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

Stem definitionDrug idCAS RN
estrogens 1057 50-28-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • estradiol
  • 17Beta-Estradiol
  • 17Beta-Oestradiol
  • Beta-Estradiol
  • estradiol hemihydrate
The 17-beta-isomer of estradiol, an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Estradiol-17-beta is the most potent form of mammalian estrogenic steroids.
  • Molecular weight: 272.39
  • Formula: C18H24O2
  • CLOGP: 3.78
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 2
  • TPSA: 40.46
  • ALOGS: -4.11
  • ROTB: 0
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.30 mg N
2 mg O
1 mg P
0.30 mg P
5 mg R
50 mcg TD
1 mg TD
1.53 mg TD
25 mcg V
7.50 mcg V

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.01 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.84 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 5 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.20 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 30 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.02 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.70 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 3.490 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.378 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 57.943 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 47.643 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 2.380 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 7.410 % High 1
herg hERG pIC50 4.694 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 86.696 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 13.964 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 2.400 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,EIF2AK3,ERBB2,GRK2,ITK,MAP2K6,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CG,PRKDC,TEK,TGFBR1 22
kinase-selectivity-class EIF2AK3,GRK2 2
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 2.455 High 1
mh-clint Mouse hepatocyte intrinsic clearance 223.872 High 1
mppb Mouse plasma protein binding (% unbound) 3.530 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 5.623 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 6.170 % High 1
rh-clint Rat hepatocyte intrinsic clearance 222.844 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 26.820 % High 1
rppb Rat plasma protein binding (% unbound) 4.790 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 22.646 uM High 1

Approvals:

DateAgencyCompanyOrphan
July 23, 1975 FDA BRISTOL MYERS SQUIBB
Nov. 25, 2011 PMDA Shiseido Company, Limited

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
Product adhesion issue 4587.58 9.08 1140 132452 4002 90490853
Hot flush 1020.75 9.08 783 132809 58705 90436150
Application site rash 909.91 9.08 278 133314 2391 90492464
Application site erythema 600.96 9.08 242 133350 4966 90489889
Application site pruritus 551.75 9.08 215 133377 4032 90490823
Meningioma 445.33 9.08 194 133398 4877 90489978
Application site irritation 441.40 9.08 149 133443 1812 90493043
Vulvovaginal discomfort 431.58 9.08 159 133433 2538 90492317
Pemphigus 405.46 9.08 18 133574 326846 90168009
Macular degeneration 387.05 9.08 371 133221 37599 90457256
Hand deformity 343.86 9.08 24 133568 296338 90198517
Schizoaffective disorder 323.32 9.08 156 133436 4991 90489864
Glossodynia 317.05 9.08 48 133544 321731 90173124
Systemic lupus erythematosus 294.94 9.08 84 133508 361812 90133043
Anti-cyclic citrullinated peptide antibody positive 286.75 9.08 15 133577 236418 90258437
Wrong technique in product usage process 284.31 9.08 433 133159 71138 90423717
Pericarditis 281.06 9.08 34 133558 270117 90224738
Wound 272.84 9.08 57 133535 302923 90191932
Vaginal discharge 271.36 9.08 227 133365 19237 90475618
Duodenal ulcer perforation 256.40 9.08 18 133574 221270 90273585
Vulvovaginal pain 248 9.08 115 133477 3359 90491496
Menopausal symptoms 245.28 9.08 110 133482 2968 90491887
Product quality issue 244.64 9.08 428 133164 78897 90415958
Helicobacter infection 242.34 9.08 26 133566 226824 90268031
Application site reaction 234.93 9.08 75 133517 755 90494100
Chronic sinusitis 233.94 9.08 228 133364 23574 90471281
Vulvovaginal burning sensation 217.24 9.08 96 133496 2499 90492356
Rheumatoid factor positive 214.22 9.08 9 133583 171641 90323214
Arthropathy 210.16 9.08 141 133451 366101 90128754
Vaginal haemorrhage 205.53 9.08 242 133350 31029 90463826
Folliculitis 202.31 9.08 30 133562 204323 90290532
Rheumatic fever 201.84 9.08 5 133587 153116 90341739
General physical health deterioration 192.86 9.08 145 133447 354970 90139885
Device adhesion issue 192.26 9.08 121 133471 6570 90488285
Contraindicated product administered 186.69 9.08 121 133471 320018 90174837
Ovarian hyperstimulation syndrome 183.62 9.08 112 133480 5750 90489105
Breast tenderness 178.82 9.08 84 133508 2528 90492327
Liver injury 173.61 9.08 23 133569 170544 90324311
Type 2 diabetes mellitus 173.37 9.08 43 133549 203201 90291654
Vulvovaginal dryness 165.60 9.08 87 133505 3344 90491511
Application site pain 165.57 9.08 97 133495 4623 90490232
Female genital tract fistula 164.17 9.08 165 133427 17703 90477152
Pneumonia viral 161.93 9.08 121 133471 8702 90486153
Product physical issue 159.24 9.08 101 133491 5559 90489296
Muscle injury 153.36 9.08 36 133556 176618 90318237
Blood oestrogen decreased 152.26 9.08 46 133546 379 90494476
Exposure during pregnancy 151.83 9.08 81 133511 238329 90256526
Death 151.57 9.08 276 133316 456275 90038580
Product substitution issue 150.44 9.08 158 133434 17850 90477005
Paraesthesia oral 148.13 9.08 207 133385 31452 90463403
Swollen joint count increased 145.17 9.08 4 133588 111202 90383653
Feeling abnormal 143.10 9.08 556 133036 166679 90328176
Application site vesicles 142.92 9.08 61 133531 1456 90493399
Procedural pain 139.80 9.08 207 133385 33153 90461702
Soft tissue disorder 139.61 9.08 84 133508 4206 90490649
Product complaint 130.19 9.08 128 133464 13372 90481483
Application site burn 128.96 9.08 50 133542 924 90493931
No adverse event 126.04 9.08 297 133295 67685 90427170
Swelling 123.06 9.08 272 133320 418786 90076069
Impaired healing 122.79 9.08 99 133493 234100 90260755
Maternal exposure during pregnancy 122.75 9.08 214 133378 359849 90135006
Sleep disorder due to general medical condition, insomnia type 122.59 9.08 21 133571 128673 90366182
Hepatic enzyme increased 119.73 9.08 218 133374 360518 90134337
Application site urticaria 118.89 9.08 34 133558 226 90494629
Postmenopausal haemorrhage 118.37 9.08 62 133530 2368 90492487
Hormone level abnormal 116.76 9.08 65 133527 2808 90492047
Treatment failure 116.51 9.08 167 133425 303761 90191094
Drug level increased 113.08 9.08 170 133422 27592 90467263
Vaginal flatulence 112.99 9.08 115 133477 12523 90482332
Headache 112.25 9.08 1839 131753 860907 89633948
Product dose omission issue 109.65 9.08 771 132821 290916 90203939
Lower respiratory tract infection 109.24 9.08 125 133467 250534 90244321
Hysterectomy 108.31 9.08 108 133484 11476 90483379
Radiculopathy 108.22 9.08 135 133457 18370 90476485
Stomatitis 107.21 9.08 149 133443 274549 90220306
Facet joint syndrome 105.73 9.08 11 133581 98378 90396477
Blood oestrogen increased 105.48 9.08 30 133562 195 90494660
Colitis microscopic 104.27 9.08 104 133488 11055 90483800
Drug intolerance 102.96 9.08 328 133264 447263 90047592
Vaginal infection 100.56 9.08 90 133502 8350 90486505
Proctitis 100.11 9.08 118 133474 15141 90479714
Lung disorder 99.77 9.08 48 133544 149835 90345020
Sedation complication 99.70 9.08 124 133468 16820 90478035
Lip dry 99.46 9.08 15 133577 100940 90393915
Injury 94.30 9.08 91 133501 197258 90297597
Device use issue 93.98 9.08 62 133530 3651 90491204
Musculoskeletal stiffness 92.42 9.08 186 133406 296346 90198509
Confusional state 91.63 9.08 279 133313 385926 90108929
Incorrect dose administered by product 91.60 9.08 28 133564 241 90494614
Peripheral venous disease 91.17 9.08 9 133583 83912 90410943
Irritable bowel syndrome 90.86 9.08 103 133489 207345 90287510
Intermenstrual bleeding 89.97 9.08 88 133504 9135 90485720
Joint range of motion decreased 89.43 9.08 44 133548 135599 90359256
Creatinine renal clearance decreased 87.55 9.08 123 133469 18776 90476079
Drug ineffective 87.20 9.08 2660 130932 1381638 89113217
Ill-defined disorder 85.19 9.08 88 133504 184803 90310052
Constipation 84.56 9.08 704 132888 279691 90215164
Wound infection 84.18 9.08 26 133566 106376 90388479
Infusion related reaction 82.73 9.08 325 133267 416455 90078400
Therapeutic product effect decreased 82.37 9.08 179 133413 277392 90217463
Breast cancer stage III 82.16 9.08 13 133579 84434 90410421
Pulmonary fibrosis 82.00 9.08 28 133564 107475 90387380
Neutropenia 81.87 9.08 128 133464 224776 90270079
Synovitis 81.25 9.08 234 133358 329518 90165337
C-reactive protein abnormal 80.06 9.08 44 133548 127385 90367470
Live birth 79.68 9.08 11 133581 79096 90415759
Fungal infection 78.65 9.08 186 133406 42475 90452380
Salpingo-oophorectomy unilateral 78.43 9.08 35 133557 933 90493922
Herpes zoster 77.93 9.08 311 133281 94333 90400522
Obesity 77.88 9.08 29 133563 105478 90389377
Skin irritation 77.57 9.08 98 133494 13505 90481350
Prescribed overdose 76.97 9.08 24 133568 97601 90397254
Abdominal discomfort 76.92 9.08 402 133190 476926 90017929
Balance disorder 75.18 9.08 313 133279 96767 90398088
Sinus rhythm 75.13 9.08 38 133554 1348 90493507
Vaginal odour 74.05 9.08 29 133563 551 90494304
Psoriatic arthropathy 73.92 9.08 140 133452 228195 90266660
Vulvovaginal pruritus 73.81 9.08 55 133537 3938 90490917
Diverticulitis 73.73 9.08 188 133404 44999 90449856
Incorrect dose administered 73.73 9.08 270 133322 78660 90416195
Inflammation 73.60 9.08 93 133499 178499 90316356
Joint swelling 73.42 9.08 438 133154 502862 89991993
Glaucoma 71.91 9.08 118 133474 20637 90474218
Skin reaction 71.87 9.08 111 133481 18442 90476413
Grip strength decreased 70.80 9.08 24 133568 92552 90402303
Sinusitis fungal 70.57 9.08 41 133551 1923 90492932
Liver function test abnormal 70.33 9.08 199 133393 50646 90444209
Application site hypersensitivity 69.64 9.08 23 133569 260 90494595
Blister 69.57 9.08 172 133420 254826 90240029
Thrombocytopenia 69.31 9.08 126 133466 208599 90286256
Delirium 68.56 9.08 34 133558 104325 90390530
Blood calcium decreased 68.49 9.08 143 133449 30039 90464816
Breast cancer 68.20 9.08 204 133388 53557 90441298
Incorrect dose administered by device 68.00 9.08 61 133531 5676 90489179
Hypercholesterolaemia 67.61 9.08 32 133560 100860 90393995
Device material issue 67.51 9.08 25 133567 405 90494450
Intentional overdose 67.25 9.08 27 133565 93807 90401048
Alopecia 65.95 9.08 443 133149 494628 90000227
Product packaging issue 63.63 9.08 36 133556 1605 90493250
Discomfort 63.03 9.08 201 133391 274134 90220721
Embolism venous 62.79 9.08 48 133544 3572 90491283
Eye irritation 62.48 9.08 148 133444 33830 90461025
Wheezing 62.31 9.08 164 133428 237916 90256939
Product size issue 62.03 9.08 24 133568 441 90494414
Application site scar 61.72 9.08 20 133572 212 90494643
Bronchitis 61.40 9.08 411 133181 152516 90342339
Dermatitis atopic 61.39 9.08 118 133474 23354 90471501
Therapeutic response unexpected 60.96 9.08 113 133479 21767 90473088
Sputum increased 59.79 9.08 43 133549 2914 90491941
Vaginal erosion 59.70 9.08 13 133579 20 90494835
Gastrointestinal disorder 59.01 9.08 188 133404 256499 90238356
Vision blurred 58.69 9.08 319 133273 109974 90384881
Oestrogen receptor assay positive 58.46 9.08 24 133568 518 90494337
Migraine 58.41 9.08 480 133112 189912 90304943
Febrile neutropenia 57.72 9.08 90 133502 158259 90336596
Injection site pain 57.70 9.08 446 133146 173253 90321602
Oral candidiasis 57.32 9.08 147 133445 35308 90459547
Red blood cell sedimentation rate increased 57.21 9.08 25 133567 82570 90412285
Adjustment disorder with depressed mood 56.90 9.08 8 133584 56745 90438110
Pancytopenia 56.80 9.08 56 133536 120207 90374648
Product packaging quantity issue 56.39 9.08 33 133559 1569 90493286
Vulvovaginal injury 56.26 9.08 24 133568 572 90494283
Completed suicide 56.23 9.08 79 133513 144979 90349876
Depressed level of consciousness 55.82 9.08 234 133358 72550 90422305
Acute kidney injury 54.89 9.08 264 133328 320123 90174732
Application site discolouration 54.62 9.08 27 133565 911 90493944
Application site swelling 54.37 9.08 24 133568 623 90494232
Pneumonia 54.10 9.08 641 132951 637418 89857437
Creatinine renal clearance increased 53.63 9.08 42 133550 3239 90491616
Thyroid disorder 53.55 9.08 95 133497 17690 90477165
Liver disorder 53.31 9.08 60 133532 121209 90373646
Surgery 52.89 9.08 166 133426 44721 90450134
Bursitis 52.75 9.08 70 133522 131584 90363271
Onychomadesis 52.50 9.08 4 133588 45994 90448861
Oral pain 52.31 9.08 135 133457 32548 90462307
X-ray abnormal 51.70 9.08 4 133588 45420 90449435
Breast pain 51.55 9.08 70 133522 10348 90484507
Breast cancer in situ 51.33 9.08 32 133560 1708 90493147
Renal function test abnormal 51.19 9.08 58 133534 7133 90487722
Influenza like illness 51.17 9.08 245 133347 80366 90414489
Hyperkalaemia 51.16 9.08 16 133576 64948 90429907
Cardiac failure 50.55 9.08 52 133540 109444 90385411
Respiratory symptom 49.98 9.08 45 133547 4207 90490648
Dislocation of vertebra 49.36 9.08 11 133581 55957 90438898
Mood swings 49.23 9.08 100 133492 20602 90474253
Progesterone receptor assay positive 49.11 9.08 19 133573 349 90494506
Breast enlargement 48.58 9.08 31 133561 1724 90493131
Dyspareunia 48.45 9.08 37 133555 2749 90492106
Application site inflammation 48.32 9.08 19 133573 365 90494490
Sleep apnoea syndrome 47.62 9.08 128 133464 31619 90463236
Palpitations 47.60 9.08 355 133237 136373 90358482
Hyperhidrosis 47.51 9.08 354 133238 135951 90358904
Application site dermatitis 47.25 9.08 15 133577 148 90494707
Cardiac arrest 47.14 9.08 51 133541 104884 90389971
Disease recurrence 46.93 9.08 142 133450 37511 90457344
Multiple organ dysfunction syndrome 46.83 9.08 21 133571 68315 90426540
Eczema 46.16 9.08 177 133415 52693 90442162
Lupus vulgaris 46.01 9.08 6 133586 45053 90449802
Tinnitus 45.91 9.08 154 133438 42948 90451907
Fibrocystic breast disease 45.37 9.08 26 133566 1188 90493667
Stress 45.05 9.08 238 133354 81157 90413698
Retinitis 44.88 9.08 3 133589 38455 90456400
Diverticulum 44.87 9.08 71 133521 12042 90482813
Colitis 44.70 9.08 213 133379 69729 90425126
Orthostatic hypotension 44.16 9.08 149 133443 41678 90453177
Product odour abnormal 44.11 9.08 28 133564 1543 90493312
Cognitive disorder 44.09 9.08 211 133381 69196 90425659
Dermatitis contact 44.03 9.08 75 133517 13520 90481335
Irritability 43.98 9.08 134 133458 35528 90459327
Colitis ischaemic 43.86 9.08 71 133521 12275 90482580
Application site erosion 43.59 9.08 15 133577 194 90494661
Blepharospasm 43.05 9.08 14 133578 55431 90439424
Bladder prolapse 42.80 9.08 31 133561 2124 90492731
Epidermal necrosis 42.48 9.08 32 133560 2329 90492526
Abnormal uterine bleeding 42.39 9.08 30 133562 1982 90492873
Skin burning sensation 42.28 9.08 91 133501 19520 90475335
Diastolic dysfunction 42.08 9.08 53 133539 7280 90487575
Endometrial cancer 42.01 9.08 38 133554 3574 90491281
Pseudoprecocious puberty 41.63 9.08 8 133584 3 90494852
Malignant neoplasm progression 41.62 9.08 58 133534 106812 90388043
Osteopenia 41.00 9.08 99 133493 22903 90471952
Hepatic necrosis 40.93 9.08 49 133543 6389 90488466
Nail disorder 40.71 9.08 18 133574 59049 90435806
Liver function test increased 40.66 9.08 39 133553 84816 90410039
Erythema 40.46 9.08 516 133076 228730 90266125
Product shape issue 40.25 9.08 12 133580 94 90494761
Oestradiol increased 40.25 9.08 12 133580 94 90494761
Butterfly rash 40.17 9.08 30 133562 2155 90492700
Vulvovaginal mycotic infection 40.05 9.08 48 133544 6266 90488589
Intentional product use issue 39.94 9.08 174 133418 216718 90278137
Ophthalmic vein thrombosis 39.42 9.08 16 133576 335 90494520
Multiple drug therapy 39.18 9.08 50 133542 6959 90487896
Lactic acidosis 38.72 9.08 13 133579 50450 90444405
Disease progression 38.63 9.08 111 133481 156504 90338351
Oral herpes 38.60 9.08 123 133469 33401 90461454
Decreased appetite 38.46 9.08 362 133230 376178 90118677
Myalgia 38.38 9.08 411 133181 174714 90320141
COVID-19 38.29 9.08 399 133193 168444 90326411
Depression 38.19 9.08 639 132953 299962 90194893
Wrong technique in device usage process 38.07 9.08 45 133547 5790 90489065
Oedema 37.91 9.08 159 133433 200136 90294719
Rash papular 37.79 9.08 89 133503 20266 90474589
Mucosal inflammation 37.51 9.08 19 133573 57606 90437249
Back pain 37.32 9.08 666 132926 316509 90178346
Weight decreased 37.32 9.08 776 132816 379134 90115721
Device defective 37.29 9.08 35 133557 3451 90491404
Vomiting 37.12 9.08 882 132710 787411 89707444
Poor quality product administered 36.79 9.08 37 133555 3971 90490884
Insomnia 36.72 9.08 693 132899 332781 90162074
Septic shock 36.59 9.08 42 133550 84118 90410737
Gait inability 35.98 9.08 104 133488 146352 90348503
Sepsis 35.75 9.08 140 133452 179674 90315181
Burning sensation 34.74 9.08 185 133407 63267 90431588
Deep vein thrombosis postoperative 34.56 9.08 32 133560 70777 90424078
Dry eye 34.56 9.08 173 133419 57758 90437097
Myelosuppression 34.39 9.08 18 133574 53573 90441282
Pre-existing condition improved 34.32 9.08 54 133538 9115 90485740
Application site dryness 34.20 9.08 12 133580 165 90494690
Placenta accreta 34.15 9.08 13 133579 228 90494627
Abdominal distension 33.67 9.08 317 133275 130284 90364571
Electrocardiogram QT prolonged 33.57 9.08 202 133390 72254 90422601
Drug tolerance decreased 33.48 9.08 4 133588 32126 90462729
Inappropriate schedule of product administration 33.37 9.08 353 133239 149580 90345275
Adhesive tape use 33.33 9.08 7 133585 8 90494847
Illness 33.31 9.08 221 133371 81748 90413107
Toxicity to various agents 33.26 9.08 268 133324 287578 90207277
Frequent bowel movements 33.25 9.08 169 133423 56766 90438089
Photosensitivity reaction 33.21 9.08 78 133514 17729 90477126
Product use complaint 33.14 9.08 33 133559 3500 90491355
Tricuspid valve incompetence 33.09 9.08 75 133517 16656 90478199
Musculoskeletal pain 32.99 9.08 135 133457 171116 90323739
Product administration interrupted 32.91 9.08 63 133529 12429 90482426
Application site exfoliation 32.86 9.08 15 133577 422 90494433
Rectal prolapse 32.76 9.08 27 133565 2240 90492615
Spinal operation 32.70 9.08 56 133536 10140 90484715
Periodontal disease 32.58 9.08 24 133568 1688 90493167
C-reactive protein 32.45 9.08 4 133588 31363 90463492
Dermal absorption impaired 32.40 9.08 9 133583 53 90494802
Nipple pain 32.05 9.08 14 133578 354 90494501
Lupus-like syndrome 31.95 9.08 16 133576 48830 90446025
Coma 31.85 9.08 36 133556 72596 90422259
Atypical haemolytic uraemic syndrome 31.21 9.08 19 133573 972 90493883
Hip arthroplasty 31.05 9.08 40 133552 76168 90418687
Oestradiol decreased 30.94 9.08 10 133582 105 90494750
Hypersensitivity 30.80 9.08 478 133114 454199 90040656
Colitis ulcerative 30.50 9.08 172 133420 60094 90434761
Endometrial stromal sarcoma 30.35 9.08 7 133585 16 90494839
Pregnancy 30.33 9.08 28 133564 62019 90432836
Cystocele 30.32 9.08 22 133570 1512 90493343
Cholestasis 30.31 9.08 8 133584 36291 90458564
Mobility decreased 30.10 9.08 231 133361 250503 90244352
Nasal polyps 30.07 9.08 56 133536 10824 90484031
Product availability issue 29.67 9.08 45 133547 7359 90487496
Endometrial cancer stage I 29.62 9.08 12 133580 250 90494605
Bone erosion 29.57 9.08 21 133571 53000 90441855
Condition aggravated 29.21 9.08 662 132930 594883 89899972
Insulin-like growth factor increased 28.95 9.08 18 133574 956 90493899
Nasopharyngitis 28.93 9.08 424 133168 406680 90088175
Prescribed underdose 28.92 9.08 41 133551 74978 90419877
Uterine leiomyoma 28.88 9.08 55 133537 10809 90484046
Endometrial hyperplasia 28.87 9.08 18 133574 961 90493894
Product dispensing error 28.84 9.08 59 133533 12214 90482641
Sedation 28.84 9.08 144 133448 48027 90446828
Haematochezia 28.69 9.08 191 133401 70722 90424133
Application site ulcer 28.52 9.08 9 133583 87 90494768
Atrophic vulvovaginitis 28.37 9.08 23 133569 1864 90492991
Malaise 28.23 9.08 1093 132499 584893 89909962
Autoimmune disorder 27.59 9.08 44 133548 76700 90418155
Taste disorder 27.54 9.08 30 133562 61516 90433339
Pyrexia 27.31 9.08 753 132839 659732 89835123
Sciatica 27.14 9.08 69 133523 101313 90393542
Product administered at inappropriate site 27.06 9.08 32 133560 4119 90490736
Cardio-respiratory arrest 26.92 9.08 32 133560 63108 90431747
Anti-cyclic citrullinated peptide antibody 26.91 9.08 4 133588 27217 90467638
Application site discharge 26.89 9.08 10 133582 164 90494691
Emphysema 26.89 9.08 57 133535 12098 90482757
Low density lipoprotein increased 26.71 9.08 45 133547 8040 90486815
Application site discomfort 26.68 9.08 13 133579 425 90494430
Nausea 26.52 9.08 1938 131654 1108378 89386477
Blood pressure increased 26.42 9.08 423 133169 196794 90298061
Rheumatoid arthritis 26.34 9.08 376 133216 362238 90132617
Meniscus injury 26.10 9.08 45 133547 8192 90486663
Finger deformity 26.08 9.08 8 133584 32889 90461966
Carpal tunnel syndrome 25.93 9.08 86 133506 23842 90471013
Spinal stenosis 25.88 9.08 70 133522 17354 90477501
Withdrawal bleed 25.86 9.08 8 133584 72 90494783
Hypertension 25.83 9.08 497 133095 457035 90037820
Coeliac disease 25.77 9.08 17 133575 44593 90450262
Vulvovaginal erythema 25.66 9.08 14 133578 581 90494274
Respiratory failure 25.63 9.08 89 133503 118329 90376526
Respiratory depression 25.61 9.08 65 133527 15510 90479345
Bone marrow failure 25.25 9.08 8 133584 32213 90462642
Breast calcifications 25.15 9.08 19 133573 1389 90493466
Anxiety 25.14 9.08 616 132976 309156 90185699
Endometriosis 25.07 9.08 38 133554 6210 90488645
Pulmonary embolism 25.02 9.08 299 133293 130521 90364334
Crying 25.02 9.08 89 133503 25556 90469299
Renal failure 24.78 9.08 104 133488 130903 90363952
Product prescribing error 24.75 9.08 99 133493 30046 90464809
Medication error 24.74 9.08 55 133537 84597 90410258
Infection 24.73 9.08 380 133212 361714 90133141
Libido decreased 24.61 9.08 26 133566 2956 90491899
Toxic epidermal necrolysis 24.48 9.08 104 133488 32424 90462431
Urinary incontinence 24.43 9.08 115 133477 37451 90457404
Epilepsy 24.37 9.08 53 133539 82153 90412702
Device physical property issue 24.34 9.08 25 133567 2751 90492104
Endometrial hypertrophy 24.31 9.08 11 133581 303 90494552
Neoplasm progression 24.31 9.08 18 133574 44468 90450387
Therapeutic product effect increased 24.25 9.08 18 133574 1281 90493574
Lower limb fracture 24.23 9.08 56 133536 84957 90409898
Retinal vein occlusion 24.21 9.08 24 133568 2532 90492323
Breast mass 24.10 9.08 47 133545 9400 90485455
Uterine haemorrhage 23.62 9.08 32 133560 4720 90490135
Arthritis 23.60 9.08 362 133230 166953 90327902
Poor quality sleep 23.50 9.08 85 133507 24608 90470247
Urinary tract infection 23.39 9.08 603 132989 305029 90189826
Vessel puncture site bruise 23.26 9.08 12 133580 444 90494411
Product design issue 23.24 9.08 5 133587 7 90494848
Bacterial vulvovaginitis 23.13 9.08 15 133577 858 90493997
Drug interaction 23.11 9.08 552 133040 275901 90218954
Eye pain 22.98 9.08 127 133465 44041 90450814
Abortion spontaneous 22.72 9.08 147 133445 53909 90440946
Blood oestrogen abnormal 22.47 9.08 5 133587 9 90494846
Therapeutic product effect incomplete 22.38 9.08 406 133186 193490 90301365
Uterine polyp 22.35 9.08 23 133569 2537 90492318
Intervertebral disc degeneration 22.33 9.08 66 133526 17208 90477647
Bone density abnormal 22.30 9.08 29 133563 4111 90490744
Breast cancer female 22.30 9.08 60 133532 14826 90480029
Cytomegalovirus infection 21.95 9.08 6 133586 26596 90468259
Product colour issue 21.95 9.08 14 133578 778 90494077
Vulvovaginal swelling 21.88 9.08 14 133578 782 90494073
Pneumocystis jirovecii pneumonia 21.78 9.08 3 133589 21613 90473242
Platelet count decreased 21.64 9.08 116 133476 136853 90358002
Muscle fatigue 21.52 9.08 24 133568 2900 90491955
Therapy non-responder 21.48 9.08 116 133476 136588 90358267
Stress urinary incontinence 21.35 9.08 22 133570 2430 90492425
Hepatic function abnormal 21.34 9.08 22 133570 46266 90448589
Exposure via skin contact 21.18 9.08 48 133544 10657 90484198
Loss of personal independence in daily activities 21.10 9.08 116 133476 135989 90358866
Phyllodes tumour 21.05 9.08 7 133585 81 90494774
Renal impairment 21.00 9.08 82 133510 105339 90389516
Vertigo 20.85 9.08 175 133417 69636 90425219
Hiatus hernia 20.59 9.08 83 133509 25278 90469577
Ventricular dyskinesia 20.43 9.08 8 133584 152 90494703
Hepatic cytolysis 20.41 9.08 10 133582 30906 90463949
Vaginal disorder 20.37 9.08 13 133579 723 90494132
Hypokalaemia 20.19 9.08 112 133480 131004 90363851
Craniopharyngioma 20.19 9.08 8 133584 157 90494698
Lip swelling 20.07 9.08 111 133481 38499 90456356
Rectal haemorrhage 19.92 9.08 198 133394 82546 90412309
Application site infection 19.91 9.08 6 133586 49 90494806
Pleural effusion 19.90 9.08 91 133501 111900 90382955
Rheumatoid nodule 19.85 9.08 3 133589 20163 90474692
Acne 19.82 9.08 89 133503 28418 90466437
Breast cancer stage II 19.70 9.08 14 133578 35320 90459535
Histamine intolerance 19.70 9.08 6 133586 51 90494804
Altered state of consciousness 19.63 9.08 11 133581 31521 90463334
Expired product administered 19.59 9.08 36 133556 6886 90487969
Muscle spasms 19.57 9.08 498 133094 251385 90243470
Sopor 19.53 9.08 6 133586 24638 90470217
Dry skin 19.42 9.08 207 133385 87866 90406989
Lymphogranuloma venereum 19.32 9.08 4 133588 4 90494851
Corticosteroid binding globulin increased 19.32 9.08 4 133588 4 90494851
Breast discomfort 19.26 9.08 12 133580 640 90494215
Spinal osteoarthritis 19.15 9.08 67 133525 19081 90475774
Emotional disorder 19.10 9.08 57 133535 14940 90479915
Suicide attempt 18.91 9.08 53 133539 75346 90419509
Bladder disorder 18.81 9.08 46 133546 10726 90484129
Swelling face 18.78 9.08 193 133399 81159 90413696
Product storage error 18.69 9.08 69 133523 20172 90474683
Abdominal pain lower 18.63 9.08 91 133501 30086 90464769
Walking aid user 18.60 9.08 15 133577 35491 90459364
Product outer packaging issue 18.52 9.08 5 133587 26 90494829
Product residue present 18.51 9.08 27 133565 4264 90490591
Candida infection 18.44 9.08 99 133493 33958 90460897
Product prescribing issue 18.33 9.08 38 133554 7941 90486914
Bradycardia 18.16 9.08 63 133529 83784 90411071
Mood altered 18.03 9.08 61 133531 17083 90477772
Vaginal prolapse 18.01 9.08 11 133581 566 90494289
Neck injury 17.97 9.08 20 133572 2412 90492443
Head discomfort 17.96 9.08 59 133533 16274 90478581
Mediastinal effusion 17.92 9.08 6 133586 71 90494784
Injection site erythema 17.90 9.08 223 133369 98279 90396576
Blood testosterone decreased 17.84 9.08 6 133586 72 90494783
White blood cell count decreased 17.75 9.08 159 133433 166950 90327905
Thermal burn 17.69 9.08 34 133558 6728 90488127
Vitamin D decreased 17.66 9.08 48 133544 11931 90482924
Pituitary tumour 17.63 9.08 13 133579 916 90493939
Micturition urgency 17.56 9.08 46 133546 11187 90483668
Periorbital oedema 17.56 9.08 34 133558 6765 90488090
Expulsion of medication 17.51 9.08 5 133587 33 90494822
Abnormal dreams 17.50 9.08 46 133546 11211 90483644
Chest discomfort 17.49 9.08 294 133298 138071 90356784
Breast hyperplasia 17.47 9.08 9 133583 332 90494523
Hypothalamo-pituitary disorder 17.47 9.08 19 133573 2233 90492622
Intestinal polyp 17.44 9.08 16 133576 1533 90493322
Respiratory distress 17.41 9.08 19 133573 38927 90455928
Speech disorder 17.38 9.08 121 133471 45464 90449391
Brain neoplasm 17.32 9.08 28 133564 4836 90490019
Musculoskeletal discomfort 17.29 9.08 69 133523 20922 90473933
Scar 17.28 9.08 56 133536 15339 90479516
Device colour issue 17.26 9.08 5 133587 35 90494820
Metabolic acidosis 17.25 9.08 35 133557 55641 90439214
Premature delivery 17.22 9.08 19 133573 38743 90456112
Poor quality device used 17.19 9.08 19 133573 2274 90492581
Neck surgery 17.14 9.08 18 133574 2032 90492823
Device expulsion 17.13 9.08 21 133571 40865 90453990
Palmar-plantar erythrodysaesthesia syndrome 17.13 9.08 10 133582 28013 90466842
Flatulence 17.08 9.08 112 133480 41255 90453600
Oestrogen deficiency 17.05 9.08 7 133585 151 90494704
Foetal exposure during pregnancy 17.05 9.08 23 133569 42952 90451903
Soft tissue swelling 17.02 9.08 15 133577 1363 90493492
Knee arthroplasty 17.02 9.08 64 133528 83118 90411737
Pelvic infection 17.01 9.08 9 133583 351 90494504
Prosopagnosia 17.00 9.08 6 133586 84 90494771
Onychomycosis 16.96 9.08 18 133574 37358 90457497
Shock 16.58 9.08 11 133581 28767 90466088
Infusion site erythema 16.51 9.08 51 133541 13619 90481236
Right ventricular failure 16.48 9.08 4 133588 19201 90475654
Ovarian atrophy 16.44 9.08 6 133586 93 90494762
Thyroxine decreased 16.28 9.08 11 133581 674 90494181
Gingival ulceration 16.28 9.08 13 133579 1031 90493824
Periodontitis 16.27 9.08 24 133568 3829 90491026
Drug effective for unapproved indication 16.22 9.08 36 133556 7882 90486973
Aptyalism 16.19 9.08 11 133581 680 90494175
Rotator cuff syndrome 16.18 9.08 56 133536 15863 90478992
Hypoglycaemia 16.14 9.08 51 133541 69797 90425058
Transient ischaemic attack 16.10 9.08 114 133478 43062 90451793
Product taste abnormal 16.10 9.08 19 133573 2441 90492414
Rectocele 16.00 9.08 14 133578 1260 90493595
Injection site inflammation 15.98 9.08 26 133566 4515 90490340
Toothache 15.91 9.08 70 133522 22160 90472695
Breast disorder 15.88 9.08 20 133572 2747 90492108
Intentional self-injury 15.86 9.08 12 133580 29322 90465533
Tenderness 15.86 9.08 80 133512 26788 90468067
Eosinophilic pneumonia acute 15.85 9.08 11 133581 704 90494151
Drug abuse 15.80 9.08 65 133527 82282 90412573
Drug resistance 15.78 9.08 13 133579 30436 90464419
Oropharyngeal pain 15.77 9.08 248 133344 114939 90379916
Disturbance in attention 15.64 9.08 121 133471 46988 90447867
Eye swelling 15.62 9.08 85 133507 29301 90465554
Drug hypersensitivity 15.60 9.08 543 133049 463066 90031789
Depressed mood 15.58 9.08 127 133465 50095 90444760
Circumstance or information capable of leading to medication error 15.56 9.08 27 133565 4940 90489915
Injection site bruising 15.55 9.08 131 133461 52176 90442679
Anger 15.49 9.08 50 133542 13670 90481185
Cold urticaria 15.46 9.08 8 133584 298 90494557
Hypoxia 15.27 9.08 55 133537 72344 90422511
Breast cyst 15.27 9.08 17 133575 2050 90492805
Maternal exposure timing unspecified 15.26 9.08 7 133585 22476 90472379
Ulcer haemorrhage 15.24 9.08 10 133582 26311 90468544
Cor pulmonale acute 15.19 9.08 9 133583 438 90494417
Muscle tightness 15.19 9.08 49 133543 13390 90481465
Hypogonadism 15.18 9.08 6 133586 117 90494738
Gastroenteritis 15.17 9.08 84 133508 29145 90465710
Poikiloderma 15.17 9.08 8 133584 310 90494545
Exostosis 15.14 9.08 35 133557 53099 90441756
Product physical consistency issue 15.13 9.08 12 133580 942 90493913
C-reactive protein increased 15.02 9.08 183 133409 181206 90313649
XIth nerve injury 14.95 9.08 5 133587 59 90494796
Duodenogastric reflux 14.81 9.08 6 133586 125 90494730
Tracheal pain 14.80 9.08 5 133587 61 90494794
Biochemical pregnancy 14.72 9.08 5 133587 62 90494793
Optic neuropathy 14.69 9.08 19 133573 2679 90492176
Tachycardia 14.65 9.08 155 133437 157518 90337337
Exposure keratitis 14.65 9.08 5 133587 63 90494792
Oesophageal irritation 14.64 9.08 8 133584 333 90494522
Uterine disorder 14.58 9.08 21 133571 3280 90491575
Circumstance or information capable of leading to device use error 14.53 9.08 7 133585 223 90494632
Hysterotomy 14.49 9.08 3 133589 3 90494852
Vertebrobasilar insufficiency 14.45 9.08 7 133585 226 90494629
Blood pressure systolic abnormal 14.45 9.08 62 133530 19416 90475439
Hospitalisation 14.44 9.08 120 133472 127980 90366875
International normalised ratio increased 14.44 9.08 30 133562 47286 90447569
Pericardial effusion 14.33 9.08 20 133572 36813 90458042
Umbilical hernia 14.23 9.08 22 133570 3658 90491197
Nail bed disorder 14.22 9.08 8 133584 353 90494502
Heliotrope rash 14.11 9.08 7 133585 238 90494617
Toxic skin eruption 14.11 9.08 3 133589 15771 90479084
Meningioma surgery 14.10 9.08 5 133587 71 90494784
Hyperlipidaemia 14.07 9.08 69 133523 22847 90472008
Trans-sexualism 14.03 9.08 3 133589 4 90494851
Deep vein thrombosis 13.99 9.08 201 133391 91419 90403436
Gastrointestinal haemorrhage 13.94 9.08 77 133515 90171 90404684
Application site pustules 13.93 9.08 4 133588 27 90494828
Abdominal pain 13.92 9.08 715 132877 395006 90099849
Feeling hot 13.92 9.08 176 133416 77832 90417023
Decreased interest 13.86 9.08 24 133568 4383 90490472
Joint dislocation 13.83 9.08 28 133564 44554 90450301
Narcolepsy 13.80 9.08 14 133578 1518 90493337
Hepatic encephalopathy 13.61 9.08 48 133544 13724 90481131
Retinal vein thrombosis 13.58 9.08 9 133583 534 90494321
Immunodeficiency 13.55 9.08 27 133565 43207 90451648
Breast disorder female 13.51 9.08 6 133586 158 90494697
Budd-Chiari syndrome 13.50 9.08 5 133587 81 90494774
Infusion site swelling 13.49 9.08 43 133549 11677 90483178
Hepatitis 13.47 9.08 56 133536 70683 90424172
Limb injury 13.43 9.08 86 133506 31422 90463433
Tooth fracture 13.40 9.08 45 133547 12555 90482300
Hyperthyroidism 13.36 9.08 58 133534 18252 90476603
Thyrotoxic periodic paralysis 13.34 9.08 4 133588 32 90494823
Premature ageing 13.28 9.08 3 133589 6 90494849
Ovarian haemorrhage 13.25 9.08 8 133584 403 90494452
Withdrawal syndrome 13.25 9.08 67 133525 22457 90472398
Neuroleptic malignant syndrome 13.24 9.08 3 133589 15093 90479762
Cytokine release syndrome 13.23 9.08 13 133579 27960 90466895
Facial asymmetry 13.18 9.08 11 133581 929 90493926
Parotid gland enlargement 13.15 9.08 11 133581 932 90493923
Contraindicated product prescribed 13.14 9.08 14 133578 1608 90493247
Hypoacusis 13.12 9.08 78 133514 27772 90467083
Increased tendency to bruise 13.12 9.08 43 133549 11847 90483008
Urine flow decreased 13.11 9.08 8 133584 411 90494444
Food allergy 13.05 9.08 11 133581 25467 90469388
Application site haemorrhage 13.05 9.08 12 133580 1153 90493702
Menopause 13.05 9.08 20 133572 3301 90491554
Facial paresis 13.02 9.08 22 133570 3941 90490914
Application site nodule 12.96 9.08 3 133589 7 90494848
Bladder pain 12.95 9.08 18 133574 2719 90492136
Breast swelling 12.91 9.08 14 133578 1640 90493215
Encephalopathy 12.91 9.08 31 133561 46413 90448442
Adenomyosis 12.87 9.08 9 133583 583 90494272
Tendonitis 12.87 9.08 64 133528 21308 90473547
Pituitary tumour recurrent 12.87 9.08 5 133587 93 90494762
Pollakiuria 12.81 9.08 88 133504 32917 90461938
Hepatic adenoma 12.77 9.08 8 133584 431 90494424
Lip injury 12.74 9.08 12 133580 1189 90493666
Blood pressure abnormal 12.67 9.08 60 133532 19585 90475270
Application site scab 12.67 9.08 6 133586 184 90494671
Agranulocytosis 12.65 9.08 20 133572 34982 90459873
Neurotoxicity 12.65 9.08 8 133584 21459 90473396
Transfusion 12.58 9.08 5 133587 17483 90477372
Acromegaly 12.58 9.08 5 133587 99 90494756
Ageusia 12.57 9.08 52 133540 16024 90478831
Spondylolisthesis 12.57 9.08 22 133570 4053 90490802
Vaginal ulceration 12.55 9.08 8 133584 444 90494411
Abdominal pain upper 12.52 9.08 384 133208 332290 90162565
Interstitial lung disease 12.46 9.08 64 133528 76341 90418514
Injection site swelling 12.43 9.08 139 133453 59700 90435155
Cystitis interstitial 12.43 9.08 14 133578 1710 90493145
Feeling cold 12.36 9.08 76 133516 27389 90467466
Adverse event 12.35 9.08 112 133480 117306 90377549
Blood creatinine increased 12.35 9.08 93 133499 101293 90393562
Precocious puberty 12.33 9.08 7 133585 314 90494541
Endometrial disorder 12.33 9.08 10 133582 811 90494044
Gingival recession 12.31 9.08 14 133578 1729 90493126
External ear disorder 12.29 9.08 4 133588 43 90494812
Dysgeusia 12.28 9.08 125 133467 52435 90442420
Hypertransaminasaemia 12.28 9.08 4 133588 15821 90479034
Injection site rash 12.24 9.08 69 133523 24104 90470751
Neuralgia 12.23 9.08 84 133508 31416 90463439
Full blood count abnormal 12.22 9.08 22 133570 36575 90458280
Essential hypertension 12.15 9.08 28 133564 6287 90488568
Mammogram abnormal 12.12 9.08 10 133582 831 90494024
Hyponatraemia 12.11 9.08 132 133460 133406 90361449
Normal newborn 12.07 9.08 10 133582 23352 90471503
Low turnover osteopathy 12.02 9.08 22 133570 4196 90490659
Overdose 11.98 9.08 162 133430 157547 90337308
Tandem gait test abnormal 11.97 9.08 4 133588 47 90494808
Visual field defect 11.88 9.08 30 133562 7136 90487719
Erythema of eyelid 11.83 9.08 19 133573 3264 90491591
Meningioma benign 11.79 9.08 7 133585 342 90494513
Product formulation issue 11.72 9.08 9 133583 674 90494181
Vulvovaginal inflammation 11.70 9.08 11 133581 1087 90493768
Iron deficiency anaemia 11.62 9.08 67 133525 23595 90471260
Eye haematoma 11.61 9.08 5 133587 122 90494733
Dry mouth 11.60 9.08 196 133396 183863 90310992
Nervousness 11.60 9.08 88 133504 33968 90460887
Porphyria acute 11.59 9.08 6 133586 17969 90476886
Application site laceration 11.56 9.08 3 133589 13 90494842
Intra-abdominal haematoma 11.52 9.08 15 133577 2129 90492726
Neurodermatitis 11.52 9.08 18 133574 3020 90491835
Back injury 11.52 9.08 33 133559 46589 90448266
Dysgraphia 11.51 9.08 20 133572 3663 90491192
Foot deformity 11.50 9.08 47 133545 59604 90435251
Bruxism 11.49 9.08 22 133570 4341 90490514
Device breakage 11.43 9.08 46 133546 13998 90480857
Blood pressure diastolic decreased 11.30 9.08 73 133519 26753 90468102
Joint stiffness 11.30 9.08 68 133524 77974 90416881
Restless legs syndrome 11.28 9.08 64 133528 22406 90472449
Fibula agenesis 11.27 9.08 4 133588 57 90494798
Suicidal ideation 11.27 9.08 162 133430 73693 90421162
Ovarian cyst 11.25 9.08 53 133539 17265 90477590
Intentional dose omission 11.24 9.08 54 133538 17729 90477126
Spina bifida occulta 11.21 9.08 4 133588 58 90494797
Dizziness 11.15 9.08 1011 132581 588273 89906582
Nephrolithiasis 11.12 9.08 116 133476 48969 90445886
Device issue 11.02 9.08 78 133514 29459 90465396
Lumbar spinal stenosis 10.97 9.08 25 133567 5572 90489283
Joint destruction 10.96 9.08 3 133589 13284 90481571
Transferrin decreased 10.94 9.08 7 133585 391 90494464
Abnormal sensation in eye 10.92 9.08 14 133578 1957 90492898
Paraneoplastic dermatomyositis 10.85 9.08 5 133587 144 90494711
Sciatic nerve injury 10.83 9.08 9 133583 755 90494100
Product label issue 10.83 9.08 10 133582 966 90493889
Skin cancer 10.78 9.08 44 133548 13475 90481380
Mouth swelling 10.77 9.08 25 133567 5637 90489218
Acute respiratory distress syndrome 10.74 9.08 16 133576 28670 90466185
Frontotemporal dementia 10.74 9.08 7 133585 404 90494451
Poor venous access 10.73 9.08 57 133535 19470 90475385
Pelvic pain 10.72 9.08 48 133544 15309 90479546
Product solubility abnormal 10.71 9.08 10 133582 979 90493876
Ultrasound liver abnormal 10.62 9.08 4 133588 68 90494787
Transposition of the great vessels 10.62 9.08 6 133586 267 90494588
Sleep disorder 10.58 9.08 217 133375 197813 90297042
Hypoaesthesia 10.56 9.08 368 133224 313842 90181013
Neutrophil count decreased 10.53 9.08 62 133530 71470 90423385
Xanthoma 10.52 9.08 4 133588 70 90494785
Uterine cancer 10.49 9.08 24 133568 5361 90489494
Off label use of device 10.49 9.08 7 133585 420 90494435
Ventricular extrasystoles 10.47 9.08 43 133549 13207 90481648
Gangrene 10.45 9.08 3 133589 12873 90481982
Suspected product quality issue 10.42 9.08 7 133585 425 90494430
Premature baby 10.38 9.08 13 133579 25064 90469791
Blood triglycerides increased 10.36 9.08 44 133548 13717 90481138
Incorrect product administration duration 10.35 9.08 56 133536 19266 90475589
Pneumonia bacterial 10.34 9.08 3 133589 12787 90482068
Anosmia 10.32 9.08 35 133557 9813 90485042
Transplant rejection 10.30 9.08 3 133589 12755 90482100
Stress fracture 10.28 9.08 32 133560 8579 90486276
Executive dysfunction 10.20 9.08 6 133586 288 90494567
Dermatomyositis 10.14 9.08 18 133574 3352 90491503
Impatience 10.09 9.08 7 133585 448 90494407
Porphyria non-acute 10.03 9.08 6 133586 297 90494558
Soft tissue sarcoma 10.03 9.08 5 133587 172 90494683
Microgenia 10.01 9.08 3 133589 24 90494831
Benign breast neoplasm 10.00 9.08 11 133581 1309 90493546
Breast injury 9.98 9.08 4 133588 81 90494774
Spider naevus 9.97 9.08 5 133587 174 90494681
Seasonal allergy 9.96 9.08 63 133529 22920 90471935
Carpal tunnel decompression 9.95 9.08 10 133582 1073 90493782
Intercepted product prescribing error 9.94 9.08 6 133586 302 90494553
Contusion 9.94 9.08 288 133304 250928 90243927
Iron binding capacity total decreased 9.94 9.08 7 133585 459 90494396
Hepatic rupture 9.93 9.08 4 133588 82 90494773
Vaginal perforation 9.90 9.08 3 133589 25 90494830
Muscle atrophy 9.83 9.08 31 133561 8370 90486485
Cardiogenic shock 9.80 9.08 13 133579 24455 90470400
Laryngitis 9.77 9.08 40 133552 50713 90444142
Impaired quality of life 9.76 9.08 63 133529 23081 90471774
Pain in jaw 9.76 9.08 111 133481 47874 90446981
Atypical femur fracture 9.74 9.08 26 133566 6395 90488460
Acute generalised exanthematous pustulosis 9.72 9.08 4 133588 13699 90481156
Ocular hyperaemia 9.71 9.08 84 133508 33714 90461141
Attention deficit hyperactivity disorder 9.70 9.08 20 133572 4164 90490691
Hypomagnesaemia 9.70 9.08 24 133568 35564 90459291
Drug level decreased 9.69 9.08 34 133558 9696 90485159
Loss of libido 9.69 9.08 11 133581 1356 90493499
Skin discomfort 9.65 9.08 13 133579 1908 90492947
Adnexa uteri pain 9.63 9.08 7 133585 482 90494373
Post procedural cellulitis 9.63 9.08 4 133588 89 90494766
Pruritus 9.63 9.08 925 132667 540600 89954255
Ovarian failure 9.63 9.08 12 133580 1631 90493224
Body height decreased 9.62 9.08 39 133553 11910 90482945
Schizophrenia 9.58 9.08 5 133587 14909 90479946
Acarodermatitis 9.56 9.08 11 133581 1375 90493480
Adverse drug reaction 9.56 9.08 118 133474 116583 90378272
Pustular psoriasis 9.52 9.08 8 133584 18548 90476307
Bacterial vaginosis 9.51 9.08 12 133580 1651 90493204
Deep dissecting haematoma 9.51 9.08 3 133589 29 90494826
Product preparation error 9.49 9.08 35 133557 10226 90484629
Bone pain 9.47 9.08 136 133456 61847 90433008
Hyperkeratosis 9.46 9.08 27 133565 6901 90487954
Product package associated injury 9.41 9.08 3 133589 30 90494825
Pneumonia aspiration 9.38 9.08 30 133562 40910 90453945
Foetal death 9.38 9.08 10 133582 20713 90474142
Vasculitis gastrointestinal 9.35 9.08 4 133588 96 90494759
Asthenia 9.34 9.08 669 132923 533082 89961773
Polyarthritis 9.31 9.08 8 133584 18342 90476513
Alanine aminotransferase abnormal 9.29 9.08 23 133569 5403 90489452
Carotid artery dissection 9.29 9.08 5 133587 202 90494653
Cardiac failure acute 9.28 9.08 3 133589 11926 90482929
Product lot number issue 9.24 9.08 5 133587 204 90494651
Injection site mass 9.24 9.08 60 133532 22030 90472825
Phlebitis 9.24 9.08 28 133564 7402 90487453
Abortion induced 9.23 9.08 3 133589 11885 90482970
Inability to afford medication 9.22 9.08 18 133574 3604 90491251
Tooth infection 9.19 9.08 56 133536 20114 90474741
Foreign body sensation in eyes 9.14 9.08 17 133575 3283 90491572
Limb discomfort 9.12 9.08 91 133501 37969 90456886
Frustration tolerance decreased 9.12 9.08 29 133563 7867 90486988
Upper motor neurone lesion 9.11 9.08 5 133587 210 90494645
Acute stress disorder 9.10 9.08 6 133586 353 90494502

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Meningioma 221.60 17.64 48 4300 1679 42615308
Meningioma benign 58.12 17.64 9 4339 42 42616945
Injection related reaction 51.10 17.64 12 4336 604 42616383
Keratoconus 48.07 17.64 9 4339 147 42616840
Invasive ductal breast carcinoma 46.82 17.64 8 4340 75 42616912
Epiphyses premature fusion 44.95 17.64 8 4340 97 42616890
Optic atrophy 42.69 17.64 12 4336 1237 42615750
Oestradiol increased 41.53 17.64 7 4341 60 42616927
Foetal exposure during pregnancy 39.28 17.64 35 4313 47276 42569711
Gynaecomastia 39.05 17.64 21 4327 12546 42604441
Product use issue 36.51 17.64 42 4306 76709 42540278
Hyperprolactinaemia 36.41 17.64 12 4336 2111 42614876
Precocious puberty 36.23 17.64 7 4341 136 42616851
Phyllodes tumour 34.28 17.64 5 4343 14 42616973
Hormone receptor positive breast cancer 30.20 17.64 5 4343 38 42616949
Premature baby 29.50 17.64 22 4326 23131 42593856
Exposure via partner 29.10 17.64 4 4344 6 42616981
Volvulus 29.07 17.64 10 4338 2003 42614984
Prolactin-producing pituitary tumour 28.79 17.64 5 4343 52 42616935
Off label use 28.37 17.64 134 4214 638201 41978786
Porphyria non-acute 27.59 17.64 7 4341 487 42616500
Oesophageal injury 27.59 17.64 6 4342 213 42616774
Growth accelerated 26.75 17.64 4 4344 14 42616973
Skin reaction 25.34 17.64 13 4335 7054 42609933
Pseudoprecocious puberty 24.57 17.64 3 4345 0 42616987
Inflammatory myofibroblastic tumour 23.77 17.64 5 4343 151 42616836
Accidental exposure to product by child 23.47 17.64 8 4340 1559 42615428
Gender dysphoria 22.75 17.64 4 4344 45 42616942
Blood oestrogen decreased 22.49 17.64 3 4345 3 42616984
Lupus nephritis 22.30 17.64 6 4342 525 42616462
Blood oestrogen increased 22.14 17.64 4 4344 53 42616934
Product use in unapproved indication 21.89 17.64 54 4294 184402 42432585
Unmasking of previously unidentified disease 21.29 17.64 7 4341 1222 42615765
Testicular germ cell cancer metastatic 21.10 17.64 4 4344 70 42616917
Self-medication 21.01 17.64 9 4339 3257 42613730
Testicular cancer metastatic 19.94 17.64 4 4344 95 42616892
Pelvic venous thrombosis 18.99 17.64 6 4342 923 42616064
Retroperitoneal mass 18.95 17.64 4 4344 123 42616864
Gastrointestinal injury 17.84 17.64 6 4342 1123 42615864

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
Product adhesion issue 1439.39 9.79 372 105716 2634 110480577
Meningioma 610.97 9.79 223 105865 5442 110477769
Application site rash 426.47 9.79 138 105950 2312 110480899
Hot flush 382.68 9.79 390 105698 65646 110417565
Vulvovaginal discomfort 334.85 9.79 111 105977 2013 110481198
Chronic sinusitis 286.67 9.79 218 105870 24866 110458345
Vaginal discharge 283.95 9.79 190 105898 17718 110465493
Application site pruritus 272.20 9.79 114 105974 4046 110479165
Application site erythema 245.63 9.79 116 105972 5494 110477717
Female genital tract fistula 223.59 9.79 159 105929 16360 110466851
Ovarian hyperstimulation syndrome 219.95 9.79 106 105982 5254 110477957
Macular degeneration 214.55 9.79 173 105915 21486 110461725
Vulvovaginal pain 198.70 9.79 82 106006 2802 110480409
Paraesthesia oral 193.44 9.79 198 105890 33473 110449738
Death 188.92 9.79 236 105852 698633 109784578
Application site irritation 185.90 9.79 70 106018 1867 110481344
Procedural pain 184.42 9.79 198 105890 35367 110447844
Vaginal haemorrhage 174.96 9.79 164 105924 24910 110458301
Headache 162.14 9.79 1419 104669 880958 109602253
Menopausal symptoms 161.84 9.79 68 106020 2433 110480778
Vaginal flatulence 157.72 9.79 114 105974 12030 110471181
Pemphigus 144.14 9.79 18 106070 214552 110268659
Vulvovaginal burning sensation 136.38 9.79 57 106031 2012 110481199
Hand deformity 135.95 9.79 23 106065 218483 110264728
Proctitis 134.31 9.79 119 105969 16808 110466403
Radiculopathy 134.00 9.79 126 105962 19210 110464001
Sedation complication 129.28 9.79 125 105963 19730 110463481
Hysterectomy 126.01 9.79 85 106003 8029 110475182
General physical health deterioration 125.15 9.79 134 105954 425161 110058050
Pericarditis 123.91 9.79 29 106059 219085 110264126
Anti-cyclic citrullinated peptide antibody positive 122.88 9.79 15 106073 181969 110301242
Acute kidney injury 119.43 9.79 271 105817 635159 109848052
Creatinine renal clearance decreased 119.39 9.79 125 105963 21690 110461521
Wound 115.99 9.79 40 106048 234397 110248814
Neutropenia 111.35 9.79 117 105971 374503 110108708
Duodenal ulcer perforation 109.89 9.79 19 106069 177681 110305530
Vulvovaginal dryness 108.72 9.79 53 106035 2694 110480517
Pneumonia viral 106.03 9.79 87 106001 11070 110472141
Helicobacter infection 104.98 9.79 23 106065 181854 110301357
Device use issue 103.61 9.79 57 106031 3727 110479484
Systemic lupus erythematosus 102.82 9.79 58 106030 254280 110228931
Application site reaction 101.30 9.79 36 106052 811 110482400
Postmenopausal haemorrhage 99.14 9.79 44 106044 1802 110481409
Breast tenderness 98.71 9.79 49 106039 2591 110480620
Glossodynia 98.15 9.79 45 106043 221959 110261252
Rheumatic fever 96.86 9.79 5 106083 122574 110360637
Colitis microscopic 96.13 9.79 89 105999 13305 110469906
Blood calcium decreased 95.25 9.79 143 105945 35702 110447509
Salpingo-oophorectomy unilateral 94.41 9.79 34 106054 797 110482414
Febrile neutropenia 94.04 9.79 99 105989 316668 110166543
Rheumatoid factor positive 93.58 9.79 9 106079 131631 110351580
Thrombocytopenia 92.85 9.79 119 105969 348766 110134445
Folliculitis 89.38 9.79 25 106063 167628 110315583
Product quality issue 89.18 9.79 216 105872 77083 110406128
Blood oestrogen decreased 89.05 9.79 25 106063 250 110482961
Blood oestrogen increased 86.17 9.79 23 106065 187 110483024
Soft tissue disorder 85.41 9.79 49 106039 3475 110479736
Product substitution issue 83.81 9.79 107 105981 22954 110460257
Constipation 83.78 9.79 609 105479 357177 110126034
Product physical issue 83.62 9.79 55 106033 4981 110478230
Product complaint 83.59 9.79 84 106004 13888 110469323
Multiple organ dysfunction syndrome 82.04 9.79 22 106066 151688 110331523
Balance disorder 81.73 9.79 272 105816 116288 110366923
Bronchitis 80.37 9.79 331 105757 156701 110326510
Wrong technique in product usage process 80.15 9.79 224 105864 87124 110396087
Vaginal infection 79.64 9.79 60 106028 6744 110476467
Diverticulitis 79.03 9.79 165 105923 53357 110429854
Feeling abnormal 77.33 9.79 361 105727 180350 110302861
Application site pain 76.89 9.79 54 106034 5445 110477766
Application site vesicles 76.74 9.79 35 106053 1529 110481682
Type 2 diabetes mellitus 75.16 9.79 38 106050 177194 110306017
Lung disorder 74.29 9.79 40 106048 180007 110303204
Liver injury 73.80 9.79 26 106062 150387 110332824
Application site burn 73.76 9.79 30 106058 987 110482224
Skin reaction 73.55 9.79 96 105992 21048 110462163
Vulvovaginal pruritus 71.98 9.79 43 106045 3288 110479923
Sinusitis fungal 71.81 9.79 40 106048 2680 110480531
Arthropathy 71.50 9.79 103 105985 287419 110195792
Device adhesion issue 70.98 9.79 64 106024 9246 110473965
Glaucoma 70.32 9.79 97 105991 22420 110460791
Oral candidiasis 69.63 9.79 141 105947 44619 110438592
Pancytopenia 68.61 9.79 60 106028 209553 110273658
Migraine 68.44 9.79 336 105752 171316 110311895
Oestrogen receptor assay positive 68.18 9.79 22 106066 365 110482846
Breast cancer 67.97 9.79 128 105960 38414 110444797
Creatinine renal clearance increased 66.12 9.79 42 106046 3583 110479628
Cardiac arrest 66.01 9.79 55 106033 196698 110286513
Sepsis 65.21 9.79 135 105953 327211 110156000
Embolism venous 64.88 9.79 47 106041 4976 110478235
Application site urticaria 64.47 9.79 19 106069 229 110482982
Swollen joint count increased 64.29 9.79 4 106084 83657 110399554
Hyperkalaemia 64.05 9.79 25 106063 135771 110347440
Oestradiol increased 63.74 9.79 16 106072 99 110483112
Renal function test abnormal 63.34 9.79 59 106029 8887 110474324
Confusional state 63.01 9.79 234 105854 468446 110014765
Breast cancer in situ 62.49 9.79 28 106060 1173 110482038
Cardiac failure 62.27 9.79 53 106035 187573 110295638
Lip dry 61.21 9.79 11 106077 100072 110383139
Progesterone receptor assay positive 60.99 9.79 18 106070 218 110482993
Pseudoprecocious puberty 60.67 9.79 11 106077 6 110483205
Facet joint syndrome 60.63 9.79 10 106078 96818 110386393
Pain 59.58 9.79 1264 104824 953691 109529520
Cognitive disorder 58.51 9.79 201 105887 87310 110395901
Muscle injury 58.50 9.79 31 106057 140776 110342435
Injection site pain 58.37 9.79 330 105758 177592 110305619
Incorrect dose administered by product 58.28 9.79 18 106070 257 110482954
Multiple drug therapy 57.02 9.79 53 106035 7961 110475250
Fungal infection 55.45 9.79 139 105949 50667 110432544
Product dose omission issue 55.45 9.79 511 105577 321271 110161940
Septic shock 55.40 9.79 42 106046 157486 110325725
Butterfly rash 55.34 9.79 31 106057 2100 110481111
Bladder prolapse 54.61 9.79 27 106061 1415 110481796
Maternal exposure during pregnancy 54.31 9.79 101 105987 254782 110228429
Peripheral venous disease 54.23 9.79 8 106080 84109 110399102
Obesity 53.24 9.79 21 106067 113330 110369881
Thyroid disorder 52.84 9.79 73 106015 16896 110466315
Nausea 52.80 9.79 1554 104534 1234136 109249075
Intentional overdose 52.41 9.79 31 106057 132470 110350741
Hormone level abnormal 52.15 9.79 31 106057 2349 110480862
Sputum increased 50.82 9.79 43 106045 5708 110477503
Ophthalmic vein thrombosis 50.77 9.79 16 106072 245 110482966
Pneumonia 50.05 9.79 569 105519 876145 109607066
Intermenstrual bleeding 49.61 9.79 46 106042 6888 110476323
Eye irritation 49.23 9.79 103 105985 33349 110449862
Completed suicide 49.07 9.79 99 105989 242282 110240929
Abnormal uterine bleeding 48.66 9.79 25 106063 1422 110481789
Vision blurred 48.20 9.79 248 105840 128774 110354437
Renal failure 48.08 9.79 90 105998 226484 110256727
Vulvovaginal injury 47.92 9.79 17 106071 381 110482830
Depressed level of consciousness 47.79 9.79 224 105864 112054 110371157
Dermatitis atopic 47.76 9.79 87 106001 25454 110457757
Epidermal necrosis 47.48 9.79 32 106056 3018 110480193
Herpes zoster 47.44 9.79 218 105870 108161 110375050
Device material issue 47.39 9.79 18 106070 492 110482719
Sleep disorder due to general medical condition, insomnia type 47.32 9.79 21 106067 105622 110377589
Phyllodes tumour 46.53 9.79 12 106076 84 110483127
Joint range of motion decreased 46.11 9.79 30 106058 121802 110361409
Osteopenia 45.85 9.79 79 106009 22130 110461081
Disease progression 45.80 9.79 104 105984 243930 110239281
Vaginal odour 45.27 9.79 17 106071 450 110482761
Toxicity to various agents 45.13 9.79 273 105815 480282 110002929
Therapeutic product effect incomplete 45.11 9.79 368 105720 223437 110259774
Influenza like illness 44.93 9.79 186 105902 88226 110394985
Prolactin-producing pituitary tumour 44.86 9.79 13 106075 147 110483064
Mucosal inflammation 44.84 9.79 18 106070 96123 110387088
Exposure during pregnancy 44.61 9.79 57 106031 167367 110315844
Frequent bowel movements 44.30 9.79 160 105928 71230 110411981
Delirium 43.75 9.79 39 106049 134986 110348225
Back pain 43.32 9.79 545 105543 370451 110112760
Contraindicated product administered 43.27 9.79 110 105978 248157 110235054
Oral herpes 42.87 9.79 102 105986 35978 110447233
Diverticulum 42.76 9.79 63 106025 15463 110467748
Coma 41.99 9.79 31 106057 117838 110365373
Malignant neoplasm progression 41.95 9.79 64 106024 174503 110308708
Therapeutic response unexpected 41.81 9.79 79 106009 23764 110459447
Breast cancer stage III 41.78 9.79 12 106076 79105 110404106
Fibrocystic breast disease 41.72 9.79 18 106070 688 110482523
Vaginal erosion 41.13 9.79 8 106080 10 110483201
Colitis ulcerative 41.09 9.79 165 105923 77198 110406013
Impaired healing 40.98 9.79 79 106009 196638 110286573
Incorrect dose administered by device 40.82 9.79 41 106047 6773 110476438
Hepatic necrosis 40.82 9.79 49 106039 9873 110473338
Orthostatic hypotension 40.70 9.79 148 105940 66101 110417110
Cardio-respiratory arrest 40.58 9.79 31 106057 115805 110367406
Placenta accreta 40.38 9.79 13 106075 214 110482997
Burning sensation 40.33 9.79 152 105936 69060 110414151
Urinary tract infection 40.10 9.79 484 105604 325798 110157413
Erythema 39.69 9.79 441 105647 291006 110192205
Live birth 39.65 9.79 9 106079 69475 110413736
Breast cancer female 39.37 9.79 54 106034 12414 110470797
Colitis 39.14 9.79 198 105890 102125 110381086
Colitis ischaemic 39.11 9.79 65 106023 17685 110465526
Vulvovaginal mycotic infection 39.11 9.79 36 106052 5341 110477870
Breast pain 38.89 9.79 48 106040 9952 110473259
Pulmonary fibrosis 38.79 9.79 25 106063 102017 110381194
Endometrial cancer 38.60 9.79 26 106062 2450 110480761
Dyspareunia 38.41 9.79 25 106063 2224 110480987
Application site scar 38.37 9.79 12 106076 179 110483032
Bradycardia 38.36 9.79 56 106032 155461 110327750
C-reactive protein abnormal 37.94 9.79 41 106047 129654 110353557
Rectal prolapse 37.78 9.79 26 106062 2537 110480674
Lower respiratory tract infection 37.68 9.79 114 105974 242992 110240219
Malaise 37.60 9.79 876 105212 670943 109812268
Weight decreased 37.45 9.79 644 105444 467413 110015798
Inflammation 37.36 9.79 81 106007 193157 110290054
Renal impairment 37.26 9.79 78 106010 188367 110294844
Rash papular 37.11 9.79 82 106006 27557 110455654
Breast enlargement 37.01 9.79 22 106066 1667 110481544
Precocious puberty 36.71 9.79 14 106074 387 110482824
Disease recurrence 36.67 9.79 135 105953 60649 110422562
Lactic acidosis 36.30 9.79 22 106066 92789 110390422
Wound infection 36.17 9.79 24 106064 96441 110386770
Myelosuppression 36.02 9.79 23 106065 94317 110388894
Eczema 35.88 9.79 151 105937 72142 110411069
Dyspepsia 35.81 9.79 309 105779 190656 110292555
Oral pain 35.30 9.79 97 105991 37347 110445864
Stomatitis 34.94 9.79 137 105951 270105 110213106
Carpal tunnel syndrome 34.90 9.79 71 106017 22539 110460672
Keratoconus 34.87 9.79 11 106077 169 110483042
Cytokine release syndrome 34.74 9.79 12 106076 70294 110412917
Depression 34.43 9.79 460 105628 316875 110166336
Ill-defined disorder 34.43 9.79 61 106027 156792 110326419
Bone density abnormal 34.11 9.79 29 106059 3874 110479337
Respiratory failure 34.08 9.79 100 105988 215232 110267979
Bone marrow failure 34.01 9.79 7 106081 57841 110425370
Product size issue 33.98 9.79 17 106071 914 110482297
Prescribed overdose 33.92 9.79 21 106067 87560 110395651
Palpitations 33.82 9.79 265 105823 158947 110324264
Uterine polyp 33.76 9.79 22 106066 1961 110481250
Injury 33.70 9.79 75 106013 177190 110306021
Liver function test abnormal 33.43 9.79 143 105945 68807 110414404
Tricuspid valve incompetence 33.39 9.79 72 106016 23801 110459410
Periodontal disease 33.37 9.79 22 106066 2000 110481211
Liver disorder 33.37 9.79 53 106035 142190 110341021
Product odour abnormal 33.08 9.79 20 106068 1563 110481648
Nasal polyps 32.72 9.79 51 106037 13149 110470062
Treatment failure 32.46 9.79 146 105942 277088 110206123
Meningioma benign 32.45 9.79 12 106076 304 110482907
Musculoskeletal stiffness 32.38 9.79 148 105940 279674 110203537
Hypercholesterolaemia 32.21 9.79 24 106064 90813 110392398
Breast mass 31.53 9.79 39 106049 8102 110475109
Drug abuse 31.37 9.79 78 106010 177333 110305878
Tinnitus 31.26 9.79 128 105960 60412 110422799
Cytomegalovirus infection 31.17 9.79 7 106081 54437 110428774
Product shape issue 31.02 9.79 8 106080 56 110483155
Sinusitis 30.92 9.79 427 105661 296261 110186950
Swelling 30.59 9.79 204 105884 350837 110132374
Sedation 30.37 9.79 140 105948 69543 110413668
Platelet count decreased 30.31 9.79 116 105972 230327 110252884
Decreased appetite 30.25 9.79 301 105787 475545 110007666
Cholestasis 30.22 9.79 12 106076 64506 110418705
Swelling face 30.10 9.79 171 105917 92150 110391061
Endometrial cancer stage I 30.08 9.79 10 106078 183 110483028
Grip strength decreased 29.99 9.79 20 106068 80154 110403057
Dry eye 29.63 9.79 119 105969 55674 110427537
Endometriosis 29.56 9.79 28 106060 4306 110478905
Cystocele 29.23 9.79 16 106072 1036 110482175
Metabolic acidosis 28.65 9.79 32 106056 99712 110383499
Uterine haemorrhage 28.59 9.79 25 106063 3469 110479742
Arthralgia 28.55 9.79 963 105125 778669 109704542
Skin irritation 28.53 9.79 54 106034 16265 110466946
Endometrial stromal sarcoma 28.49 9.79 6 106082 14 110483197
Atypical haemolytic uraemic syndrome 28.48 9.79 18 106070 1522 110481689
Gastrointestinal haemorrhage 28.32 9.79 74 106014 165444 110317767
Diastolic dysfunction 28.11 9.79 46 106042 12358 110470853
Spinal operation 28.05 9.79 43 106045 10929 110472282
Sleep apnoea syndrome 27.99 9.79 94 105994 40353 110442858
Illness 27.99 9.79 154 105934 82017 110401194
Stress 27.95 9.79 185 105903 105163 110378048
Pneumocystis jirovecii pneumonia 27.69 9.79 4 106084 42731 110440480
Low density lipoprotein increased 27.55 9.79 42 106046 10624 110472587
Exposure via skin contact 27.45 9.79 47 106041 13100 110470111
Hypoxia 26.98 9.79 52 106036 129463 110353748
Surgery 26.87 9.79 94 105994 41189 110442022
Photosensitivity reaction 26.87 9.79 69 106019 25520 110457691
Endometrial hypertrophy 26.66 9.79 9 106079 173 110483038
Vessel puncture site bruise 26.62 9.79 12 106076 510 110482701
Uterine leiomyoma 26.48 9.79 35 106053 7765 110475446
Interstitial lung disease 26.44 9.79 59 106029 139275 110343936
Endometrial hyperplasia 26.16 9.79 13 106075 689 110482522
Spinal stenosis 26.11 9.79 57 106031 18999 110464212
Myalgia 26.06 9.79 327 105761 222054 110261157
Drug intolerance 25.89 9.79 257 105831 406255 110076956
International normalised ratio increased 25.86 9.79 27 106061 86745 110396466
Product administration interrupted 25.75 9.79 42 106046 11250 110471961
Dermatitis contact 25.42 9.79 47 106041 13906 110469305
Pruritus 25.41 9.79 734 105354 580826 109902385
Full blood count abnormal 25.32 9.79 11 106077 56041 110427170
Porphyria non-acute 25.23 9.79 13 106075 744 110482467
Skin burning sensation 25.18 9.79 61 106027 21764 110461447
Atrophic vulvovaginitis 24.99 9.79 16 106072 1384 110481827
Red blood cell sedimentation rate increased 24.91 9.79 23 106065 78279 110404932
Hepatic enzyme increased 24.79 9.79 193 105895 320699 110162512
Application site inflammation 24.77 9.79 11 106077 451 110482760
Product packaging issue 24.75 9.79 17 106071 1654 110481557
Respiratory distress 24.68 9.79 18 106070 68856 110414355
Psoriatic arthropathy 24.63 9.79 101 105987 196660 110286551
Encephalopathy 24.40 9.79 25 106063 81030 110402181
Pleural effusion 24.32 9.79 88 106000 177621 110305590
Epiphyses premature fusion 24.24 9.79 8 106080 143 110483068
Oropharyngeal pain 23.86 9.79 216 105872 135060 110348151
Bursitis 23.85 9.79 56 106032 129862 110353349
Coeliac disease 23.84 9.79 6 106082 43181 110440030
Retinal vein occlusion 23.80 9.79 24 106064 3983 110479228
X-ray abnormal 23.72 9.79 4 106084 38113 110445098
Vaginal disorder 23.67 9.79 11 106077 502 110482709
Vulvovaginal erythema 23.59 9.79 11 106077 506 110482705
Hiatus hernia 23.57 9.79 69 106019 27537 110455674
Meniscus injury 23.48 9.79 33 106055 7760 110475451
Shock 23.45 9.79 11 106077 53577 110429634
Blister 23.02 9.79 126 105962 227250 110255961
Wheezing 22.89 9.79 147 105941 255083 110228128
Blepharospasm 22.89 9.79 12 106076 54839 110428372
Atrial fibrillation 22.84 9.79 128 105960 229514 110253697
Application site dermatitis 22.82 9.79 8 106080 173 110483038
Histamine intolerance 22.68 9.79 6 106082 47 110483164
Adjustment disorder with depressed mood 22.54 9.79 7 106081 43876 110439335
Neuroleptic malignant syndrome 22.51 9.79 3 106085 34056 110449155
COVID-19 22.48 9.79 345 105743 244715 110238496
Mood swings 22.41 9.79 60 106028 22752 110460459
Injection site erythema 22.39 9.79 161 105927 94015 110389196
Nail disorder 22.28 9.79 14 106074 57921 110425290
Hypoglycaemia 22.16 9.79 49 106039 116055 110367156
Melaena 22.10 9.79 20 106068 68737 110414474
Injection site inflammation 22.03 9.79 25 106063 4746 110478465
Abdominal pain 22.00 9.79 646 105442 512343 109970868
Breast calcifications 21.97 9.79 13 106075 977 110482234
Poor quality sleep 21.92 9.79 68 106020 28009 110455202
Osteoporosis 21.89 9.79 151 105937 87001 110396210
Head discomfort 21.81 9.79 53 106035 18947 110464264
Therapeutic product effect decreased 21.76 9.79 141 105947 244175 110239036
Dermal absorption impaired 21.72 9.79 5 106083 20 110483191
Pre-existing condition improved 21.72 9.79 29 106059 6497 110476714
Blood creatinine increased 21.59 9.79 96 105992 182793 110300418
Application site ulcer 21.53 9.79 7 106081 119 110483092
Insomnia 21.31 9.79 474 105614 360116 110123095
Muscle tightness 21.19 9.79 45 106043 14717 110468494
Drug resistance 21.17 9.79 14 106074 56360 110426851
Toxic epidermal necrolysis 21.15 9.79 109 105979 56618 110426593
Corticosteroid binding globulin increased 21.03 9.79 4 106084 4 110483207
Retinitis 21.01 9.79 3 106085 32324 110450887
Application site hypersensitivity 20.98 9.79 9 106079 339 110482872
Rectal haemorrhage 20.96 9.79 191 105897 119642 110363569
Injection site bruising 20.88 9.79 101 105987 51162 110432049
Neutrophil count decreased 20.74 9.79 54 106034 120887 110362324
Irritable bowel syndrome 20.74 9.79 84 106004 164131 110319080
Altered state of consciousness 20.72 9.79 15 106073 57611 110425600
Cardiogenic shock 20.52 9.79 15 106073 57323 110425888
Gastrointestinal disorder 20.37 9.79 142 105946 241810 110241401
Stress urinary incontinence 20.34 9.79 16 106072 1917 110481294
Toothache 20.20 9.79 59 106029 23516 110459695
Muscle spasms 20.19 9.79 377 105711 277780 110205431
Mediastinal effusion 20.09 9.79 6 106082 76 110483135
Transposition of the great vessels 20.01 9.79 6 106082 77 110483134
Pain in extremity 19.96 9.79 610 105478 486508 109996703
Insulin-like growth factor increased 19.95 9.79 17 106071 2279 110480932
Invasive ductal breast carcinoma 19.81 9.79 28 106060 6618 110476593
Uterine disorder 19.75 9.79 17 106071 2309 110480902
Respiratory symptom 19.68 9.79 44 106044 14901 110468310
Neurotoxicity 19.52 9.79 8 106080 42199 110441012
Emphysema 19.44 9.79 52 106036 19704 110463507
Periorbital oedema 19.42 9.79 35 106053 10157 110473054
Abdominal pain lower 19.38 9.79 79 106009 37204 110446007
Neoplasm progression 19.36 9.79 20 106068 64575 110418636
Hepatic function abnormal 19.35 9.79 35 106053 89260 110393951
Dizziness 19.24 9.79 836 105252 697357 109785854
Intervertebral disc degeneration 19.23 9.79 49 106039 18036 110465175
Blood pressure systolic abnormal 19.23 9.79 60 106028 24790 110458421
Ovarian atrophy 19.21 9.79 6 106082 89 110483122
Pituitary tumour 19.16 9.79 13 106075 1240 110481971
Haematochezia 19.13 9.79 182 105906 115342 110367869
Hepatic cytolysis 18.94 9.79 15 106073 55038 110428173
Vulvovaginal swelling 18.92 9.79 10 106078 603 110482608
Liver function test increased 18.92 9.79 35 106053 88513 110394698
Prosopagnosia 18.91 9.79 6 106082 94 110483117
Lymphogranuloma venereum 18.80 9.79 4 106084 10 110483201
Taste disorder 18.76 9.79 21 106067 65366 110417845
Hypothalamo-pituitary disorder 18.68 9.79 18 106070 2828 110480383
Injection related reaction 18.66 9.79 14 106074 1564 110481647
Thermal burn 18.61 9.79 30 106058 7958 110475253
Poor quality device used 18.59 9.79 18 106070 2845 110480366
Body height decreased 18.52 9.79 35 106053 10528 110472683
Pyrexia 18.51 9.79 690 105398 897575 109585636
Sopor 18.47 9.79 6 106082 36540 110446671
Product prescribing issue 18.41 9.79 39 106049 12733 110470478
Crying 18.12 9.79 60 106028 25568 110457643
Biochemical pregnancy 18.03 9.79 4 106084 13 110483198
Eye swelling 17.96 9.79 71 106017 32977 110450234
Application site erosion 17.75 9.79 8 106080 340 110482871
Gastroenteritis 17.68 9.79 79 106009 38721 110444490
Nail bed disorder 17.68 9.79 8 106080 343 110482868
Thyroxine decreased 17.63 9.79 11 106077 909 110482302
Injection site rash 17.62 9.79 56 106032 23363 110459848
Poor quality product administered 17.60 9.79 22 106066 4619 110478592
Respiratory arrest 17.53 9.79 18 106070 58281 110424930
Withdrawal bleed 17.46 9.79 5 106083 54 110483157
Pregnancy 17.46 9.79 14 106074 51053 110432158
Feeling hot 17.37 9.79 148 105940 90958 110392253
Vitamin D decreased 17.26 9.79 37 106051 12178 110471033
Breast cyst 17.26 9.79 13 106075 1461 110481750
White blood cell count decreased 17.23 9.79 139 105949 229251 110253960
Bladder disorder 17.22 9.79 35 106053 11102 110472109
C-reactive protein 17.16 9.79 4 106084 30327 110452884
Product dispensing error 17.08 9.79 44 106044 16301 110466910
Ovarian failure 17.04 9.79 11 106077 965 110482246
Neck surgery 17.03 9.79 15 106073 2102 110481109
Hyperhidrosis 16.91 9.79 263 105825 187035 110296176
Drug tolerance decreased 16.90 9.79 3 106085 27537 110455674
Rhabdomyolysis 16.88 9.79 59 106029 120342 110362869
Toxic skin eruption 16.87 9.79 3 106085 27512 110455699
Gender dysphoria 16.84 9.79 5 106083 62 110483149
Pericardial effusion 16.83 9.79 18 106070 57199 110426012
Atypical femur fracture 16.79 9.79 25 106063 6194 110477017
Accidental overdose 16.75 9.79 15 106073 51819 110431392
Pneumonitis 16.58 9.79 30 106058 76501 110406710
Urinary incontinence 16.50 9.79 91 105997 48496 110434715
Product taste abnormal 16.49 9.79 16 106072 2536 110480675
Sciatic nerve injury 16.48 9.79 10 106078 787 110482424
Pelvic infection 16.42 9.79 8 106080 406 110482805
Hypokalaemia 16.40 9.79 105 105983 182343 110300868
Lupus vulgaris 16.37 9.79 6 106082 33877 110449334
Pulmonary embolism 16.37 9.79 293 105795 214181 110269030
Candida infection 16.36 9.79 90 105998 47919 110435292
Gastrooesophageal reflux disease 16.36 9.79 253 105835 179723 110303488
Blood pressure increased 16.33 9.79 343 105745 258030 110225181
Application site discolouration 16.32 9.79 11 106077 1038 110482173
Anxiety 16.29 9.79 440 105648 344638 110138573
Haemophagocytic lymphohistiocytosis 16.27 9.79 5 106083 31554 110451657
Dislocation of vertebra 16.22 9.79 11 106077 43710 110439501
Application site dryness 16.09 9.79 7 106081 273 110482938
Expulsion of medication 16.09 9.79 5 106083 73 110483138
Prostate cancer 16.06 9.79 8 106080 37633 110445578
Vertigo 15.98 9.79 140 105948 86730 110396481
Oestradiol decreased 15.96 9.79 5 106083 75 110483136
Haematuria 15.87 9.79 35 106053 82970 110400241
Spinal osteoarthritis 15.86 9.79 49 106039 20134 110463077
Tenderness 15.80 9.79 63 106025 29374 110453837
Hysterotomy 15.77 9.79 3 106085 3 110483208
Oestrone increased 15.77 9.79 3 106085 3 110483208
Finger deformity 15.75 9.79 6 106082 33086 110450125
Vaginal ulceration 15.74 9.79 7 106081 288 110482923
Tumour lysis syndrome 15.67 9.79 5 106083 30796 110452415
Palmar-plantar erythrodysaesthesia syndrome 15.66 9.79 10 106078 41015 110442196
Intentional product use issue 15.65 9.79 157 105931 247749 110235462
Ventricular dyskinesia 15.64 9.79 8 106080 451 110482760
Musculoskeletal pain 15.61 9.79 107 105981 182916 110300295
Oesophageal irritation 15.52 9.79 7 106081 298 110482913
Bacterial vulvovaginitis 15.42 9.79 9 106079 659 110482552
Tooth fracture 15.40 9.79 37 106051 13130 110470081
Acute respiratory distress syndrome 15.35 9.79 17 106071 53181 110430030
Trans-sexualism 15.31 9.79 3 106085 4 110483207
Lip injury 15.31 9.79 12 106076 1430 110481781
Intestinal polyp 15.26 9.79 15 106073 2414 110480797
Poor venous access 15.24 9.79 55 106033 24467 110458744
Muscle fatigue 15.21 9.79 19 106069 3988 110479223
Medication error 15.20 9.79 51 106037 105315 110377896
Eye pain 15.16 9.79 91 105997 50008 110433203
Incorrect dose administered 15.09 9.79 159 105929 103482 110379729
Brain neoplasm 15.04 9.79 24 106064 6313 110476898
Testicular cancer metastatic 15.01 9.79 5 106083 92 110483119
Arthritis 15.01 9.79 235 105853 167351 110315860
Pain in jaw 14.88 9.79 92 105996 51085 110432126
Blood pressure diastolic decreased 14.83 9.79 71 106017 35814 110447397
Drug interaction 14.78 9.79 366 105722 499817 109983394
Unresponsive to stimuli 14.74 9.79 24 106064 63766 110419445
Gingival ulceration 14.58 9.79 11 106077 1239 110481972
Irritability 14.57 9.79 87 106001 47722 110435489
Myelodysplastic syndrome 14.50 9.79 9 106079 37475 110445736
Breast discomfort 14.42 9.79 8 106080 532 110482679
Synovitis 14.38 9.79 181 105907 273911 110209300
Cor pulmonale acute 14.35 9.79 9 106079 751 110482460
Device breakage 14.32 9.79 37 106051 13732 110469479
Device defective 14.31 9.79 18 106070 3804 110479407
Anaphylactic shock 14.30 9.79 17 106071 51529 110431682
Injection site pruritus 14.19 9.79 91 105997 51167 110432044
Iron deficiency anaemia 14.19 9.79 64 106024 31495 110451716
Hypertransaminasaemia 14.12 9.79 3 106085 24252 110458959
Epilepsy 14.12 9.79 49 106039 100160 110383051
Tachycardia 14.12 9.79 144 105944 226501 110256710
Lip swelling 14.06 9.79 90 105998 50577 110432634
Vertebrobasilar insufficiency 14.03 9.79 7 106081 374 110482837
Stress fracture 14.02 9.79 25 106063 7196 110476015
Application site exfoliation 14.01 9.79 8 106080 562 110482649
Breast disorder 14.00 9.79 14 106074 2300 110480911
Rectocele 13.96 9.79 9 106079 788 110482423
Therapy non-responder 13.90 9.79 91 105997 157216 110325995
Volvulus 13.86 9.79 17 106071 3501 110479710
Haemoptysis 13.71 9.79 30 106058 71324 110411887
Heliotrope rash 13.70 9.79 6 106082 238 110482973
Mouth swelling 13.69 9.79 25 106063 7329 110475882
Abdominal distension 13.64 9.79 240 105848 174863 110308348
Withdrawal syndrome 13.64 9.79 63 106025 31317 110451894
Neck injury 13.62 9.79 16 106072 3152 110480059
Wrong technique in device usage process 13.53 9.79 24 106064 6877 110476334
Condition aggravated 13.49 9.79 572 105516 734264 109748947
Cold urticaria 13.35 9.79 6 106082 253 110482958
Ventricular fibrillation 13.30 9.79 12 106076 41301 110441910
Bronchopulmonary aspergillosis 13.27 9.79 6 106082 29857 110453354
Device colour issue 13.16 9.79 4 106084 54 110483157
Feeling cold 13.15 9.79 66 106022 33921 110449290
Nipple pain 13.10 9.79 10 106078 1146 110482065
Benign breast neoplasm 13.06 9.79 9 106079 880 110482331
Intraductal proliferative breast lesion 13.04 9.79 15 106073 2890 110480321
Vaginal perforation 13.03 9.79 3 106085 12 110483199
Cystitis interstitial 12.98 9.79 11 106077 1463 110481748
Facial paresis 12.95 9.79 22 106066 6091 110477120
Lupus-like syndrome 12.95 9.79 12 106076 40780 110442431
Device physical property issue 12.84 9.79 17 106071 3777 110479434
Spondylolisthesis 12.83 9.79 17 106071 3781 110479430
Acromegaly 12.82 9.79 5 106083 147 110483064
Overdose 12.79 9.79 153 105935 233641 110249570
Chest discomfort 12.74 9.79 236 105852 173612 110309599
Hypotension 12.72 9.79 394 105694 523455 109959756
Agranulocytosis 12.68 9.79 25 106063 61735 110421476
Frontotemporal dementia 12.67 9.79 8 106080 675 110482536
Microgenia 12.66 9.79 3 106085 14 110483197
Injection site swelling 12.65 9.79 102 105986 61688 110421523
Vulvitis 12.61 9.79 6 106082 289 110482922
Bone pain 12.52 9.79 106 105982 65027 110418184
Spider naevus 12.51 9.79 5 106083 157 110483054
Nervousness 12.50 9.79 69 106019 36782 110446429
Emotional disorder 12.49 9.79 39 106049 16121 110467090
Bronchiectasis 12.48 9.79 10 106078 36483 110446728
Transplant rejection 12.48 9.79 4 106084 24563 110458648
Paranasal sinus inflammation 12.46 9.79 6 106082 297 110482914
Splenomegaly 12.42 9.79 4 106084 24494 110458717
Electrocardiogram QT prolonged 12.37 9.79 58 106030 108902 110374309
Poikiloderma 12.35 9.79 7 106081 485 110482726
Musculoskeletal discomfort 12.33 9.79 50 106038 23488 110459723
Asthenia 12.29 9.79 538 105550 688461 109794750
Oesophageal injury 12.27 9.79 6 106082 307 110482904
Testicular germ cell cancer metastatic 12.25 9.79 4 106084 69 110483142
Limb discomfort 12.23 9.79 74 106014 40780 110442431
Hair growth abnormal 12.21 9.79 16 106072 3521 110479690
Deep vein thrombosis 12.09 9.79 195 105893 139692 110343519
Retinal vein thrombosis 12.03 9.79 8 106080 738 110482473
Vulvovaginal inflammation 12.00 9.79 8 106080 741 110482470
Blood pressure systolic increased 11.93 9.79 127 105961 82864 110400347
Eosinophilic pneumonia acute 11.82 9.79 11 106077 1654 110481557
Breast hyperplasia 11.82 9.79 5 106083 182 110483029
Hyperprolactinaemia 11.79 9.79 22 106066 6553 110476658
Pituitary tumour recurrent 11.79 9.79 5 106083 183 110483028
Pulmonary oedema 11.78 9.79 53 106035 100606 110382605
Breast injury 11.75 9.79 4 106084 79 110483132
Troponin increased 11.72 9.79 7 106081 29759 110453452
Hyponatraemia 11.69 9.79 143 105945 217510 110265701
Oedema 11.64 9.79 137 105951 209839 110273372
Status epilepticus 11.64 9.79 8 106080 31563 110451648
Oestrogen deficiency 11.61 9.79 4 106084 82 110483129
External ear disorder 11.56 9.79 4 106084 83 110483128
Transfusion 11.50 9.79 5 106083 25467 110457744
Onychomycosis 11.47 9.79 12 106076 38519 110444692
Post procedural cellulitis 11.39 9.79 4 106084 87 110483124
Vomiting 11.37 9.79 737 105351 909938 109573273
Soft tissue swelling 11.36 9.79 11 106077 1738 110481473
Hospitalisation 11.32 9.79 85 106003 142408 110340803
Hormone receptor positive breast cancer 11.32 9.79 7 106081 570 110482641
Product use complaint 11.30 9.79 16 106072 3787 110479424
Blood pressure abnormal 11.25 9.79 47 106041 22377 110460834
Chronic fatigue syndrome 11.24 9.79 10 106078 1419 110481792
Menopause 11.21 9.79 13 106075 2525 110480686
Flatulence 11.18 9.79 87 106001 52062 110431149
Limb injury 11.16 9.79 68 106020 37568 110445643
Product packaging quantity issue 11.10 9.79 11 106077 1788 110481423
Visual impairment 11.10 9.79 186 105902 134242 110348969
Product preparation error 11.08 9.79 29 106059 10850 110472361
Hypervolaemia 11.06 9.79 19 106069 49441 110433770
Neutropenic sepsis 11.06 9.79 8 106080 30738 110452473
Dehydration 11.05 9.79 195 105893 279316 110203895
Abnormal sensation in eye 11.03 9.79 12 106076 2174 110481037
Hyperbilirubinaemia 11.01 9.79 8 106080 30663 110452548
Growth accelerated 10.97 9.79 3 106085 27 110483184
Vaginal prolapse 10.97 9.79 6 106082 388 110482823
Tachypnoea 10.92 9.79 13 106075 39382 110443829
Intra-abdominal haematoma 10.90 9.79 15 106073 3457 110479754
Congenital cystic kidney disease 10.90 9.79 6 106082 393 110482818
Rheumatoid nodule 10.86 9.79 3 106085 20293 110462918
Migraine with aura 10.84 9.79 15 106073 3477 110479734
Libido decreased 10.82 9.79 20 106068 5915 110477296
Repetitive strain injury 10.78 9.79 5 106083 227 110482984
Application site swelling 10.78 9.79 8 106080 879 110482332
Pollakiuria 10.76 9.79 76 106012 44119 110439092
Intentional self-injury 10.76 9.79 12 106076 37417 110445794
Infusion site swelling 10.75 9.79 27 106061 9850 110473361
Inflammatory myofibroblastic tumour 10.74 9.79 5 106083 229 110482982
Uterine spasm 10.69 9.79 7 106081 629 110482582
Deep dissecting haematoma 10.69 9.79 3 106085 30 110483181
Spinal disorder 10.68 9.79 30 106058 11698 110471513
Increased tendency to bruise 10.63 9.79 30 106058 11728 110471483
Scar 10.61 9.79 38 106050 16843 110466368
Paraneoplastic dermatomyositis 10.60 9.79 5 106083 236 110482975
Myocarditis 10.58 9.79 8 106080 30047 110453164
Contraindicated product prescribed 10.56 9.79 12 106076 2281 110480930
Executive dysfunction 10.54 9.79 6 106082 419 110482792
Intercepted product prescribing error 10.53 9.79 6 106082 420 110482791
Therapy partial responder 10.52 9.79 12 106076 37049 110446162
Electrolyte imbalance 10.50 9.79 12 106076 37016 110446195
Acute myocardial infarction 10.48 9.79 43 106045 83734 110399477
Human papilloma virus test positive 10.43 9.79 7 106081 656 110482555
Budd-Chiari syndrome 10.41 9.79 4 106084 113 110483098
Injection site mass 10.39 9.79 49 106039 24564 110458647
Breast disorder female 10.37 9.79 4 106084 114 110483097
Dysphonia 10.37 9.79 115 105973 75814 110407397
Right ventricular failure 10.36 9.79 6 106082 25948 110457263
Tendonitis 10.34 9.79 51 106037 26032 110457179
Schizophrenia 10.32 9.79 4 106084 21822 110461389
Application site pustules 10.27 9.79 3 106085 35 110483176
Uterine haematoma 10.27 9.79 3 106085 35 110483176
Breast swelling 10.26 9.79 10 106078 1594 110481617
Nasal discomfort 10.25 9.79 20 106068 6161 110477050
Acarodermatitis 10.22 9.79 11 106077 1970 110481241
Ovarian cyst 10.20 9.79 33 106055 13897 110469314
Acute generalised exanthematous pustulosis 10.19 9.79 4 106084 21660 110461551
Product outer packaging issue 10.19 9.79 3 106085 36 110483175
Fatigue 10.18 9.79 1323 104765 1214635 109268576
Foot operation 10.16 9.79 22 106066 7291 110475920
Tongue geographic 10.09 9.79 4 106084 123 110483088
Periodontitis 10.07 9.79 18 106070 5190 110478021
Dysgraphia 10.06 9.79 17 106071 4688 110478523
Hepatic adenoma 10.02 9.79 6 106082 461 110482750
Psoriasis 9.89 9.79 189 105899 139804 110343407
Upper limb fracture 9.87 9.79 43 106045 20845 110462366
Product label issue 9.80 9.79 8 106080 1010 110482201

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC G03AA14 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
Progestogens and estrogens, fixed combinations
ATC G03AA17 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
Progestogens and estrogens, fixed combinations
ATC G03AB08 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
Progestogens and estrogens, sequential preparations
ATC G03CA03 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
ESTROGENS
Natural and semisynthetic estrogens, plain
ATC G03CA53 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
ESTROGENS
Natural and semisynthetic estrogens, plain
ATC H01CC53 SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
HYPOTHALAMIC HORMONES
Anti-gonadotropin-releasing hormones
ATC H01CC54 SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
HYPOTHALAMIC HORMONES
Anti-gonadotropin-releasing hormones
FDA CS M0447348 Estradiol Congeners
FDA MoA N0000000100 Estrogen Receptor Agonists
MeSH PA D004967 Estrogens
MeSH PA D006728 Hormones
FDA EPC N0000175825 Estrogen
CHEBI has role CHEBI:50114 estrogen
CHEBI has role CHEBI:62872 EC 1.2.3.1 (aldehyde oxidase) inhibitor
CHEBI has role CHEBI:75771 mouse metabolite
CHEBI has role CHEBI:77746 human metabolite
CHEBI has role CHEBI:83056 <em>Daphnia magna</em> metabolite
CHEBI has role CHEBI:176497 geroprotector

Related Drugs by ATC class:

G03AA Progestogens and estrogens, fixed combinations 17 drugs
chlormadinonedesogestreldienogestdrospirenoneestetrolethinylestradioletynodiolgestodenelevonorgestrellynestrenolmedroxyprogesteronemegestrol acetate show all 17 →
G03AB Progestogens and estrogens, sequential preparations 10 drugs
chlormadinonedesogestreldienogestethinylestradiolgestodenelevonorgestrellynestrenolmegestrol acetatenorethisteronenorgestimate
G03CA Natural and semisynthetic estrogens, plain 7 drugs
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Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Premenstrual dysphoric disorder indication 596004
Contraception indication 13197004
Female hypogonadism syndrome indication 16041008
Atrophic vaginitis indication 52441000
Urethral atrophy indication 52620003
Primary ovarian failure indication 65846009
Acne vulgaris indication 88616000
Postmenopausal osteoporosis indication 102447009
Ovarian deficiency symptoms indication 111550004
Vasomotor symptoms associated with menopausal disorder indication 123756000
Menopausal flushing indication 198436008
Atrophic vulva indication 248861000 DOID:14275
Hormone replacement cycle in embryo transfer indication 266717002
Controlled ovarian stimulation indication 732970000
Advanced Prostatic Carcinoma indication
Metastatic Prostate Carcinoma indication
Metastatic Breast Carcinoma indication
Amenorrhea off-label use 14302001 DOID:13938
Polycystic ovaries off-label use 69878008
Dysmenorrhea off-label use 266599000
Postcoital contraception off-label use 268463003
Abnormal uterine bleeding unrelated to menstrual cycle off-label use 312984006
Menorrhagia off-label use 386692008
Pre-Menopausal Osteoporosis off-label use
Heart valve disorder contraindication 368009 DOID:4079
Hyperlipoproteinemia contraindication 3744001 DOID:1168
Gynecomastia contraindication 4754008 DOID:12698
Hypocalcemia contraindication 5291005
Alcoholism contraindication 7200002
Weight gain finding contraindication 8943002
Hypercholesterolemia contraindication 13644009
Hyperkalemia contraindication 14140009
Jaundice contraindication 18165001
Toxic shock syndrome contraindication 18504008 DOID:14115
Myocardial infarction contraindication 22298006 DOID:5844
Fibroadenosis of breast contraindication 23260002 DOID:10352
Diplopia contraindication 24982008
Retinal hemorrhage contraindication 28998008
Depressive disorder contraindication 35489007
Chloasma contraindication 36209000
Migraine contraindication 37796009 DOID:6364
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Hypothyroidism contraindication 40930008 DOID:1459
Body fluid retention contraindication 43498006
Thrombosis of retinal vein contraindication 46085004
Humoral hypercalcemia of malignancy contraindication 47709007
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Dementia contraindication 52448006
Hepatic porphyria contraindication 55056006 DOID:3133
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Hyperlipidemia contraindication 55822004 DOID:1168
Heart disease contraindication 56265001 DOID:114
Anorexia nervosa contraindication 56882008 DOID:8689
Benign mammary dysplasia contraindication 57993004
Acute nephropathy contraindication 58574008
Obstructive hyperbilirubinemia contraindication 59848001
Hepatic failure contraindication 59927004
Cerebrovascular disease contraindication 62914000 DOID:6713
Thrombophlebitis contraindication 64156001 DOID:3875
Osteoporosis contraindication 64859006 DOID:11476
Intermenstrual bleeding - irregular contraindication 64996003
Hypercalcemia contraindication 66931009 DOID:12678
Diabetes mellitus contraindication 73211009 DOID:9351
Sleep apnea contraindication 73430006 DOID:0050847
Hyperglycemia contraindication 80394007 DOID:4195
Heart failure contraindication 84114007 DOID:6000
Epilepsy contraindication 84757009 DOID:1826
Breast lump contraindication 89164003
Kidney disease contraindication 90708001 DOID:557
Malignant neoplasm of liver contraindication 93870000 DOID:3571
Uterine fibroids contraindication 95315005 DOID:13223
Neoplasm of prostate contraindication 126906006 DOID:10283
Neoplasm of female genital organ contraindication 126907002 DOID:120
Deep venous thrombosis contraindication 128053003
Seizure disorder contraindication 128613002
Endometriosis contraindication 129103003
Bed-ridden contraindication 160685001
Liver function tests abnormal contraindication 166603001
Mammography abnormal contraindication 168750009
Angina pectoris contraindication 194828000
Asthma contraindication 195967001 DOID:2841
Cerebrovascular accident contraindication 230690007
Pulmonary thromboembolism contraindication 233935004
Thrombophilia contraindication 234467004 DOID:2452
Disease of liver contraindication 235856003 DOID:409
Cholestasis of pregnancy contraindication 235888006
Metabolic syndrome X contraindication 237602007 DOID:14221
Endometrial carcinoma contraindication 254878006 DOID:2871
Benign prostatic hyperplasia contraindication 266569009
Edema contraindication 267038008
Chorea contraindication 271700006
Pregnancy, function contraindication 289908002
Hypertriglyceridemia contraindication 302870006
Osteopenia contraindication 312894000
Functional visual loss contraindication 313165001
Non-Q wave myocardial infarction contraindication 314207007
Malignant tumor of cervix contraindication 363354003 DOID:4362
Malignant tumor of ovary contraindication 363443007 DOID:2394
Thromboembolic disorder contraindication 371039008
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Cardiovascular event risk contraindication 395112001
Breastfeeding (mother) contraindication 413712001
Chronic lung disease contraindication 413839001
Disorder of coronary artery contraindication 414024009
Obesity contraindication 414916001 DOID:9970
Estrogen receptor positive tumor contraindication 416053008
Porphyria contraindication 418470004
Resistance to activated protein C due to Factor V Leiden contraindication 421527008
Optic disc edema contraindication 423341008 DOID:146
Family history of malignant neoplasm of breast contraindication 429740004
Hypertensive urgency contraindication 443482000
Carcinoma of female breast contraindication 447782002
Smokes tobacco daily contraindication 449868002
Nonspecific Abnormal Papanicolaou Smear of Cervix contraindication
Diabetes with Vascular Disease Complication contraindication
Major Surgery with Prolonged Post-Operative Immobilization contraindication
Worsening Headache Disorder contraindication
Acute Thromboembolic Stroke contraindication
Benign Hepatic Cell Adenoma contraindication
Breast Carcinoma in Males contraindication




🐶 Veterinary Drug Use

SpeciesUseRelation
Cattle To increase rate of weight gain Indication
Cattle To improve feed efficiency Indication
Cattle Synchronization of estrus/ovulation Indication

🐶 Veterinary products

ProductApplicantIngredients
Compudose 200, Encore (Compudose 400 ) Elanco US Inc. 2
Component E-H with Tylan Elanco US Inc. 3
Revalor-G, Revalor-IS, Revalor-S Intervet Inc. 2
Revalor-200, Revalor-H, Revalor-IH Intervet Inc. 2
Revalor-XH, Revalor-XS Intervet Inc. 2
Revalor-XR Intervet Inc. 2
Component TE-G, Component TE-G with Tylan, Component TE-ID with Tylan, Component TE-IS, Component TE-IS with Tylan, Component TE-S, Component TE-S with Tylan Elanco US Inc. 3
Component TE-200 with Tylan, Component TE-H with Tylan, Component TE-IH with Tylan Elanco US Inc. 3
Synovex T120, Synovex T40, Synovex T80 Zoetis Inc. 2

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.13 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.025MG/24HR MINIVELLE NOVEN N203752 Sept. 23, 2014 RX FILM, EXTENDED RELEASE TRANSDERMAL 9730900 July 10, 2028 A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
0.0375MG/24HR MINIVELLE NOVEN N203752 Oct. 29, 2012 RX FILM, EXTENDED RELEASE TRANSDERMAL 9730900 July 10, 2028 A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
0.05MG/24HR MINIVELLE NOVEN N203752 Oct. 29, 2012 RX FILM, EXTENDED RELEASE TRANSDERMAL 9730900 July 10, 2028 A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
0.075MG/24HR MINIVELLE NOVEN N203752 Oct. 29, 2012 RX FILM, EXTENDED RELEASE TRANSDERMAL 9730900 July 10, 2028 A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
0.1MG/24HR MINIVELLE NOVEN N203752 Oct. 29, 2012 RX FILM, EXTENDED RELEASE TRANSDERMAL 9730900 July 10, 2028 A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE ORIAHNN (COPACKAGED) ABBVIE N213388 May 29, 2020 RX CAPSULE ORAL 11459305 Nov. 7, 2028 MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS)
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10258630 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10258630 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10398708 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10398708 Nov. 21, 2032 TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10471072 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10471072 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10537581 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10537581 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10568891 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10568891 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10668082 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10668082 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10835487 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10835487 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10888516 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10888516 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 11241445 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 11241445 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 11246875 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 11246875 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 11351182 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 11351182 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 9180091 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 9180091 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10258630 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10258630 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10398708 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10398708 Nov. 21, 2032 TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10471072 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10471072 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10537581 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10537581 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10568891 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10568891 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10668082 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10668082 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10835487 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10835487 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10888516 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10888516 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 11241445 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 11241445 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 11246875 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 11246875 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 11351182 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 11351182 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 11497709 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 11497709 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 9180091 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 9180091 Nov. 21, 2032 TREATMENT OF DYSPAREUNIA
0.5MG;100MG BIJUVA MAYNE PHARMA N210132 Dec. 28, 2021 RX CAPSULE ORAL 10206932 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA MAYNE PHARMA N210132 Dec. 28, 2021 RX CAPSULE ORAL 10675288 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA MAYNE PHARMA N210132 Dec. 28, 2021 RX CAPSULE ORAL 11033626 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA MAYNE PHARMA N210132 Dec. 28, 2021 RX CAPSULE ORAL 11793819 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA MAYNE PHARMA N210132 Dec. 28, 2021 RX CAPSULE ORAL 8846648 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA MAYNE PHARMA N210132 Dec. 28, 2021 RX CAPSULE ORAL 8846649 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA MAYNE PHARMA N210132 Dec. 28, 2021 RX CAPSULE ORAL 8933059 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA MAYNE PHARMA N210132 Dec. 28, 2021 RX CAPSULE ORAL 9114145 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA MAYNE PHARMA N210132 Dec. 28, 2021 RX CAPSULE ORAL 9114146 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA MAYNE PHARMA N210132 Dec. 28, 2021 RX CAPSULE ORAL 9301920 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA MAYNE PHARMA N210132 Oct. 28, 2018 RX CAPSULE ORAL 10206932 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA MAYNE PHARMA N210132 Oct. 28, 2018 RX CAPSULE ORAL 10675288 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA MAYNE PHARMA N210132 Oct. 28, 2018 RX CAPSULE ORAL 10806740 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA MAYNE PHARMA N210132 Oct. 28, 2018 RX CAPSULE ORAL 11033626 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA MAYNE PHARMA N210132 Oct. 28, 2018 RX CAPSULE ORAL 11103513 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA MAYNE PHARMA N210132 Oct. 28, 2018 RX CAPSULE ORAL 11793819 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA MAYNE PHARMA N210132 Oct. 28, 2018 RX CAPSULE ORAL 8846648 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA MAYNE PHARMA N210132 Oct. 28, 2018 RX CAPSULE ORAL 8846649 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA MAYNE PHARMA N210132 Oct. 28, 2018 RX CAPSULE ORAL 9006222 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA MAYNE PHARMA N210132 Oct. 28, 2018 RX CAPSULE ORAL 9114145 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA MAYNE PHARMA N210132 Oct. 28, 2018 RX CAPSULE ORAL 9114146 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA MAYNE PHARMA N210132 Oct. 28, 2018 RX CAPSULE ORAL 9301920 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 11266661 Feb. 2, 2034 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 11266661 Feb. 2, 2034 TREATMENT OF DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 11266661 Feb. 2, 2034 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 11266661 Feb. 2, 2034 TREATMENT OF DYSPAREUNIA
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE ORIAHNN (COPACKAGED) ABBVIE N213388 May 29, 2020 RX CAPSULE ORAL 10881659 March 14, 2034 MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS)
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE ORIAHNN (COPACKAGED) ABBVIE N213388 May 29, 2020 RX CAPSULE ORAL 11045470 March 14, 2034 MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS)
1MG;0.5MG;40MG MYFEMBREE SUMITOMO PHARMA AM N214846 May 26, 2021 RX TABLET ORAL 11033551 Sept. 29, 2037 MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) IN PREMENOPAUSAL WOMEN
1MG;0.5MG;40MG MYFEMBREE SUMITOMO PHARMA AM N214846 May 26, 2021 RX TABLET ORAL 11957684 Sept. 29, 2037 MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) IN PREMENOPAUSAL WOMEN
1MG;0.5MG;40MG MYFEMBREE SUMITOMO PHARMA AM N214846 May 26, 2021 RX TABLET ORAL 11793812 May 3, 2038 MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE ORIAHNN (COPACKAGED) ABBVIE N213388 May 29, 2020 RX CAPSULE ORAL 12083227 Aug. 20, 2038 MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS)
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE ORIAHNN (COPACKAGED) ABBVIE N213388 May 29, 2020 RX CAPSULE ORAL 11690845 Aug. 27, 2040 MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) USING 300 MG ELAGOLIX WHILE CO-ADMINISTERING OMEPRAZOLE

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
1MG;0.5MG;40MG MYFEMBREE SUMITOMO PHARMA AM N214846 May 26, 2021 RX TABLET ORAL Jan. 27, 2026 INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF MVT-601-035

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Estrogen receptor Nuclear hormone receptor AGONIST EC50 10.30 WOMBAT-PK CHEMBL
Aldehyde oxidase Enzyme IC50 6.54 WOMBAT-PK
Glucocorticoid receptor Nuclear hormone receptor Ki 4.73 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Ki 4.93 DRUG MATRIX
Androgen receptor Nuclear hormone receptor IC50 7.72 CHEMBL
Calcium-activated potassium channel subunit alpha-1 Ion channel ACTIVATOR EC50 5.60 IUPHAR
Estrogen receptor beta Nuclear hormone receptor EC50 9.70 WOMBAT-PK
G-protein coupled estrogen receptor 1 GPCR EC50 9.52 WOMBAT-PK
Aldose reductase Enzyme IC50 4.62 CHEMBL
Corticosteroid-binding globulin Secreted Ki 5 CHEMBL
Steryl-sulfatase Enzyme IC50 4.08 CHEMBL
Sex hormone-binding globulin Secreted Kd 8.83 CHEMBL
Steroid hormone receptor ERR1 Nuclear hormone receptor IC50 8.44 CHEMBL
Steroid hormone receptor ERR2 Nuclear hormone receptor IC50 8.49 CHEMBL
Aldo-keto reductase family 1 member B10 Enzyme IC50 5.52 CHEMBL
Cytochrome P450 1B1 Enzyme Ki 5.72 CHEMBL
Sodium-dependent serotonin transporter Transporter Ki 5.24 DRUG MATRIX
Alpha-synuclein Transporter IC50 4.22 CHEMBL
Androgen receptor Transcription factor IC50 6.39 CHEMBL
Arachidonate 15-lipoxygenase Enzyme IC50 4.95 DRUG MATRIX
Progesterone receptor Transcription factor Ki 5.37 DRUG MATRIX
Estrogen receptor Transcription factor IC50 8.72 CHEMBL
Estrogen receptor beta Transcription factor IC50 8.77 CHEMBL
Estrogen receptor beta Transcription factor IC50 8.64 CHEMBL
Estrogen receptor Transcription factor IC50 8.66 CHEMBL
Estrogen receptor Transcription factor IC50 9.45 CHEMBL

External reference:

IDSource
4021205 VUID
N0000148651 NUI
D00105 KEGG_DRUG
35380-71-3 SECONDARY_CAS_RN
4017609 VANDF
4021205 VANDF
C0014912 UMLSCUI
CHEBI:16469 CHEBI
EST PDB_CHEM_ID
CHEMBL135 ChEMBL_ID
DB00783 DRUGBANK_ID
D004958 MESH_DESCRIPTOR_UI
5757 PUBCHEM_CID
406 INN_ID
4TI98Z838E UNII
236859 RXNORM
160774 MMSL
18201 MMSL
36188 MMSL
4684 MMSL
6157 MMSL
73244 MMSL
8602 MMSL
d00537 MMSL
001265 NDDF
007018 NDDF
116070003 SNOMEDCT_US
126172005 SNOMEDCT_US
12839006 SNOMEDCT_US
4TI98Z838E INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Estring HUMAN PRESCRIPTION DRUG LABEL 1 0013-1042 SYSTEM 2 mg VAGINAL NDA 27 sections
ELESTRIN HUMAN PRESCRIPTION DRUG LABEL 1 0037-4801 GEL, METERED 0.52 mg TOPICAL NDA 33 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0093-3223 INSERT 10 ug VAGINAL ANDA 31 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0093-3541 CREAM 0.10 mg VAGINAL ANDA 25 sections
Mimvey HUMAN PRESCRIPTION DRUG LABEL 2 0093-5455 TABLET, FILM COATED 1 mg ORAL ANDA 30 sections
Vagifem HUMAN PRESCRIPTION DRUG LABEL 1 0169-5176 INSERT 10 ug VAGINAL NDA 30 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-3349 PATCH 0.03 mg TRANSDERMAL ANDA 29 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-3350 PATCH 0.05 mg TRANSDERMAL ANDA 29 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-3351 PATCH 0.08 mg TRANSDERMAL ANDA 29 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-3352 PATCH 0.10 mg TRANSDERMAL ANDA 29 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-3360 PATCH 0.04 mg TRANSDERMAL ANDA 29 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-3361 PATCH 0.06 mg TRANSDERMAL ANDA 29 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-4619 PATCH 0.03 mg TRANSDERMAL ANDA 30 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-4620 PATCH 0.04 mg TRANSDERMAL ANDA 30 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-4621 PATCH 0.05 mg TRANSDERMAL ANDA 30 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-4622 PATCH 0.08 mg TRANSDERMAL ANDA 30 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-4623 PATCH 0.10 mg TRANSDERMAL ANDA 30 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-4640 PATCH 0.10 mg TRANSDERMAL ANDA 30 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-4641 PATCH 0.08 mg TRANSDERMAL ANDA 30 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-4642 PATCH 0.05 mg TRANSDERMAL ANDA 30 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-4643 PATCH 0.04 mg TRANSDERMAL ANDA 30 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-4644 PATCH 0.03 mg TRANSDERMAL ANDA 30 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-8770 CREAM 0.10 mg VAGINAL ANDA 18 sections
ESTRACE HUMAN PRESCRIPTION DRUG LABEL 1 0430-3754 CREAM 0.10 mg VAGINAL ANDA 25 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0555-0886 TABLET 1 mg ORAL ANDA 17 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0555-0887 TABLET 2 mg ORAL ANDA 17 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0555-0899 TABLET 0.50 mg ORAL ANDA 17 sections
Evamist HUMAN PRESCRIPTION DRUG LABEL 1 0574-2067 SPRAY 1.53 mg TRANSDERMAL NDA 29 sections
Estradiol Transdermal System HUMAN PRESCRIPTION DRUG LABEL 1 0781-7104 PATCH 0.10 mg TRANSDERMAL NDA authorized generic 30 sections
Estradiol Transdermal System HUMAN PRESCRIPTION DRUG LABEL 1 0781-7119 PATCH 0.03 mg TRANSDERMAL NDA AUTHORIZED GENERIC 30 sections