 | 29815453 |
| Hypophagia | 17.78 | 10.53 | 42 | 125614 | 22194 | 29804628 |
| Blood cholesterol decreased | 17.73 | 10.53 | 21 | 125635 | 938 | 29825884 |
| Platelet count decreased | 17.68 | 10.53 | 326 | 125330 | 105803 | 29721019 |
| Myoglobin blood increased | 17.66 | 10.53 | 29 | 125627 | 1764 | 29825058 |
| Disease recurrence | 17.64 | 10.53 | 20 | 125636 | 14141 | 29812681 |
| Cerebral vasoconstriction | 17.56 | 10.53 | 11 | 125645 | 201 | 29826621 |
| Musculoskeletal stiffness | 17.55 | 10.53 | 84 | 125572 | 35797 | 29791025 |
| Headache | 17.40 | 10.53 | 608 | 125048 | 181698 | 29645124 |
| Gamma-glutamyltransferase increased | 17.35 | 10.53 | 194 | 125462 | 29156 | 29797666 |
| Left ventricular failure | 17.16 | 10.53 | 53 | 125603 | 4938 | 29821884 |
| Ischaemic stroke | 17.10 | 10.53 | 122 | 125534 | 16153 | 29810669 |
| Multiple organ dysfunction syndrome | 17.05 | 10.53 | 177 | 125479 | 63310 | 29763512 |
| Unevaluable event | 16.99 | 10.53 | 72 | 125584 | 31713 | 29795109 |
| Sprue-like enteropathy | 16.92 | 10.53 | 13 | 125643 | 334 | 29826488 |
| Accidental overdose | 16.72 | 10.53 | 32 | 125624 | 18243 | 29808579 |
| Myelosuppression | 16.64 | 10.53 | 5 | 125651 | 7317 | 29819505 |
| Lower respiratory tract infection | 16.55 | 10.53 | 57 | 125599 | 26657 | 29800165 |
| Tachycardia | 16.53 | 10.53 | 214 | 125442 | 73525 | 29753297 |
| Miosis | 16.47 | 10.53 | 6 | 125650 | 7770 | 29819052 |
| Multiple sclerosis | 16.45 | 10.53 | 5 | 125651 | 7262 | 29819560 |
| Laboratory test abnormal | 16.43 | 10.53 | 30 | 125626 | 17412 | 29809410 |
| Intestinal obstruction | 16.41 | 10.53 | 35 | 125621 | 19177 | 29807645 |
| Subacute hepatic failure | 16.39 | 10.53 | 8 | 125648 | 87 | 29826735 |
| Posterior reversible encephalopathy syndrome | 16.38 | 10.53 | 8 | 125648 | 8699 | 29818123 |
| Illness | 16.34 | 10.53 | 40 | 125616 | 3254 | 29823568 |
| Breast discomfort | 16.32 | 10.53 | 5 | 125651 | 12 | 29826810 |
| Fungal infection | 16.09 | 10.53 | 20 | 125636 | 13580 | 29813242 |
| Urinary tract infection | 16.06 | 10.53 | 215 | 125441 | 73444 | 29753378 |
| Chills | 15.82 | 10.53 | 211 | 125445 | 72127 | 29754695 |
| Extrapyramidal disorder | 15.76 | 10.53 | 13 | 125643 | 10680 | 29816142 |
| Hypocalvaria | 15.69 | 10.53 | 4 | 125652 | 3 | 29826819 |
| Painful respiration | 15.67 | 10.53 | 23 | 125633 | 1269 | 29825553 |
| Substance abuse | 15.66 | 10.53 | 5 | 125651 | 7035 | 29819787 |
| Arteriosclerosis | 15.60 | 10.53 | 88 | 125568 | 10745 | 29816077 |
| Delirium | 15.59 | 10.53 | 103 | 125553 | 40528 | 29786294 |
| Hypocapnia | 15.56 | 10.53 | 8 | 125648 | 98 | 29826724 |
| Atrial enlargement | 15.49 | 10.53 | 8 | 125648 | 99 | 29826723 |
| Neuroleptic malignant syndrome | 15.37 | 10.53 | 28 | 125628 | 16267 | 29810555 |
| Atrial thrombosis | 15.35 | 10.53 | 28 | 125628 | 1853 | 29824969 |
| Goitre | 15.34 | 10.53 | 25 | 125631 | 1511 | 29825311 |
| Pain in jaw | 15.33 | 10.53 | 17 | 125639 | 12139 | 29814683 |
| Chronic pigmented purpura | 15.28 | 10.53 | 8 | 125648 | 102 | 29826720 |
| Oscillopsia | 15.21 | 10.53 | 6 | 125650 | 37 | 29826785 |
| Peripheral arterial occlusive disease | 15.18 | 10.53 | 52 | 125604 | 5116 | 29821706 |
| Impaired reasoning | 15.12 | 10.53 | 7 | 125649 | 67 | 29826755 |
| Diffuse large B-cell lymphoma | 15.07 | 10.53 | 7 | 125649 | 7834 | 29818988 |
| Walking aid user | 15.06 | 10.53 | 24 | 125632 | 1423 | 29825399 |
| Osteonecrosis of jaw | 15.02 | 10.53 | 35 | 125621 | 18583 | 29808239 |
| Dyspnoea exertional | 14.93 | 10.53 | 220 | 125436 | 35210 | 29791612 |
| Lymphopenia | 14.91 | 10.53 | 20 | 125636 | 13143 | 29813679 |
| Rhythm idioventricular | 14.68 | 10.53 | 11 | 125645 | 272 | 29826550 |
| Bile duct cancer | 14.62 | 10.53 | 16 | 125640 | 655 | 29826167 |
| Tonic clonic movements | 14.61 | 10.53 | 20 | 125636 | 1034 | 29825788 |
| Pericarditis | 14.60 | 10.53 | 9 | 125647 | 8597 | 29818225 |
| Rales | 14.59 | 10.53 | 60 | 125596 | 6440 | 29820382 |
| Anaphylactic reaction | 14.58 | 10.53 | 64 | 125592 | 27918 | 29798904 |
| Rash erythematous | 14.53 | 10.53 | 47 | 125609 | 22405 | 29804417 |
| Progressive multifocal leukoencephalopathy | 14.51 | 10.53 | 10 | 125646 | 9003 | 29817819 |
| Adrenal adenoma | 14.51 | 10.53 | 11 | 125645 | 277 | 29826545 |
| Pulmonary hypoplasia | 14.45 | 10.53 | 13 | 125643 | 418 | 29826404 |
| Death | 14.40 | 10.53 | 1710 | 123946 | 355573 | 29471249 |
| Joint stiffness | 14.28 | 10.53 | 11 | 125645 | 9350 | 29817472 |
| Pyonephrosis | 14.28 | 10.53 | 7 | 125649 | 77 | 29826745 |
| Miscarriage of partner | 14.27 | 10.53 | 4 | 125652 | 6 | 29826816 |
| Aspiration | 14.15 | 10.53 | 14 | 125642 | 10537 | 29816285 |
| Osteonecrosis | 14.11 | 10.53 | 29 | 125627 | 16106 | 29810716 |
| Neoplasm malignant | 14.04 | 10.53 | 125 | 125531 | 17689 | 29809133 |
| Unresponsive to stimuli | 14.02 | 10.53 | 60 | 125596 | 26359 | 29800463 |
| Prostate cancer | 14.00 | 10.53 | 158 | 125498 | 23799 | 29803023 |
| Leukocytosis | 13.92 | 10.53 | 45 | 125611 | 21457 | 29805365 |
| Dependence on oxygen therapy | 13.92 | 10.53 | 8 | 125648 | 124 | 29826698 |
| Adrenal insufficiency | 13.90 | 10.53 | 14 | 125642 | 10449 | 29816373 |
| Cardiovascular somatic symptom disorder | 13.89 | 10.53 | 6 | 125650 | 48 | 29826774 |
| Presyncope | 13.88 | 10.53 | 115 | 125541 | 15941 | 29810881 |
| Heart rate increased | 13.87 | 10.53 | 234 | 125422 | 38487 | 29788335 |
| Gastric cancer | 13.84 | 10.53 | 49 | 125607 | 4901 | 29821921 |
| Heart valve incompetence | 13.83 | 10.53 | 20 | 125636 | 1088 | 29825734 |
| Acute coronary syndrome | 13.83 | 10.53 | 101 | 125555 | 13472 | 29813350 |
| Penile oedema | 13.82 | 10.53 | 11 | 125645 | 298 | 29826524 |
| Hypertrophic osteoarthropathy | 13.82 | 10.53 | 7 | 125649 | 83 | 29826739 |
| Splenomegaly | 13.79 | 10.53 | 22 | 125634 | 13458 | 29813364 |
| Paraesthesia oral | 13.65 | 10.53 | 40 | 125616 | 3621 | 29823201 |
| Surfactant protein increased | 13.55 | 10.53 | 4 | 125652 | 8 | 29826814 |
| Staphylococcal infection | 13.50 | 10.53 | 73 | 125583 | 30151 | 29796671 |
| Melaena | 13.50 | 10.53 | 201 | 125455 | 32236 | 29794586 |
| Blepharochalasis | 13.43 | 10.53 | 3 | 125653 | 0 | 29826822 |
| Superinfection mycobacterial | 13.43 | 10.53 | 3 | 125653 | 0 | 29826822 |
| Alcohol abuse | 13.42 | 10.53 | 3 | 125653 | 5350 | 29821472 |
| Second primary malignancy | 13.30 | 10.53 | 5 | 125651 | 6351 | 29820471 |
| Somnolence | 13.22 | 10.53 | 307 | 125349 | 96456 | 29730366 |
| Electrocardiogram QT prolonged | 13.17 | 10.53 | 92 | 125564 | 35743 | 29791079 |
| Product monitoring error | 13.07 | 10.53 | 25 | 125631 | 1716 | 29825106 |
| Adverse event | 13.06 | 10.53 | 28 | 125628 | 15313 | 29811509 |
| Urticaria chronic | 13.06 | 10.53 | 7 | 125649 | 94 | 29826728 |
| Low cardiac output syndrome | 13.01 | 10.53 | 11 | 125645 | 325 | 29826497 |
| Acquired C1 inhibitor deficiency | 12.94 | 10.53 | 4 | 125652 | 10 | 29826812 |
| Coma | 12.91 | 10.53 | 108 | 125548 | 40341 | 29786481 |
| Failure to thrive | 12.88 | 10.53 | 9 | 125647 | 8045 | 29818777 |
| Cytomegalovirus viraemia | 12.86 | 10.53 | 4 | 125652 | 5725 | 29821097 |
| Multiple sclerosis relapse | 12.83 | 10.53 | 16 | 125640 | 10846 | 29815976 |
| Asthenia | 12.79 | 10.53 | 1086 | 124570 | 220204 | 29606618 |
| Liver function test increased | 12.75 | 10.53 | 17 | 125639 | 11199 | 29815623 |
| Drug interaction | 12.72 | 10.53 | 696 | 124960 | 198872 | 29627950 |
| Atrial tachycardia | 12.66 | 10.53 | 28 | 125628 | 2131 | 29824691 |
| Osteitis deformans | 12.65 | 10.53 | 5 | 125651 | 31 | 29826791 |
| Stevens-Johnson syndrome | 12.62 | 10.53 | 35 | 125621 | 17521 | 29809301 |
| Heart rate abnormal | 12.58 | 10.53 | 23 | 125633 | 1525 | 29825297 |
| Thrombotic stroke | 12.56 | 10.53 | 10 | 125646 | 271 | 29826551 |
| Pollakiuria | 12.50 | 10.53 | 117 | 125539 | 16789 | 29810033 |
| Mania | 12.45 | 10.53 | 12 | 125644 | 9142 | 29817680 |
| Blood pressure systolic increased | 12.42 | 10.53 | 107 | 125549 | 15003 | 29811819 |
| Body mass index increased | 12.37 | 10.53 | 15 | 125641 | 687 | 29826135 |
| Polyuria | 12.33 | 10.53 | 62 | 125594 | 7244 | 29819578 |
| Cellulitis | 12.32 | 10.53 | 131 | 125525 | 46653 | 29780169 |
| Peritonitis | 12.32 | 10.53 | 47 | 125609 | 21328 | 29805494 |
| Renal dysplasia | 12.27 | 10.53 | 8 | 125648 | 157 | 29826665 |
| Product substitution issue | 12.21 | 10.53 | 78 | 125578 | 9957 | 29816865 |
| Creatinine urine increased | 12.18 | 10.53 | 8 | 125648 | 159 | 29826663 |
| Neoplasm progression | 12.17 | 10.53 | 37 | 125619 | 17986 | 29808836 |
| Hypertensive nephropathy | 12.17 | 10.53 | 12 | 125644 | 434 | 29826388 |
| Blood potassium decreased | 12.16 | 10.53 | 115 | 125541 | 16547 | 29810275 |
| Device issue | 12.16 | 10.53 | 9 | 125647 | 7807 | 29819015 |
| Nipple pain | 12.13 | 10.53 | 14 | 125642 | 608 | 29826214 |
| Decreased activity | 12.04 | 10.53 | 38 | 125618 | 3583 | 29823239 |
| Toxic epidermal necrolysis | 12.00 | 10.53 | 37 | 125619 | 17903 | 29808919 |
| Injection site erythema | 11.99 | 10.53 | 25 | 125631 | 13809 | 29813013 |
| Klebsiella infection | 11.97 | 10.53 | 7 | 125649 | 6880 | 29819942 |
| Dyskinesia | 11.95 | 10.53 | 49 | 125607 | 21785 | 29805037 |
| Myocardial ischaemia | 11.89 | 10.53 | 118 | 125538 | 17199 | 29809623 |
| Withdrawal syndrome | 11.85 | 10.53 | 18 | 125638 | 11232 | 29815590 |
| Genital candidiasis | 11.78 | 10.53 | 6 | 125650 | 72 | 29826750 |
| Renal pain | 11.75 | 10.53 | 31 | 125625 | 2641 | 29824181 |
| Hypoparathyroidism | 11.69 | 10.53 | 12 | 125644 | 456 | 29826366 |
| Exposure during pregnancy | 11.62 | 10.53 | 13 | 125643 | 9248 | 29817574 |
| Full blood count decreased | 11.55 | 10.53 | 31 | 125625 | 15686 | 29811136 |
| Gallbladder hypofunction | 11.54 | 10.53 | 4 | 125652 | 16 | 29826806 |
| Anxiety | 11.48 | 10.53 | 288 | 125368 | 89583 | 29737239 |
| Device related infection | 11.44 | 10.53 | 35 | 125621 | 16980 | 29809842 |
| Gait disturbance | 11.43 | 10.53 | 402 | 125254 | 74375 | 29752447 |
| Congenital inguinal hernia | 11.41 | 10.53 | 7 | 125649 | 123 | 29826699 |
| Epstein-Barr virus infection | 11.40 | 10.53 | 7 | 125649 | 6699 | 29820123 |
| Chromophobe renal cell carcinoma | 11.37 | 10.53 | 3 | 125653 | 3 | 29826819 |
| Aortic valve thickening | 11.37 | 10.53 | 3 | 125653 | 3 | 29826819 |
| Coronary artery stenosis | 11.34 | 10.53 | 71 | 125585 | 8999 | 29817823 |
| Cardiac output decreased | 11.27 | 10.53 | 16 | 125640 | 856 | 29825966 |
| Peritonitis bacterial | 11.23 | 10.53 | 19 | 125637 | 11359 | 29815463 |
| Renal failure neonatal | 11.23 | 10.53 | 6 | 125650 | 80 | 29826742 |
| Squamous cell carcinoma of skin | 11.16 | 10.53 | 13 | 125643 | 9082 | 29817740 |
| Coagulopathy | 11.08 | 10.53 | 40 | 125616 | 18447 | 29808375 |
| Incorrect route of product administration | 11.08 | 10.53 | 19 | 125637 | 11296 | 29815526 |
| Lipid metabolism disorder | 11.02 | 10.53 | 9 | 125647 | 253 | 29826569 |
| Inferior vena cava dilatation | 10.95 | 10.53 | 8 | 125648 | 190 | 29826632 |
| Psychomotor hyperactivity | 10.93 | 10.53 | 11 | 125645 | 8213 | 29818609 |
| Cardiac discomfort | 10.93 | 10.53 | 10 | 125646 | 329 | 29826493 |
| Renal function test abnormal | 10.87 | 10.53 | 28 | 125628 | 2351 | 29824471 |
| Shock | 10.86 | 10.53 | 145 | 125511 | 22714 | 29804108 |
| Heart valve stenosis | 10.83 | 10.53 | 4 | 125652 | 20 | 29826802 |
| Ventricular dyssynchrony | 10.83 | 10.53 | 4 | 125652 | 20 | 29826802 |
| Colon cancer | 10.76 | 10.53 | 66 | 125590 | 8306 | 29818516 |
| Bronchitis | 10.76 | 10.53 | 227 | 125429 | 38898 | 29787924 |
| Intestinal perforation | 10.65 | 10.53 | 12 | 125644 | 8507 | 29818315 |
| Atrial flutter | 10.64 | 10.53 | 99 | 125557 | 14182 | 29812640 |
| Bladder cancer | 10.61 | 10.53 | 70 | 125586 | 9032 | 29817790 |
| Pseudohyponatraemia | 10.61 | 10.53 | 6 | 125650 | 90 | 29826732 |
| Retinopathy | 10.60 | 10.53 | 25 | 125631 | 1985 | 29824837 |
| Injection site reaction | 10.59 | 10.53 | 18 | 125638 | 10742 | 29816080 |
| Febrile bone marrow aplasia | 10.57 | 10.53 | 11 | 125645 | 8086 | 29818736 |
| Angioplasty | 10.56 | 10.53 | 17 | 125639 | 1017 | 29825805 |
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | C09CA03 | CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN Angiotensin II receptor blockers (ARBs), plain |
| ATC | C09DA03 | CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs) and diuretics |
| ATC | C09DB01 | CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs) and calcium channel blockers |
| ATC | C09DB08 | CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs) and calcium channel blockers |
| ATC | C09DX01 | CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs), other combinations |
| ATC | C09DX02 | CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs), other combinations |
| ATC | C09DX04 | CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs), other combinations |
| ATC | C09DX05 | CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs), other combinations |
| ATC | C10BX10 | CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Lipid modifying agents in combination with other drugs |
| FDA MoA | N0000000070 | Angiotensin 2 Receptor Antagonists |
| FDA EPC | N0000175561 | Angiotensin 2 Receptor Blocker |
| MeSH PA | D047228 | Angiotensin II Type 1 Receptor Blockers |
| MeSH PA | D057911 | Angiotensin Receptor Antagonists |
| MeSH PA | D000959 | Antihypertensive Agents |
| MeSH PA | D002317 | Cardiovascular Agents |
| CHEBI has role | CHEBI:35674 | antihypertensive |
| CHEBI has role | CHEBI:35703 | xenobiotic |
| CHEBI has role | CHEBI:61016 | angiotensin receptor antagonists |
| CHEBI has role | CHEBI:78298 | environmental contaminants |
Drug Use (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hypertensive disorder | indication | 38341003 | DOID:10763 |
| Chronic heart failure | indication | 48447003 | |
| Left ventricular cardiac dysfunction | indication | 429589006 | |
| Atrial fibrillation | off-label use | 49436004 | DOID:0060224 |
| Diabetic renal disease | off-label use | 127013003 | |
| Diastolic heart failure | off-label use | 418304008 | DOID:9775 |
| Nondiabetic Proteinuric Nephropathy | off-label use | ||
| Anuria | contraindication | 2472002 | DOID:2983 |
| Hypercholesterolemia | contraindication | 13644009 | |
| Hyperkalemia | contraindication | 14140009 | |
| Secondary angle-closure glaucoma | contraindication | 21571006 | |
| Hypovolemia | contraindication | 28560003 | |
| Obstruction of bile duct | contraindication | 30144000 | |
| Dehydration | contraindication | 34095006 | |
| Hyperuricemia | contraindication | 35885006 | DOID:1920 |
| Angioedema | contraindication | 41291007 | DOID:1558 |
| Hypokalemia | contraindication | 43339004 | |
| Low blood pressure | contraindication | 45007003 | |
| Systemic lupus erythematosus | contraindication | 55464009 | DOID:9074 |
| Sympathectomy | contraindication | 57071006 | |
| Acute nephropathy | contraindication | 58574008 | |
| Hepatic failure | contraindication | 59927004 | |
| Hypercalcemia | contraindication | 66931009 | DOID:12678 |
| Hyperparathyroidism | contraindication | 66999008 | DOID:13543 |
| Hypochloremic alkalosis | contraindication | 70134007 | |
| Hepatic coma | contraindication | 72836002 | DOID:12550 |
| Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
| Chronic idiopathic constipation | contraindication | 82934008 | |
| Hyponatremia | contraindication | 89627008 | |
| Gout | contraindication | 90560007 | DOID:13189 |
| Hypomagnesemia | contraindication | 190855004 | |
| Acute pancreatitis | contraindication | 197456007 | DOID:2913 |
| Impaired renal function disorder | contraindication | 197663003 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Neonatal hyperbilirubinemia | contraindication | 281610001 | |
| Pregnancy, function | contraindication | 289908002 | |
| Renal artery stenosis | contraindication | 302233006 | |
| Neutropenic disorder | contraindication | 303011007 | DOID:1227 |
| Azotemia | contraindication | 445009001 | |
| Severe Aortic Valve Stenosis | contraindication |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 3.8 | acidic |
| pKa2 | 4.44 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 24MG;26MG | ENTRESTO | NOVARTIS PHARMS CORP | N207620 | July 7, 2015 | RX | TABLET | ORAL | Jan. 7, 2021 | PEDIATRIC EXCLUSIVITY |
| 49MG;51MG | ENTRESTO | NOVARTIS PHARMS CORP | N207620 | July 7, 2015 | RX | TABLET | ORAL | Jan. 7, 2021 | PEDIATRIC EXCLUSIVITY |
| 97MG;103MG | ENTRESTO | NOVARTIS PHARMS CORP | N207620 | July 7, 2015 | RX | TABLET | ORAL | Jan. 7, 2021 | PEDIATRIC EXCLUSIVITY |
| 24MG;26MG | ENTRESTO | NOVARTIS PHARMS CORP | N207620 | July 7, 2015 | RX | TABLET | ORAL | Oct. 1, 2022 | NEW PATIENT POPULATION |
| 49MG;51MG | ENTRESTO | NOVARTIS PHARMS CORP | N207620 | July 7, 2015 | RX | TABLET | ORAL | Oct. 1, 2022 | NEW PATIENT POPULATION |
| 97MG;103MG | ENTRESTO | NOVARTIS PHARMS CORP | N207620 | July 7, 2015 | RX | TABLET | ORAL | Oct. 1, 2022 | NEW PATIENT POPULATION |
| 24MG;26MG | ENTRESTO | NOVARTIS PHARMS CORP | N207620 | July 7, 2015 | RX | TABLET | ORAL | April 1, 2023 | PEDIATRIC EXCLUSIVITY |
| 49MG;51MG | ENTRESTO | NOVARTIS PHARMS CORP | N207620 | July 7, 2015 | RX | TABLET | ORAL | April 1, 2023 | PEDIATRIC EXCLUSIVITY |
| 97MG;103MG | ENTRESTO | NOVARTIS PHARMS CORP | N207620 | July 7, 2015 | RX | TABLET | ORAL | April 1, 2023 | PEDIATRIC EXCLUSIVITY |
| 24MG;26MG | ENTRESTO | NOVARTIS PHARMS CORP | N207620 | July 7, 2015 | RX | TABLET | ORAL | Feb. 16, 2024 | LABELING REVISIONS RELATED TO CLINICAL STUDIES |
| 49MG;51MG | ENTRESTO | NOVARTIS PHARMS CORP | N207620 | July 7, 2015 | RX | TABLET | ORAL | Feb. 16, 2024 | LABELING REVISIONS RELATED TO CLINICAL STUDIES |
| 97MG;103MG | ENTRESTO | NOVARTIS PHARMS CORP | N207620 | July 7, 2015 | RX | TABLET | ORAL | Feb. 16, 2024 | LABELING REVISIONS RELATED TO CLINICAL STUDIES |
| 160MG | DIOVAN | NOVARTIS | N021283 | July 18, 2001 | RX | TABLET | ORAL | April 19, 2024 | NEW PATIENT POPULATION |
| 40MG | DIOVAN | NOVARTIS | N021283 | Aug. 14, 2002 | RX | TABLET | ORAL | April 19, 2024 | NEW PATIENT POPULATION |
| 80MG | DIOVAN | NOVARTIS | N021283 | July 18, 2001 | RX | TABLET | ORAL | April 19, 2024 | NEW PATIENT POPULATION |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Type-1 angiotensin II receptor | GPCR | ANTAGONIST | Ki | 5.33 | CHEMBL | CHEMBL | |||
| Type-1B angiotensin II receptor | GPCR | IC50 | 8.72 | CHEMBL | |||||
| Type-1A angiotensin II receptor | GPCR | IC50 | 8.47 | CHEMBL | |||||
| Angiotensin II receptor (AT-1) type-1 | GPCR | IC50 | 8.57 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D00400 | KEGG_DRUG |
| 4020986 | VANDF |
| C0527644 | UMLSCUI |
| CHEBI:9927 | CHEBI |
| CHEMBL1069 | ChEMBL_ID |
| D000068756 | MESH_DESCRIPTOR_UI |
| 60846 | PUBCHEM_CID |
| 7016 | INN_ID |
| DB00177 | DRUGBANK_ID |
| 80M03YXJ7I | UNII |
| 3937 | IUPHAR_LIGAND_ID |
| 216652 | RXNORM |
| 53010 | MMSL |
| 5663 | MMSL |
| 8844 | MMSL |
| d04113 | MMSL |
| 006279 | NDDF |
| 108581009 | SNOMEDCT_US |
| 386876001 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Diovan HCT | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0078-0314 | TABLET, FILM COATED | 80 mg | ORAL | NDA | 31 sections |
| Diovan HCT | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0078-0315 | TABLET, FILM COATED | 160 mg | ORAL | NDA | 31 sections |
| Diovan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0358 | TABLET | 80 mg | ORAL | NDA | 33 sections |
| Diovan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0359 | TABLET | 160 mg | ORAL | NDA | 33 sections |
| Diovan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0360 | TABLET | 320 mg | ORAL | NDA | 33 sections |
| Diovan HCT | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0078-0383 | TABLET, FILM COATED | 160 mg | ORAL | NDA | 31 sections |
| Diovan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0423 | TABLET | 40 mg | ORAL | NDA | 33 sections |
| Diovan HCT | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0078-0471 | TABLET, FILM COATED | 320 mg | ORAL | NDA | 31 sections |
| Diovan HCT | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0078-0472 | TABLET, FILM COATED | 320 mg | ORAL | NDA | 31 sections |
| Exforge | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0078-0488 | TABLET, FILM COATED | 160 mg | ORAL | NDA | 31 sections |
| Exforge | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0078-0489 | TABLET, FILM COATED | 160 mg | ORAL | NDA | 31 sections |
| Exforge | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0078-0490 | TABLET, FILM COATED | 320 mg | ORAL | NDA | 31 sections |
| Exforge | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0078-0491 | TABLET, FILM COATED | 320 mg | ORAL | NDA | 31 sections |
| Exforge HCT | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0078-0559 | TABLET, FILM COATED | 160 mg | ORAL | NDA | 31 sections |
| Exforge HCT | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0078-0560 | TABLET, FILM COATED | 160 mg | ORAL | NDA | 31 sections |
| Exforge HCT | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0078-0561 | TABLET, FILM COATED | 160 mg | ORAL | NDA | 31 sections |
| Exforge HCT | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0078-0562 | TABLET, FILM COATED | 160 mg | ORAL | NDA | 31 sections |
| Exforge HCT | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0078-0563 | TABLET, FILM COATED | 320 mg | ORAL | NDA | 31 sections |
| ENTRESTO | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0078-0659 | TABLET, FILM COATED | 26 mg | ORAL | NDA | 34 sections |
| ENTRESTO | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0078-0696 | TABLET, FILM COATED | 103 mg | ORAL | NDA | 34 sections |
| ENTRESTO | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0078-0777 | TABLET, FILM COATED | 51 mg | ORAL | NDA | 34 sections |
| AMLODIPINE AND VALSARTAN | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0378-1721 | TABLET, FILM COATED | 160 mg | ORAL | ANDA | 27 sections |
| AMLODIPINE AND VALSARTAN | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0378-1722 | TABLET, FILM COATED | 160 mg | ORAL | ANDA | 27 sections |
| AMLODIPINE AND VALSARTAN | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0378-1723 | TABLET, FILM COATED | 320 mg | ORAL | ANDA | 27 sections |
| AMLODIPINE AND VALSARTAN | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0378-1724 | TABLET, FILM COATED | 320 mg | ORAL | ANDA | 27 sections |
| Valsartan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-5807 | TABLET, FILM COATED | 40 mg | ORAL | ANDA | 29 sections |
| Valsartan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-5813 | TABLET, FILM COATED | 80 mg | ORAL | ANDA | 29 sections |
| Valsartan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-5814 | TABLET, FILM COATED | 160 mg | ORAL | ANDA | 29 sections |
| Valsartan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-5815 | TABLET, FILM COATED | 320 mg | ORAL | ANDA | 29 sections |
| Valsartan and Hydrochlorothiazide | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0378-6321 | TABLET, FILM COATED | 80 mg | ORAL | ANDA | 28 sections |