conjugated estrogens 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

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
Schizoaffective disorder 392.76 10.66 156 83945 4991 90539355
Coronary artery disease 346.35 10.66 271 83830 33352 90510994
Hot flush 299.72 10.66 321 83780 59167 90485179
Cerebrovascular accident 280.68 10.66 450 83651 123083 90421263
Vulvovaginal burning sensation 275.10 10.66 100 84001 2495 90541851
Maternal exposure during pregnancy 270.11 10.66 16 84085 360047 90184299
Breast cancer 267.14 10.66 288 83813 53473 90490873
Pericarditis 222.66 10.66 6 84095 270145 90274201
Myocardial infarction 212.45 10.66 365 83736 105607 90438739
Wound 196.05 10.66 25 84076 302955 90241391
Glossodynia 195.56 10.66 32 84069 321747 90222599
Hyperlipidaemia 194.45 10.66 165 83936 22751 90521595
Vulvovaginal discomfort 192.80 10.66 78 84023 2619 90541727
Systemic lupus erythematosus 185.45 10.66 53 84048 361843 90182503
Drug level increased 182.35 10.66 173 83928 27589 90516757
Exposure during pregnancy 174.53 10.66 12 84089 238398 90305948
Product prescribing error 170.31 10.66 173 83928 29972 90514374
Infusion related reaction 167.53 10.66 89 84012 416691 90127655
Folliculitis 159.74 10.66 7 84094 204346 90340000
Depression 154.03 10.66 619 83482 299982 90244364
Contraindicated product administered 138.27 10.66 62 84039 320077 90224269
Synovitis 131.61 10.66 71 84030 329681 90214665
Rheumatoid factor positive 130.55 10.66 7 84094 171643 90372703
Drug intolerance 127.98 10.66 136 83965 447455 90096891
Transient ischaemic attack 127.62 10.66 178 83923 42998 90501348
Treatment failure 126.40 10.66 62 84039 303866 90240480
Spinal osteoarthritis 123.23 10.66 118 83983 19030 90525316
Osteopenia 122.69 10.66 128 83973 22874 90521472
Muscle injury 120.69 10.66 12 84089 176642 90367704
Vulvovaginal dryness 119.38 10.66 60 84041 3371 90540975
General physical health deterioration 119.22 10.66 93 84008 355022 90189324
Fibrocystic breast disease 118.40 10.66 44 84057 1170 90543176
Anxiety 117.22 10.66 583 83518 309189 90235157
Intervertebral disc degeneration 116.02 10.66 109 83992 17165 90527181
Low turnover osteopathy 115.98 10.66 63 84038 4155 90540191
Hepatic enzyme increased 110.67 10.66 103 83998 360633 90183713
Liver injury 110.45 10.66 14 84087 170553 90373793
Feeling abnormal 110.45 10.66 374 83727 166861 90377485
Mitral valve incompetence 108.94 10.66 119 83982 22405 90521941
Stomatitis 108.35 10.66 60 84041 274638 90269708
Abdominal discomfort 106.80 10.66 174 83927 477154 90067192
Cardiac failure congestive 106.19 10.66 263 83838 98431 90445915
Femur fracture 104.73 10.66 168 83933 45914 90498432
Product complaint 104.00 10.66 92 84009 13408 90530938
Vulvovaginal pain 101.43 10.66 54 84047 3420 90540926
Oestrogen receptor assay positive 101.40 10.66 32 84069 510 90543836
Carpal tunnel syndrome 101.37 10.66 118 83983 23810 90520536
Lower respiratory tract infection 98.48 10.66 55 84046 250604 90293742
Swelling 95.37 10.66 151 83950 418907 90125439
Spinal stenosis 94.79 10.66 98 84003 17326 90527020
Rotator cuff syndrome 94.76 10.66 94 84007 15825 90528521
Angina unstable 94.64 10.66 67 84034 7076 90537270
Discomfort 94.40 10.66 70 84031 274265 90270081
Psoriatic arthropathy 94.27 10.66 47 84054 228288 90316058
Ventricular hypertrophy 91.44 10.66 50 84051 3341 90541005
Stress fracture 89.93 10.66 70 84031 8541 90535805
Toxicity to various agents 89.67 10.66 81 84020 287765 90256581
Sinus rhythm 88.59 10.66 37 84064 1349 90542997
Chest pain 88.48 10.66 553 83548 319092 90225254
Breast cancer in situ 86.82 10.66 39 84062 1701 90542645
Blister 86.53 10.66 66 84035 254932 90289414
Breast tenderness 85.98 10.66 44 84057 2568 90541778
Progesterone receptor assay positive 82.68 10.66 25 84076 343 90544003
Peripheral swelling 82.11 10.66 162 83939 412944 90131402
Mobility decreased 81.19 10.66 68 84033 250666 90293680
Carotid artery stenosis 80.00 10.66 54 84047 5280 90539066
Arteriosclerosis 79.72 10.66 72 84029 10781 90533565
Dental caries 78.63 10.66 73 84028 11324 90533022
Ill-defined disorder 77.92 10.66 37 84064 184854 90359492
Helicobacter infection 77.88 10.66 58 84043 226792 90317554
Stress urinary incontinence 76.95 10.66 40 84061 2412 90541934
Cardiac disorder 75.93 10.66 165 83936 56707 90487639
Body height decreased 75.68 10.66 73 84028 11876 90532470
Meniscus injury 75.44 10.66 62 84039 8175 90536171
Neutropenia 75.30 10.66 59 84042 224845 90319501
Lip dry 74.08 10.66 5 84096 100950 90443396
Expired product administered 73.88 10.66 57 84044 6865 90537481
Death 73.09 10.66 201 83900 456350 90087996
Lacunar infarction 72.76 10.66 43 84058 3334 90541012
Haemorrhoids 71.43 10.66 105 83996 26597 90517749
Coronary artery occlusion 71.35 10.66 61 84040 8493 90535853
Electrocardiogram QT prolonged 70.58 10.66 186 83915 72270 90472076
Breast calcifications 68.48 10.66 31 84070 1377 90542969
Vaginal haemorrhage 66.98 10.66 111 83990 31160 90513186
Cystocele 65.94 10.66 31 84070 1503 90542843
Temporomandibular joint syndrome 65.89 10.66 43 84058 3974 90540372
Wound infection 65.89 10.66 10 84091 106392 90437954
Alopecia 65.18 10.66 238 83863 494833 90049513
Nervousness 63.90 10.66 114 83987 33942 90510404
Vulvovaginal pruritus 63.69 10.66 42 84059 3951 90540395
Urinary incontinence 63.24 10.66 120 83981 37446 90506900
Cataract 63.16 10.66 178 83923 71914 90472432
Fracture nonunion 62.37 10.66 34 84067 2258 90542088
Diverticulum 62.09 10.66 66 84035 12047 90532299
Infection 62.06 10.66 154 83947 361940 90182406
Irritable bowel syndrome 61.51 10.66 61 84040 207387 90336959
Epilepsy 60.52 10.66 4 84097 82202 90462144
Febrile neutropenia 60.38 10.66 36 84065 158313 90386033
Arteriosclerosis coronary artery 59.57 10.66 58 84043 9545 90534801
Exostosis of jaw 58.80 10.66 27 84074 1240 90543106
Gastrooesophageal reflux disease 58.58 10.66 307 83794 166030 90378316
Product use in unapproved indication 58.40 10.66 142 83959 336094 90208252
Joint swelling 58 10.66 255 83846 503045 90041301
Anaemia postoperative 57.94 10.66 32 84069 2181 90542165
Emotional distress 57.91 10.66 114 83987 36548 90507798
Product dispensing error 57.88 10.66 64 84037 12209 90532137
Angina pectoris 57.36 10.66 118 83983 39042 90505304
Breast mass 56.63 10.66 56 84045 9391 90534955
Arthropathy 56.55 10.66 164 83937 366078 90178268
Pyrexia 56.01 10.66 371 83730 660114 89884232
Back pain 55.86 10.66 493 83608 316682 90227664
Type 2 diabetes mellitus 55.53 10.66 64 84037 203180 90341166
Facet joint syndrome 54.99 10.66 12 84089 98377 90445969
Aortic valve incompetence 54.76 10.66 47 84054 6577 90537769
Bronchial neoplasm 54.60 10.66 20 84081 510 90543836
Grip strength decreased 54.44 10.66 10 84091 92566 90451780
Chronic disease 54.35 10.66 16 84085 199 90544147
Vaginal infection 54.28 10.66 52 84049 8388 90535958
Hiatus hernia 51.62 10.66 88 84013 25273 90519073
Atrophic vulvovaginitis 51.37 10.66 28 84073 1859 90542487
Acute kidney injury 51.27 10.66 141 83960 320246 90224100
Breast cancer female 51.05 10.66 66 84035 14820 90529526
Osteonecrosis 50.73 10.66 89 84012 26152 90518194
Urinary tract infection 50.72 10.66 469 83632 305163 90239183
Deep vein thrombosis postoperative 50.54 10.66 4 84097 70805 90473541
Intramedullary rod insertion 50.35 10.66 29 84072 2143 90542203
Bronchitis 50.28 10.66 277 83824 152650 90391696
Drug withdrawal syndrome 49.90 10.66 93 84008 28630 90515716
Cardiovascular disorder 49.72 10.66 62 84039 13430 90530916
Tricuspid valve incompetence 49.46 10.66 69 84032 16662 90527684
Breast cyst 48.99 10.66 28 84073 2039 90542307
Insomnia 48.61 10.66 498 83603 332976 90211370
Drug abuse 48.19 10.66 9 84092 82338 90462008
Wheezing 47.56 10.66 93 84008 237987 90306359
Burning sensation 47.34 10.66 148 83953 63304 90481042
Postmenopausal haemorrhage 47.33 10.66 29 84072 2401 90541945
Jaw disorder 47.09 10.66 40 84061 5519 90538827
Nasal turbinate hypertrophy 47.09 10.66 21 84080 900 90543446
Bronchial haemorrhage 47.07 10.66 19 84082 634 90543712
Hypoacusis 46.92 10.66 89 84012 27761 90516585
Chronic obstructive pulmonary disease 46.85 10.66 163 83938 73666 90470680
Disease progression 46.48 10.66 46 84055 156569 90387777
Breast disorder 46.32 10.66 30 84071 2737 90541609
Joint range of motion decreased 46.13 10.66 35 84066 135608 90408738
Therapeutic response unexpected 45.96 10.66 77 84024 21803 90522543
Pregnancy 45.73 10.66 3 84098 62044 90482302
Mammogram abnormal 45.66 10.66 20 84081 821 90543525
Prescribed overdose 45.18 10.66 17 84084 97608 90446738
Acute myocardial infarction 45.18 10.66 100 84001 34790 90509556
Peptic ulcer 43.55 10.66 38 84063 5437 90538909
Menopausal symptoms 43.41 10.66 30 84071 3048 90541298
Blood pressure increased 43.06 10.66 322 83779 196895 90347451
Drug-induced liver injury 43.03 10.66 15 84086 90303 90454043
Poor quality product administered 42.76 10.66 33 84068 3975 90540371
Ventricular dysfunction 42.63 10.66 32 84069 3699 90540647
Seborrhoeic keratosis 42.53 10.66 30 84071 3150 90541196
Nocturia 42.48 10.66 50 84051 10205 90534141
Lung disorder 42.24 10.66 46 84055 149837 90394509
Peripheral vascular disorder 42.08 10.66 40 84061 6391 90537955
Peripheral venous disease 41.63 10.66 13 84088 83908 90460438
Palpitations 41.22 10.66 242 83859 136486 90407860
Nasopharyngitis 41.19 10.66 216 83885 406888 90137458
Hospitalisation 41.12 10.66 35 84066 128065 90416281
Large intestine polyp 40.95 10.66 47 84054 9339 90535007
Mitral valve prolapse 40.71 10.66 27 84074 2564 90541782
Impaired healing 40.57 10.66 99 84002 234100 90310246
Dislocation of vertebra 40.40 10.66 3 84098 55965 90488381
Hyperhidrosis 40.28 10.66 240 83861 136065 90408281
Malignant neoplasm progression 39.76 10.66 25 84076 106845 90437501
Gastrointestinal disorder 39.55 10.66 115 83986 256572 90287774
Wrong strength 39.23 10.66 10 84091 69 90544277
Vaginal prolapse 38.89 10.66 16 84085 561 90543785
Endometrial ablation 38.78 10.66 19 84082 1010 90543336
Renal impairment 38.75 10.66 25 84076 105396 90438950
Musculoskeletal stiffness 38.68 10.66 143 83958 296389 90247957
Uterine leiomyoma 38.57 10.66 49 84052 10815 90533531
Ligament sprain 38.46 10.66 57 84044 14542 90529804
Adjustment disorder with depressed mood 38.37 10.66 4 84097 56749 90487597
Myelosuppression 38.32 10.66 3 84098 53588 90490758
Muscle strain 38.10 10.66 46 84055 9641 90534705
Spondylolisthesis 38.01 10.66 31 84070 4044 90540302
Thrombocytopenia 37.94 10.66 86 84015 208639 90335707
Scoliosis 37.85 10.66 44 84057 8863 90535483
Rectocele 37.75 10.66 20 84081 1254 90543092
Diabetes mellitus 37.55 10.66 139 83962 64736 90479610
Confusional state 37.36 10.66 208 83893 385997 90158349
Blepharospasm 37.25 10.66 4 84097 55441 90488905
Vulvovaginal swelling 37.05 10.66 17 84084 779 90543567
Blood triglycerides increased 36.64 10.66 54 84047 13707 90530639
Cervicobrachial syndrome 36.55 10.66 19 84082 1146 90543200
Rash 36.45 10.66 520 83581 795580 89748766
Foot fracture 36.43 10.66 78 84023 26528 90517818
Cardiomegaly 36.34 10.66 64 84037 18861 90525485
Hormone level abnormal 35.88 10.66 26 84075 2847 90541499
Blood pressure abnormal 35.88 10.66 65 84036 19580 90524766
Ischaemic cardiomyopathy 35.76 10.66 25 84076 2588 90541758
Breast hyperplasia 35.62 10.66 13 84088 328 90544018
Morton's neuralgia 35.20 10.66 9 84092 63 90544283
Bladder prolapse 35.18 10.66 23 84078 2132 90542214
Drug effective for unapproved indication 35.13 10.66 40 84061 7878 90536468
Drug abuser 35.10 10.66 25 84076 2665 90541681
Hypertension 35.10 10.66 608 83493 456924 90087422
Intentional product use issue 35.01 10.66 95 84006 216797 90327549
Cardiac valve disease 34.53 10.66 31 84070 4604 90539742
Thyroid disorder 33.96 10.66 60 84041 17725 90526621
Hypothyroidism 33.44 10.66 117 83984 53010 90491336
Lumbar spinal stenosis 33.22 10.66 33 84068 5564 90538782
Tendonitis 33.20 10.66 66 84035 21306 90523040
Intervertebral disc protrusion 33.04 10.66 76 84025 27120 90517226
Oral infection 32.95 10.66 32 84069 5248 90539098
Inflammation 32.93 10.66 73 84028 178519 90365827
Therapeutic product effect decreased 32.92 10.66 139 83962 277432 90266914
Tooth fracture 32.91 10.66 49 84052 12551 90531795
Autoimmune disorder 32.87 10.66 15 84086 76729 90467617
Deep vein thrombosis 32.86 10.66 170 83931 91450 90452896
Blood oestrogen decreased 32.84 10.66 13 84088 412 90543934
Gastritis 32.64 10.66 99 84002 41654 90502692
Vision blurred 32.46 10.66 194 83907 110099 90434247
Intentional overdose 32.17 10.66 24 84077 93810 90450536
Vaginal disorder 32.02 10.66 15 84086 721 90543625
Vulvovaginal erythema 31.82 10.66 14 84087 581 90543765
Vulvovaginal injury 31.79 10.66 14 84087 582 90543764
Bronchial disorder 31.48 10.66 19 84082 1531 90542815
Pulmonary fibrosis 31.40 10.66 32 84069 107471 90436875
Lumbar radiculopathy 31.35 10.66 23 84078 2568 90541778
Dysuria 31.34 10.66 94 84007 39307 90505039
Obesity 31.28 10.66 31 84070 105476 90438870
Osteoarthritis 31.26 10.66 298 83803 195432 90348914
Aortic arteriosclerosis 31.06 10.66 37 84064 7647 90536699
Device failure 30.87 10.66 35 84066 6862 90537484
Pain in extremity 30.79 10.66 588 83513 449941 90094405
Pancytopenia 30.59 10.66 40 84061 120223 90424123
Musculoskeletal discomfort 30.44 10.66 63 84038 20928 90523418
Crying 30.42 10.66 71 84030 25574 90518772
Pollakiuria 30.39 10.66 83 84018 32922 90511424
Bone graft 30.19 10.66 16 84085 1004 90543342
Liver function test increased 30.01 10.66 21 84080 84834 90459512
Osteomyelitis 29.71 10.66 74 84027 27772 90516574
Taste disorder 29.70 10.66 10 84091 61536 90482810
Completed suicide 29.53 10.66 56 84045 145002 90399344
Tooth disorder 29.44 10.66 79 84022 31011 90513335
Breast pain 29.37 10.66 42 84059 10376 90533970
Post procedural complication 28.62 10.66 58 84043 18984 90525362
Anger 28.44 10.66 48 84053 13672 90530674
Hypertonic bladder 28.36 10.66 27 84074 4321 90540025
Ventricular extrasystoles 28.33 10.66 47 84054 13203 90531143
Non-cardiac chest pain 28.22 10.66 33 84068 6688 90537658
Hypersensitivity 28.07 10.66 278 83823 454399 90089947
Breast conserving surgery 27.94 10.66 16 84085 1169 90543177
Gait inability 27.71 10.66 59 84042 146397 90397949
Panic disorder 27.60 10.66 23 84078 3092 90541254
Cerebrovascular disorder 27.56 10.66 22 84079 2784 90541562
Coronary artery stenosis 27.53 10.66 29 84072 5237 90539109
Resorption bone increased 27.52 10.66 16 84085 1203 90543143
Vomiting 27.51 10.66 541 83560 787752 89756594
Vertigo 27.48 10.66 133 83968 69678 90474668
Fall 27.40 10.66 612 83489 481198 90063148
Prescribed underdose 27.29 10.66 18 84083 75001 90469345
Dilatation atrial 27.22 10.66 19 84082 1962 90542384
Red blood cell sedimentation rate increased 27.20 10.66 22 84079 82573 90461773
Uterine polyp 27.14 10.66 21 84080 2539 90541807
Granuloma 27.03 10.66 31 84070 6154 90538192
Gingivitis 26.75 10.66 38 84063 9331 90535015
Intervertebral disc disorder 26.66 10.66 29 84072 5431 90538915
Homicidal ideation 26.65 10.66 18 84083 1762 90542584
Gingival disorder 26.45 10.66 25 84076 3966 90540380
Rhonchi 26.41 10.66 22 84079 2956 90541390
Lower limb fracture 26.35 10.66 24 84077 84989 90459357
Eye disorder 26.34 10.66 70 84031 27320 90517026
Vitamin D deficiency 25.82 10.66 53 84048 17503 90526843
Influenza like illness 25.80 10.66 145 83956 80466 90463880
Vaginal odour 25.79 10.66 12 84089 568 90543778
Premature delivery 25.52 10.66 3 84098 38759 90505587
Irritability 25.51 10.66 82 84019 35580 90508766
Decreased appetite 25.47 10.66 225 83876 376315 90168031
Carotid artery disease 25.39 10.66 17 84084 1640 90542706
Stress 25.13 10.66 145 83956 81250 90463096
Joint injury 25.11 10.66 77 84024 32587 90511759
Product residue present 24.91 10.66 25 84076 4266 90540080
Nerve compression 24.66 10.66 39 84062 10527 90533819
Multiple sclerosis 24.63 10.66 69 84032 27771 90516575
Liver disorder 24.52 10.66 47 84054 121222 90423124
Uterine disorder 24.44 10.66 22 84079 3279 90541067
Melanocytic naevus 24.38 10.66 27 84074 5159 90539187
Libido decreased 24.33 10.66 21 84080 2961 90541385
Emotional disorder 24.13 10.66 47 84054 14950 90529396
Cystitis 24.06 10.66 124 83977 66594 90477752
Rhinitis allergic 23.90 10.66 50 84051 16735 90527611
Breast cancer metastatic 23.83 10.66 47 84054 15085 90529261
Bone density abnormal 23.82 10.66 24 84077 4116 90540230
Calcium deficiency 23.67 10.66 15 84086 1318 90543028
Oral discomfort 23.51 10.66 38 84063 10445 90533901
Bone erosion 23.28 10.66 10 84091 53011 90491335
Nerve injury 23.21 10.66 39 84062 11067 90533279
Bone disorder 23.17 10.66 60 84041 23060 90521286
Limb injury 23.04 10.66 73 84028 31435 90512911
Tinnitus 23.00 10.66 90 84011 43012 90501334
Subclavian artery embolism 23 10.66 5 84096 15 90544331
Myalgia 22.90 10.66 256 83845 174869 90369477
Walking aid user 22.77 10.66 3 84098 35503 90508843
Gallbladder disorder 22.59 10.66 54 84047 19749 90524597
Thyroid neoplasm 22.56 10.66 23 84078 3998 90540348
Gastroenteritis 22.56 10.66 69 84032 29160 90515186
Endometrial hyperplasia 22.50 10.66 13 84088 966 90543380
Underdose 22.45 10.66 11 84090 54006 90490340
Cardiac murmur 22.27 10.66 51 84050 18143 90526203
Leukopenia 22.19 10.66 37 84064 100673 90443673
Therapy non-responder 21.96 10.66 60 84041 136644 90407702
Defaecation urgency 21.91 10.66 28 84073 6214 90538132
Myocardial ischaemia 21.87 10.66 43 84058 13771 90530575
Pulmonary embolism 21.79 10.66 201 83900 130619 90413727
Spinal disorder 21.78 10.66 39 84062 11640 90532706
Lung neoplasm 21.76 10.66 29 84072 6706 90537640
Intentional product misuse 21.68 10.66 150 83951 89454 90454892
Vulvovaginal mycotic infection 21.66 10.66 28 84073 6286 90538060
Chronic fatigue syndrome 21.36 10.66 15 84086 1564 90542782
Tooth abscess 21.20 10.66 47 84054 16366 90527980
Fungal infection 21.10 10.66 87 84014 42574 90501772
Radicular pain 21.06 10.66 10 84091 496 90543850
Sleep apnoea syndrome 20.93 10.66 71 84030 31676 90512670
Kyphosis 20.78 10.66 19 84082 2889 90541457
Laryngeal pain 20.75 10.66 23 84078 4399 90539947
Suspected counterfeit product 20.69 10.66 10 84091 516 90543830
Urticaria pressure 20.58 10.66 6 84095 72 90544274
Biopsy breast abnormal 20.51 10.66 5 84096 28 90544318
Open reduction of fracture 20.44 10.66 13 84088 1149 90543197
Nail disorder 20.38 10.66 15 84086 59052 90485294
Cervical spinal stenosis 20.38 10.66 18 84083 2617 90541729
Micturition urgency 20.30 10.66 37 84064 11196 90533150
Essential hypertension 20.11 10.66 27 84074 6288 90538058
Dizziness 20.08 10.66 701 83400 588583 89955763
Affective disorder 19.92 10.66 30 84071 7763 90536583
Suicidal ideation 19.89 10.66 127 83974 73728 90470618
Cardiolipin antibody positive 19.87 10.66 7 84094 159 90544187
Varicose vein 19.87 10.66 29 84072 7298 90537048
Oedema peripheral 19.83 10.66 343 83758 257572 90286774
Bone fragmentation 19.83 10.66 11 84090 756 90543590
Stab wound 19.80 10.66 6 84095 83 90544263
Vaginal cyst 19.79 10.66 8 84093 268 90544078
Coma 19.68 10.66 23 84078 72609 90471737
Skin laceration 19.67 10.66 61 84040 25974 90518372
Plantar fasciitis 19.66 10.66 22 84079 4252 90540094
Dyspareunia 19.52 10.66 18 84083 2768 90541578
Urethral stenosis 19.43 10.66 8 84093 281 90544065
Mucosal inflammation 19.42 10.66 15 84086 57610 90486736
Heart rate irregular 19.40 10.66 58 84043 24210 90520136
Seasonal allergy 19.39 10.66 56 84045 22927 90521419
Cholelithiasis 19.22 10.66 98 84003 52408 90491938
Condition aggravated 19.18 10.66 414 83687 595131 89949215
Vulvovaginal rash 19.04 10.66 8 84093 296 90544050
Modified radical mastectomy 18.93 10.66 4 84097 10 90544336
Gastric disorder 18.87 10.66 71 84030 33313 90511033
Lupus-like syndrome 18.76 10.66 11 84090 48835 90495511
Anxiety disorder 18.75 10.66 23 84078 4899 90539447
Neoplasm progression 18.58 10.66 9 84092 44477 90499869
Alanine aminotransferase abnormal 18.52 10.66 24 84077 5402 90538944
Chromaturia 18.42 10.66 49 84052 19138 90525208
Cervical radiculopathy 18.23 10.66 13 84088 1389 90542957
Rib fracture 18.20 10.66 60 84041 26375 90517971
Jaw fracture 18.18 10.66 17 84084 2661 90541685
Agranulocytosis 18.13 10.66 5 84096 34997 90509349
Uterine prolapse 18.08 10.66 13 84088 1407 90542939
Periodontal disease 18.06 10.66 14 84087 1698 90542648
Vaginal cancer metastatic 17.95 10.66 3 84098 0 90544346
Lip neoplasm 17.93 10.66 4 84097 14 90544332
Labile hypertension 17.90 10.66 9 84092 506 90543840
Oedema mouth 17.86 10.66 16 84085 2370 90541976
Interstitial lung disease 17.85 10.66 27 84074 76378 90467968
Malabsorption 17.82 10.66 23 84078 5155 90539191
Oxygen saturation increased 17.78 10.66 8 84093 350 90543996
Abnormal dreams 17.77 10.66 35 84066 11222 90533124
Drug dispensed to wrong patient 17.76 10.66 8 84093 351 90543995
Carotid bruit 17.75 10.66 10 84091 708 90543638
Mood altered 17.70 10.66 45 84056 17099 90527247
Tonsillar disorder 17.62 10.66 12 84089 1190 90543156
Intermenstrual bleeding 17.46 10.66 31 84070 9192 90535154
Restless legs syndrome 17.30 10.66 53 84048 22417 90521929
Intermittent claudication 17.28 10.66 14 84087 1809 90542537
Rheumatoid arthritis 17.19 10.66 235 83866 362379 90181967
Fracture delayed union 17.19 10.66 16 84085 2490 90541856
Barrett's oesophagus 17.14 10.66 9 84092 554 90543792
Emphysema 17.06 10.66 36 84065 12119 90532227
Dysphagia 16.96 10.66 169 83932 112109 90432237
Hip arthroplasty 16.79 10.66 28 84073 76180 90468166
Sepsis 16.74 10.66 98 84003 179716 90364630
Ecchymosis 16.72 10.66 36 84065 12287 90532059
Hepatotoxicity 16.67 10.66 11 84090 45831 90498515
Glucose tolerance impaired 16.64 10.66 28 84073 7957 90536389
Skin abrasion 16.62 10.66 34 84067 11201 90533145
Lipoma 16.61 10.66 17 84084 2969 90541377
Pelvic pain 16.58 10.66 41 84060 15316 90529030
Rhinitis 16.56 10.66 38 84063 13534 90530812
Fear 16.51 10.66 43 84058 16579 90527767
Change of bowel habit 16.48 10.66 15 84086 2268 90542078
Oestrogen deficiency 16.42 10.66 6 84095 152 90544194
Bladder disorder 16.41 10.66 33 84068 10739 90533607
Fistula discharge 16.40 10.66 11 84090 1064 90543282
Impaired driving ability 16.29 10.66 22 84079 5151 90539195
Breast disorder female 16.20 10.66 6 84095 158 90544188
Oedema 16.17 10.66 114 83987 200181 90344165
Sleep disorder due to a general medical condition 15.91 10.66 11 84090 44727 90499619
Hysterectomy 15.90 10.66 34 84067 11550 90532796
Drug tolerance decreased 15.89 10.66 5 84096 32125 90512221
Plague 15.87 10.66 3 84098 3 90544343
Amaurosis fugax 15.86 10.66 9 84092 646 90543700
Septic shock 15.84 10.66 34 84067 84126 90460220
Coronary artery thrombosis 15.80 10.66 11 84090 1131 90543215
Limb asymmetry 15.78 10.66 10 84091 879 90543467
Neck injury 15.67 10.66 15 84086 2417 90541929
Hepatic function abnormal 15.66 10.66 12 84089 46276 90498070
Aneurysm 15.66 10.66 18 84083 3582 90540764
Ankle fracture 15.64 10.66 48 84053 20322 90524024
Endometrial cancer 15.61 10.66 18 84083 3594 90540752
Nightmare 15.58 10.66 50 84051 21675 90522671
Bundle branch block left 15.57 10.66 27 84074 7858 90536488
Frustration tolerance decreased 15.54 10.66 27 84074 7869 90536477
Dyslipidaemia 15.44 10.66 31 84070 10076 90534270
Mitral valve calcification 15.32 10.66 11 84090 1187 90543159
Angiopathy 15.31 10.66 22 84079 5458 90538888
Abdominal pain upper 15.27 10.66 217 83884 332457 90211889
Hepatocellular injury 15.26 10.66 4 84097 28954 90515392
Thyrotoxic periodic paralysis 15.18 10.66 4 84097 32 90544314
Bowel movement irregularity 15.14 10.66 24 84077 6490 90537856
Neutrophil count decreased 15.10 10.66 27 84074 71505 90472841
Glaucoma 15.10 10.66 48 84053 20707 90523639
Tooth loss 15.09 10.66 26 84075 7528 90536818
Intestinal adhesion lysis 15.01 10.66 3 84098 5 90544341
Multiple injuries 14.95 10.66 13 84088 1852 90542494
Osteoporosis 14.92 10.66 146 83955 96385 90447961
Back disorder 14.90 10.66 55 84046 25576 90518770
Immunodeficiency 14.89 10.66 11 84090 43223 90501123
Product quality issue 14.82 10.66 125 83976 79200 90465146
Cardiac failure 14.79 10.66 52 84049 109444 90434902
Musculoskeletal chest pain 14.68 10.66 52 84049 23698 90520648
Fungal cystitis 14.66 10.66 3 84098 6 90544340
Hypertensive heart disease 14.63 10.66 15 84086 2625 90541721
Disturbance in attention 14.59 10.66 84 84017 47025 90497321
Mixed incontinence 14.56 10.66 5 84096 105 90544241
Encephalopathy 14.52 10.66 13 84088 46431 90497915
Toxic epidermal necrolysis 14.50 10.66 6 84095 32522 90511824
Nasal septum deviation 14.49 10.66 13 84088 1930 90542416
Pulpitis dental 14.38 10.66 10 84091 1026 90543320
Oesophageal disorder 14.29 10.66 15 84086 2698 90541648
Medical device removal 14.28 10.66 11 84090 1322 90543024
Aortic stenosis 14.25 10.66 23 84078 6313 90538033
Platelet count decreased 14.20 10.66 72 84029 136897 90407449
Otitis media 14.16 10.66 22 84079 5848 90538498
Adverse reaction 14.04 10.66 5 84096 29707 90514639
Acute coronary syndrome 14.00 10.66 31 84070 10782 90533564
Sinus tachycardia 13.99 10.66 58 84043 28455 90515891
Feelings of worthlessness 13.96 10.66 7 84094 391 90543955
Osteoma 13.87 10.66 4 84097 46 90544300
Muscle disorder 13.87 10.66 21 84080 5458 90538888
Atelectasis 13.87 10.66 52 84049 24357 90519989
Atrial fibrillation 13.86 10.66 187 83914 133424 90410922
Gallbladder oedema 13.82 10.66 6 84095 241 90544105
C-reactive protein increased 13.80 10.66 105 83996 181284 90363062
Altered state of consciousness 13.76 10.66 6 84095 31526 90512820
Tremor 13.74 10.66 209 83892 152964 90391382
Urticaria 13.65 10.66 206 83895 312528 90231818
Breast enlargement 13.60 10.66 12 84089 1743 90542603
Hypersexuality 13.56 10.66 8 84093 618 90543728
Platelet aggregation increased 13.56 10.66 3 84098 10 90544336
Endometrial cancer stage I 13.48 10.66 6 84095 256 90544090
Loose tooth 13.47 10.66 17 84084 3726 90540620
Raynaud's phenomenon 13.46 10.66 10 84091 1138 90543208
Liver function test abnormal 13.43 10.66 87 84014 50758 90493588
Cerebral atrophy 13.40 10.66 21 84080 5625 90538721
Bone pain 13.39 10.66 101 84000 61882 90482464
Physical assault 13.36 10.66 9 84092 877 90543469
Toe operation 13.31 10.66 10 84091 1158 90543188
Osteomalacia 13.28 10.66 9 84092 886 90543460
Major depression 13.26 10.66 29 84072 10006 90534340
Dermal cyst 13.25 10.66 13 84088 2158 90542188
Panic attack 13.22 10.66 54 84047 26311 90518035
Delirium 13.15 10.66 51 84050 104308 90440038
Eosinophilia 13.15 10.66 5 84096 28528 90515818
Endometriosis 13.14 10.66 22 84079 6226 90538120
Vulval oedema 13.05 10.66 5 84096 145 90544201
Therapeutic product effect incomplete 13.03 10.66 116 83985 193780 90350566
Arthritis 13.03 10.66 223 83878 167092 90377254
Aortic valve sclerosis 12.99 10.66 10 84091 1200 90543146
Urge incontinence 12.93 10.66 10 84091 1209 90543137
Cholestasis 12.81 10.66 9 84092 36290 90508056
Urethral disorder 12.80 10.66 6 84095 289 90544057
Palmar-plantar erythrodysaesthesia syndrome 12.76 10.66 5 84096 28018 90516328
Pelvic fracture 12.76 10.66 37 84064 15182 90529164
Mental status changes 12.76 10.66 78 84023 44601 90499745
Hyperaesthesia teeth 12.73 10.66 13 84088 2264 90542082
Metabolic acidosis 12.69 10.66 20 84081 55656 90488690
Breast reconstruction 12.65 10.66 6 84095 297 90544049
Traumatic liver injury 12.63 10.66 6 84095 298 90544048
Lactic acidosis 12.61 10.66 17 84084 50446 90493900
Adhesion 12.60 10.66 10 84091 1254 90543092
Otitis externa 12.51 10.66 12 84089 1939 90542407
Scar 12.50 10.66 37 84064 15358 90528988
Fracture malunion 12.50 10.66 5 84096 163 90544183
Clubbing 12.46 10.66 7 84094 493 90543853
Hyperkalaemia 12.43 10.66 26 84075 64938 90479408
Drug dependence 12.36 10.66 57 84044 29270 90515076
Product packaging issue 12.27 10.66 11 84090 1630 90542716
Headache 12.26 10.66 944 83157 861802 89682544
Benign breast neoplasm 12.22 10.66 10 84091 1310 90543036
Stevens-Johnson syndrome 12.18 10.66 6 84095 29370 90514976
Migraine with aura 12.13 10.66 15 84086 3221 90541125
Cerebral ischaemia 12.12 10.66 23 84078 7173 90537173
Pneumonia 12.07 10.66 477 83624 637582 89906764
Vulval disorder 12.07 10.66 10 84091 1334 90543012
Urticaria thermal 12.04 10.66 7 84094 526 90543820
Foaming at mouth 12.03 10.66 10 84091 1340 90543006
Withdrawal bleed 12.02 10.66 4 84097 76 90544270
Vascular calcification 11.83 10.66 8 84093 784 90543562
Application site pain 11.82 10.66 18 84083 4702 90539644
Meniere's disease 11.80 10.66 5 84096 189 90544157
Vertebral lateral recess stenosis 11.79 10.66 6 84095 346 90544000
Acute sinusitis 11.75 10.66 17 84084 4244 90540102
Diverticulitis 11.74 10.66 77 84024 45110 90499236
Gingival recession 11.71 10.66 11 84090 1732 90542614
Cellulitis 11.70 10.66 133 83968 91204 90453142
Mood swings 11.68 10.66 44 84057 20658 90523688
Dyslexia 11.64 10.66 7 84094 560 90543786
Lithotripsy 11.61 10.66 3 84098 22 90544324
Marital problem 11.58 10.66 5 84096 198 90544148
Nipple pain 11.54 10.66 6 84095 362 90543984
Osteoarthropathy 11.54 10.66 6 84095 362 90543984
Oedema genital 11.54 10.66 5 84096 200 90544146
Intervertebral disc space narrowing 11.51 10.66 9 84092 1105 90543241
Iron deficiency anaemia 11.50 10.66 48 84053 23614 90520732
Application site reaction 11.50 10.66 8 84093 822 90543524
Retinal vein occlusion 11.49 10.66 13 84088 2543 90541803
Blood albumin decreased 11.45 10.66 38 84063 16765 90527581
Suicide attempt 11.44 10.66 34 84067 75365 90468981
Post procedural cellulitis 11.43 10.66 4 84097 89 90544257
Low density lipoprotein increased 11.41 10.66 24 84077 8061 90536285
Ligamentum flavum hypertrophy 11.40 10.66 6 84095 371 90543975
Off label use 11.38 10.66 875 83226 1101377 89442969
Pneumocystis jirovecii pneumonia 11.36 10.66 3 84098 21613 90522733
Giant cell arteritis 11.29 10.66 14 84087 3015 90541331
Neurotoxicity 11.24 10.66 3 84098 21464 90522882
Migraine 11.16 10.66 243 83858 190149 90354197
Vaginal dysplasia 11.15 10.66 4 84097 96 90544250
Cholecystitis 11.13 10.66 38 84063 17002 90527344
Osteitis deformans 11.13 10.66 5 84096 218 90544128
Postmenopause 11.11 10.66 4 84097 97 90544249
Reaction to excipient 11.10 10.66 11 84090 1849 90542497
Pharyngeal oedema 11.09 10.66 33 84068 13738 90530608
Tendon injury 11.06 10.66 12 84089 2241 90542105
Onychomycosis 11.06 10.66 11 84090 37365 90506981
Increased tendency to bruise 11.04 10.66 30 84071 11860 90532486
Obsessive-compulsive disorder 11.03 10.66 17 84084 4487 90539859
Visual acuity reduced 11.00 10.66 47 84054 23363 90520983
Varicose vein operation 10.97 10.66 3 84098 28 90544318
Gait disturbance 10.97 10.66 318 83783 260178 90284168
Peripheral artery occlusion 10.96 10.66 10 84091 1516 90542830
Tibia fracture 10.94 10.66 20 84081 6067 90538279
Arrhythmia 10.91 10.66 72 84029 42260 90502086
Medication error 10.90 10.66 41 84060 84611 90459735
Insulin-like growth factor decreased 10.90 10.66 6 84095 406 90543940
Device dislocation 10.86 10.66 8 84093 31474 90512872
Application site swelling 10.79 10.66 7 84094 640 90543706
Product cleaning inadequate 10.79 10.66 3 84098 30 90544316
Vaginal erosion 10.79 10.66 3 84098 30 90544316
Anhedonia 10.78 10.66 29 84072 11402 90532944
Renal disorder 10.75 10.66 66 84035 37793 90506553
Bone density decreased 10.74 10.66 38 84063 17307 90527039

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 256.66 11.20 250 64190 65786 110459073
Vulvovaginal burning sensation 236.04 11.20 75 64365 1994 110522865
Coronary artery disease 235.83 11.20 248 64192 71442 110453417
Cerebrovascular accident 226.98 11.20 391 64049 180893 110343966
Vulvovaginal discomfort 174.13 11.20 60 64380 2064 110522795
Product prescribing error 162.46 11.20 174 64266 51157 110473702
Depression 159.65 11.20 476 63964 316859 110208000
Hyperlipidaemia 149.25 11.20 141 64299 35707 110489152
Carpal tunnel syndrome 126.18 11.20 105 64335 22505 110502354
Breast cancer 126.12 11.20 133 64307 38409 110486450
Vulvovaginal dryness 120.27 11.20 49 64391 2698 110522161
Acute kidney injury 118.97 11.20 117 64323 635313 109889546
Myocardial infarction 117.02 11.20 309 64131 191774 110333085
Pericarditis 113.55 11.20 3 64437 219111 110305748
Toxicity to various agents 113.32 11.20 70 64370 480485 110044374
Transient ischaemic attack 111.93 11.20 161 64279 63821 110461038
Oestrogen receptor assay positive 107.24 11.20 28 64412 359 110524500
Intervertebral disc degeneration 107.23 11.20 87 64353 17998 110506861
Anxiety 106.08 11.20 440 64000 344638 110180221
Chest pain 105.76 11.20 467 63973 375908 110148951
Neutropenia 105.67 11.20 43 64397 374577 110150282
Fibrocystic breast disease 103.41 11.20 31 64409 675 110524184
Spinal osteoarthritis 102.93 11.20 89 64351 20094 110504765
Death 102.04 11.20 156 64284 698713 109826146
Osteopenia 101.44 11.20 92 64348 22117 110502742
Febrile neutropenia 100.26 11.20 30 64410 316737 110208122
Mitral valve incompetence 100.24 11.20 110 64330 33219 110491640
Breast cancer in situ 98.74 11.20 34 64406 1167 110523692
Maternal exposure during pregnancy 97.01 11.20 16 64424 254867 110269992
Vulvovaginal pain 94.87 11.20 42 64398 2842 110522017
Feeling abnormal 92.60 11.20 273 64167 180438 110344421
Spinal stenosis 91.10 11.20 81 64359 18975 110505884
Rotator cuff syndrome 85.53 11.20 74 64366 16720 110508139
Progesterone receptor assay positive 84.74 11.20 21 64419 215 110524644
Meniscus injury 84.26 11.20 54 64386 7739 110517120
Low turnover osteopathy 81.51 11.20 34 64406 1988 110522871
General physical health deterioration 81.04 11.20 77 64363 425218 110099641
Body height decreased 80.53 11.20 59 64381 10504 110514355
Drug abuse 80.37 11.20 6 64434 177405 110347454
Product complaint 80.29 11.20 66 64374 13906 110510953
Ventricular hypertrophy 79.11 11.20 50 64390 6995 110517864
Dental caries 79.03 11.20 63 64377 12710 110512149
Expired product administered 78.63 11.20 53 64387 8267 110516592
Wound 78.28 11.20 20 64420 234417 110290442
Vulvovaginal pruritus 76.98 11.20 38 64402 3293 110521566
Stress urinary incontinence 76.23 11.20 32 64408 1901 110522958
Folliculitis 75.02 11.20 6 64434 167647 110357212
Pyrexia 72.56 11.20 274 64166 897991 109626868
Carotid artery stenosis 71.21 11.20 52 64388 9211 110515648
Cardiac disorder 69.80 11.20 144 64296 76136 110448723
Vaginal haemorrhage 68.97 11.20 79 64361 24995 110499864
Cardiac failure congestive 68.82 11.20 219 64221 150781 110374078
Glossodynia 68.48 11.20 22 64418 221982 110302877
Angina unstable 67.18 11.20 64 64376 16368 110508491
Temporomandibular joint syndrome 66.01 11.20 36 64404 3833 110521026
Gastrooesophageal reflux disease 65.38 11.20 242 64198 179734 110345125
Femur fracture 65.10 11.20 103 64337 44366 110480493
Exposure during pregnancy 64.84 11.20 10 64430 167414 110357445
Cystocele 64.64 11.20 24 64416 1028 110523831
Emotional distress 64.45 11.20 103 64337 44744 110480115
Exostosis of jaw 64.42 11.20 25 64415 1210 110523649
Breast mass 63.26 11.20 46 64394 8095 110516764
Urinary tract infection 62.77 11.20 364 64076 325918 110198941
Thrombocytopenia 62.07 11.20 67 64373 348818 110176041
Lacunar infarction 61.70 11.20 41 64399 6245 110518614
Stress fracture 61.16 11.20 43 64397 7178 110517681
Back pain 60.74 11.20 397 64043 370599 110154260
Chronic disease 60.59 11.20 16 64424 215 110524644
Bronchial neoplasm 59.37 11.20 19 64421 517 110524342
Hypertension 59.19 11.20 503 63937 509581 110015278
Treatment failure 59.13 11.20 45 64395 277189 110247670
Haemorrhoids 58.37 11.20 87 64353 35585 110489274
Nasal turbinate hypertrophy 58.33 11.20 21 64419 823 110524036
Bronchitis 57.74 11.20 212 64228 156820 110368039
Osteonecrosis 57.68 11.20 84 64356 33657 110491202
Nervousness 57.64 11.20 88 64352 36763 110488096
Infusion related reaction 57.56 11.20 83 64357 381079 110143780
Cataract 55.80 11.20 135 64305 79350 110445509
Rheumatoid factor positive 55.46 11.20 6 64434 131634 110393225
Stomatitis 54.96 11.20 46 64394 270196 110254663
Disease progression 54.14 11.20 38 64402 243996 110280863
Breast cancer female 53.73 11.20 50 64390 12418 110512441
Jaw disorder 53.60 11.20 35 64405 5177 110519682
Hypoacusis 53.58 11.20 83 64357 35108 110489751
Pancytopenia 52.97 11.20 28 64412 209585 110315274
Product dispensing error 52.75 11.20 56 64384 16289 110508570
Vaginal infection 51.86 11.20 38 64402 6766 110518093
Breast calcifications 51.50 11.20 20 64420 970 110523889
Atrophic vulvovaginitis 51.30 11.20 22 64418 1378 110523481
Drug interaction 51.22 11.20 137 64303 500046 110024813
Renal impairment 50.91 11.20 23 64417 188422 110336437
Systemic lupus erythematosus 50.85 11.20 44 64396 254294 110270565
Urinary incontinence 50.80 11.20 97 64343 48490 110476369
Tricuspid valve incompetence 50.69 11.20 66 64374 23807 110501052
Angina pectoris 50.54 11.20 112 64328 62183 110462676
Menopausal symptoms 50.38 11.20 26 64414 2475 110522384
Coronary artery occlusion 49.07 11.20 53 64387 15719 110509140
Endometrial ablation 48.78 11.20 19 64421 929 110523930
Product use in unapproved indication 48.52 11.20 119 64321 447258 110077601
Liver injury 48.01 11.20 14 64426 150399 110374460
Sepsis 47.74 11.20 73 64367 327273 110197586
Malignant neoplasm progression 47.64 11.20 21 64419 174546 110350313
Drug intolerance 47.41 11.20 104 64336 406408 110118451
Arteriosclerosis 47.27 11.20 65 64375 24702 110500157
Contraindicated product administered 47.19 11.20 45 64395 248222 110276637
Muscle injury 47.02 11.20 12 64428 140795 110384064
Breast disorder 46.45 11.20 24 64416 2290 110522569
Mammogram abnormal 46.39 11.20 16 64424 552 110524307
Diverticulum 46.26 11.20 51 64389 15475 110509384
Hiatus hernia 46.13 11.20 68 64372 27538 110497321
Psoriatic arthropathy 45.85 11.20 29 64411 196732 110328127
Mitral valve prolapse 45.84 11.20 24 64416 2354 110522505
Osteoarthritis 45.57 11.20 219 64221 182404 110342455
Synovitis 45.11 11.20 56 64384 274036 110250823
Morton's neuralgia 43.77 11.20 9 64431 35 110524824
Fracture nonunion 43.06 11.20 20 64420 1514 110523345
Uterine leiomyoma 43.05 11.20 36 64404 7764 110517095
Spondylolisthesis 42.76 11.20 27 64413 3771 110521088
Peripheral vascular disorder 42.08 11.20 37 64403 8539 110516320
Bronchial haemorrhage 41.80 11.20 19 64421 1368 110523491
Aortic valve incompetence 41.57 11.20 41 64399 10940 110513919
Lip dry 41.06 11.20 5 64435 100078 110424781
Pain in extremity 40.97 11.20 449 63991 486669 110038190
Breast tenderness 40.75 11.20 23 64417 2617 110522242
Insomnia 40.42 11.20 353 64087 360237 110164622
Vaginal disorder 40.15 11.20 14 64426 499 110524360
Back disorder 40.07 11.20 55 64385 20867 110503992
Blood pressure abnormal 40.04 11.20 57 64383 22367 110502492
Lower respiratory tract infection 39.65 11.20 50 64390 243056 110281803
Postmenopausal haemorrhage 39.53 11.20 20 64420 1826 110523033
Palpitations 39.05 11.20 190 64250 159022 110365837
Therapeutic response unexpected 38.79 11.20 58 64382 23785 110501074
Anaemia postoperative 38.78 11.20 20 64420 1901 110522958
Ligament sprain 38.20 11.20 47 64393 16021 110508838
Breast cyst 37.63 11.20 18 64422 1456 110523403
Wrong strength 37.29 11.20 11 64429 226 110524633
Blood pressure increased 37.21 11.20 268 64172 258105 110266754
Headache 36.59 11.20 719 63721 881658 109643201
Oral infection 36.45 11.20 30 64410 6331 110518528
Completed suicide 36.35 11.20 53 64387 242328 110282531
Tooth disorder 36.02 11.20 63 64377 29446 110495413
Cystitis 35.95 11.20 102 64338 65934 110458925
Foot fracture 35.78 11.20 58 64382 25488 110499371
Tooth fracture 35.40 11.20 41 64399 13126 110511733
Decreased appetite 35.24 11.20 150 64290 475696 110049163
Hepatic enzyme increased 35.05 11.20 85 64355 320807 110204052
Cervicobrachial syndrome 34.89 11.20 16 64424 1176 110523683
Rectocele 34.15 11.20 14 64426 783 110524076
Ventricular dysfunction 34.07 11.20 31 64409 7480 110517379
Scoliosis 33.79 11.20 33 64407 8700 110516159
Mobility decreased 33.60 11.20 54 64386 237368 110287491
Drug-induced liver injury 33.46 11.20 14 64426 120053 110404806
Blister 32.85 11.20 51 64389 227325 110297534
Multiple sclerosis 32.85 11.20 56 64384 25642 110499217
Ill-defined disorder 32.75 11.20 26 64414 156827 110368032
Uterine disorder 32.53 11.20 19 64421 2307 110522552
Bone density abnormal 32.50 11.20 23 64417 3880 110520979
Intervertebral disc protrusion 32.35 11.20 58 64382 27640 110497219
Cardiovascular disorder 32.32 11.20 52 64388 22708 110502151
Hormone level abnormal 32.12 11.20 19 64421 2361 110522498
Hospitalisation 31.84 11.20 22 64418 142471 110382388
Vaginal prolapse 31.79 11.20 11 64429 383 110524476
Seborrhoeic keratosis 31.77 11.20 21 64419 3171 110521688
Crying 31.65 11.20 55 64385 25573 110499286
Blood oestrogen decreased 31.50 11.20 10 64430 265 110524594
Drug effective for unapproved indication 31.39 11.20 40 64400 14127 110510732
Resorption bone increased 31.05 11.20 16 64424 1518 110523341
Musculoskeletal discomfort 31.03 11.20 52 64388 23486 110501373
Facet joint syndrome 30.92 11.20 9 64431 96819 110428040
Septic shock 30.58 11.20 28 64412 157500 110367359
Nerve compression 30.48 11.20 35 64405 11102 110513757
Hyperkalaemia 30.30 11.20 21 64419 135775 110389084
Discomfort 30.22 11.20 49 64391 214658 110310201
Intentional overdose 30.22 11.20 20 64420 132481 110392378
Cardiac valve disease 30.11 11.20 27 64413 6394 110518465
Thyroid disorder 30.10 11.20 43 64397 16926 110507933
Drug abuser 29.93 11.20 25 64415 5384 110519475
Abdominal discomfort 29.87 11.20 123 64317 393735 110131124
Peptic ulcer 29.87 11.20 29 64411 7590 110517269
Uterine polyp 29.87 11.20 17 64423 1966 110522893
Bronchial disorder 29.43 11.20 19 64421 2757 110522102
Hepatic function abnormal 29.07 11.20 8 64432 89287 110435572
Wound infection 28.96 11.20 10 64430 96455 110428404
Poor quality product administered 28.94 11.20 23 64417 4618 110520241
Cerebrovascular disorder 28.91 11.20 21 64419 3690 110521169
Muscle strain 28.65 11.20 34 64406 11168 110513691
Arteriosclerosis coronary artery 28.57 11.20 52 64388 25066 110499793
Gastritis 28.31 11.20 82 64358 53617 110471242
Multiple organ dysfunction syndrome 28.24 11.20 28 64412 151682 110373177
Interstitial lung disease 27.97 11.20 24 64416 139310 110385549
Vaginal cyst 27.76 11.20 8 64432 151 110524708
Aortic arteriosclerosis 27.64 11.20 33 64407 10905 110513954
Platelet count decreased 27.63 11.20 58 64382 230385 110294474
Vertigo 27.60 11.20 112 64328 86758 110438101
Rhonchi 27.34 11.20 22 64418 4496 110520363
Tendonitis 27.17 11.20 52 64388 26031 110498828
Nocturia 27.17 11.20 41 64399 16949 110507910
Peripheral swelling 27.14 11.20 132 64308 403902 110120957
Pain 27.10 11.20 738 63702 954217 109570642
Leukopenia 27.08 11.20 28 64412 148763 110376096
Rhinitis allergic 26.90 11.20 42 64398 17880 110506979
Breast pain 26.65 11.20 31 64409 9969 110514890
Confusional state 26.59 11.20 162 64278 468518 110056341
Seasonal allergy 26.57 11.20 44 64396 19678 110505181
Breast hyperplasia 26.48 11.20 8 64432 179 110524680
Grip strength decreased 26.44 11.20 7 64433 80167 110444692
Lung disorder 26.38 11.20 40 64400 180007 110344852
Vaginal odour 26.31 11.20 10 64430 457 110524402
Hypertonic bladder 26.27 11.20 23 64417 5279 110519580
Lumbar spinal stenosis 26.19 11.20 25 64415 6408 110518451
Swelling 25.77 11.20 111 64329 350930 110173929
Lumbar radiculopathy 25.75 11.20 17 64423 2561 110522298
Panic disorder 25.64 11.20 19 64421 3442 110521417
Bone disorder 25.55 11.20 45 64395 21147 110503712
Agranulocytosis 25.54 11.20 3 64437 61757 110463102
Vision blurred 25.46 11.20 145 64295 128877 110395982
Dyspareunia 25.35 11.20 16 64424 2233 110522626
Cholelithiasis 25.33 11.20 88 64352 63334 110461525
Subclavian artery embolism 25.32 11.20 5 64435 15 110524844
Coma 25.29 11.20 19 64421 117850 110407009
Defaecation urgency 24.80 11.20 28 64412 8719 110516140
Peripheral venous disease 24.77 11.20 9 64431 84108 110440751
Non-cardiac chest pain 24.52 11.20 30 64410 10168 110514691
Joint range of motion decreased 24.43 11.20 21 64419 121811 110403048
Cardiac failure 24.42 11.20 45 64395 187581 110337278
Cardiomegaly 24.33 11.20 53 64387 29077 110495782
Burning sensation 24.22 11.20 92 64348 69120 110455739
Gingivitis 24.21 11.20 30 64410 10301 110514558
Vulvovaginal injury 24.16 11.20 9 64431 389 110524470
Migraine 24.09 11.20 177 64263 171475 110353384
Blood triglycerides increased 24.07 11.20 47 64393 23879 110500980
Mucosal inflammation 24.05 11.20 13 64427 96128 110428731
Joint injury 23.97 11.20 64 64376 39930 110484929
Hypotension 23.87 11.20 193 64247 523656 110001203
Dilatation atrial 23.83 11.20 19 64421 3833 110521026
Chronic obstructive pulmonary disease 23.77 11.20 126 64314 109032 110415827
Intervertebral disc disorder 23.55 11.20 22 64418 5490 110519369
Bladder prolapse 23.45 11.20 13 64427 1429 110523430
Osteomyelitis 23.40 11.20 60 64380 36540 110488319
Gallbladder disorder 23.24 11.20 43 64397 20986 110503873
Urticaria pressure 23.19 11.20 6 64434 74 110524785
Lung neoplasm 23.15 11.20 26 64414 8050 110516809
Carotid artery disease 23.04 11.20 15 64425 2208 110522651
Granuloma 22.95 11.20 28 64412 9462 110515397
Post procedural complication 22.83 11.20 49 64391 26609 110498250
Infection 22.80 11.20 121 64319 362079 110162780
Gastric disorder 22.71 11.20 56 64384 33301 110491558
Drug resistance 22.68 11.20 3 64437 56371 110468488
Eye disorder 22.35 11.20 51 64389 28855 110496004
Cardiolipin antibody positive 22.25 11.20 7 64433 180 110524679
Modified radical mastectomy 22.13 11.20 4 64436 6 110524853
Essential hypertension 22.05 11.20 25 64415 7822 110517037
Deep vein thrombosis postoperative 21.93 11.20 4 64436 59287 110465572
Vulvovaginal erythema 21.88 11.20 9 64431 508 110524351
Dizziness 21.63 11.20 546 63894 697647 109827212
Frustration tolerance decreased 21.51 11.20 26 64414 8705 110516154
Metabolic acidosis 21.50 11.20 16 64424 99728 110425131
Eosinophilia 21.23 11.20 4 64436 57932 110466927
Altered state of consciousness 21.08 11.20 4 64436 57622 110467237
Pollakiuria 20.95 11.20 65 64375 44130 110480729
Vulvovaginal rash 20.88 11.20 7 64433 221 110524638
Arthritis 20.84 11.20 168 64272 167418 110357441
Hyperhidrosis 20.77 11.20 183 64257 187115 110337744
Large intestine polyp 20.74 11.20 34 64406 15083 110509776
Affective disorder 20.70 11.20 29 64411 11212 110513647
Vulval oedema 20.69 11.20 6 64434 116 110524743
Neutrophil count decreased 20.64 11.20 24 64416 120917 110403942
Oedema mouth 20.57 11.20 16 64424 3114 110521745
Vulvovaginal swelling 20.40 11.20 9 64431 604 110524255
Emotional disorder 20.37 11.20 35 64405 16125 110508734
Device failure 20.31 11.20 23 64417 7184 110517675
Tooth abscess 20.24 11.20 38 64402 18751 110506108
Skin laceration 20.22 11.20 54 64386 33699 110491160
Encephalopathy 20.21 11.20 11 64429 81044 110443815
Gastroenteritis 20.21 11.20 59 64381 38741 110486118
Dyslexia 20.18 11.20 8 64432 410 110524449
Ankle fracture 20.02 11.20 39 64401 19780 110505079
Drug withdrawal syndrome 19.95 11.20 58 64382 37996 110486863
Osteoporosis 19.94 11.20 102 64338 87050 110437809
Thyroid neoplasm 19.82 11.20 16 64424 3285 110521574
Wheezing 19.78 11.20 79 64361 255151 110269708
Spinal disorder 19.75 11.20 29 64411 11699 110513160
Blood cholesterol increased 19.70 11.20 179 64261 184606 110340253
Inflammation 19.69 11.20 53 64387 193185 110331674
Memory impairment 19.60 11.20 188 64252 196756 110328103
Cytomegalovirus infection 19.45 11.20 4 64436 54440 110470419
Limb injury 19.39 11.20 57 64383 37579 110487280
Illness 19.38 11.20 97 64343 82074 110442785
Liver function test increased 19.35 11.20 14 64426 88534 110436325
Vaginal cancer metastatic 19.35 11.20 3 64437 0 110524859
Varicose vein 19.31 11.20 22 64418 6918 110517941
Diabetes mellitus 19.15 11.20 111 64329 99270 110425589
Bone pain 19.14 11.20 82 64358 65051 110459808
Prescribed overdose 18.94 11.20 14 64426 87567 110437292
Cholestasis 18.84 11.20 7 64433 64511 110460348
Carotid bruit 18.81 11.20 9 64431 728 110524131
Nerve injury 18.79 11.20 27 64413 10686 110514173
Toxic epidermal necrolysis 18.62 11.20 5 64435 56722 110468137
Lactic acidosis 18.61 11.20 16 64424 92795 110432064
Gingival disorder 18.56 11.20 17 64423 4136 110520723
Mixed incontinence 18.42 11.20 5 64435 75 110524784
Respiratory failure 18.42 11.20 64 64376 215268 110309591
Hyponatraemia 18.41 11.20 65 64375 217588 110307271
Ischaemic cardiomyopathy 18.35 11.20 23 64417 7988 110516871
Hepatotoxicity 18.31 11.20 7 64433 63393 110461466
Arthralgia 18.13 11.20 588 63852 779044 109745815
Oestrogen deficiency 18.07 11.20 5 64435 81 110524778
Suspected counterfeit product 18.05 11.20 9 64431 797 110524062
Endometrial cancer stage I 17.97 11.20 6 64434 187 110524672
Heart rate irregular 17.74 11.20 52 64388 34222 110490637
Taste disorder 17.62 11.20 8 64432 65379 110459480
Melanocytic naevus 17.59 11.20 19 64421 5635 110519224
Bowel movement irregularity 17.56 11.20 22 64418 7638 110517221
Phyllodes tumour 17.52 11.20 5 64435 91 110524768
Change of bowel habit 17.43 11.20 14 64426 2855 110522004
Stress 17.36 11.20 113 64327 105235 110419624
Neoplasm progression 17.26 11.20 8 64432 64587 110460272
Hypothyroidism 17.15 11.20 86 64354 72813 110452046
Dysuria 17.06 11.20 75 64365 60156 110464703
Incorrect route of product administration 17.01 11.20 8 64432 64053 110460806
Intentional product misuse 16.94 11.20 134 64306 132770 110392089
Pelvic pain 16.87 11.20 32 64408 15910 110508949
Myalgia 16.86 11.20 201 64239 222180 110302679
Pneumonia 16.80 11.20 386 64054 876328 109648531
Laryngeal pain 16.73 11.20 19 64421 5956 110518903
Cervical radiculopathy 16.63 11.20 11 64429 1663 110523196
Bladder disorder 16.58 11.20 26 64414 11111 110513748
Breast disorder female 16.50 11.20 5 64435 113 110524746
Uterine prolapse 16.46 11.20 9 64431 963 110523896
Barrett's oesophagus 16.35 11.20 8 64432 680 110524179
Type 2 diabetes mellitus 16.31 11.20 51 64389 177181 110347678
Mitral valve calcification 16.31 11.20 11 64429 1717 110523142
Coronary artery stenosis 16.31 11.20 29 64411 13729 110511130
Jaw fracture 16.26 11.20 14 64426 3142 110521717
Neck injury 16.21 11.20 14 64426 3154 110521705
Endometrial hyperplasia 16.20 11.20 8 64432 694 110524165
Adjustment disorder with depressed mood 16.15 11.20 3 64437 43880 110480979
Kyphosis 16.14 11.20 14 64426 3173 110521686
Dislocation of vertebra 16.06 11.20 3 64437 43718 110481141
Vaginal dysplasia 15.88 11.20 4 64436 44 110524815
Rash maculo-papular 15.87 11.20 12 64428 74210 110450649
Fall 15.84 11.20 462 63978 603020 109921839
Obesity 15.82 11.20 26 64414 113325 110411534
Urge incontinence 15.78 11.20 10 64430 1405 110523454
Musculoskeletal stiffness 15.71 11.20 97 64343 279725 110245134
Drug dispensed to wrong patient 15.71 11.20 8 64432 741 110524118
Chronic fatigue syndrome 15.69 11.20 10 64430 1419 110523440
Stevens-Johnson syndrome 15.65 11.20 4 64436 46897 110477962
Bone fragmentation 15.61 11.20 8 64432 751 110524108
Alanine aminotransferase abnormal 15.61 11.20 23 64417 9311 110515548
Gait disturbance 15.55 11.20 238 64202 277970 110246889
Oxygen saturation increased 15.52 11.20 8 64432 760 110524099
Cardiac murmur 15.36 11.20 40 64400 24588 110500271
Underdose 15.31 11.20 9 64431 63545 110461314
Neurotoxicity 15.29 11.20 3 64437 42204 110482655
Stab wound 15.20 11.20 6 64434 304 110524555
Plague 15.19 11.20 3 64437 9 110524850
Sleep apnoea syndrome 15.19 11.20 55 64385 40392 110484467
Urticaria thermal 15.14 11.20 7 64433 524 110524335
Acute myocardial infarction 15.13 11.20 92 64348 83685 110441174
Cervical spinal stenosis 15.05 11.20 13 64427 2929 110521930
Gingival recession 14.97 11.20 10 64430 1536 110523323
Hypoglycaemia 14.96 11.20 28 64412 116076 110408783
Helicobacter infection 14.92 11.20 55 64385 181822 110343037
Radicular pain 14.87 11.20 7 64433 546 110524313
Endometrial cancer 14.86 11.20 12 64428 2464 110522395
Periodontal disease 14.75 11.20 11 64429 2011 110522848
Glucose tolerance impaired 14.69 11.20 23 64417 9814 110515045
Rhabdomyolysis 14.68 11.20 30 64410 120371 110404488
Low density lipoprotein increased 14.64 11.20 24 64416 10642 110514217
Irritable bowel syndrome 14.59 11.20 48 64392 164167 110360692
Reaction to excipient 14.57 11.20 11 64429 2048 110522811
Goitre 14.51 11.20 18 64422 6186 110518673
Liver disorder 14.50 11.20 39 64401 142204 110382655
Sinus disorder 14.47 11.20 47 64393 32681 110492178
Vertebral lateral recess stenosis 14.46 11.20 6 64434 346 110524513
Benign breast neoplasm 14.42 11.20 8 64432 881 110523978
Intermittent claudication 14.35 11.20 14 64426 3687 110521172
Labile hypertension 14.34 11.20 7 64433 592 110524267
Vulval disorder 14.22 11.20 8 64432 905 110523954
Ascites 14.19 11.20 20 64420 92788 110432071
Ligamentum flavum hypertrophy 14.10 11.20 6 64434 369 110524490
Influenza like illness 14.06 11.20 94 64346 88318 110436541
Osteoarthropathy 14.03 11.20 6 64434 373 110524486
Vaginal erosion 13.98 11.20 3 64437 15 110524844
Aneurysm 13.93 11.20 15 64425 4431 110520428
Loose tooth 13.93 11.20 13 64427 3240 110521619
Irritability 13.90 11.20 60 64380 47749 110477110
Progressive multiple sclerosis 13.88 11.20 9 64431 1315 110523544
Migraine without aura 13.87 11.20 7 64433 636 110524223
Biopsy breast abnormal 13.82 11.20 3 64437 16 110524843
Fear 13.78 11.20 37 64403 23156 110501703
Red blood cells urine 13.62 11.20 7 64433 661 110524198
Marital problem 13.60 11.20 5 64435 208 110524651
Vomiting 13.49 11.20 416 64024 910259 109614600
Fungal infection 13.44 11.20 62 64378 50744 110474115
Toe operation 13.44 11.20 8 64432 1006 110523853
Hyperaesthesia teeth 13.41 11.20 11 64429 2311 110522548
Major depression 13.38 11.20 23 64417 10598 110514261
Myocardial ischaemia 13.35 11.20 40 64400 26644 110498215
Post procedural cellulitis 13.35 11.20 4 64436 87 110524772
Musculoskeletal chest pain 13.28 11.20 42 64398 28805 110496054
Pelvic fracture 13.27 11.20 27 64413 14127 110510732
Pain in jaw 13.21 11.20 62 64378 51115 110473744
Costochondritis 13.17 11.20 12 64428 2901 110521958
Migraine with aura 13.15 11.20 13 64427 3479 110521380
Skin abrasion 13.05 11.20 29 64411 16122 110508737
Cystitis interstitial 13.00 11.20 9 64431 1465 110523394
Sinusitis 13.00 11.20 244 64196 296444 110228415
Increased tendency to bruise 12.94 11.20 24 64416 11734 110513125
Intermenstrual bleeding 12.93 11.20 18 64422 6916 110517943
Tonsillar disorder 12.92 11.20 9 64431 1480 110523379
Fungal cystitis 12.88 11.20 3 64437 23 110524836
Nail disorder 12.87 11.20 9 64431 57926 110466933
Intentional product use issue 12.86 11.20 88 64352 247818 110277041
Intentional self-injury 12.86 11.20 3 64437 37426 110487433
Multiple injuries 12.77 11.20 13 64427 3601 110521258
Ecchymosis 12.76 11.20 30 64410 17308 110507551
COVID-19 pneumonia 12.72 11.20 3 64437 37140 110487719
Deep vein thrombosis 12.68 11.20 131 64309 139756 110385103
Knee deformity 12.53 11.20 9 64431 1554 110523305
Urethral disorder 12.52 11.20 6 64434 487 110524372
Diverticulitis 12.49 11.20 63 64377 53459 110471400
Melaena 12.44 11.20 13 64427 68744 110456115
Restless legs syndrome 12.40 11.20 37 64403 24589 110500270
Anxiety disorder 12.40 11.20 15 64425 5025 110519834
Upper respiratory tract infection 12.39 11.20 124 64316 131204 110393655
Clubbing 12.39 11.20 7 64433 798 110524061
Giant cell arteritis 12.37 11.20 13 64427 3736 110521123
Ventricular extrasystoles 12.35 11.20 35 64405 22606 110502253
Calcium deficiency 12.31 11.20 8 64432 1174 110523685
Pre-existing condition improved 12.26 11.20 17 64423 6509 110518350
Dysphonia 12.24 11.20 81 64359 75848 110449011
Physical assault 12.20 11.20 9 64431 1619 110523240
Scar 12.19 11.20 29 64411 16852 110508007
Tooth loss 12.19 11.20 19 64421 8077 110516782
Anaemia 12.18 11.20 235 64205 546851 109978008
Tibia fracture 12.14 11.20 17 64423 6568 110518291
Face injury 12.09 11.20 14 64426 4478 110520381
Bone density decreased 12.07 11.20 28 64412 16014 110508845
Herpes zoster 12.06 11.20 106 64334 108273 110416586
Acute sinusitis 12.00 11.20 15 64425 5196 110519663
Skin indentation 11.99 11.20 3 64437 32 110524827
Anger 11.99 11.20 31 64409 18976 110505883
Libido decreased 11.97 11.20 16 64424 5919 110518940
Fracture malunion 11.94 11.20 4 64436 126 110524733
Muscle spasms 11.92 11.20 228 64212 277929 110246930
Rib fracture 11.91 11.20 45 64395 33725 110491134
Cerebral atrophy 11.88 11.20 20 64420 9065 110515794
Urinary bladder suspension 11.85 11.20 4 64436 129 110524730
Nasal septum deviation 11.83 11.20 10 64430 2188 110522671
Vertigo positional 11.82 11.20 13 64427 3935 110520924
Generalised anxiety disorder 11.70 11.20 11 64429 2768 110522091
Breast reconstruction 11.65 11.20 4 64436 136 110524723
Vulvovaginal mycotic infection 11.62 11.20 15 64425 5362 110519497
Bone marrow failure 11.56 11.20 10 64430 57838 110467021
Rhinitis 11.47 11.20 34 64406 22511 110502348
Vitamin D deficiency 11.43 11.20 30 64410 18522 110506337
Panic attack 11.42 11.20 40 64400 28900 110495959
Oedema peripheral 11.35 11.20 261 64179 328399 110196460
Raynaud's phenomenon 11.28 11.20 7 64433 948 110523911
Tinnitus 11.26 11.20 67 64373 60473 110464386

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
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:50249 anticoagulant
CHEBI has role CHEBI:50646 bone density conservation agent
CHEBI has role CHEBI:50779 appetite enhancer
CHEBI has role CHEBI:63726 neuroprotective agent
CHEBI has role CHEBI:66980 nootropic agent

Related Drugs by ATC class:

G03CA Natural and semisynthetic estrogens, plain 7 drugs
chlorotrianiseneestetrolestradiolestriolestroneethinylestradiolpromestriene
G03CC Estrogens, combinations with other drugs 6 drugs
bazedoxifenedienestroldiethylstilbestrolestriolestronemethallenestril

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

DiseaseRelationSNOMED_IDDOID
Dyspareunia indication 71315007
Menopausal flushing indication 198436008




🐶 Veterinary Drug Use

None

🐶 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 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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.9MG CONJUGATED ESTROGENS NOVAST LABS A214023 Oct. 15, 2025 RX TABLET ORAL April 15, 2026 COMPETITIVE GENERIC THERAPY
1.25MG CONJUGATED ESTROGENS NOVAST LABS A214023 Oct. 15, 2025 RX TABLET ORAL April 15, 2026 COMPETITIVE GENERIC THERAPY
0.3MG CONJUGATED ESTROGENS NOVAST LABS A214025 Oct. 15, 2025 RX TABLET ORAL April 15, 2026 COMPETITIVE GENERIC THERAPY
0.45MG CONJUGATED ESTROGENS NOVAST LABS A214025 Oct. 15, 2025 RX TABLET ORAL April 15, 2026 COMPETITIVE GENERIC THERAPY
0.625MG CONJUGATED ESTROGENS NOVAST LABS A214025 Oct. 15, 2025 RX TABLET ORAL April 15, 2026 COMPETITIVE GENERIC THERAPY

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:749574 CHEBI
CHEMBL1201649 ChEMBL_ID
DB00286 DRUGBANK_ID
202896 RXNORM
307 MMSL
398534 MMSL
4500 MMSL
d00541 MMSL
001272 NDDF
126098001 SNOMEDCT_US
16832004 SNOMEDCT_US
C0014938 UMLSCUI
45357473 PUBCHEM_CID
D004966 MESH_DESCRIPTOR_UI
IU5QR144QX UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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
PremarinVaginal HUMAN PRESCRIPTION DRUG LABEL 1 0046-0872 CREAM 0.63 mg VAGINAL NDA 35 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 0046-1100 TABLET, FILM COATED 0.30 mg ORAL NDA 35 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 0046-1101 TABLET, FILM COATED 0.45 mg ORAL NDA 35 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 0046-1102 TABLET, FILM COATED 0.63 mg ORAL NDA 35 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 0046-1103 TABLET, FILM COATED 0.90 mg ORAL NDA 35 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 0046-1104 TABLET, FILM COATED 1.25 mg ORAL NDA 35 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1105 TABLET, SUGAR COATED 0.30 mg ORAL NDA 34 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1105 TABLET, SUGAR COATED 0.30 mg ORAL NDA 34 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1106 TABLET, SUGAR COATED 0.45 mg ORAL NDA 34 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1106 TABLET, SUGAR COATED 0.45 mg ORAL NDA 34 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1107 TABLET, SUGAR COATED 0.63 mg ORAL NDA 34 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1107 TABLET, SUGAR COATED 0.63 mg ORAL NDA 34 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1108 TABLET, SUGAR COATED 0.63 mg ORAL NDA 34 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1108 TABLET, SUGAR COATED 0.63 mg ORAL NDA 34 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 35 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
estrogens, conjugated HUMAN PRESCRIPTION DRUG LABEL 1 50742-387 TABLET, FILM COATED 0.30 mg ORAL ANDA 31 sections
estrogens, conjugated HUMAN PRESCRIPTION DRUG LABEL 1 50742-388 TABLET, FILM COATED 0.45 mg ORAL ANDA 31 sections
estrogens, conjugated HUMAN PRESCRIPTION DRUG LABEL 1 50742-389 TABLET, FILM COATED 0.63 mg ORAL ANDA 31 sections
estrogens, conjugated HUMAN PRESCRIPTION DRUG LABEL 1 50742-390 TABLET, FILM COATED 0.90 mg ORAL ANDA 31 sections
estrogens, conjugated HUMAN PRESCRIPTION DRUG LABEL 1 50742-391 TABLET, FILM COATED 1.25 mg ORAL ANDA 31 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
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 54868-0451 TABLET, FILM COATED 0.63 mg ORAL NDA 14 sections
Premarin HUMAN PRESCRIPTION DRUG LABEL 1 54868-0453 TABLET, FILM COATED 1.25 mg ORAL NDA 14 sections