conjugated estrogens ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
estrogens 4855 12126-59-9

Description:

MoleculeDescription

Synonyms:

  • estrogen conjugated
  • estrogenic substances, conjugated
  • oestrogens conjugated
  • conjugated estrogens
  • premarin
  • estrogens, conjugated
  • estrogens conjugated
  • conjugated oestrogens
A pharmaceutical preparation containing a mixture of water-soluble, conjugated estrogens derived wholly or in part from URINE of pregnant mares or synthetically from ESTRONE and EQUILIN. It contains a sodium-salt mixture of estrone sulfate (52-62%) and equilin sulfate (22-30%) with a total of the two between 80-88%. Other concomitant conjugates include 17-alpha-dihydroequilin, 17-alpha-estradiol, and 17-beta-dihydroequilin. The potency of the preparation is expressed in terms of an equivalent quantity of sodium estrone sulfate.
  • Molecular weight: 3556.05
  • Formula: C180H202Na10O40S10
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA: 74.27
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
0.63 mg O
0.63 mg V

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.09 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
May 8, 1942 FDA WYETH PHARMS INC

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
Coronary artery disease 285.15 10.70 273 80390 32104 63376255
Hot flush 258.67 10.70 322 80341 50837 63357522
Vulvovaginal burning sensation 243.15 10.70 94 80569 2015 63406344
Cerebrovascular accident 221.03 10.70 449 80214 107575 63300784
Breast cancer 215.49 10.70 286 80377 48097 63360262
Maternal exposure during pregnancy 215.42 10.70 17 80646 220045 63188314
Schizoaffective disorder 214.13 10.70 100 80563 3462 63404897
Depression 197.25 10.70 623 80040 195869 63212490
Vulvovaginal discomfort 168.94 10.70 75 80588 2303 63406056
Hyperlipidaemia 168.47 10.70 163 80500 19408 63388951
Exposure during pregnancy 152.22 10.70 12 80651 155535 63252824
Myocardial infarction 149.97 10.70 367 80296 99526 63308833
Pericarditis 141.37 10.70 6 80657 131573 63276786
Wound 136.28 10.70 22 80641 163241 63245118
Systemic lupus erythematosus 133.94 10.70 49 80614 208869 63199490
Glossodynia 132.77 10.70 32 80631 178844 63229515
Contraindicated product administered 129.81 10.70 57 80606 217591 63190768
Toxicity to various agents 125.05 10.70 80 80583 247170 63161189
Infusion related reaction 122.05 10.70 81 80582 245440 63162919
Death 116.48 10.70 185 80478 374196 63034163
Drug intolerance 115.76 10.70 133 80530 308528 63099831
Anxiety 115.18 10.70 564 80099 216977 63191382
Vulvovaginal dryness 108.32 10.70 59 80604 2842 63405517
Product prescribing error 107.30 10.70 149 80514 26140 63382219
Chest pain 105.94 10.70 548 80115 215411 63192948
Fibrocystic breast disease 105.77 10.70 44 80619 1148 63407211
Treatment failure 103.95 10.70 62 80601 198981 63209378
Osteopenia 103.92 10.70 127 80536 19658 63388701
Spinal osteoarthritis 98.45 10.70 112 80551 16074 63392285
Transient ischaemic attack 98.28 10.70 174 80489 37579 63370780
Low turnover osteopathy 98.09 10.70 63 80600 4122 63404237
Intervertebral disc degeneration 95.93 10.70 109 80554 15623 63392736
Gastrooesophageal reflux disease 93.75 10.70 301 80362 95338 63313021
Mitral valve incompetence 93.69 10.70 120 80543 19474 63388885
Oestrogen receptor assay positive 93.32 10.70 32 80631 480 63407879
Rheumatoid factor positive 90.15 10.70 4 80659 84402 63323957
Vulvovaginal pain 89.49 10.70 51 80612 2684 63405675
Abdominal discomfort 89.34 10.70 170 80493 320715 63087644
Osteoarthritis 85.35 10.70 291 80372 95052 63313307
Neutropenia 85.24 10.70 59 80604 174946 63233413
Carpal tunnel syndrome 84.97 10.70 118 80545 20699 63387660
Product complaint 81.95 10.70 91 80572 12718 63395641
Rotator cuff syndrome 81.39 10.70 93 80570 13409 63394950
Synovitis 80.93 10.70 71 80592 186847 63221512
Breast cancer in situ 80.45 10.70 39 80624 1469 63406890
Femur fracture 77.64 10.70 167 80496 41589 63366770
Breast tenderness 77.37 10.70 44 80619 2306 63406053
Drug level increased 77.00 10.70 118 80545 22618 63385741
Ventricular hypertrophy 76.29 10.70 50 80613 3386 63404973
Peripheral swelling 75.66 10.70 139 80524 265803 63142556
Stress fracture 75.54 10.70 70 80593 7893 63400466
Progesterone receptor assay positive 74.82 10.70 25 80638 345 63408014
Swelling 74.79 10.70 148 80515 275230 63133129
Angina unstable 74.43 10.70 66 80597 7029 63401330
Acute kidney injury 72.90 10.70 140 80523 263275 63145084
Febrile neutropenia 72.20 10.70 30 80633 118419 63289940
Spinal stenosis 70.72 10.70 91 80572 14834 63393525
General physical health deterioration 69.94 10.70 92 80571 201310 63207049
Feeling abnormal 68.88 10.70 371 80292 148021 63260338
Hypertension 68.78 10.70 597 80066 278706 63129653
Discomfort 68.40 10.70 67 80596 167307 63241052
Carotid artery stenosis 66.34 10.70 54 80609 5116 63403243
Arteriosclerosis 65.23 10.70 72 80591 9994 63398365
Folliculitis 64.55 10.70 7 80656 70310 63338049
Stress urinary incontinence 64.14 10.70 39 80624 2316 63406043
Lacunar infarction 63.88 10.70 44 80619 3236 63405123
Body height decreased 63.44 10.70 71 80592 10007 63398352
Cardiac failure congestive 63.41 10.70 259 80404 92174 63316185
Hepatic enzyme increased 62.80 10.70 100 80563 202228 63206131
Meniscus injury 62.63 10.70 60 80603 7054 63401305
Drug abuse 62.24 10.70 9 80654 72509 63335850
Completed suicide 62.24 10.70 56 80607 145617 63262742
Breast calcifications 62.06 10.70 31 80632 1247 63407112
Dental caries 61.21 10.70 72 80591 10707 63397652
Coronary artery occlusion 57.30 10.70 61 80602 8130 63400229
Insomnia 57.15 10.70 468 80195 214784 63193575
Lower respiratory tract infection 56.35 10.70 51 80612 132256 63276103
Disease progression 55.11 10.70 45 80618 122713 63285646
Pyrexia 55.05 10.70 361 80302 470117 62938242
Vulvovaginal pruritus 55.05 10.70 40 80623 3203 63405156
Stomatitis 54.99 10.70 57 80606 138668 63269691
Haemorrhoids 54.97 10.70 100 80563 22050 63386309
Alopecia 53.33 10.70 234 80429 337302 63071057
Angina pectoris 53.30 10.70 118 80545 29960 63378399
Temporomandibular joint syndrome 53.08 10.70 43 80620 4046 63404313
Fracture nonunion 52.43 10.70 34 80629 2261 63406098
Cystocele 52.26 10.70 27 80636 1167 63407192
Vaginal haemorrhage 51.17 10.70 110 80553 27377 63380982
Product dispensing error 50.67 10.70 64 80599 10241 63398118
Exostosis of jaw 50.31 10.70 27 80636 1262 63407097
Aortic valve incompetence 49.89 10.70 49 80614 5939 63402420
Bronchial neoplasm 49.63 10.70 20 80643 480 63407879
Joint swelling 48.87 10.70 232 80431 327434 63080925
Breast mass 48.48 10.70 55 80608 7867 63400492
Renal impairment 48.27 10.70 26 80637 88329 63320030
Anaemia postoperative 48.26 10.70 32 80631 2210 63406149
Diverticulum 47.49 10.70 67 80596 11924 63396435
Cardiac disorder 46.24 10.70 156 80507 50660 63357699
Arteriosclerosis coronary artery 46.01 10.70 55 80608 8318 63400041
Muscle injury 45.95 10.70 13 80650 65332 63343027
Infection 45.91 10.70 144 80519 229029 63179330
Cataract 45.76 10.70 168 80495 56885 63351474
Product quality issue 45.74 10.70 124 80539 35741 63372618
Nervousness 45.57 10.70 113 80550 30866 63377493
Malignant neoplasm progression 45.11 10.70 24 80639 82097 63326262
Postmenopausal haemorrhage 44.73 10.70 30 80633 2112 63406247
Nasal turbinate hypertrophy 44.56 10.70 21 80642 742 63407617
Vulvovaginal swelling 44.42 10.70 19 80644 532 63407827
Breast cyst 44.13 10.70 28 80635 1793 63406566
Expired product administered 43.18 10.70 46 80617 6135 63402224
Urinary incontinence 43.17 10.70 113 80550 31901 63376458
Bronchial haemorrhage 43.11 10.70 19 80644 573 63407786
Breast cancer female 42.61 10.70 68 80595 13491 63394868
Seborrhoeic keratosis 42.30 10.70 30 80633 2312 63406047
Ventricular dysfunction 41.57 10.70 32 80631 2796 63405563
Mammogram abnormal 41.56 10.70 20 80643 741 63407618
Tricuspid valve incompetence 41.46 10.70 70 80593 14551 63393808
Blister 41.36 10.70 63 80600 129751 63278608
Cardiovascular disorder 40.97 10.70 62 80601 11750 63396609
Vaginal infection 40.68 10.70 49 80614 7469 63400890
Thrombocytopenia 40.34 10.70 82 80581 151075 63257284
Intramedullary rod insertion 40.22 10.70 28 80635 2095 63406264
Rash 40.15 10.70 488 80175 560383 62847976
Peptic ulcer 39.08 10.70 38 80625 4549 63403810
Liver injury 39.07 10.70 14 80649 60506 63347853
Emotional distress 39.00 10.70 110 80553 32439 63375920
Menopausal symptoms 38.72 10.70 29 80634 2432 63405927
Hiatus hernia 38.58 10.70 85 80578 21509 63386850
Rectocele 38.01 10.70 21 80642 1040 63407319
Breast disorder 38.01 10.70 29 80634 2501 63405858
Nocturia 37.57 10.70 49 80614 8092 63400267
Atrophic vulvovaginitis 37.49 10.70 25 80638 1743 63406616
Intentional overdose 37.42 10.70 24 80639 74128 63334231
Pancytopenia 37.10 10.70 41 80622 96892 63311467
Vulvovaginal erythema 36.92 10.70 14 80649 284 63408075
Chronic disease 36.85 10.70 12 80651 152 63408207
Migraine 36.13 10.70 240 80423 103106 63305253
Hospitalisation 35.98 10.70 33 80630 85048 63323311
Large intestine polyp 35.95 10.70 48 80615 8109 63400250
Arthropathy 35.71 10.70 165 80498 234627 63173732
Spondylolisthesis 35.32 10.70 32 80631 3504 63404855
Mitral valve prolapse 35.01 10.70 27 80636 2366 63405993
Bronchitis 34.95 10.70 275 80388 124660 63283699
Chronic obstructive pulmonary disease 34.87 10.70 165 80498 62521 63345838
Drug withdrawal syndrome 34.66 10.70 94 80569 27100 63381259
Endometrial ablation 34.32 10.70 19 80644 945 63407414
Jaw disorder 34.21 10.70 38 80625 5311 63403048
Cervicobrachial syndrome 34.08 10.70 19 80644 958 63407401
Vaginal prolapse 34.02 10.70 15 80648 453 63407906
Therapeutic response unexpected 33.69 10.70 74 80589 18685 63389674
Drug ineffective 33.42 10.70 1043 79620 1043722 62364637
Hypoacusis 33.34 10.70 86 80577 24065 63384294
Wrong strength 33.17 10.70 9 80654 57 63408302
Bladder prolapse 33.02 10.70 25 80638 2131 63406228
Mobility decreased 32.94 10.70 65 80598 121094 63287265
Breast hyperplasia 32.77 10.70 13 80650 299 63408060
Drug effective for unapproved indication 32.74 10.70 30 80633 3334 63405025
Muscle strain 32.42 10.70 46 80617 8228 63400131
Coma 32.25 10.70 21 80642 64343 63344016
Peripheral vascular disorder 32.11 10.70 39 80624 5996 63402363
Sepsis 31.51 10.70 95 80568 153028 63255331
Uterine leiomyoma 31.51 10.70 48 80615 9150 63399209
Osteonecrosis 31.47 10.70 85 80578 24445 63383914
Acute myocardial infarction 31.35 10.70 101 80562 32023 63376336
Morton's neuralgia 31.34 10.70 9 80654 72 63408287
Nasopharyngitis 31.25 10.70 192 80471 254065 63154294
Vomiting 30.47 10.70 514 80149 559103 62849256
Therapeutic product effect decreased 30.42 10.70 134 80529 193053 63215306
Ill-defined disorder 29.75 10.70 36 80627 81719 63326640
Scoliosis 29.66 10.70 43 80620 7845 63400514
Oral infection 29.57 10.70 34 80629 4934 63403425
Hyperhidrosis 29.41 10.70 236 80427 107600 63300759
Bronchial disorder 29.20 10.70 19 80644 1271 63407088
Burning sensation 28.67 10.70 141 80522 54266 63354093
Back pain 28.23 10.70 482 80181 263663 63144696
Blood triglycerides increased 28.01 10.70 54 80609 12434 63395925
Ischaemic cardiomyopathy 27.91 10.70 24 80639 2453 63405906
Hormone level abnormal 27.86 10.70 24 80639 2459 63405900
Premature delivery 27.83 10.70 3 80660 30278 63378081
Memory impairment 27.79 10.70 227 80436 104031 63304328
Psoriatic arthropathy 27.65 10.70 46 80617 91474 63316885
Blood cholesterol increased 27.41 10.70 209 80454 93823 63314536
Lumbar spinal stenosis 27.03 10.70 32 80631 4790 63403569
Vaginal disorder 26.97 10.70 15 80648 753 63407606
Cardiac valve disease 26.84 10.70 30 80633 4222 63404137
Panic disorder 26.64 10.70 24 80639 2609 63405750
Palpitations 26.63 10.70 239 80424 112531 63295828
Poor quality product administered 26.62 10.70 26 80637 3130 63405229
Aortic arteriosclerosis 26.55 10.70 36 80627 6173 63402186
Vulvovaginal injury 26.44 10.70 13 80650 505 63407854
Drug abuser 26.39 10.70 25 80638 2898 63405461
Thyroid disorder 26.31 10.70 59 80604 15103 63393256
Bone graft 26.24 10.70 16 80647 955 63407404
Hypotension 26.15 10.70 221 80442 272383 63135976
Tooth fracture 26.11 10.70 49 80614 11061 63397298
Device failure 25.92 10.70 35 80628 5976 63402383
Sinus rhythm 25.45 10.70 15 80648 841 63407518
Uterine polyp 25.44 10.70 21 80642 2029 63406330
Back disorder 25.16 10.70 48 80615 10969 63397390
Blood pressure abnormal 25.11 10.70 58 80605 15140 63393219
Breast conserving surgery 25.10 10.70 16 80647 1033 63407326
Hypothyroidism 25.02 10.70 114 80549 42518 63365841
Breast pain 24.78 10.70 42 80621 8756 63399603
Ligament sprain 24.71 10.70 52 80611 12748 63395611
Intervertebral disc protrusion 24.47 10.70 76 80587 23633 63384726
Chronic fatigue syndrome 24.17 10.70 16 80647 1102 63407257
Diabetes mellitus 24.16 10.70 137 80526 55673 63352686
Leukopenia 24.14 10.70 38 80625 77252 63331107
Blood oestrogen decreased 24.14 10.70 10 80653 258 63408101
Lumbar radiculopathy 24.08 10.70 20 80643 1949 63406410
Cardiac failure 24.08 10.70 48 80615 89094 63319265
Mucosal inflammation 23.94 10.70 15 80648 46913 63361446
Interstitial lung disease 23.89 10.70 26 80637 61882 63346477
Suspected counterfeit product 23.57 10.70 11 80652 380 63407979
Musculoskeletal stiffness 23.41 10.70 138 80525 184480 63223879
Non-cardiac chest pain 23.30 10.70 34 80629 6238 63402121
Vaginal odour 23.24 10.70 12 80651 518 63407841
Platelet count decreased 23.21 10.70 73 80590 116049 63292310
Rhonchi 23.19 10.70 22 80641 2554 63405805
Pain in extremity 22.89 10.70 567 80096 330919 63077440
Product use in unapproved indication 22.64 10.70 134 80529 178946 63229413
Coronary artery stenosis 22.59 10.70 29 80634 4715 63403644
Neoplasm progression 22.55 10.70 9 80654 36419 63371940
Granuloma 22.53 10.70 32 80631 5729 63402630
Septic shock 22.53 10.70 31 80632 66598 63341761
Intentional product use issue 22.45 10.70 85 80578 127807 63280552
Osteoporosis 22.40 10.70 137 80526 57201 63351158
Resorption bone increased 22.28 10.70 16 80647 1258 63407101
Tendonitis 22.25 10.70 65 80598 19550 63388809
Pollakiuria 22.17 10.70 82 80581 27855 63380504
Hepatocellular injury 22.14 10.70 4 80659 27377 63380982
Gingivitis 22.12 10.70 39 80624 8390 63399969
Intervertebral disc disorder 22.12 10.70 29 80634 4814 63403545
Hypertonic bladder 22.11 10.70 25 80638 3563 63404796
Muscle spasms 22.11 10.70 299 80364 155851 63252508
Cerebrovascular disorder 22.10 10.70 22 80641 2710 63405649
Ventricular extrasystoles 22.01 10.70 47 80616 11640 63396719
Vitamin D deficiency 21.84 10.70 52 80611 13840 63394519
Dilatation atrial 21.84 10.70 19 80644 1972 63406387
Calcium deficiency 21.83 10.70 15 80648 1099 63407260
Epilepsy 21.79 10.70 4 80659 27061 63381298
Cardiomegaly 21.56 10.70 60 80603 17554 63390805
Bone density abnormal 21.49 10.70 24 80639 3374 63404985
Subclavian artery embolism 21.44 10.70 5 80658 15 63408344
Varicose vein 21.41 10.70 29 80634 4966 63403393
Foot fracture 21.39 10.70 73 80590 23841 63384518
Lactic acidosis 21.30 10.70 11 80652 38276 63370083
Diarrhoea 21.14 10.70 721 79942 714645 62693714
Breast cancer metastatic 21.12 10.70 47 80616 11971 63396388
Uterine disorder 21.11 10.70 23 80640 3146 63405213
Eye disorder 20.95 10.70 70 80593 22615 63385744
Blood pressure increased 20.80 10.70 305 80358 161757 63246602
Rhinitis allergic 20.76 10.70 46 80617 11681 63396678
Post procedural complication 20.74 10.70 58 80605 17016 63391343
Carotid artery disease 20.69 10.70 17 80646 1632 63406727
Gingival disorder 20.68 10.70 24 80639 3518 63404841
Libido decreased 20.67 10.70 21 80642 2651 63405708
Crying 20.65 10.70 71 80592 23272 63385087
Gastritis 20.61 10.70 98 80565 37205 63371154
Melanocytic naevus 20.60 10.70 27 80636 4481 63403878
Myelosuppression 20.20 10.70 3 80660 23700 63384659
Cervical spinal stenosis 20.15 10.70 19 80644 2189 63406170
Hepatotoxicity 20.08 10.70 11 80652 37030 63371329
Endometrial hyperplasia 20.01 10.70 13 80650 867 63407492
Confusional state 19.90 10.70 198 80465 236182 63172177
Toxic epidermal necrolysis 19.85 10.70 4 80659 25330 63383029
Intentional product misuse 19.81 10.70 139 80524 60778 63347581
Homicidal ideation 19.79 10.70 17 80646 1735 63406624
Dysuria 19.64 10.70 90 80573 33648 63374711
Oedema peripheral 19.57 10.70 344 80319 189167 63219192
Bursitis 19.52 10.70 96 80567 36945 63371414
Plantar fasciitis 19.44 10.70 24 80639 3751 63404608
Stevens-Johnson syndrome 19.42 10.70 4 80659 24946 63383413
Neutrophil count decreased 19.32 10.70 26 80637 56380 63351979
Cardiac murmur 19.24 10.70 51 80612 14501 63393858
Defaecation urgency 19.07 10.70 25 80638 4150 63404209
Vulvovaginal mycotic infection 19 10.70 29 80634 5537 63402822
Encephalopathy 18.81 10.70 13 80650 38607 63369752
Biopsy breast abnormal 18.80 10.70 5 80658 29 63408330
Radicular pain 18.80 10.70 10 80653 459 63407900
Helicobacter infection 18.77 10.70 58 80605 92727 63315632
Hepatic function abnormal 18.77 10.70 12 80651 37130 63371229
Modified radical mastectomy 18.64 10.70 4 80659 7 63408352
Hyperkalaemia 18.55 10.70 25 80638 54178 63354181
Labile hypertension 18.47 10.70 10 80653 476 63407883
Product residue present 18.44 10.70 24 80639 3955 63404404
Dizziness 18.29 10.70 693 79970 429232 62979127
Exostosis 18.20 10.70 57 80606 17805 63390554
Vaginal cyst 18.19 10.70 8 80655 240 63408119
Amnesia 18.17 10.70 127 80536 55458 63352901
Gallbladder disorder 18.17 10.70 59 80604 18783 63389576
Influenza like illness 18.07 10.70 146 80517 66678 63341681
Urinary tract infection 18.04 10.70 452 80211 264232 63144127
Musculoskeletal discomfort 18.00 10.70 57 80606 17910 63390449
Drug-induced liver injury 17.72 10.70 15 80648 40207 63368152
Spinal disorder 17.71 10.70 39 80624 9863 63398496
Cardiolipin antibody positive 17.69 10.70 7 80656 160 63408199
Agranulocytosis 17.67 10.70 5 80658 25129 63383230
Nerve compression 17.64 10.70 37 80626 9050 63399309
Lung neoplasm 17.50 10.70 29 80634 5937 63402422
Vertigo 17.38 10.70 133 80530 59754 63348605
Vision blurred 17.38 10.70 186 80477 91738 63316621
Urethral stenosis 17.37 10.70 8 80655 268 63408091
Vaginal discharge 17.33 10.70 37 80626 9161 63399198
Oral discomfort 17.33 10.70 37 80626 9164 63399195
Road traffic accident 17.25 10.70 92 80571 36540 63371819
Osteomyelitis 17.11 10.70 72 80591 25948 63382411
Tooth disorder 17.05 10.70 76 80587 28081 63380278
Vulvovaginal rash 17.03 10.70 7 80656 177 63408182
Vaginal cancer metastatic 17.01 10.70 3 80660 0 63408359
Essential hypertension 16.87 10.70 26 80637 5007 63403352
Affective disorder 16.86 10.70 29 80634 6117 63402242
Emotional disorder 16.80 10.70 46 80617 13333 63395026
Open reduction of fracture 16.76 10.70 13 80650 1149 63407210
Thyroid neoplasm 16.72 10.70 23 80640 3996 63404363
Product dose omission issue 16.65 10.70 204 80459 234109 63174250
Bone fragmentation 16.64 10.70 11 80652 756 63407603
Electrocardiogram QT prolonged 16.61 10.70 131 80532 59399 63348960
Anxiety disorder 16.59 10.70 23 80640 4027 63404332
Malabsorption 16.49 10.70 23 80640 4049 63404310
Bone disorder 16.43 10.70 62 80601 21264 63387095
Limb injury 16.37 10.70 70 80593 25407 63382952
Lip neoplasm 16.26 10.70 4 80659 16 63408343
Mitral valve calcification 16.24 10.70 12 80651 986 63407373
Metabolic acidosis 16.23 10.70 20 80643 45049 63363310
Hyponatraemia 16.19 10.70 80 80583 111820 63296539
Kyphosis 16.17 10.70 18 80645 2522 63405837
Altered state of consciousness 16.01 10.70 6 80657 25224 63383135
Irritability 15.89 10.70 81 80582 31613 63376746
Anger 15.81 10.70 43 80620 12413 63395946
Uterine prolapse 15.68 10.70 13 80650 1264 63407095
Cholestasis 15.58 10.70 9 80654 29425 63378934
White blood cell count decreased 15.57 10.70 108 80555 138996 63269363
Pneumonia 15.47 10.70 452 80211 456315 62952044
Tooth abscess 15.46 10.70 48 80615 14921 63393438
Suicide attempt 15.44 10.70 34 80629 60884 63347475
Condition aggravated 15.44 10.70 391 80272 401826 63006533
Palmar-plantar erythrodysaesthesia syndrome 15.41 10.70 5 80658 23010 63385349
Dyslipidaemia 15.41 10.70 31 80632 7362 63400997
Nerve injury 15.39 10.70 37 80626 9909 63398450
Breast disorder female 15.25 10.70 6 80657 135 63408224
Oedema mouth 15.19 10.70 17 80646 2396 63405963
Hypersensitivity 15.18 10.70 271 80392 292414 63115945
Eosinophilia 15.14 10.70 5 80658 22751 63385608
Micturition urgency 15.14 10.70 36 80627 9575 63398784
Deep vein thrombosis 15.12 10.70 168 80495 83632 63324727
Lipoma 15.08 10.70 17 80646 2414 63405945
Myocardial ischaemia 14.96 10.70 43 80620 12816 63395543
Dyspareunia 14.95 10.70 17 80646 2438 63405921
Plague 14.93 10.70 3 80660 3 63408356
Device dislocation 14.88 10.70 7 80656 25698 63382661
Haemoglobin decreased 14.83 10.70 116 80547 145369 63262990
Decreased appetite 14.81 10.70 227 80436 250825 63157534
Rheumatoid arthritis 14.80 10.70 230 80433 253589 63154770
Thyrotoxic periodic paralysis 14.79 10.70 4 80659 25 63408334
Laryngeal pain 14.74 10.70 23 80640 4475 63403884
Alanine aminotransferase abnormal 14.72 10.70 23 80640 4481 63403878
Tonsillar disorder 14.70 10.70 12 80651 1141 63407218
Periodontal disease 14.70 10.70 14 80649 1634 63406725
Gastrointestinal disorder 14.64 10.70 102 80561 131137 63277222
Carotid bruit 14.60 10.70 10 80653 729 63407630
Tinnitus 14.47 10.70 86 80577 35542 63372817
Oestrogen deficiency 14.37 10.70 6 80657 158 63408201
Sleep apnoea syndrome 14.29 10.70 74 80589 29059 63379300
Therapy non-responder 14.27 10.70 49 80614 75852 63332507
Salpingo-oophorectomy bilateral 14.23 10.70 6 80657 162 63408197
Mixed incontinence 14.23 10.70 5 80658 81 63408278
Glucose tolerance impaired 14.22 10.70 28 80635 6549 63401810
Cholelithiasis 14.15 10.70 100 80563 43825 63364534
Multiple organ dysfunction syndrome 14.12 10.70 32 80631 56720 63351639
COVID-19 14.09 10.70 85 80578 113018 63295341
Intestinal adhesion lysis 14.07 10.70 3 80660 5 63408354
Arthritis 14.03 10.70 216 80447 115705 63292654
Jaw fracture 13.98 10.70 17 80646 2617 63405742
Intermenstrual bleeding 13.93 10.70 31 80632 7895 63400464
Depressed level of consciousness 13.88 10.70 37 80626 62041 63346318
Joint injury 13.74 10.70 74 80589 29498 63378861
Gait disturbance 13.74 10.70 317 80346 182861 63225498
Fungal cystitis 13.72 10.70 3 80660 6 63408353
Skin abrasion 13.69 10.70 34 80629 9295 63399064
Nasal septum deviation 13.61 10.70 13 80650 1523 63406836
Amaurosis fugax 13.58 10.70 8 80655 448 63407911
Restless legs syndrome 13.56 10.70 53 80610 18478 63389881
Bladder disorder 13.54 10.70 33 80630 8913 63399446
Barrett's oesophagus 13.52 10.70 9 80654 626 63407733
Migraine with aura 13.44 10.70 17 80646 2723 63405636
Multiple sclerosis 13.44 10.70 64 80599 24308 63384051
Hip arthroplasty 13.43 10.70 25 80638 47621 63360738
Intermittent claudication 13.40 10.70 14 80649 1825 63406534
Red blood cell sedimentation rate increased 13.38 10.70 22 80641 43960 63364399
Cervical radiculopathy 13.36 10.70 11 80652 1059 63407300
Meniscus removal 13.32 10.70 4 80659 38 63408321
Vulval oedema 13.25 10.70 5 80658 100 63408259
Limb asymmetry 13.23 10.70 10 80653 850 63407509
Hypercholesterolaemia 13.23 10.70 58 80605 21276 63387083
Rhinitis 13.21 10.70 38 80625 11328 63397031
Chromaturia 13.21 10.70 49 80614 16668 63391691
Mood altered 13.18 10.70 45 80618 14698 63393661
Fistula discharge 13.15 10.70 11 80652 1082 63407277
Osteoma 13.14 10.70 4 80659 40 63408319
Frustration tolerance decreased 13.04 10.70 28 80635 6960 63401399
Seasonal allergy 13.03 10.70 57 80606 20893 63387466
Gallbladder oedema 13.03 10.70 6 80657 201 63408158
Disseminated intravascular coagulation 13.01 10.70 4 80659 19047 63389312
Anaemia 12.99 10.70 279 80384 293151 63115208
Angiopathy 12.96 10.70 22 80641 4591 63403768
Rib fracture 12.94 10.70 60 80603 22537 63385822
Aortic stenosis 12.88 10.70 23 80640 4997 63403362
Skin indentation 12.88 10.70 4 80659 43 63408316
Feelings of worthlessness 12.85 10.70 7 80656 337 63408022
Off label use 12.77 10.70 714 79949 673748 62734611
Coronary artery thrombosis 12.76 10.70 11 80652 1128 63407231
Urge incontinence 12.75 10.70 10 80653 898 63407461
Endometrial cancer 12.74 10.70 18 80645 3207 63405152
Neurotoxicity 12.67 10.70 3 80660 16987 63391372
Major depression 12.59 10.70 30 80633 7988 63400371
Pneumocystis jirovecii pneumonia 12.59 10.70 3 80660 16911 63391448
Hypersexuality 12.58 10.70 8 80655 514 63407845
Pulpitis dental 12.56 10.70 10 80653 918 63407441
Fungal infection 12.50 10.70 85 80578 36789 63371570
Tender joint count 12.40 10.70 6 80657 225 63408134
Gamma-glutamyltransferase increased 12.36 10.70 15 80648 34016 63374343
Aortic valve sclerosis 12.30 10.70 11 80652 1185 63407174
Stress 12.27 10.70 135 80528 67032 63341327
Osteomalacia 12.22 10.70 9 80654 736 63407623
Fibromyalgia 12.21 10.70 156 80507 80264 63328095
Cystitis 12.19 10.70 115 80548 54876 63353483
Oesophageal disorder 12.08 10.70 15 80648 2358 63406001
Otitis media 12.03 10.70 22 80641 4869 63403490
Creatinine renal clearance decreased 11.92 10.70 3 80660 16305 63392054
Vascular calcification 11.92 10.70 9 80654 764 63407595
Multiple injuries 11.89 10.70 13 80650 1785 63406574
Postmenopause 11.85 10.70 4 80659 57 63408302
Fracture delayed union 11.84 10.70 15 80648 2407 63405952
Breast reconstruction 11.84 10.70 6 80657 249 63408110
Fatigue 11.81 10.70 970 79693 887058 62521301
Urethral disorder 11.79 10.70 5 80658 137 63408222
Hyperaesthesia teeth 11.77 10.70 13 80650 1805 63406554
Cardio-respiratory arrest 11.76 10.70 38 80625 59921 63348438
Heart rate irregular 11.73 10.70 58 80605 22363 63385996
Bundle branch block left 11.73 10.70 27 80636 7032 63401327
Hypertensive heart disease 11.69 10.70 15 80648 2437 63405922
Cytomegalovirus infection 11.68 10.70 6 80657 20946 63387413
Medical device removal 11.68 10.70 11 80652 1266 63407093
Neck pain 11.62 10.70 137 80526 69181 63339178
Withdrawal bleed 11.60 10.70 4 80659 61 63408298
Endometrial cancer stage I 11.58 10.70 6 80657 261 63408098
Prescribed overdose 11.43 10.70 16 80647 34137 63374222
Change of bowel habit 11.39 10.70 14 80649 2179 63406180
Drug tolerance decreased 11.35 10.70 4 80659 17469 63390890
Platelet aggregation increased 11.34 10.70 3 80660 17 63408342
Gastroenteritis 11.33 10.70 65 80598 26525 63381834
Hysterectomy 11.28 10.70 32 80631 9467 63398892
Eating disorder 11.27 10.70 51 80612 18965 63389394
Arterial occlusive disease 11.27 10.70 24 80639 5934 63402425
Emphysema 11.23 10.70 35 80628 10903 63397456
Posterior reversible encephalopathy syndrome 11.21 10.70 4 80659 17341 63391018
Transaminases increased 11.21 10.70 14 80649 31353 63377006
Suicidal ideation 11.19 10.70 125 80538 62296 63346063
Clubbing 11.16 10.70 7 80656 439 63407920
Tooth loss 11.15 10.70 26 80637 6830 63401529
Abnormal dreams 11.12 10.70 34 80629 10482 63397877
Breast enlargement 11.12 10.70 12 80651 1624 63406735
Therapy interrupted 11.07 10.70 15 80648 32440 63375919
Marital problem 10.98 10.70 5 80658 163 63408196
Ecchymosis 10.93 10.70 35 80628 11059 63397300
Traumatic liver injury 10.86 10.70 6 80657 297 63408062
Therapeutic product effect incomplete 10.83 10.70 104 80559 124952 63283407
Fracture malunion 10.82 10.70 5 80658 169 63408190
Intentional self-injury 10.81 10.70 10 80653 25677 63382682
Nipple pain 10.77 10.70 6 80657 302 63408057
Impaired driving ability 10.73 10.70 20 80643 4491 63403868

FDA Adverse Event Reporting System (Male)

None

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
Hot flush 244.17 10.90 254 61158 54623 79628353
Vulvovaginal burning sensation 209.30 10.90 69 61343 1548 79681428
Coronary artery disease 201.00 10.90 250 61162 65224 79617752
Depression 193.61 10.90 479 60933 216311 79466665
Cerebrovascular accident 190.01 10.90 389 61023 154903 79528073
Vulvovaginal discomfort 155.09 10.90 57 61355 1781 79681195
Hyperlipidaemia 150.04 10.90 139 61273 25954 79657022
Toxicity to various agents 149.31 10.90 69 61343 421471 79261505
Acute kidney injury 141.07 10.90 116 61296 519288 79163688
Death 136.73 10.90 141 61271 566373 79116603
Carpal tunnel syndrome 114.16 10.90 105 61307 19423 79663553
Vulvovaginal dryness 113.72 10.90 48 61364 2176 79680800
Neutropenia 108.33 10.90 43 61369 287667 79395309
Febrile neutropenia 104.03 10.90 25 61387 230974 79452002
Oestrogen receptor assay positive 103.92 10.90 28 61384 302 79682674
Anxiety 103.51 10.90 422 60990 248090 79434886
Chest pain 102.64 10.90 460 60952 281844 79401132
Product prescribing error 102.09 10.90 148 61264 44665 79638311
Breast cancer 102.05 10.90 128 61284 33653 79649323
Drug abuse 101.17 10.90 6 61406 162685 79520291
Osteoarthritis 101.17 10.90 214 61198 87095 79595881
Gastrooesophageal reflux disease 97.88 10.90 235 61177 104011 79578965
Breast cancer in situ 97.40 10.90 34 61378 912 79682064
Fibrocystic breast disease 96.49 10.90 31 61381 639 79682337
Transient ischaemic attack 94.75 10.90 156 61256 52539 79630437
Osteopenia 94.47 10.90 92 61320 18272 79664704
Intervertebral disc degeneration 94.46 10.90 86 61326 15699 79667277
Mitral valve incompetence 90.72 10.90 111 61301 28454 79654522
Hypertension 85.58 10.90 490 60922 330502 79352474
Vulvovaginal pain 84.77 10.90 39 61373 2176 79680800
Spinal osteoarthritis 83.72 10.90 83 61329 16844 79666132
Progesterone receptor assay positive 77.90 10.90 21 61391 227 79682749
Pyrexia 76.19 10.90 268 61144 678441 79004535
Myocardial infarction 76.08 10.90 312 61100 183817 79499159
Drug interaction 75.78 10.90 127 61285 415056 79267920
Meniscus injury 75.15 10.90 53 61359 6715 79676261
Rotator cuff syndrome 75.11 10.90 72 61340 14023 79668953
Spinal stenosis 73.64 10.90 75 61337 15716 79667260
Low turnover osteopathy 72.99 10.90 34 61378 1952 79681024
Body height decreased 72.45 10.90 57 61355 8523 79674453
Completed suicide 68.96 10.90 53 61359 245714 79437262
Feeling abnormal 67.53 10.90 272 61140 158927 79524049
Pericarditis 67.46 10.90 3 61409 104233 79578743
Thrombocytopenia 67.33 10.90 63 61349 265196 79417780
Ventricular hypertrophy 67.17 10.90 50 61362 6888 79676088
Vulvovaginal pruritus 66.73 10.90 35 61377 2598 79680378
Dental caries 66.08 10.90 62 61350 11758 79671218
Stress urinary incontinence 65.98 10.90 31 61381 1815 79681161
Product complaint 65.18 10.90 65 61347 13284 79669692
Blood cholesterol increased 63.32 10.90 174 61238 83546 79599430
Carotid artery stenosis 60.97 10.90 52 61360 8706 79674270
Sepsis 60.50 10.90 71 61341 269357 79413619
General physical health deterioration 59.20 10.90 75 61337 275163 79407813
Renal impairment 58.66 10.90 24 61388 157759 79525217
Vaginal haemorrhage 58.58 10.90 78 61334 21739 79661237
Exostosis of jaw 57.31 10.90 25 61387 1229 79681747
Breast mass 57.31 10.90 45 61367 6709 79676267
Maternal exposure during pregnancy 57.24 10.90 17 61395 136521 79546455
Stress fracture 56.78 10.90 44 61368 6436 79676540
Temporomandibular joint syndrome 56.39 10.90 36 61376 3869 79679107
Nasal turbinate hypertrophy 56.02 10.90 21 61391 694 79682282
Pancytopenia 55.75 10.90 29 61383 165716 79517260
Migraine 55.72 10.90 171 61241 87322 79595654
Lacunar infarction 55.60 10.90 42 61370 5915 79677061
Bronchial neoplasm 55.17 10.90 19 61393 489 79682487
Femur fracture 54.67 10.90 103 61309 38549 79644427
Disease progression 53.98 10.90 38 61374 184324 79498652
Insomnia 53.81 10.90 348 61064 244822 79438154
Malignant neoplasm progression 51.67 10.90 20 61392 135970 79547006
Cystocele 50.81 10.90 20 61392 756 79682220
Angina unstable 50.51 10.90 63 61349 16464 79666512
Product dispensing error 49.52 10.90 56 61356 13207 79669769
Expired product administered 49.36 10.90 42 61370 7009 79675967
Breast calcifications 48.33 10.90 20 61392 862 79682114
Cardiac disorder 48.07 10.90 135 61277 65622 79617354
Haemorrhoids 48.06 10.90 83 61329 29045 79653931
Tricuspid valve incompetence 47.68 10.90 67 61345 19645 79663331
Emotional distress 47.47 10.90 99 61313 39870 79643106
Exposure during pregnancy 47.39 10.90 10 61402 101122 79581854
Arteriosclerosis 47.16 10.90 64 61348 18163 79664813
Menopausal symptoms 46.66 10.90 25 61387 1938 79681038
Breast cancer female 45.56 10.90 50 61362 11411 79671565
Endometrial ablation 44.75 10.90 19 61393 874 79682102
Nervousness 44.74 10.90 87 61325 33328 79649648
Mammogram abnormal 44.37 10.90 16 61396 473 79682503
Wound 44.28 10.90 17 61395 116162 79566814
Angina pectoris 43.65 10.90 112 61300 51620 79631356
Spondylolisthesis 42.72 10.90 28 61384 3147 79679829
Mitral valve prolapse 42.28 10.90 24 61388 2083 79680893
Cataract 41.99 10.90 124 61288 61996 79620980
Back disorder 41.73 10.90 48 61364 11530 79671446
Jaw disorder 41.72 10.90 33 61379 4973 79678003
Hypotension 41.59 10.90 186 61226 440131 79242845
Treatment failure 41.49 10.90 42 61370 170444 79512532
Back pain 41.22 10.90 386 61026 303794 79379182
Hypoacusis 40.98 10.90 79 61333 30071 79652905
Breast tenderness 40.64 10.90 24 61388 2244 79680732
Osteonecrosis 40.47 10.90 80 61332 31015 79651961
Postmenopausal haemorrhage 40.39 10.90 21 61391 1531 79681445
Aortic valve incompetence 40.37 10.90 43 61369 9487 79673489
Fibromyalgia 40.26 10.90 125 61287 64215 79618761
Bronchitis 40.19 10.90 203 61209 130441 79552535
Cardiac failure congestive 40.17 10.90 216 61196 142186 79540790
Breast disorder 39.88 10.90 23 61389 2058 79680918
Morton's neuralgia 39.61 10.90 9 61403 44 79682932
Vaginal infection 39.08 10.90 34 61378 5846 79677130
Infusion related reaction 38.73 10.90 74 61338 230163 79452813
Hyperkalaemia 38.48 10.90 20 61392 114378 79568598
Atrophic vulvovaginitis 38.48 10.90 19 61393 1242 79681734
Chronic disease 38.47 10.90 11 61401 150 79682826
Coronary artery occlusion 38.45 10.90 53 61359 15262 79667714
Uterine leiomyoma 38.34 10.90 35 61377 6408 79676568
Fracture nonunion 37.91 10.90 20 61392 1502 79681474
Headache 37.87 10.90 710 60702 653062 79029914
Bronchial haemorrhage 37.65 10.90 19 61393 1301 79681675
Rectocele 37.07 10.90 15 61397 610 79682366
Hiatus hernia 36.60 10.90 65 61347 23247 79659729
Diverticulum 36.57 10.90 51 61361 14845 79668131
Urinary tract infection 36.02 10.90 346 61066 274166 79408810
Urinary incontinence 36.00 10.90 90 61322 40819 79642157
Platelet count decreased 35.96 10.90 59 61353 194605 79488371
Oral infection 35.93 10.90 32 61380 5675 79677301
Contraindicated product administered 35.89 10.90 41 61371 157497 79525479
Vaginal disorder 35.62 10.90 14 61398 527 79682449
Breast cyst 35.18 10.90 18 61394 1269 79681707
Pain in extremity 35.12 10.90 432 60980 364106 79318870
Septic shock 35.04 10.90 26 61386 122775 79560201
Rheumatoid factor positive 34.90 10.90 3 61409 59836 79623140
Coma 34.75 10.90 17 61395 100632 79582344
Memory impairment 34.63 10.90 174 61238 111560 79571416
Cardiac failure 34.52 10.90 41 61371 154801 79528175
Anaemia postoperative 34.02 10.90 20 61392 1854 79681122
Peripheral vascular disorder 33.61 10.90 36 61376 7994 79674982
Intentional overdose 33.51 10.90 20 61392 105940 79577036
Interstitial lung disease 33.22 10.90 23 61389 112577 79570399
Hepatic function abnormal 32.71 10.90 8 61404 73099 79609877
Ventricular dysfunction 32.53 10.90 31 61381 5992 79676984
Wrong strength 32.44 10.90 10 61402 179 79682797
Multiple organ dysfunction syndrome 32.36 10.90 27 61385 120219 79562757
Seborrhoeic keratosis 32.21 10.90 21 61391 2339 79680637
Bone density abnormal 31.76 10.90 23 61389 3037 79679939
Cervicobrachial syndrome 31.25 10.90 16 61396 1130 79681846
Drug intolerance 31.08 10.90 102 61310 264017 79418959
Palpitations 31.05 10.90 185 61227 126425 79556551
Uterine disorder 31.01 10.90 20 61392 2187 79680789
Tooth fracture 30.61 10.90 41 61371 11489 79671487
Cardiovascular disorder 30.57 10.90 52 61360 17973 79665003
Therapeutic response unexpected 30.53 10.90 55 61357 19891 79663085
Scoliosis 30.43 10.90 33 61379 7431 79675545
Product quality issue 30.22 10.90 75 61337 33865 79649111
Glossodynia 29.32 10.90 22 61390 103315 79579661
Uterine polyp 29.01 10.90 17 61395 1567 79681409
Drug effective for unapproved indication 28.89 10.90 29 61383 5972 79677004
Intervertebral disc protrusion 28.63 10.90 59 61353 23562 79659414
Blood pressure abnormal 28.42 10.90 49 61363 17120 79665856
Vulvovaginal swelling 28.25 10.90 11 61401 404 79682572
Decreased appetite 28.06 10.90 152 61260 342266 79340710
Peptic ulcer 28.01 10.90 29 61383 6194 79676782
Leukopenia 28.00 10.90 29 61383 116484 79566492
Respiratory failure 27.99 10.90 61 61351 180850 79502126
Exostosis 27.76 10.90 48 61364 16810 79666166
Vaginal prolapse 27.72 10.90 10 61402 296 79682680
Bursitis 27.59 10.90 75 61337 35769 79647207
Stomatitis 27.55 10.90 44 61368 146713 79536263
Resorption bone increased 27.46 10.90 16 61396 1459 79681517
Vaginal cyst 27.46 10.90 8 61404 117 79682859
Lactic acidosis 27.30 10.90 10 61402 70349 79612627
Rhinitis allergic 27.18 10.90 40 61372 12229 79670747
Ligament sprain 27.13 10.90 42 61370 13422 79669554
Arteriosclerosis coronary artery 27.11 10.90 49 61363 17767 79665209
Bronchial disorder 26.50 10.90 19 61393 2470 79680506
Vulvovaginal erythema 25.90 10.90 9 61403 238 79682738
Muscle spasms 25.81 10.90 226 61186 174504 79508472
Breast hyperplasia 25.81 10.90 8 61404 146 79682830
Pneumonia 25.75 10.90 356 61056 659890 79023086
Mucosal inflammation 25.73 10.90 13 61399 75567 79607409
Thyroid disorder 25.73 10.90 42 61370 14037 79668939
Hospitalisation 25.55 10.90 21 61391 94215 79588761
Panic disorder 25.53 10.90 20 61392 2972 79680004
Metabolic acidosis 25.51 10.90 16 61396 82513 79600463
Muscle strain 25.40 10.90 34 61378 9521 79673455
Hormone level abnormal 25.35 10.90 17 61395 1985 79680991
Bladder prolapse 25.11 10.90 15 61397 1432 79681544
Crying 24.97 10.90 55 61357 22988 79659988
Folliculitis 24.89 10.90 6 61406 55374 79627602
Peripheral swelling 24.76 10.90 115 61297 269502 79413474
Nerve compression 24.75 10.90 33 61379 9206 79673770
Vaginal odour 24.52 10.90 10 61402 415 79682561
Cardiac valve disease 24.49 10.90 26 61386 5715 79677261
Lumbar spinal stenosis 24.47 10.90 25 61387 5257 79677719
Breast pain 24.45 10.90 31 61381 8234 79674742
Tooth disorder 24.45 10.90 59 61353 26174 79656802
Foot fracture 24.43 10.90 53 61359 21928 79661048
Agranulocytosis 24.34 10.90 3 61409 45027 79637949
Rhonchi 24.17 10.90 22 61390 4014 79678962
Aortic arteriosclerosis 24.12 10.90 32 61380 8886 79674090
Subclavian artery embolism 23.93 10.90 5 61407 15 79682961
Nocturia 23.91 10.90 40 61372 13641 79669335
Cystitis 23.87 10.90 92 61320 52640 79630336
Encephalopathy 23.85 10.90 11 61401 67386 79615590
Cerebrovascular disorder 23.77 10.90 21 61391 3684 79679292
Seasonal allergy 23.54 10.90 44 61368 16362 79666614
Osteoporosis 23.35 10.90 93 61319 54019 79628957
Arthritis 23.31 10.90 160 61252 114720 79568256
Haemoglobin decreased 23.31 10.90 90 61322 222029 79460947
Vertigo 23.13 10.90 110 61302 68972 79614004
Multiple sclerosis 22.82 10.90 52 61360 22230 79660746
Hyponatraemia 22.82 10.90 66 61346 177782 79505194
Cytomegalovirus infection 22.67 10.90 3 61409 42641 79640335
Varicose vein 22.47 10.90 22 61390 4397 79678579
Modified radical mastectomy 22.44 10.90 4 61408 3 79682973
Drug resistance 22.37 10.90 3 61409 42210 79640766
Gingivitis 22.32 10.90 31 61381 8990 79673986
Cholelithiasis 22.32 10.90 90 61322 52574 79630402
Bone disorder 22.30 10.90 47 61365 19066 79663910
Eosinophilia 22.26 10.90 4 61408 45341 79637635
Gallbladder disorder 21.91 10.90 47 61365 19293 79663683
Anaemia 21.90 10.90 228 61184 444787 79238189
Drug abuser 21.79 10.90 25 61387 5988 79676988
Toxic epidermal necrolysis 21.74 10.90 4 61408 44577 79638399
Chronic obstructive pulmonary disease 21.70 10.90 126 61286 85293 79597683
Blood oestrogen decreased 21.53 10.90 7 61405 150 79682826
Hypertonic bladder 21.52 10.90 21 61391 4180 79678796
Hypoglycaemia 21.49 10.90 28 61384 101566 79581410
Confusional state 21.44 10.90 150 61262 317847 79365129
Suspected counterfeit product 21.43 10.90 10 61402 576 79682400
Epilepsy 21.42 10.90 3 61409 40857 79642119
Vulval oedema 21.39 10.90 6 61406 76 79682900
Granuloma 21.26 10.90 29 61383 8268 79674708
Altered state of consciousness 21.23 10.90 4 61408 43818 79639158
Dyspareunia 21.11 10.90 15 61397 1923 79681053
Non-cardiac chest pain 21.02 10.90 31 61381 9493 79673483
Cholestasis 20.92 10.90 7 61405 52102 79630874
Vulvovaginal injury 20.88 10.90 8 61404 281 79682695
Cardio-respiratory arrest 20.87 10.90 32 61380 108478 79574498
Intervertebral disc disorder 20.84 10.90 22 61390 4803 79678173
Neutrophil count decreased 20.81 10.90 25 61387 93934 79589042
Defaecation urgency 20.74 10.90 24 61388 5800 79677176
Lumbar radiculopathy 20.69 10.90 15 61397 1984 79680992
Blood pressure increased 20.55 10.90 251 61161 211109 79471867
Vaginal discharge 20.52 10.90 27 61385 7436 79675540
Road traffic accident 20.44 10.90 77 61335 43587 79639389
Hepatotoxicity 20.43 10.90 7 61405 51345 79631631
Frustration tolerance decreased 20.41 10.90 27 61385 7475 79675501
Vulvovaginal rash 20.33 10.90 6 61406 92 79682884
Gastritis 20.32 10.90 82 61330 47911 79635065
Stevens-Johnson syndrome 20.24 10.90 3 61409 39163 79643813
Rhabdomyolysis 20.24 10.90 30 61382 103101 79579875
Cardiolipin antibody positive 20.19 10.90 7 61405 184 79682792
Lung neoplasm 20.10 10.90 26 61386 7043 79675933
Eye disorder 20.07 10.90 51 61361 23361 79659615
Essential hypertension 19.99 10.90 24 61388 6029 79676947
Musculoskeletal discomfort 19.99 10.90 46 61366 19789 79663187
Dilatation atrial 19.88 10.90 19 61393 3685 79679291
Cardiac murmur 19.74 10.90 40 61372 15784 79667192
Joint injury 19.71 10.90 61 61351 31274 79651702
Affective disorder 19.71 10.90 28 61384 8291 79674685
Post procedural complication 19.49 10.90 51 61361 23778 79659198
Tendonitis 19.49 10.90 51 61361 23779 79659197
Systemic lupus erythematosus 19.44 10.90 40 61372 121109 79561867
Mixed incontinence 19.37 10.90 5 61407 45 79682931
Synovitis 19.29 10.90 56 61356 150678 79532298
Blood triglycerides increased 19.26 10.90 47 61365 20993 79661983
Carotid artery disease 19.03 10.90 15 61397 2249 79680727
Oedema mouth 18.99 10.90 17 61395 3034 79679942
Neoplasm progression 18.97 10.90 8 61404 51674 79631302
Drug-induced liver injury 18.85 10.90 14 61398 66103 79616873
Melaena 18.55 10.90 12 61400 60878 79622098
Dyslexia 18.54 10.90 7 61405 236 79682740
Vaginal cancer metastatic 18.51 10.90 3 61409 0 79682976
Sinusitis 18.50 10.90 231 61181 195270 79487706
Product use in unapproved indication 18.43 10.90 115 61297 250244 79432732
Infection 18.33 10.90 110 61302 241602 79441374
Large intestine polyp 18.13 10.90 34 61378 12674 79670302
Dizziness 18.11 10.90 532 60880 525909 79157067
Lower respiratory tract infection 18.04 10.90 46 61366 129174 79553802
Tooth abscess 17.92 10.90 39 61373 16171 79666805
Sleep disorder 17.78 10.90 120 61292 85557 79597419
Device failure 17.76 10.90 23 61389 6238 79676738
Mitral valve calcification 17.44 10.90 12 61400 1461 79681515
Pain 17.33 10.90 684 60728 703118 78979858
Discomfort 17.32 10.90 45 61367 125572 79557404
Hypothyroidism 17.23 10.90 83 61329 52309 79630667
Ascites 16.84 10.90 20 61392 75542 79607434
Blood creatinine increased 16.80 10.90 62 61350 154995 79527981
Skin indentation 16.77 10.90 4 61408 25 79682951
Upper respiratory tract infection 16.76 10.90 124 61288 91044 79591932
Ankle fracture 16.72 10.90 39 61373 16930 79666046
Migraine with aura 16.70 10.90 15 61397 2690 79680286
Oestrogen deficiency 16.69 10.90 5 61407 81 79682895
Spinal disorder 16.61 10.90 29 61383 10231 79672745
Thyroid neoplasm 16.55 10.90 16 61396 3148 79679828
Cervical spinal stenosis 16.41 10.90 14 61398 2345 79680631
Injury 16.36 10.90 109 61303 77387 79605589
Phyllodes tumour 16.26 10.90 4 61408 29 79682947
Endometrial cancer stage I 16.16 10.90 6 61406 193 79682783
Vomiting 16.16 10.90 390 61022 665438 79017538
Chronic fatigue syndrome 16.01 10.90 11 61401 1336 79681640
Melanocytic naevus 15.99 10.90 19 61393 4722 79678254
Pollakiuria 15.99 10.90 64 61348 37253 79645723
Labile hypertension 15.95 10.90 8 61404 541 79682435
Carotid bruit 15.93 10.90 9 61403 774 79682202
Vaginal dysplasia 15.92 10.90 4 61408 32 79682944
Tender joint count 15.87 10.90 6 61406 203 79682773
Rash maculo-papular 15.83 10.90 12 61400 56066 79626910
Breast disorder female 15.80 10.90 5 61407 98 79682878
Neurotoxicity 15.68 10.90 3 61409 32515 79650461
Bone marrow failure 15.66 10.90 10 61402 51097 79631879
Intentional self-injury 15.61 10.90 3 61409 32416 79650560
Illness 15.53 10.90 74 61338 46437 79636539
Gait disturbance 15.48 10.90 235 61177 207271 79475705
Urge incontinence 15.47 10.90 10 61402 1098 79681878
Uterine prolapse 15.43 10.90 9 61403 822 79682154
Osteomyelitis 15.42 10.90 58 61354 32807 79650169
Radicular pain 15.38 10.90 7 61405 381 79682595
Burning sensation 15.23 10.90 87 61325 58545 79624431
Diabetes mellitus 15.21 10.90 108 61304 78282 79604694
Vision blurred 15.13 10.90 136 61276 105762 79577214
Hepatic enzyme increased 14.97 10.90 81 61331 182529 79500447
Bladder disorder 14.96 10.90 26 61386 9139 79673837
Endometrial hyperplasia 14.84 10.90 8 61404 628 79682348
Kyphosis 14.82 10.90 14 61398 2677 79680299
Poor quality product administered 14.66 10.90 16 61396 3629 79679347
Gingival disorder 14.63 10.90 16 61396 3635 79679341
Hypercholesterolaemia 14.56 10.90 45 61367 23050 79659926
Nerve injury 14.50 10.90 26 61386 9366 79673610
Cardiomegaly 14.49 10.90 49 61363 26303 79656673
Bone fragmentation 14.45 10.90 8 61404 662 79682314
Sinus disorder 14.38 10.90 44 61368 22420 79660556
Plague 14.36 10.90 3 61409 9 79682967
Blood bilirubin increased 14.27 10.90 18 61394 66214 79616762
Gingival recession 14.25 10.90 10 61402 1257 79681719
Abdominal discomfort 14.21 10.90 124 61288 250603 79432373
White blood cell count decreased 14.10 10.90 86 61326 188202 79494774
Emotional disorder 14.10 10.90 33 61379 14354 79668622
Intentional product misuse 14.00 10.90 123 61289 95042 79587934
Urethral disorder 13.96 10.90 5 61407 145 79682831
Hyperhidrosis 13.90 10.90 178 61234 151314 79531662
Depressed level of consciousness 13.81 10.90 34 61378 96618 79586358
Limb injury 13.76 10.90 52 61360 29476 79653500
Cardiac arrest 13.75 10.90 77 61335 172019 79510957
Diarrhoea 13.72 10.90 547 60865 879942 78803034
Liver injury 13.70 10.90 14 61398 56600 79626376
Endometrial cancer 13.70 10.90 12 61400 2082 79680894
Drug withdrawal syndrome 13.66 10.90 58 61354 34660 79648316
Plantar fasciitis 13.59 10.90 15 61397 3445 79679531
Electrocardiogram QT prolonged 13.54 10.90 31 61381 90355 79592621
Biopsy breast abnormal 13.50 10.90 3 61409 13 79682963
Fungal cystitis 13.50 10.90 3 61409 13 79682963
Amnesia 13.49 10.90 89 61323 62968 79620008
Rhinitis 13.47 10.90 33 61379 14774 79668202
Jaw fracture 13.47 10.90 14 61398 3003 79679973
Overdose 13.35 10.90 85 61327 184121 79498855
Vaginal erosion 13.32 10.90 3 61409 14 79682962
Glucose tolerance impaired 13.29 10.90 23 61389 8061 79674915
Arthralgia 13.19 10.90 552 60860 571251 79111725
Cerebral haemorrhage 13.14 10.90 15 61397 57658 79625318
Post procedural cellulitis 13.06 10.90 4 61408 70 79682906
Barrett's oesophagus 13.04 10.90 8 61404 801 79682175
Hyperaesthesia teeth 12.93 10.90 11 61401 1835 79681141
COVID-19 12.89 10.90 70 61342 157604 79525372
Periodontal disease 12.81 10.90 11 61401 1859 79681117
Blister 12.79 10.90 48 61364 119428 79563548
Suicide attempt 12.79 10.90 28 61384 82904 79600072
Ischaemic cardiomyopathy 12.79 10.90 22 61390 7673 79675303
Major depression 12.78 10.90 24 61388 8956 79674020
Gamma-glutamyltransferase increased 12.70 10.90 14 61398 54666 79628310
Gastroenteritis 12.69 10.90 56 61356 34026 79648950
Change of bowel habit 12.68 10.90 13 61399 2744 79680232
Skin laceration 12.67 10.90 50 61362 28912 79654064
Coronary artery stenosis 12.64 10.90 29 61383 12455 79670521
Benign breast neoplasm 12.58 10.90 8 61404 854 79682122
Visual impairment 12.49 10.90 117 61295 92014 79590962
Neck pain 12.43 10.90 100 61312 75317 79607659
Micturition urgency 12.39 10.90 29 61383 12612 79670364
Palmar-plantar erythrodysaesthesia syndrome 12.37 10.90 5 61407 33129 79649847
Progressive multiple sclerosis 12.30 10.90 9 61403 1208 79681768
Vulval disorder 12.30 10.90 7 61405 611 79682365
Transaminases increased 12.29 10.90 13 61399 51730 79631246
Stress 12.28 10.90 104 61308 79508 79603468
Calcium deficiency 12.27 10.90 8 61404 891 79682085
Lymphocyte count decreased 12.25 10.90 11 61401 47278 79635698
Laryngeal pain 12.22 10.90 19 61393 6095 79676881
Goitre 12.18 10.90 18 61394 5521 79677455
Postmenopause 12.05 10.90 3 61409 23 79682953
Costochondritis 12.04 10.90 12 61400 2449 79680527
Marital problem 12.01 10.90 5 61407 219 79682757
Tonsillar disorder 11.98 10.90 9 61403 1257 79681719
Sciatica 11.93 10.90 54 61358 33168 79649808
Mobility decreased 11.87 10.90 51 61361 122124 79560852
Knee deformity 11.86 10.90 9 61403 1276 79681700
Cervical radiculopathy 11.86 10.90 9 61403 1276 79681700
Intermittent claudication 11.86 10.90 14 61398 3457 79679519
Radiculopathy 11.84 10.90 23 61389 8801 79674175
Vulvovaginal mycotic infection 11.76 10.90 16 61396 4550 79678426
Menopause 11.70 10.90 11 61401 2091 79680885
Breast reconstruction 11.69 10.90 4 61408 101 79682875
Salpingo-oophorectomy bilateral 11.53 10.90 3 61409 28 79682948
Posterior reversible encephalopathy syndrome 11.52 10.90 3 61409 26278 79656698
Psoriatic arthropathy 11.49 10.90 27 61385 77972 79605004
Swelling 11.49 10.90 109 61303 216602 79466374
Shock 11.44 10.90 10 61402 43538 79639438
Agitation 11.38 10.90 39 61373 99676 79583300
Red blood cells urine 11.37 10.90 7 61405 706 79682270
Loose tooth 11.36 10.90 13 61399 3104 79679872
COVID-19 pneumonia 11.36 10.90 4 61408 28845 79654131
Intermenstrual bleeding 11.36 10.90 18 61394 5866 79677110
Clubbing 11.35 10.90 7 61405 708 79682268
Pelvic pain 11.31 10.90 29 61383 13352 79669624
Generalised anxiety disorder 11.29 10.90 11 61401 2186 79680790
Anxiety disorder 11.29 10.90 15 61397 4172 79678804
Cystitis interstitial 11.27 10.90 9 61403 1374 79681602
Back injury 11.27 10.90 25 61387 10498 79672478
Therapy interrupted 11.27 10.90 5 61407 31336 79651640
Asthma 11.26 10.90 156 61256 134939 79548037
Face injury 11.25 10.90 14 61398 3650 79679326
Aortic valve sclerosis 11.24 10.90 10 61402 1770 79681206
Influenza like illness 11.24 10.90 94 61318 71613 79611363
Skin abrasion 11.21 10.90 29 61383 13427 79669549
Tibia fracture 11.19 10.90 17 61395 5344 79677632
Bradycardia 11.18 10.90 60 61352 135497 79547479
Erythema 11.13 10.90 114 61298 223176 79459800
Procedural pain 11.04 10.90 41 61371 23043 79659933
Musculoskeletal chest pain 11.04 10.90 43 61369 24721 79658255
Low density lipoprotein increased 11.00 10.90 22 61390 8600 79674376
Meningioma 10.98 10.90 15 61397 4283 79678693
Piriformis syndrome 10.97 10.90 4 61408 122 79682854
Dyspepsia 10.96 10.90 130 61282 108557 79574419
Giant cell arteritis 10.93 10.90 12 61400 2739 79680237
Urticaria pressure 10.92 10.90 3 61409 35 79682941
Heart rate irregular 10.91 10.90 52 61360 32627 79650349

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC G03CA57 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
ESTROGENS
Natural and semisynthetic estrogens, plain
ATC G03CC07 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
ESTROGENS
Estrogens, combinations with other drugs
FDA CS M0007792 Estrogens, Conjugated (USP)
FDA MoA N0000000100 Estrogen Receptor Agonists
MeSH PA D004967 Estrogens
MeSH PA D006728 Hormones
FDA EPC N0000175825 Estrogen

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

DiseaseRelationSNOMED_IDDOID
Dyspareunia indication 71315007
Menopausal flushing indication 198436008




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 20MG BASE;0.45MG DUAVEE WYETH PHARMS N022247 Oct. 3, 2013 RX TABLET ORAL 6479535 May 6, 2024 PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
EQ 20MG BASE;0.45MG DUAVEE WYETH PHARMS N022247 Oct. 3, 2013 RX TABLET ORAL 6479535 May 6, 2024 TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
EQ 20MG BASE;0.45MG DUAVEE WYETH PHARMS N022247 Oct. 3, 2013 RX TABLET ORAL 7683051 March 10, 2027 PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
EQ 20MG BASE;0.45MG DUAVEE WYETH PHARMS N022247 Oct. 3, 2013 RX TABLET ORAL 7683051 March 10, 2027 TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Estrogen receptor Nuclear hormone receptor AGONIST DRUG LABEL DRUG LABEL
Estrogen receptor beta Nuclear hormone receptor AGONIST DRUG LABEL DRUG LABEL

External reference:

IDSource
D04070 KEGG_DRUG
4018403 VUID
N0000167510 NUI
4018403 VANDF
CHEBI:8389 CHEBI
CHEMBL1201649 ChEMBL_ID
DB00286 DRUGBANK_ID
202896 RXNORM
307 MMSL
4500 MMSL
d00541 MMSL
001272 NDDF
126098001 SNOMEDCT_US
16832004 SNOMEDCT_US
C0014938 UMLSCUI
D004966 MESH_DESCRIPTOR_UI
3001028 PUBCHEM_CID
IU5QR144QX UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Duavee HUMAN PRESCRIPTION DRUG LABEL 2 0008-1123 TABLET, FILM COATED 0.45 mg ORAL NDA 34 sections
Duavee HUMAN PRESCRIPTION DRUG LABEL 2 0008-1123 TABLET, FILM COATED 0.45 mg ORAL NDA 34 sections
Duavee HUMAN PRESCRIPTION DRUG LABEL 2 0008-1123 TABLET, FILM COATED 0.45 mg ORAL NDA 34 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 0046-0749 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 25 mg INTRAVENOUS NDA 26 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 0046-0749 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 25 mg INTRAVENOUS NDA 26 sections
Premarin Vaginal HUMAN PRESCRIPTION DRUG LABEL 1 0046-0872 CREAM 0.63 mg VAGINAL NDA 32 sections
Premarin Vaginal HUMAN PRESCRIPTION DRUG LABEL 1 0046-0872 CREAM 0.63 mg VAGINAL NDA 32 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 0046-1100 TABLET, FILM COATED 0.30 mg ORAL NDA 32 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 0046-1101 TABLET, FILM COATED 0.45 mg ORAL NDA 32 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 0046-1102 TABLET, FILM COATED 0.63 mg ORAL NDA 32 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 0046-1103 TABLET, FILM COATED 0.90 mg ORAL NDA 32 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 0046-1104 TABLET, FILM COATED 1.25 mg ORAL NDA 32 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1105 TABLET, SUGAR COATED 0.30 mg ORAL NDA 30 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1105 TABLET, SUGAR COATED 0.30 mg ORAL NDA 30 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1106 TABLET, SUGAR COATED 0.45 mg ORAL NDA 30 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1106 TABLET, SUGAR COATED 0.45 mg ORAL NDA 30 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1107 TABLET, SUGAR COATED 0.63 mg ORAL NDA 30 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1107 TABLET, SUGAR COATED 0.63 mg ORAL NDA 30 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1108 TABLET, SUGAR COATED 0.63 mg ORAL NDA 30 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1108 TABLET, SUGAR COATED 0.63 mg ORAL NDA 30 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 43353-687 TABLET, FILM COATED 0.30 mg ORAL NDA 25 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 43353-688 TABLET, FILM COATED 0.63 mg ORAL NDA 25 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 50090-0167 TABLET, FILM COATED 0.63 mg ORAL NDA 31 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 50090-0167 TABLET, FILM COATED 0.63 mg ORAL NDA 31 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 50090-0573 TABLET, SUGAR COATED 0.63 mg ORAL NDA 30 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 50090-1853 TABLET, FILM COATED 0.30 mg ORAL NDA 31 sections
Esterified Estrogens and Methyltestosterone HUMAN PRESCRIPTION DRUG LABEL 2 51293-639 TABLET 0.63 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Esterified Estrogens and Methyltestosterone HUMAN PRESCRIPTION DRUG LABEL 2 51293-640 TABLET 1.25 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 53808-0770 TABLET, FILM COATED 0.63 mg ORAL NDA 25 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 54868-0365 TABLET, FILM COATED 0.90 mg ORAL NDA 14 sections