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

Stem definitionDrug idCAS RN
Vitamin D analogues/derivatives 466 32222-06-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • rocaltrol
  • calcitriol
  • Dihydroxyvitamin D3
  • topitriol
  • 1,25-dihydroxyvitamin D3
The physiologically active form of vitamin D. It is formed primarily in the kidney by enzymatic hydroxylation of 25-hydroxycholecalciferol (CALCIFEDIOL). Its production is stimulated by low blood calcium levels and parathyroid hormone. Calcitriol increases intestinal absorption of calcium and phosphorus, and in concert with parathyroid hormone increases bone resorption.
  • Molecular weight: 416.65
  • Formula: C27H44O3
  • CLOGP: 6.04
  • LIPINSKI: 1
  • HAC: 3
  • HDO: 3
  • TPSA: 60.69
  • ALOGS: -4.80
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
1 mcg O
1 mcg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 8 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.00 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 61 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.25 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.31 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 11 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,CDK5,EIF2AK3,GRK2,ITK,PDK1,PDK2,PDK4,PRKDC 9
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
Aug. 17, 1978 FDA VALIDUS PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Recalled product 1130.69 12.33 217 28402 1171 90598657
Hypocalcaemia 558.83 12.33 271 28348 42097 90557731
Hypercalcaemia 518.83 12.33 241 28378 33999 90565829
Milk-alkali syndrome 271.14 12.33 66 28553 1207 90598621
Calciphylaxis 224.06 12.33 70 28549 3306 90596522
Peritonitis bacterial 179.86 12.33 66 28553 5105 90594723
Blood calcium decreased 159.04 12.33 106 28513 30076 90569752
Drug hypersensitivity 153.66 12.33 404 28215 463205 90136623
Nephrocalcinosis 141.11 12.33 39 28580 1193 90598635
Shunt stenosis 134.60 12.33 32 28587 527 90599301
Blood parathyroid hormone increased 127.47 12.33 46 28573 3391 90596437
Arteriovenous fistula site complication 127.05 12.33 30 28589 479 90599349
Tetany 120.44 12.33 41 28578 2543 90597285
Renal impairment 113.89 12.33 153 28466 105268 90494560
Hypoparathyroidism 111.49 12.33 31 28588 970 90598858
Blood calcium abnormal 110.61 12.33 36 28583 1941 90597887
Shunt occlusion 104.97 12.33 28 28591 747 90599081
Blood calcium increased 103.82 12.33 58 28561 12000 90587828
Body mass index abnormal 92.10 12.33 25 28594 714 90599114
Hypercalciuria 91.82 12.33 22 28597 375 90599453
Chronic kidney disease 91.08 12.33 95 28524 50096 90549732
Blood phosphorus increased 86.52 12.33 37 28582 4281 90595547
Peritonitis 84.52 12.33 61 28558 19644 90580184
Gout 83.51 12.33 57 28562 16802 90583026
Glossodynia 81.72 12.33 5 28614 321774 90278054
Hyperphosphataemia 81.69 12.33 34 28585 3677 90596151
Nephrogenic systemic fibrosis 81.65 12.33 35 28584 4073 90595755
Synovitis 81.18 12.33 6 28613 329746 90270082
Paraesthesia oral 80.22 12.33 72 28547 31587 90568241
Anaemia 79.97 12.33 269 28350 352533 90247295
End stage renal disease 78.65 12.33 43 28576 8528 90591300
Serositis 77.83 12.33 25 28594 1292 90598536
Central nervous system lupus 76.99 12.33 25 28594 1338 90598490
Acute kidney injury 75.91 12.33 248 28371 320139 90279689
Renal failure 73.44 12.33 141 28478 130866 90468962
Pericarditis 69.19 12.33 4 28615 270147 90329681
Systemic lupus erythematosus 68.99 12.33 15 28604 361881 90237947
Joint swelling 68.27 12.33 37 28582 503263 90096565
Rheumatoid arthritis 67.19 12.33 16 28603 362598 90237230
Arthropathy 66.23 12.33 17 28602 366225 90233603
Blood creatinine increased 65.47 12.33 116 28503 101270 90498558
Hepatic enzyme increased 64.74 12.33 17 28602 360719 90239109
Aplasia pure red cell 64.73 12.33 32 28587 5162 90594666
Lupus nephritis 63.90 12.33 31 28588 4801 90595027
Contraindicated product administered 61.57 12.33 13 28606 320126 90279702
Chronic kidney disease-mineral and bone disorder 60.22 12.33 13 28606 135 90599693
Treatment failure 59.15 12.33 12 28607 303916 90295912
Wound 58.89 12.33 12 28607 302968 90296860
Vaginal flatulence 58.53 12.33 41 28578 12597 90587231
Proctitis 58.16 12.33 44 28575 15215 90584613
Renal transplant 56.69 12.33 21 28598 1667 90598161
Irritable bowel syndrome 53.33 12.33 3 28616 207445 90392383
Chronic sinusitis 52.30 12.33 50 28569 23752 90576076
Hyperparathyroidism 52.08 12.33 24 28595 3313 90596515
Female genital tract fistula 52.04 12.33 44 28575 17824 90582004
Kidney transplant rejection 51.98 12.33 27 28592 4830 90594998
Impaired healing 50.53 12.33 7 28612 234192 90365636
Analgesic therapy 49.09 12.33 15 28604 657 90599171
Radiculopathy 48.69 12.33 43 28576 18462 90581366
Nephrolithiasis 48.10 12.33 68 28551 49017 90550811
Antacid therapy 47.39 12.33 15 28604 739 90599089
Appendicolith 47.25 12.33 15 28604 746 90599082
Abdominal pain 47.21 12.33 248 28371 395473 90204355
Peritoneal dialysis complication 46.69 12.33 17 28602 1285 90598543
Drug therapy 46.35 12.33 15 28604 794 90599034
Anticoagulant therapy 46.21 12.33 15 28604 802 90599026
Alopecia 46.19 12.33 53 28566 495018 90104810
Hyperparathyroidism secondary 44.76 12.33 18 28601 1783 90598045
Hyperparathyroidism tertiary 44.69 12.33 8 28611 27 90599801
Therapeutic product effect decreased 44.53 12.33 16 28603 277555 90322273
Hungry bone syndrome 43.12 12.33 10 28609 147 90599681
Cardiac failure 43.00 12.33 102 28517 109394 90490434
Vaginal discharge 42.97 12.33 41 28578 19423 90580405
Fibromyalgia 42.58 12.33 7 28612 206262 90393566
Unresponsive to stimuli 40.63 12.33 55 28564 38066 90561762
Haematuria 39.68 12.33 52 28567 34885 90564943
Mental status changes 39.56 12.33 59 28560 44620 90555208
Dialysis 39.53 12.33 31 28588 11298 90588530
Skin hypertrophy 38.44 12.33 20 28599 3590 90596238
Lower respiratory tract infection 37.64 12.33 16 28603 250643 90349185
Aortic stenosis 37.64 12.33 24 28595 6312 90593516
Skin induration 37.42 12.33 19 28600 3243 90596585
Infusion related reaction 36.34 12.33 47 28572 416733 90183095
Sinusitis 36.21 12.33 33 28586 343055 90256773
Hypersensitivity 35.94 12.33 55 28564 454622 90145206
Haematochezia 35.70 12.33 73 28546 70840 90528988
Completed suicide 34.66 12.33 3 28616 145055 90454773
Oral candidiasis 34.56 12.33 49 28570 35406 90564422
Brown tumour 34.52 12.33 7 28612 52 90599776
Drug intolerance 33.62 12.33 56 28563 447535 90152293
Psoriatic arthropathy 33.61 12.33 15 28604 228320 90371508
Macular degeneration 33.41 12.33 50 28569 37920 90561908
Discomfort 33.20 12.33 23 28596 274312 90325516
Gastrointestinal disorder 33.13 12.33 20 28599 256667 90343161
Procedural pain 32.36 12.33 46 28573 33314 90566514
Swelling 31.87 12.33 52 28567 419006 90180822
Blister 31.36 12.33 21 28598 254977 90344851
Hypervitaminosis D 30.91 12.33 7 28612 92 90599736
Acute myocardial infarction 30.78 12.33 46 28573 34844 90564984
Liver injury 30.64 12.33 8 28611 170559 90429269
Wheezing 30.10 12.33 19 28600 238061 90361767
Pulmonary renal syndrome 30.10 12.33 10 28609 575 90599253
Septic shock 29.43 12.33 75 28544 84085 90515743
Drug ineffective 29.35 12.33 288 28331 1384010 89215818
Fungal peritonitis 29.13 12.33 10 28609 636 90599192
Parathyroid tumour benign 29.08 12.33 11 28608 925 90598903
Arthralgia 28.36 12.33 138 28481 778384 89821444
Bursitis 28.23 12.33 4 28615 131650 90468178
Abdominal discomfort 27.93 12.33 69 28550 477259 90122569
Peritoneal dialysis 27.84 12.33 9 28610 475 90599353
Ill-defined disorder 27.44 12.33 12 28607 184879 90414949
Hyperlipidaemia 27.42 12.33 35 28584 22881 90576947
Sepsis 27.40 12.33 121 28498 179693 90420135
Premature delivery 27.16 12.33 46 28573 38716 90561112
Blood uric acid increased 26.70 12.33 21 28598 7683 90592145
Parathyroidectomy 26.41 12.33 8 28611 340 90599488
Constipation 26.35 12.33 165 28454 280230 90319598
Calcinosis 26.06 12.33 14 28605 2681 90597147
Hyperkalaemia 26.02 12.33 61 28558 64903 90534925
Product use issue 25.96 12.33 40 28579 329879 90269949
Osteomalacia 25.95 12.33 10 28609 885 90598943
Urinary tract infection 25.77 12.33 175 28444 305457 90294371
Hospitalisation 25.76 12.33 94 28525 128006 90471822
Osteoarthritis 25.61 12.33 15 28604 195715 90404113
Rectal haemorrhage 25.14 12.33 70 28549 82674 90517154
Stomatitis 24.95 12.33 30 28589 274668 90325160
Hypervolaemia 24.46 12.33 40 28579 32717 90567111
Haemodialysis 24.37 12.33 21 28598 8726 90591102
Pulse absent 24.28 12.33 18 28601 6037 90593791
Musculoskeletal stiffness 24.26 12.33 35 28584 296497 90303331
Skin tightness 24.20 12.33 16 28603 4472 90595356
Hyperparathyroidism primary 24.01 12.33 8 28611 464 90599364
Ultrafiltration failure 23.87 12.33 7 28612 266 90599562
Nausea 23.63 12.33 486 28133 1109830 89489998
Nasopharyngitis 22.92 12.33 60 28559 407044 90192784
Cardio-respiratory arrest 22.84 12.33 57 28562 63083 90536745
Haemoglobin decreased 22.45 12.33 106 28513 161850 90437978
C-reactive protein increased 22.21 12.33 15 28604 181374 90418454
Blood potassium increased 22.20 12.33 30 28589 20719 90579109
Type 2 diabetes mellitus 22.09 12.33 19 28600 203225 90396603
Injury 22 12.33 18 28601 197331 90402497
Lip dry 21.80 12.33 3 28616 100952 90498876
Coagulation test abnormal 21.72 12.33 9 28610 962 90598866
Azotaemia 21.67 12.33 16 28603 5332 90594496
Bone pain 21.42 12.33 55 28564 61928 90537900
Night sweats 21.37 12.33 7 28612 128759 90471069
Vitamin D deficiency 21.30 12.33 27 28592 17529 90582299
Frequent bowel movements 21.23 12.33 52 28567 56883 90542945
Blood urea increased 21.19 12.33 36 28583 30377 90569451
Arrhythmia 20.62 12.33 43 28576 42289 90557539
Plasma cell myeloma 20.51 12.33 42 28577 40786 90559042
Polyglandular disorder 20.46 12.33 6 28613 228 90599600
Rash 20.17 12.33 158 28461 795942 89803886
Sleep disorder 19.77 12.33 20 28599 198010 90401818
Arteriovenous fistula thrombosis 19.76 12.33 6 28613 257 90599571
Flushing 19.56 12.33 67 28552 88424 90511404
Grip strength decreased 19.42 12.33 3 28616 92573 90507255
Psychomotor hyperactivity 19.30 12.33 22 28597 12791 90587037
Hypocalcaemic seizure 19.25 12.33 4 28615 34 90599794
Vascular parkinsonism 19.17 12.33 5 28614 122 90599706
Wound infection 19.09 12.33 5 28614 106397 90493431
Skin fibrosis 19.09 12.33 8 28611 880 90598948
Polyhydramnios 18.74 12.33 11 28608 2497 90597331
Prescribed overdose 18.67 12.33 4 28615 97621 90502207
Renal tubular necrosis 18.64 12.33 23 28596 14532 90585296
Death 18.55 12.33 223 28396 456328 90143500
Treatment noncompliance 17.98 12.33 46 28573 51681 90548147
Renal disorder 17.91 12.33 38 28581 37821 90562007
Appendicitis 17.90 12.33 19 28600 10212 90589616
Mesenteric phlebosclerosis 17.89 12.33 3 28616 6 90599822
Cerebral calcification 17.87 12.33 5 28614 160 90599668
Sciatica 17.74 12.33 5 28614 101377 90498451
Alveolar bone resorption 17.70 12.33 4 28615 52 90599776
Intentional overdose 17.63 12.33 4 28615 93830 90505998
Anti-erythropoietin antibody positive 17.50 12.33 6 28613 380 90599448
Cardiogenic shock 17.09 12.33 29 28590 24439 90575389
Iron deficiency 17.08 12.33 18 28601 9594 90590234
Stress fracture 16.88 12.33 17 28602 8594 90591234
Thrombosis 16.66 12.33 56 28563 73195 90526633
Cutaneous calcification 16.66 12.33 5 28614 206 90599622
Intentional product use issue 16.39 12.33 27 28592 216865 90382963
Colitis 16.38 12.33 54 28565 69888 90529940
Delusion 16.34 12.33 21 28598 13819 90586009
Daydreaming 16.24 12.33 6 28613 473 90599355
Nephropathy toxic 16.17 12.33 20 28599 12668 90587160
Sleep disorder therapy 16.15 12.33 6 28613 480 90599348
Glomerular filtration rate decreased 15.91 12.33 23 28596 16909 90582919
Blood parathyroid hormone abnormal 15.74 12.33 5 28614 249 90599579
Peripheral swelling 15.72 12.33 72 28547 413034 90186794
Hypoglycaemia 15.54 12.33 53 28566 69795 90530033
Gastrointestinal haemorrhage 15.50 12.33 63 28556 90185 90509643
Anaemia folate deficiency 15.47 12.33 6 28613 540 90599288
Bacterial infection 15.35 12.33 27 28592 23417 90576411
Product dose omission issue 15.32 12.33 150 28469 291537 90308291
Hypotension 15.03 12.33 163 28456 325234 90274594
Dehydration 15.00 12.33 109 28510 194338 90405490
Peripheral venous disease 14.95 12.33 4 28615 83917 90515911
Asthma 14.94 12.33 34 28585 242126 90357702
Mobility decreased 14.84 12.33 36 28583 250698 90349130
Urticaria 14.77 12.33 50 28569 312684 90287144
Knee arthroplasty 14.75 12.33 4 28615 83178 90516650
Staphylococcal infection 14.73 12.33 41 28578 48398 90551430
Peritoneal cloudy effluent 14.64 12.33 5 28614 313 90599515
Urosepsis 14.61 12.33 25 28594 21207 90578621
Red blood cell sedimentation rate increased 14.59 12.33 4 28615 82591 90517237
Hyperuricaemia 14.54 12.33 14 28605 6705 90593123
Activated partial thromboplastin time prolonged 14.53 12.33 15 28604 7810 90592018
Prescribed underdose 14.50 12.33 3 28616 75016 90524812
Diabetic foot 14.46 12.33 8 28611 1623 90598205
Pulmonary fibrosis 14.40 12.33 8 28611 107495 90492333
Blood magnesium decreased 14.28 12.33 21 28598 15672 90584156
Hypercholesterolaemia 14.26 12.33 7 28612 100885 90498943
Migraine 14.11 12.33 24 28595 190368 90409460
Chronic hepatitis 14.11 12.33 7 28612 1138 90598690
Anti-neutrophil cytoplasmic antibody positive vasculitis 14.09 12.33 11 28608 3982 90595846
Clostridium difficile colitis 14.04 12.33 28 28591 26678 90573150
Staphylococcal sepsis 13.95 12.33 16 28603 9367 90590461
Obesity 13.92 12.33 8 28611 105499 90494329
Infection 13.84 12.33 63 28556 362031 90237797
Blood cholesterol increased 13.84 12.33 28 28591 207984 90391844
Simple partial seizures 13.75 12.33 6 28613 729 90599099
Diffuse alopecia 13.68 12.33 7 28612 1213 90598615
Bone metabolism biochemical marker increased 13.50 12.33 3 28616 36 90599792
Vascular calcification 13.32 12.33 6 28613 786 90599042
Papillary thyroid cancer 13.29 12.33 9 28610 2618 90597210
Dyskinesia 13.23 12.33 33 28586 36501 90563327
Mixed anxiety and depressive disorder 13.13 12.33 5 28614 428 90599400
Road traffic accident 13.04 12.33 9 28610 107617 90492211
Hip arthroplasty 12.89 12.33 4 28615 76204 90523624
Respiratory distress 12.88 12.33 34 28585 38912 90560916
Inflammation 12.79 12.33 23 28596 178569 90421259
Cardiac arrest 12.63 12.33 66 28553 104869 90494959
Weight increased 12.48 12.33 79 28540 417848 90181980
Hand fracture 12.46 12.33 13 28606 6852 90592976
Liver disorder 12.38 12.33 12 28607 121257 90478571
Vitamin D decreased 12.33 12.33 17 28602 11962 90587866

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Appendicolith 421.50 13.90 200 29579 13256 42578300
Drug hypersensitivity 373.44 13.90 401 29378 98988 42492568
Appendicitis 373.17 13.90 212 29567 20401 42571155
Blood phosphorus increased 302.50 13.90 156 29623 12369 42579187
Stress 265.33 13.90 231 29548 43981 42547575
Cardiogenic shock 263.24 13.90 210 29569 35430 42556126
Hyperphosphataemia 212.01 13.90 125 29654 12879 42578677
Ventricular fibrillation 208.66 13.90 171 29608 29952 42561604
Ascites 193.97 13.90 218 29561 56460 42535096
Hypophosphataemia 188.80 13.90 139 29640 20806 42570750
Abdominal distension 183.48 13.90 238 29541 71497 42520059
Peritonitis bacterial 181.11 13.90 91 29688 6824 42584732
Myasthenia gravis 175.27 13.90 120 29659 16017 42575539
Blood uric acid increased 174.53 13.90 118 29661 15429 42576127
Multiple organ dysfunction syndrome 161.97 13.90 263 29516 96772 42494784
Hypercalcaemia 156.38 13.90 117 29662 17941 42573615
Analgesic therapy 153.86 13.90 80 29699 6444 42585112
Sleep disorder therapy 144.11 13.90 78 29701 6816 42584740
Drug therapy 144.09 13.90 76 29703 6304 42585252
Shunt stenosis 141.21 13.90 42 29737 735 42590821
General physical health deterioration 138.77 13.90 318 29461 150928 42440628
Bacterial infection 132.66 13.90 128 29651 27751 42563805
Hyponatraemia 128.99 13.90 244 29535 101218 42490338
Dry mouth 128.93 13.90 149 29630 39730 42551826
Blood parathyroid hormone increased 128.51 13.90 49 29730 1878 42589678
Hypocalcaemia 122.34 13.90 127 29652 30046 42561510
Milk-alkali syndrome 118.91 13.90 36 29743 671 42590885
Arteriovenous fistula site complication 118.45 13.90 33 29746 452 42591104
Shunt occlusion 113.58 13.90 38 29741 989 42590567
Neuralgia 111.32 13.90 112 29667 25535 42566021
Blood cholesterol increased 107.41 13.90 112 29667 26629 42564927
Iron deficiency 105.53 13.90 76 29703 10985 42580571
Incorrect route of product administration 105.23 13.90 106 29673 24199 42567357
End stage renal disease 104.26 13.90 89 29690 16469 42575087
Sepsis 103.41 13.90 340 29439 198994 42392562
Blood calcium increased 101.69 13.90 67 29712 8387 42583169
Anticoagulant therapy 96.70 13.90 52 29727 4483 42587073
Antacid therapy 94.78 13.90 52 29727 4665 42586891
Recalled product 92.28 13.90 26 29753 372 42591184
Abdominal pain 91.79 13.90 317 29462 190154 42401402
Nephrocalcinosis 85.99 13.90 29 29750 774 42590782
Diabetes mellitus 84.47 13.90 151 29628 59936 42531620
Constipation 83.36 13.90 276 29503 162015 42429541
Activated partial thromboplastin time prolonged 79.40 13.90 75 29704 15828 42575728
Vomiting 78.99 13.90 405 29374 289318 42302238
Swelling 70.91 13.90 133 29646 54752 42536804
Gout 68.40 13.90 91 29688 27964 42563592
Drug ineffective 67.79 13.90 221 29558 629976 41961580
Congenital hiatus hernia 67.22 13.90 46 29733 6128 42585428
Bronchopulmonary aspergillosis allergic 66.64 13.90 41 29738 4557 42586999
Thrombosis 63.73 13.90 145 29634 68366 42523190
Ulcer 62.69 13.90 67 29712 16374 42575182
Hypercalciuria 62.61 13.90 19 29760 357 42591199
Chronic obstructive pulmonary disease 62.54 13.90 137 29642 62977 42528579
Blood test abnormal 59.01 13.90 58 29721 12848 42578708
Febrile neutropenia 58.99 13.90 28 29751 185675 42405881
Peritoneal dialysis complication 58.33 13.90 28 29751 1899 42589657
Zoonotic bacterial infection 57.90 13.90 13 29766 67 42591489
Peritonitis 55.83 13.90 67 29712 18566 42572990
Hyperparathyroidism 55.52 13.90 24 29755 1275 42590281
Troponin increased 54.61 13.90 67 29712 18995 42572561
Hyperparathyroidism secondary 53.45 13.90 26 29753 1816 42589740
Aplasia pure red cell 52.36 13.90 42 29737 7124 42584432
Aortic stenosis 49.00 13.90 44 29735 8701 42582855
Mean platelet volume increased 48.86 13.90 18 29761 626 42590930
Bacteroides infection 47.82 13.90 27 29752 2560 42588996
Nephrogenic systemic fibrosis 47.66 13.90 30 29749 3471 42588085
Sleep disorder 47.18 13.90 104 29675 47991 42543565
Nephrectomy 46.25 13.90 19 29760 888 42590668
Hyperlipidaemia 45.24 13.90 65 29714 21451 42570105
Cardiovascular disorder 44.95 13.90 51 29728 13314 42578242
Nausea 44.74 13.90 448 29331 396351 42195205
Blood creatinine increased 44.38 13.90 173 29606 109830 42481726
Intentional product misuse 42.78 13.90 117 29662 61783 42529773
Mycobacterium test positive 42.47 13.90 15 29764 461 42591095
Pleuritic pain 42.43 13.90 37 29742 7040 42584516
Chronic kidney disease 41.73 13.90 98 29681 47143 42544413
Hypervolaemia 41.68 13.90 65 29714 23060 42568496
Drug intolerance 41.40 13.90 137 29642 80287 42511269
Mycobacterium marinum infection 40.76 13.90 15 29764 520 42591036
Toxicity to various agents 40.40 13.90 61 29718 229075 42362481
Total lung capacity decreased 39.81 13.90 27 29752 3543 42588013
Hypochromasia 39.61 13.90 13 29766 318 42591238
Ventricular hyperkinesia 39.52 13.90 12 29767 226 42591330
Right atrial enlargement 37.26 13.90 12 29767 276 42591280
Upper respiratory tract infection 36.72 13.90 87 29692 42086 42549470
Breath sounds abnormal 35.44 13.90 43 29736 12050 42579506
Lung diffusion test decreased 33.55 13.90 15 29764 864 42590692
Anaemia 32.74 13.90 319 29460 279959 42311597
Tendon calcification 31.97 13.90 8 29771 70 42591486
Completed suicide 31.45 13.90 14 29765 96451 42495105
Mitral valve thickening 31.27 13.90 12 29767 468 42591088
Somnolence 30.79 13.90 186 29593 140919 42450637
Arthralgia 30.37 13.90 61 29718 205177 42386379
Blood calcium decreased 30.14 13.90 38 29741 11070 42580486
Neutropenia 29.75 13.90 59 29720 199372 42392184
Disease progression 29.64 13.90 34 29745 143622 42447934
Interstitial lung disease 29.59 13.90 9 29770 78453 42513103
Hungry bone syndrome 28.72 13.90 9 29770 189 42591367
Hospitalisation 28.42 13.90 115 29664 74215 42517341
Narrow anterior chamber angle 28.42 13.90 8 29771 114 42591442
Lung opacity 28.12 13.90 27 29752 5810 42585746
Micturition urgency 28.08 13.90 38 29741 11860 42579696
Calcinosis 27.47 13.90 13 29766 854 42590702
Benign prostatic hyperplasia 27.14 13.90 51 29728 21001 42570555
Respiratory symptom 27.02 13.90 36 29743 11070 42580486
Carotid arteriosclerosis 26.87 13.90 18 29761 2314 42589242
Microsporidia infection 26.79 13.90 14 29765 1138 42590418
Calciphylaxis 26.56 13.90 14 29765 1159 42590397
Aspiration 26.46 13.90 46 29733 17840 42573716
Rash 25.69 13.90 103 29676 276851 42314705
Primary familial brain calcification 25.68 13.90 6 29773 38 42591518
Hypertensive heart disease 25.23 13.90 18 29761 2562 42588994
Left ventricular enlargement 24.91 13.90 12 29767 820 42590736
Hypophosphatasia 24.79 13.90 6 29773 45 42591511
Joint injury 24.72 13.90 40 29739 14636 42576920
Hypercholesterolaemia 24.39 13.90 37 29742 12812 42578744
Mucosal inflammation 24.19 13.90 3 29776 49371 42542185
Incorrect dose administered 24.13 13.90 4 29775 52970 42538586
Renal transplant 23.90 13.90 17 29762 2408 42589148
Shunt infection 23.45 13.90 7 29772 124 42591432
Thrombocytopenia 22.98 13.90 63 29716 190216 42401340
Left atrial enlargement 22.43 13.90 12 29767 1023 42590533
Arteriovenous fistula occlusion 22.29 13.90 7 29772 148 42591408
Lower respiratory tract infection 21.91 13.90 71 29708 41135 42550421
Pulmonary embolism 21.39 13.90 150 29629 119462 42472094
Insomnia 21.28 13.90 31 29748 118222 42473334
Intentional product use issue 21.04 13.90 12 29767 71821 42519735
Malignant neoplasm progression 20.93 13.90 27 29752 108373 42483183
Bronchiolitis 20.60 13.90 19 29760 3887 42587669
Skin fibrosis 20.58 13.90 11 29768 936 42590620
Granuloma 20.05 13.90 19 29760 4022 42587534
Myasthenic syndrome 19.16 13.90 10 29769 811 42590745
Suicidal ideation 19.13 13.90 5 29774 48156 42543400
Azotaemia 18.84 13.90 22 29757 5922 42585634
Joint contracture 18.58 13.90 14 29765 2167 42589389
Proteinuria 18.49 13.90 46 29733 22937 42568619
Pancytopenia 18.26 13.90 34 29745 117709 42473847
Chronic kidney disease-mineral and bone disorder 17.96 13.90 8 29771 457 42591099
Peripheral arterial occlusive disease 17.93 13.90 23 29756 6815 42584741
Blood iron decreased 17.76 13.90 22 29757 6296 42585260
Intentional overdose 17.51 13.90 7 29772 51449 42540107
Hypertension 17.41 13.90 186 29593 167018 42424538
Blood calcium abnormal 17.16 13.90 9 29770 737 42590819
Spontaneous haematoma 17.03 13.90 9 29770 749 42590807
Serum ferritin increased 16.95 13.90 23 29756 7196 42584360
Reticulocyte count abnormal 16.90 13.90 4 29775 27 42591529
Foetal exposure during pregnancy 16.83 13.90 6 29773 47305 42544251
Aggression 16.77 13.90 5 29774 44158 42547398
Parathyroidectomy 16.52 13.90 5 29774 93 42591463
Myelosuppression 16.46 13.90 4 29775 40457 42551099
Confusional state 16.37 13.90 61 29718 167536 42424020
Blood chloride increased 16.29 13.90 16 29763 3540 42588016
Interstitial granulomatous dermatitis 16.22 13.90 6 29773 211 42591345
Obstruction 16.18 13.90 15 29764 3088 42588468
Renal transplant failure 15.88 13.90 11 29768 1494 42590062
Potentiating drug interaction 15.78 13.90 21 29758 6447 42585109
Electrocardiogram T wave inversion 15.62 13.90 13 29766 2321 42589235
Coma 15.61 13.90 9 29770 53545 42538011
Skin induration 15.60 13.90 12 29767 1915 42589641
Porphyria acute 15.56 13.90 7 29772 409 42591147
Therapeutic product effect incomplete 15.49 13.90 16 29763 70923 42520633
Infusion related reaction 15.33 13.90 12 29767 60794 42530762
Hypervitaminosis D 15.33 13.90 4 29775 42 42591514
Joint swelling 15.25 13.90 15 29764 68007 42523549
Treatment failure 14.99 13.90 13 29766 62611 42528945
Myopathy 14.91 13.90 31 29748 13730 42577826
Feeling hot 14.85 13.90 43 29736 23439 42568117
Oxygen saturation decreased 14.81 13.90 14 29765 64673 42526883
Lens dislocation 14.77 13.90 5 29774 135 42591421
Haemodialysis 14.67 13.90 26 29753 10234 42581322
Agitation 14.63 13.90 14 29765 64300 42527256
Hepatic cyst infection 14.48 13.90 4 29775 53 42591503
Pancreatitis acute 14.29 13.90 3 29776 33561 42557995
Infection in an immunocompromised host 14.24 13.90 9 29770 1048 42590508
Skin tightness 14.15 13.90 12 29767 2198 42589358
Medullary thyroid cancer 14.02 13.90 4 29775 60 42591496
Blood erythropoietin decreased 13.98 13.90 3 29776 12 42591544

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Appendicolith 542.45 12.05 215 50631 14040 110524413
Hypercalcaemia 532.20 12.05 307 50539 46350 110492103
Recalled product 455.34 12.05 104 50742 946 110537507
Drug hypersensitivity 452.12 12.05 774 50072 453316 110085137
Appendicitis 437.10 12.05 228 50618 28236 110510217
Blood phosphorus increased 409.12 12.05 183 50663 16157 110522296
Hypocalcaemia 384.55 12.05 284 50562 65082 110473371
Milk-alkali syndrome 374.37 12.05 101 50745 1904 110536549
Peritonitis bacterial 332.64 12.05 139 50707 10394 110528059
Cardiogenic shock 305.89 12.05 235 50611 57103 110481350
Hyperphosphataemia 303.47 12.05 149 50697 16232 110522221
Shunt stenosis 276.97 12.05 74 50772 1342 110537111
Ventricular fibrillation 246.29 12.05 181 50665 41132 110497321
Blood uric acid increased 240.96 12.05 140 50706 21389 110517064
Arteriovenous fistula site complication 240.74 12.05 62 50784 968 110537485
Analgesic therapy 229.58 12.05 96 50750 7188 110531265
Ascites 222.78 12.05 243 50603 92565 110445888
Stress 220.75 12.05 257 50589 105091 110433362
Hypophosphataemia 217.49 12.05 154 50692 33028 110505425
Drug therapy 216.15 12.05 92 50754 7199 110531254
Myasthenia gravis 209.77 12.05 128 50718 21383 110517070
Shunt occlusion 204.31 12.05 61 50785 1676 110536777
Calciphylaxis 201.67 12.05 75 50771 4112 110534341
Multiple organ dysfunction syndrome 194.89 12.05 291 50555 151419 110387034
Blood parathyroid hormone increased 193.34 12.05 73 50773 4175 110534278
End stage renal disease 192.22 12.05 121 50725 21352 110517101
Sleep disorder therapy 191.24 12.05 85 50761 7386 110531067
Blood calcium increased 175.02 12.05 107 50739 17933 110520520
Sepsis 167.44 12.05 425 50421 326921 110211532
Bacterial infection 167.03 12.05 151 50695 45885 110492568
Gout 163.18 12.05 135 50711 36431 110502022
Anticoagulant therapy 156.78 12.05 67 50779 5294 110533159
Nephrocalcinosis 155.53 12.05 50 50796 1764 110536689
Antacid therapy 155.31 12.05 67 50779 5417 110533036
Abdominal distension 149.90 12.05 280 50566 174823 110363630
Iron deficiency 138.13 12.05 93 50753 18383 110520070
Hyponatraemia 135.39 12.05 305 50541 217348 110321105
Peritonitis 132.36 12.05 114 50732 32493 110505960
Abdominal pain 119.90 12.05 510 50336 512479 110025974
Diabetes mellitus 116.80 12.05 183 50663 99198 110439255
Neuralgia 114.65 12.05 126 50720 48352 110490101
Activated partial thromboplastin time prolonged 111.26 12.05 88 50758 22280 110516173
Constipation 108.21 12.05 386 50460 357400 110181053
Blood creatinine increased 107.86 12.05 251 50595 182638 110355815
Synovitis 105.03 12.05 5 50841 274087 110264366
Joint swelling 98.78 12.05 40 50806 442805 110095648
Anaemia 97.05 12.05 502 50344 546584 109991869
Aortic stenosis 95.86 12.05 65 50781 12994 110525459
Chronic kidney disease 94.56 12.05 144 50702 76147 110462306
Nephrogenic systemic fibrosis 93.04 12.05 47 50799 5436 110533017
Blood calcium decreased 89.71 12.05 96 50750 35749 110502704
Thrombosis 89.51 12.05 171 50675 108491 110429962
Rheumatoid arthritis 87.45 12.05 16 50830 299597 110238856
Congenital hiatus hernia 87.18 12.05 47 50799 6212 110532241
Hyperlipidaemia 84.46 12.05 93 50753 35755 110502698
Hand deformity 83.66 12.05 4 50842 218502 110319951
Hyperparathyroidism secondary 82.67 12.05 37 50809 3267 110535186
Glossodynia 82.08 12.05 5 50841 221999 110316454
Hepatic enzyme increased 81.94 12.05 23 50823 320869 110217584
Peritoneal dialysis complication 81.72 12.05 34 50812 2512 110535941
Chronic obstructive pulmonary disease 81.70 12.05 165 50681 108993 110429460
Aplasia pure red cell 80.80 12.05 52 50794 9526 110528927
Hyperparathyroidism 80.69 12.05 38 50808 3772 110534681
General physical health deterioration 77.96 12.05 394 50452 424901 110113552
Body mass index abnormal 77.20 12.05 25 50821 903 110537550
Alopecia 76.48 12.05 36 50810 364717 110173736
Hypercalciuria 75.81 12.05 22 50824 546 110537907
Systemic lupus erythematosus 75.49 12.05 13 50833 254325 110284128
Renal impairment 73.70 12.05 222 50624 188223 110350230
Arthropathy 72.68 12.05 21 50825 287501 110250952
Pericarditis 72.56 12.05 8 50838 219106 110319347
Treatment failure 72.42 12.05 19 50827 277215 110261238
Arthralgia 71.42 12.05 158 50688 779474 109758979
Incorrect route of product administration 68.46 12.05 113 50733 63948 110474505
Central nervous system lupus 67.97 12.05 25 50821 1328 110537125
Helicobacter infection 67.53 12.05 4 50842 181873 110356580
Blood test abnormal 67.13 12.05 74 50772 28480 110509973
Contraindicated product administered 66.80 12.05 16 50830 248251 110290202
Troponin increased 66.31 12.05 75 50771 29691 110508762
Hypersensitivity 65.21 12.05 54 50792 403944 110134509
Renal transplant 64.62 12.05 31 50815 3207 110535246
Hospitalisation 64.55 12.05 177 50669 142316 110396137
Bronchopulmonary aspergillosis allergic 64.39 12.05 43 50803 8383 110530070
Serositis 64.36 12.05 25 50821 1544 110536909
Drug ineffective 64.34 12.05 423 50423 1520117 109018336
Irritable bowel syndrome 62.88 12.05 3 50843 164212 110374241
Completed suicide 62.56 12.05 17 50829 242364 110296089
Zoonotic bacterial infection 61.79 12.05 13 50833 77 110538376
Sinusitis 61.09 12.05 30 50816 296658 110241795
Drug abuse 59.97 12.05 6 50840 177405 110361048
Lupus nephritis 59.49 12.05 33 50813 4612 110533841
Hungry bone syndrome 58.26 12.05 16 50830 323 110538130
Vomiting 57.35 12.05 655 50191 910020 109628433
Paraesthesia oral 57.28 12.05 74 50772 33597 110504856
Fibromyalgia 57.20 12.05 6 50840 170903 110367550
Infusion related reaction 56.65 12.05 55 50791 381107 110157346
Therapeutic product effect decreased 56.20 12.05 21 50825 244295 110294158
Bacteroides infection 55.39 12.05 27 50819 2892 110535561
Psoriatic arthropathy 54.29 12.05 12 50834 196749 110341704
Wound 54.18 12.05 20 50826 234417 110304036
Tetany 52.83 12.05 28 50818 3576 110534877
Impaired healing 52.29 12.05 13 50833 196704 110341749
Blood calcium abnormal 51.37 12.05 22 50824 1747 110536706
Hypervolaemia 51.18 12.05 86 50760 49374 110489079
Rash 50.11 12.05 201 50645 820763 109717690
Nausea 50.03 12.05 821 50025 1234869 109303584
Cardiovascular disorder 48.42 12.05 56 50790 22704 110515749
Hypoparathyroidism 47.66 12.05 20 50826 1510 110536943
Kidney transplant rejection 46.80 12.05 41 50805 11946 110526507
Vaginal flatulence 46.34 12.05 41 50805 12103 110526350
Stomatitis 46.27 12.05 34 50812 270208 110268245
Ulcer 45.99 12.05 76 50770 43040 110495413
Mycobacterium marinum infection 45.43 12.05 16 50830 749 110537704
Blister 45.29 12.05 24 50822 227352 110311101
Bursitis 44.95 12.05 4 50842 129914 110408539
Chronic kidney disease-mineral and bone disorder 44.31 12.05 15 50831 623 110537830
Total lung capacity decreased 44.26 12.05 32 50814 7082 110531371
Mycobacterium test positive 44.24 12.05 15 50831 626 110537827
Liver injury 43.94 12.05 8 50838 150405 110388048
Toxicity to various agents 42.62 12.05 99 50747 480456 110057997
Calcinosis 41.36 12.05 22 50824 2830 110535623
Hyperparathyroidism tertiary 41.12 12.05 9 50837 66 110538387
Ventricular hyperkinesia 40.93 12.05 12 50834 309 110538144
Benign prostatic hyperplasia 40.71 12.05 46 50800 18188 110520265
Macular degeneration 40.66 12.05 50 50796 21609 110516844
Nasopharyngitis 40.22 12.05 75 50771 394286 110144167
Renal failure 40.11 12.05 208 50638 226366 110312087
Skin induration 39.91 12.05 25 50821 4370 110534083
Osteoarthritis 39.86 12.05 17 50829 182606 110355847
Dialysis 39.62 12.05 47 50799 19572 110518881
Female genital tract fistula 39.16 12.05 43 50803 16476 110521977
Febrile neutropenia 39.15 12.05 53 50793 316714 110221739
Intentional product use issue 38.92 12.05 34 50812 247872 110290581
Ill-defined disorder 38.63 12.05 12 50834 156841 110381612
Parathyroidectomy 37.56 12.05 11 50835 282 110538171
Night sweats 37.30 12.05 8 50838 133975 110404478
Mean platelet volume increased 37.08 12.05 17 50829 1587 110536866
Radiculopathy 36.88 12.05 45 50801 19291 110519162
Parathyroid tumour benign 36.82 12.05 15 50831 1050 110537403
Intentional overdose 36.71 12.05 8 50838 132493 110405960
Type 2 diabetes mellitus 36.35 12.05 18 50828 177214 110361239
Right atrial enlargement 35.32 12.05 12 50834 504 110537949
Hypochromasia 35.19 12.05 13 50833 699 110537754
Proctitis 34.92 12.05 41 50805 16886 110521567
Chronic sinusitis 34.89 12.05 50 50796 25034 110513419
Pleuritic pain 34.82 12.05 40 50806 16100 110522353
Nephrectomy 34.48 12.05 19 50827 2621 110535832
Skin hypertrophy 34.40 12.05 24 50822 5023 110533430
Wheezing 34.36 12.05 40 50806 255190 110283263
Abdominal discomfort 34.22 12.05 82 50764 393776 110144677
Urticaria 33.98 12.05 59 50787 318798 110219655
Product use issue 33.83 12.05 57 50789 311638 110226815
Vaginal discharge 33.06 12.05 41 50805 17867 110520586
Breath sounds abnormal 32.96 12.05 49 50797 25355 110513098
Peripheral arterial occlusive disease 32.78 12.05 30 50816 9250 110529203
Unresponsive to stimuli 32.70 12.05 83 50763 63707 110474746
Intentional product misuse 32.38 12.05 134 50712 132770 110405683
Tendon calcification 32.35 12.05 9 50837 191 110538262
Dry mouth 32.28 12.05 179 50667 199769 110338684
Weight increased 32.17 12.05 93 50753 419551 110118902
Carotid arteriosclerosis 31.89 12.05 19 50827 3038 110535415
Brown tumour 31.42 12.05 8 50838 119 110538334
Suicide attempt 31.30 12.05 5 50841 103389 110435064
Acute myocardial infarction 31.14 12.05 97 50749 83680 110454773
Osteomalacia 31.08 12.05 15 50831 1572 110536881
Azotaemia 30.66 12.05 30 50816 10055 110528398
Mitral valve thickening 30.65 12.05 12 50834 757 110537696
Peripheral swelling 30.63 12.05 90 50756 403944 110134509
Lung opacity 30.56 12.05 32 50814 11620 110526833
Respiratory symptom 30.50 12.05 36 50810 14909 110523544
Lung diffusion test decreased 30.40 12.05 15 50831 1650 110536803
Hypervitaminosis D 30.26 12.05 8 50838 139 110538314
Haemodialysis 30.23 12.05 39 50807 17680 110520773
Pulmonary embolism 30.08 12.05 185 50661 214289 110324164
Mobility decreased 30.07 12.05 39 50807 237383 110301070
Ultrafiltration failure 29.90 12.05 10 50836 400 110538053
Skin fibrosis 29.76 12.05 14 50832 1386 110537067
Renal cyst 29.45 12.05 39 50807 18133 110520320
Hypertensive heart disease 29.34 12.05 21 50825 4575 110533878
Left ventricular enlargement 29.20 12.05 12 50834 859 110537594
Migraine 28.85 12.05 22 50824 171630 110366823
Arthritis 28.78 12.05 21 50825 167565 110370888
Narrow anterior chamber angle 28.74 12.05 8 50838 170 110538283
Blood urea increased 28.68 12.05 72 50774 54885 110483568
Primary familial brain calcification 28.18 12.05 6 50840 38 110538415
Procedural pain 28.08 12.05 55 50791 35510 110502943
Death 28.02 12.05 464 50382 698405 109840048
Confusional state 27.74 12.05 116 50730 468564 110069889
Skin tightness 27.73 12.05 22 50824 5591 110532862
Micturition urgency 27.59 12.05 39 50807 19281 110519172
Aspiration 27.56 12.05 50 50796 30483 110507970
Proteinuria 27.01 12.05 58 50788 39960 110498493
Injury 26.99 12.05 25 50821 177240 110361213
Depression 26.82 12.05 67 50779 317268 110221185
Grip strength decreased 26.35 12.05 3 50843 80171 110458282
Peripheral venous disease 25.61 12.05 4 50842 84113 110454340
Discomfort 25.45 12.05 37 50809 214670 110323783
Shunt infection 25.03 12.05 8 50838 277 110538176
Serum ferritin increased 24.95 12.05 29 50817 11818 110526635
Cognitive disorder 24.82 12.05 5 50841 87506 110450947
Coronary artery disease 24.81 12.05 81 50765 71609 110466844
Sciatica 24.75 12.05 6 50840 92393 110446060
Insomnia 24.74 12.05 84 50762 360506 110177947
Peritoneal cloudy effluent 24.69 12.05 10 50836 690 110537763
Fungal peritonitis 24.38 12.05 12 50834 1313 110537140
Left atrial enlargement 24.11 12.05 13 50833 1718 110536735
Somnolence 23.86 12.05 225 50621 297224 110241229
Cerebral calcification 23.77 12.05 7 50839 183 110538270
Urosepsis 23.69 12.05 47 50799 30628 110507825
Suicidal ideation 23.47 12.05 7 50839 93930 110444523
Microsporidia infection 23.44 12.05 12 50834 1427 110537026
Pulmonary renal syndrome 22.92 12.05 10 50836 831 110537622
Arteriovenous fistula thrombosis 22.60 12.05 9 50837 594 110537859
Obesity 22.51 12.05 12 50834 113339 110425114
Peritoneal dialysis 22.22 12.05 10 50836 894 110537559
Joint contracture 22.19 12.05 14 50832 2477 110535976
Nephrolithiasis 22.19 12.05 74 50772 66138 110472315
Bronchiolitis 21.87 12.05 19 50827 5474 110532979
Myasthenic syndrome 21.83 12.05 11 50835 1265 110537188
Fatigue 21.83 12.05 411 50435 1215547 109322906
Haematochezia 21.79 12.05 108 50738 115416 110423037
Injection site reaction 21.60 12.05 7 50839 89063 110449390
Hypophosphatasia 21.53 12.05 6 50840 128 110538325
Memory impairment 21.37 12.05 36 50810 196908 110341545
Coma 21.26 12.05 14 50832 117855 110420598
Infection 21.21 12.05 90 50756 362110 110176343
Wound infection 21.01 12.05 9 50837 96456 110441997
Mucosal inflammation 20.89 12.05 9 50837 96132 110442321
Plasma cell myeloma 20.79 12.05 70 50776 62866 110475587
Neutropenia 20.77 12.05 95 50751 374525 110163928
Nephrogenic anaemia 20.62 12.05 17 50829 4560 110533893
Flushing 20.53 12.05 99 50747 104637 110433816
Autoimmune disorder 20.20 12.05 3 50843 65480 110472973
Hyperparathyroidism primary 20.19 12.05 8 50838 521 110537932
Diabetic foot 20.12 12.05 16 50830 4079 110534374
Pain 19.95 12.05 314 50532 954641 109583812
Arteriovenous fistula occlusion 19.90 12.05 8 50838 541 110537912
Granuloma 19.60 12.05 23 50823 9467 110528986
Blood chloride increased 19.45 12.05 19 50827 6353 110532100
Arteriovenous fistula site infection 19.13 12.05 6 50840 195 110538258
Road traffic accident 19.04 12.05 13 50833 107385 110431068
Hyperkalaemia 18.95 12.05 117 50729 135679 110402774
Cardio-respiratory arrest 18.88 12.05 104 50742 115732 110422721
Renal transplant failure 18.86 12.05 13 50833 2667 110535786
Blood parathyroid hormone abnormal 18.73 12.05 7 50839 389 110538064
Hepatic cyst infection 18.65 12.05 6 50840 212 110538241
Cutaneous calcification 18.52 12.05 6 50840 217 110538236
Cardiac arrest 18.43 12.05 154 50692 196599 110341854
Maternal exposure during pregnancy 18.43 12.05 58 50788 254825 110283628
Dyspnoea 18.41 12.05 651 50195 1106221 109432232
Hypertension 18.37 12.05 333 50513 509751 110028702
Blood erythropoietin decreased 18.31 12.05 4 50842 29 110538424
Lower limb fracture 18.13 12.05 6 50840 75342 110463111
Cytokine release syndrome 18 12.05 5 50841 70301 110468152
Premature delivery 17.98 12.05 42 50804 30590 110507863
Injection site pain 17.98 12.05 34 50812 177888 110360565
Acute kidney injury 17.94 12.05 400 50446 635030 109903423
Polyglandular disorder 17.94 12.05 6 50840 240 110538213
Prescribed underdose 17.92 12.05 4 50842 65170 110473283
Fibroblast growth factor 23 increased 17.75 12.05 4 50842 34 110538419
Anti-erythropoietin antibody positive 17.72 12.05 8 50838 721 110537732
Live birth 17.68 12.05 5 50841 69479 110468974
Polyhydramnios 17.56 12.05 11 50835 1922 110536531
Haemoglobin decreased 17.44 12.05 183 50663 248544 110289909
Vascular parkinsonism 17.43 12.05 5 50841 119 110538334
Spontaneous haematoma 17.42 12.05 11 50835 1950 110536503
Treatment noncompliance 17.31 12.05 73 50773 72917 110465536
Obstruction 17.28 12.05 17 50829 5735 110532718
Urine protein/creatinine ratio increased 16.99 12.05 10 50836 1563 110536890
Interstitial granulomatous dermatitis 16.89 12.05 6 50840 288 110538165
Hypocalcaemic seizure 16.86 12.05 5 50841 134 110538319
Oral candidiasis 16.79 12.05 52 50794 44708 110493745
Blood iron decreased 16.76 12.05 31 50815 19183 110519270
Disease progression 16.63 12.05 57 50789 243977 110294476
Cardiac failure 16.60 12.05 145 50701 187481 110350972
Pulmonary calcification 16.54 12.05 7 50839 540 110537913
Gastrointestinal haemorrhage 16.28 12.05 131 50715 165387 110373066
Inflammation 16.16 12.05 41 50805 193197 110345256
Rash maculo-papular 16.04 12.05 7 50839 74215 110464238
Knee arthroplasty 15.93 12.05 5 50841 64943 110473510
Mesenteric phlebosclerosis 15.90 12.05 3 50843 9 110538444
Potentiating drug interaction 15.89 12.05 23 50823 11620 110526833
Medullary thyroid cancer 15.77 12.05 6 50840 350 110538103
Haematocrit decreased 15.58 12.05 66 50780 66051 110472402
Hypoaesthesia 15.51 12.05 83 50763 314140 110224313
Bone deformity 15.50 12.05 6 50840 367 110538086
Epilepsy 15.41 12.05 14 50832 100195 110438258
Complications of transplanted kidney 15.31 12.05 18 50828 7424 110531029
Lens dislocation 15.30 12.05 5 50841 186 110538267
Fanconi syndrome acquired 15.22 12.05 12 50834 3022 110535431
Infection in an immunocompromised host 15.12 12.05 10 50836 1917 110536536
Ear infection 15.09 12.05 5 50841 62727 110475726
Feeling hot 14.99 12.05 82 50764 91024 110447429
Mental status changes 14.95 12.05 72 50774 76050 110462403
Alveolar bone resorption 14.89 12.05 4 50842 74 110538379
Loss of personal independence in daily activities 14.86 12.05 29 50817 149991 110388462
Blood potassium increased 14.74 12.05 41 50805 33208 110505245
Low turnover osteopathy 14.69 12.05 10 50836 2012 110536441
Joint injury 14.58 12.05 46 50800 39948 110498505
Drug reaction with eosinophilia and systemic symptoms 14.47 12.05 10 50836 82085 110456368
Musculoskeletal pain 14.42 12.05 40 50806 182983 110355470
Sedation 14.40 12.05 7 50839 69676 110468777
Overdose 14.36 12.05 57 50789 233737 110304716
Coagulation test abnormal 14.35 12.05 9 50837 1577 110536876
Contusion 14.27 12.05 57 50789 233304 110305149
Hip arthroplasty 14.23 12.05 4 50842 55809 110482644
Anti-erythropoietin antibody 14.23 12.05 3 50843 18 110538435
Oxygen saturation decreased 14.16 12.05 32 50814 156950 110381503
Hepatocellular injury 14.14 12.05 3 50843 50639 110487814
Product dose omission issue 14.12 12.05 217 50629 321565 110216888
Cardiac valve disease 13.99 12.05 16 50830 6405 110532048
Drug dependence 13.89 12.05 3 50843 50017 110488436
Renal disorder 13.75 12.05 52 50794 49427 110489026
High density lipoprotein decreased 13.72 12.05 15 50831 5718 110532735
Gastrooesophageal reflux disease 13.69 12.05 40 50806 179936 110358517
Hepatotoxicity 13.67 12.05 6 50840 63394 110475059
Graft thrombosis 13.60 12.05 6 50840 512 110537941
Upper respiratory tract infection 13.50 12.05 105 50741 131223 110407230
Pain in extremity 13.49 12.05 151 50695 486967 110051486
Megacolon 13.45 12.05 13 50833 4292 110534161
Myopathy 13.34 12.05 33 50813 24927 110513526
Visual impairment 13.31 12.05 26 50820 134402 110404051
Ear pain 13.23 12.05 4 50842 53222 110485231
Glomerular filtration rate decreased 13.13 12.05 36 50810 28920 110509533
Blood alkaline phosphatase decreased 12.95 12.05 10 50836 2443 110536010
Reticulocyte count abnormal 12.76 12.05 4 50842 130 110538323
Bone metabolism biochemical marker increased 12.46 12.05 3 50843 35 110538418
Bone erosion 12.44 12.05 3 50843 46368 110492085
Malignant neoplasm progression 12.42 12.05 40 50806 174527 110363926
Parathyroid scan abnormal 12.38 12.05 3 50843 36 110538417
Malabsorption 12.33 12.05 15 50831 6410 110532043
Hepatic cirrhosis 12.24 12.05 8 50838 67618 110470835
Breast induration 12.23 12.05 3 50843 38 110538415
Dizziness 12.17 12.05 237 50609 697956 109840497
Pulse absent 12.17 12.05 20 50826 11272 110527181
Arteriovenous fistula operation 12.15 12.05 5 50841 359 110538094
Gait inability 12.14 12.05 28 50818 136348 110402105
Electrocardiogram T wave inversion 12.12 12.05 14 50832 5666 110532787
Electrolyte imbalance 12.07 12.05 41 50805 36987 110501466
Pyelonephritis 12.06 12.05 32 50814 25218 110513235

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A11CC04 ALIMENTARY TRACT AND METABOLISM
VITAMINS
VITAMIN A AND D, INCL. COMBINATIONS OF THE TWO
Vitamin D and analogues
ATC D05AX03 DERMATOLOGICALS
ANTIPSORIATICS
ANTIPSORIATICS FOR TOPICAL USE
Other antipsoriatics for topical use
FDA CS M0004229 Cholecalciferol
MeSH PA D000077264 Calcium-Regulating Hormones and Agents
MeSH PA D002120 Calcium Channel Agonists
MeSH PA D002317 Cardiovascular Agents
MeSH PA D014662 Vasoconstrictor Agents
MeSH PA D014815 Vitamins
MeSH PA D018977 Micronutrients
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D050071 Bone Density Conservation Agents
FDA EPC N0000175908 Vitamin D3 Analog
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:24621 hormone
CHEBI has role CHEBI:25212 metabolite
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:38807 calcium channel agonist
CHEBI has role CHEBI:38808 calcium channel modulator
CHEBI has role CHEBI:50646 bone density conservation agent
CHEBI has role CHEBI:50733 nutraceutical
CHEBI has role CHEBI:50748 antipsoriatic
CHEBI has role CHEBI:50846 immunomodulator
CHEBI has role CHEBI:75771 mouse metabolite
CHEBI has role CHEBI:77746 human metabolite
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

A11CC Vitamin D and analogues 5 drugs
alfacalcidolcalcifediolcolecalciferoldihydrotachysterolergocalciferol
D05AX Other antipsoriatics for topical use 7 drugs
calcipotrienefumaric acidroflumilasttacalcitoltapinaroftazaroteneulobetasol propionate

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

DiseaseRelationSNOMED_IDDOID
Hypophosphatemia indication 4996001
Hypocalcemia indication 5291005
Renal osteodystrophy indication 16726004 DOID:13068
Hypoparathyroidism indication 36976004 DOID:11199
Plaque psoriasis indication 200965009
Hyperparathyroidism Secondary to Chronic Renal Failure indication
Hypocalcemia from End-Stage Renal Disease with Dialysis indication
Neonatal hypocalcemic tetany off-label use 18442000
Vitamin D deficiency off-label use 34713006
Rickets off-label use 41345002 DOID:10609
Familial x-linked hypophosphatemic vitamin D refractory rickets off-label use 82236004
Vitamin D Dependent Rickets off-label use
Hyperphosphatemia contraindication 20165001 DOID:0050459
Hypervitaminosis D contraindication 27712000 DOID:9971
Sarcoidosis contraindication 31541009 DOID:11335
Hypercalcemia contraindication 66931009 DOID:12678
Kidney disease contraindication 90708001 DOID:557
Kidney stone contraindication 95570007
Arteriosclerosis obliterans contraindication 361133006 DOID:5160
Hypercalcemia associated with Sarcoidosis contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.7 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Vitamin D3 receptor Nuclear hormone receptor AGONIST EC50 8.40 WOMBAT-PK CHEMBL
Vitamin D 25-hydroxylase Enzyme WOMBAT-PK
Vitamin D-binding protein Secreted Kd 7.62 CHEMBL
25-hydroxyvitamin D-1 alpha hydroxylase, mitochondrial Enzyme WOMBAT-PK
Vitamin D3 receptor Transcription factor Ki 10.30 CHEMBL
Vitamin D3 receptor Transcription factor Ki 10.60 CHEMBL
Vitamin D3 receptor Transcription factor EC50 10.30 CHEMBL
Vitamin D3 receptor Nuclear hormone receptor Kd 10.15 CHEMBL
Vitamin D3 receptor A Nuclear hormone receptor EC50 8.26 CHEMBL
Vitamin D3 receptor Nuclear hormone receptor EC50 7 CHEMBL

External reference:

IDSource
4017800 VUID
N0000146161 NUI
D00129 KEGG_DRUG
152323 RXNORM
C0006674 UMLSCUI
CHEBI:17823 CHEBI
VDX PDB_CHEM_ID
CHEMBL846 ChEMBL_ID
D002117 MESH_DESCRIPTOR_UI
DB00136 DRUGBANK_ID
5280453 PUBCHEM_CID
4393 INN_ID
FXC9231JVH UNII
1311 MMSL
42410 MMSL
4324 MMSL
d03126 MMSL
259333003 SNOMEDCT_US
68206008 SNOMEDCT_US
2779 IUPHAR_LIGAND_ID
4017800 VANDF
4021906 VANDF
C118756 MESH_SUPPLEMENTAL_RECORD_UI
001017 NDDF
FXC9231JVH INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 0054-0007 CAPSULE 0.25 ug ORAL ANDA 22 sections
Calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 0054-3120 SOLUTION 1 ug ORAL ANDA 23 sections
Calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 0093-7352 CAPSULE, LIQUID FILLED 0.25 ug ORAL ANDA 26 sections
Calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 0093-7353 CAPSULE, LIQUID FILLED 0.50 ug ORAL ANDA 26 sections
Calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 0143-9728 INJECTION 1 ug INTRAVENOUS ANDA 24 sections
Vectical HUMAN PRESCRIPTION DRUG LABEL 1 0299-2012 OINTMENT 3 ug TOPICAL NDA 26 sections
Calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 17478-831 INJECTION 1 ug INTRAVENOUS ANDA 23 sections
Calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 17478-931 INJECTION 1 ug INTRAVENOUS ANDA 23 sections
Calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 17478-932 INJECTION 2 ug INTRAVENOUS ANDA 23 sections
Calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 17856-0723 CAPSULE 0.25 ug ORAL ANDA 21 sections
Calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 17856-3120 SOLUTION 1 ug ORAL ANDA 25 sections
CALCITRIOL HUMAN PRESCRIPTION DRUG LABEL 1 23155-662 CAPSULE 0.25 ug ORAL ANDA 21 sections
CALCITRIOL HUMAN PRESCRIPTION DRUG LABEL 1 23155-663 CAPSULE 0.50 ug ORAL ANDA 21 sections
Rocaltrol HUMAN PRESCRIPTION DRUG LABEL 1 30698-143 CAPSULE, GELATIN COATED 0.25 ug ORAL NDA 24 sections
Rocaltrol HUMAN PRESCRIPTION DRUG LABEL 1 30698-144 CAPSULE, GELATIN COATED 0.50 ug ORAL NDA 24 sections
Rocaltrol HUMAN PRESCRIPTION DRUG LABEL 1 30698-911 SOLUTION 1 ug ORAL NDA 24 sections
Calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 39328-042 SOLUTION 1 ug ORAL ANDA 26 sections
CALCITRIOL HUMAN PRESCRIPTION DRUG LABEL 1 42806-732 CAPSULE 0.25 ug ORAL ANDA 20 sections
CALCITRIOL HUMAN PRESCRIPTION DRUG LABEL 1 42806-733 CAPSULE 0.50 ug ORAL ANDA 20 sections
Calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 43353-034 CAPSULE 0.25 ug ORAL ANDA 26 sections
Rocaltrol HUMAN PRESCRIPTION DRUG LABEL 1 43353-633 CAPSULE, GELATIN COATED 0.25 ug ORAL NDA 22 sections
calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 45802-608 OINTMENT 3 ug TOPICAL NDA authorized generic 25 sections
Calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 50090-6711 CAPSULE, LIQUID FILLED 0.25 ug ORAL ANDA 24 sections
CALCITRIOL HUMAN PRESCRIPTION DRUG LABEL 1 50090-7470 CAPSULE 0.25 ug ORAL ANDA 21 sections
Calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 51407-169 CAPSULE, LIQUID FILLED 0.25 ug ORAL ANDA 25 sections
Calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 51407-170 CAPSULE, LIQUID FILLED 0.50 ug ORAL ANDA 25 sections
Calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 54868-4582 CAPSULE, LIQUID FILLED 0.50 ug ORAL ANDA 12 sections
Calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 54868-4584 CAPSULE, LIQUID FILLED 0.25 ug ORAL ANDA 12 sections
Calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 54868-6265 INJECTION, SOLUTION 1 mg INTRAVENOUS ANDA 11 sections
Calcitriol HUMAN PRESCRIPTION DRUG LABEL 1 55154-8186 CAPSULE 0.25 ug ORAL ANDA 22 sections