estradiol ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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 ยตM/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

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 4001.61 9.76 1019 99585 3700 63384718
Hot flush 939.96 9.76 722 99882 50437 63337981
Application site rash 857.54 9.76 266 100338 2232 63386186
Application site erythema 560.34 9.76 230 100374 4605 63383813
Application site pruritus 494.19 9.76 199 100405 3785 63384633
Product quality issue 459.62 9.76 411 100193 35454 63352964
Application site irritation 404.07 9.76 138 100466 1612 63386806
Meningioma 403.73 9.76 171 100433 3714 63384704
Vulvovaginal discomfort 351.98 9.76 135 100469 2243 63386175
Pemphigus 244.49 9.76 11 100593 183715 63204703
Application site reaction 228.82 9.76 73 100531 677 63387741
Wrong technique in product usage process 225.75 9.76 376 100228 61964 63326454
Menopausal symptoms 209.09 9.76 94 100510 2367 63386051
Vulvovaginal pain 205.77 9.76 96 100508 2639 63385779
Schizoaffective disorder 201.81 9.76 103 100501 3459 63384959
Hand deformity 195.59 9.76 15 100589 159442 63228976
Vulvovaginal burning sensation 186.99 9.76 83 100521 2026 63386392
Glossodynia 184.16 9.76 31 100573 178845 63209573
Pneumonia viral 168.05 9.76 122 100482 7800 63380618
Death 160.74 9.76 215 100389 374166 63014252
Breast tenderness 159.99 9.76 77 100527 2273 63386145
Systemic lupus erythematosus 157.36 9.76 67 100537 208851 63179567
Vaginal haemorrhage 156.22 9.76 205 100399 27282 63361136
Vulvovaginal dryness 156.02 9.76 81 100523 2820 63385598
Application site pain 154.06 9.76 91 100513 4091 63384327
Product physical issue 149.30 9.76 95 100509 4885 63383533
Anti-cyclic citrullinated peptide antibody positive 148.13 9.76 9 100595 116203 63272215
Blood oestrogen decreased 146.80 9.76 41 100563 227 63388191
Application site vesicles 135.40 9.76 59 100545 1376 63387042
Toxicity to various agents 134.98 9.76 116 100488 247134 63141284
Wound 131.77 9.76 47 100557 163216 63225202
Soft tissue disorder 131.68 9.76 84 100520 4338 63384080
Maternal exposure during pregnancy 129.20 9.76 96 100508 219966 63168452
Product complaint 126.24 9.76 127 100477 12682 63375736
Pericarditis 124.44 9.76 28 100576 131551 63256867
Ovarian hyperstimulation syndrome 121.40 9.76 77 100527 3937 63384481
Arthropathy 120.02 9.76 117 100487 234675 63153743
Contraindicated product administered 116.50 9.76 104 100500 217544 63170874
Application site urticaria 116.08 9.76 34 100570 229 63388189
Feeling abnormal 115.75 9.76 504 100100 147888 63240530
Rheumatoid factor positive 112.40 9.76 5 100599 84401 63304017
Application site burn 111.57 9.76 44 100560 790 63387628
Vaginal discharge 111.07 9.76 102 100502 9096 63379322
Product substitution issue 109.57 9.76 131 100473 15865 63372553
Colitis microscopic 107.82 9.76 101 100503 9238 63379180
Migraine 107.26 9.76 384 100220 102962 63285456
Hormone level abnormal 104.71 9.76 59 100545 2424 63385994
Device adhesion issue 104.13 9.76 77 100527 5064 63383354
Duodenal ulcer perforation 99.43 9.76 11 100593 87198 63301220
Hysterectomy 95.11 9.76 95 100509 9404 63379014
Helicobacter infection 93.43 9.76 17 100587 92768 63295650
Exposure during pregnancy 91.07 9.76 68 100536 155479 63232939
Postmenopausal haemorrhage 90.60 9.76 51 100553 2091 63386327
Incorrect dose administered by product 88.15 9.76 26 100578 180 63388238
Infusion related reaction 86.26 9.76 161 100443 245360 63143058
Drug abuse 83.05 9.76 9 100595 72509 63315909
General physical health deterioration 81.96 9.76 120 100484 201282 63187136
Neutropenia 81.79 9.76 94 100510 174911 63213507
Salpingo-oophorectomy unilateral 79.16 9.76 35 100569 846 63387572
Completed suicide 78.64 9.76 69 100535 145604 63242814
Vaginal infection 78.63 9.76 77 100527 7441 63380977
Skin reaction 78.62 9.76 107 100497 14742 63373676
Febrile neutropenia 75.71 9.76 47 100557 118402 63270016
Device material issue 75.18 9.76 24 100580 223 63388195
Product dose omission issue 74.73 9.76 630 99974 233683 63154735
Acute kidney injury 72.73 9.76 197 100407 263218 63125200
Application site hypersensitivity 71.45 9.76 23 100581 220 63388198
Vaginal odour 71.03 9.76 28 100576 502 63387916
Sinusitis fungal 70.49 9.76 41 100563 1790 63386628
Treatment failure 70.35 9.76 130 100474 198913 63189505
Intermenstrual bleeding 69.82 9.76 74 100530 7852 63380566
Headache 69.82 9.76 1398 99206 631843 62756575
Glaucoma 69.69 9.76 115 100489 18790 63369628
No adverse event 68.35 9.76 181 100423 41224 63347194
Depression 66.76 9.76 536 100068 195956 63192462
Bronchitis 66.57 9.76 381 100223 124554 63263864
Fungal infection 65.82 9.76 166 100438 36708 63351710
Intentional overdose 65.78 9.76 18 100586 74134 63314284
Skin irritation 65.45 9.76 79 100525 9662 63378756
Sputum increased 64.15 9.76 43 100561 2416 63386002
Insomnia 64.04 9.76 570 100034 214682 63173736
Thrombocytopenia 63.52 9.76 88 100516 151069 63237349
Embolism venous 63.34 9.76 47 100557 3107 63385311
Vulvovaginal pruritus 62.17 9.76 47 100557 3196 63385222
Incorrect dose administered by device 62.03 9.76 53 100551 4295 63384123
Breast cancer 61.92 9.76 193 100411 48190 63340228
Blood oestrogen increased 60.74 9.76 17 100587 95 63388323
Liver function test abnormal 60.56 9.76 191 100413 47990 63340428
Diverticulitis 60.37 9.76 168 100436 39389 63349029
Pancytopenia 59.85 9.76 40 100564 96893 63291525
Herpes zoster 59.66 9.76 274 100330 82188 63306230
Cardiac arrest 58.75 9.76 37 100567 92508 63295910
Oestrogen receptor assay positive 58.11 9.76 24 100580 488 63387930
Hyperkalaemia 56.62 9.76 9 100595 54194 63334224
Application site scar 56.09 9.76 19 100585 216 63388202
Thyroid disorder 55.57 9.76 92 100512 15070 63373348
Folliculitis 55.42 9.76 21 100583 70296 63318122
Pyrexia 54.97 9.76 479 100125 469999 62918419
Incorrect dose administered 54.83 9.76 214 100390 59754 63328664
Drug level increased 54.53 9.76 115 100489 22621 63365797
Respiratory symptom 54.41 9.76 44 100560 3303 63385115
Sleep disorder due to general medical condition, insomnia type 53.80 9.76 9 100595 52208 63336210
Swelling 53.68 9.76 239 100365 275139 63113279
Vaginal erosion 53.65 9.76 12 100592 20 63388398
Product size issue 51.71 9.76 20 100584 340 63388078
Drug intolerance 50.93 9.76 284 100320 308377 63080041
Abdominal discomfort 50.40 9.76 300 100304 320585 63067833
Night sweats 50.28 9.76 181 100423 48633 63339785
Device use issue 50.16 9.76 38 100566 2592 63385826
Cardiac failure 49.59 9.76 41 100563 89101 63299317
Sepsis 48.95 9.76 106 100498 153017 63235401
Application site swelling 48.85 9.76 22 100582 556 63387862
Fibromyalgia 48.71 9.76 254 100350 80166 63308252
Hypotension 48.20 9.76 245 100359 272359 63116059
Liver injury 47.82 9.76 18 100586 60502 63327916
Progesterone receptor assay positive 47.68 9.76 19 100585 351 63388067
Application site discolouration 47.26 9.76 24 100580 797 63387621
Oral pain 46.73 9.76 124 100480 28270 63360148
Arthritis 46.54 9.76 329 100275 115592 63272826
Product packaging issue 46.42 9.76 27 100577 1179 63387239
Breast cancer in situ 45.78 9.76 29 100575 1479 63386939
Ophthalmic vein thrombosis 45.15 9.76 16 100588 210 63388208
Product odour abnormal 44.62 9.76 27 100577 1269 63387149
Hyperhidrosis 44.43 9.76 308 100296 107528 63280890
Application site dermatitis 44.24 9.76 15 100589 171 63388247
Fibrocystic breast disease 44.07 9.76 26 100578 1166 63387252
Sleep apnoea syndrome 43.73 9.76 123 100481 29010 63359408
Breast enlargement 43.62 9.76 29 100575 1607 63386811
Application site erosion 43.55 9.76 15 100589 180 63388238
Colitis ischaemic 43.38 9.76 68 100536 10640 63377778
Application site inflammation 43.35 9.76 18 100586 371 63388047
Therapeutic product effect decreased 43.07 9.76 159 100445 193028 63195390
Multiple organ dysfunction syndrome 43.00 9.76 18 100586 56734 63331684
Disease progression 42.62 9.76 81 100523 122677 63265741
Mucosal inflammation 42.36 9.76 11 100593 46917 63341501
Musculoskeletal stiffness 41.78 9.76 151 100453 184467 63203951
Muscle spasms 41.63 9.76 404 100200 155746 63232672
Mood swings 41.12 9.76 90 100514 18158 63370260
Diastolic dysfunction 41.08 9.76 51 100553 6420 63381998
Cardio-respiratory arrest 40.85 9.76 22 100582 59937 63328481
Bladder prolapse 40.79 9.76 31 100573 2125 63386293
Disease recurrence 40.77 9.76 117 100487 27913 63360505
Malignant neoplasm progression 40.67 9.76 42 100562 82079 63306339
Alopecia 40.10 9.76 342 100262 337194 63051224
Platelet count decreased 39.98 9.76 77 100527 116045 63272373
Product shape issue 39.85 9.76 12 100592 90 63388328
Butterfly rash 39.19 9.76 28 100576 1745 63386673
Vulvovaginal mycotic infection 38.80 9.76 46 100558 5520 63382898
Nasal polyps 37.38 9.76 47 100557 5992 63382426
Therapeutic response unexpected 37.25 9.76 88 100516 18671 63369747
Breast pain 37.22 9.76 57 100547 8741 63379677
Discomfort 36.49 9.76 139 100465 167235 63221183
Diverticulum 36.45 9.76 67 100537 11924 63376494
Lower respiratory tract infection 36.43 9.76 99 100505 132208 63256210
Muscle injury 36.41 9.76 30 100574 65315 63323103
Oestradiol increased 36.13 9.76 11 100593 86 63388332
Wrong technique in device usage process 36.05 9.76 36 100568 3562 63384856
Product packaging quantity issue 36.02 9.76 24 100580 1335 63387083
Joint swelling 35.86 9.76 339 100265 327327 63061091
Influenza like illness 35.71 9.76 204 100400 66620 63321798
Respiratory failure 35.54 9.76 67 100537 101791 63286627
Dyspareunia 35.18 9.76 30 100574 2425 63385993
Type 2 diabetes mellitus 34.75 9.76 30 100574 63838 63324580
Dermatitis contact 34.08 9.76 62 100542 10946 63377472
Placenta accreta 34.05 9.76 13 100591 213 63388205
Endometrial cancer 33.67 9.76 33 100571 3192 63385226
Application site dryness 33.62 9.76 12 100592 161 63388257
Eczema 33.48 9.76 120 100484 32171 63356247
Osteopenia 33.16 9.76 87 100517 19698 63368720
Abdominal distension 33.12 9.76 243 100361 86372 63302046
Septic shock 33.08 9.76 34 100570 66595 63321823
Vision blurred 32.96 9.76 254 100350 91670 63296748
Lactic acidosis 32.65 9.76 10 100594 38277 63350141
Oestradiol decreased 32.54 9.76 8 100596 24 63388394
Overdose 32.52 9.76 85 100519 114993 63273425
Vulvovaginal injury 32.34 9.76 16 100588 502 63387916
Anxiety 32.29 9.76 504 100100 217037 63171381
Hepatic enzyme increased 31.81 9.76 189 100415 202139 63186279
Tricuspid valve incompetence 31.69 9.76 71 100533 14550 63373868
Application site exfoliation 31.28 9.76 15 100589 439 63387979
Hepatic function abnormal 31.14 9.76 10 100594 37132 63351286
Mobility decreased 30.91 9.76 94 100510 121065 63267353
Tinnitus 30.84 9.76 125 100479 35503 63352915
Palpitations 30.65 9.76 293 100311 112477 63275941
Hypoglycaemia 30.56 9.76 30 100574 60035 63328383
Irritability 30.52 9.76 115 100489 31579 63356839
Confusional state 30.11 9.76 235 100369 236145 63152273
Spinal operation 30.06 9.76 50 100554 8221 63380197
Rectal prolapse 29.99 9.76 25 100579 1958 63386460
Decreased appetite 29.96 9.76 254 100350 250798 63137620
Endometrial stromal sarcoma 29.84 9.76 7 100597 16 63388402
Stomatitis 29.73 9.76 116 100488 138609 63249809
Lung disorder 29.54 9.76 33 100571 62228 63326190
Surgery 29.51 9.76 124 100480 35788 63352630
Endometrial hyperplasia 29.44 9.76 18 100586 862 63387556
Female genital tract fistula 29.24 9.76 47 100557 7512 63380906
Renal failure 28.80 9.76 93 100511 117559 63270859
Endometrial cancer stage I 28.57 9.76 12 100592 255 63388163
Coma 28.52 9.76 36 100568 64328 63324090
Delirium 28.41 9.76 23 100581 50518 63337900
Cholestasis 28.35 9.76 6 100598 29428 63358990
Renal impairment 27.53 9.76 62 100542 88293 63300125
White blood cell count decreased 27.51 9.76 120 100484 138984 63249434
Pseudoprecocious puberty 27.25 9.76 5 100599 0 63388418
Application site ulcer 27.08 9.76 9 100595 96 63388322
Nipple pain 26.92 9.76 12 100592 296 63388122
Skin burning sensation 26.67 9.76 61 100543 12673 63375745
Stress 26.58 9.76 190 100414 66977 63321441
Therapy non-responder 26.41 9.76 50 100554 75851 63312567
Blood creatinine increased 26.28 9.76 63 100541 87781 63300637
Bone marrow failure 26.18 9.76 7 100597 29283 63359135
Application site discharge 26.02 9.76 10 100594 167 63388251
Emphysema 25.85 9.76 55 100549 10883 63377535
Gastrooesophageal reflux disease 25.74 9.76 248 100356 95391 63293027
Spinal stenosis 25.39 9.76 66 100538 14859 63373559
Periodontal disease 25.39 9.76 21 100583 1627 63386791
Poor quality product administered 25.24 9.76 28 100576 3128 63385290
Pre-existing condition improved 24.98 9.76 46 100558 8198 63380220
Red blood cell sedimentation rate increased 24.74 9.76 20 100584 43962 63344456
Crying 24.41 9.76 87 100517 23256 63365162
Blood cholesterol increased 24.41 9.76 242 100362 93790 63294628
Photosensitivity reaction 24.19 9.76 65 100539 14929 63373489
Hypothalamo-pituitary disorder 24.17 9.76 15 100589 738 63387680
Therapeutic product effect increased 24.16 9.76 18 100586 1197 63387221
Vulvovaginal erythema 24.10 9.76 11 100593 287 63388131
Condition aggravated 24.03 9.76 471 100133 401746 62986672
Application site discomfort 23.98 9.76 12 100592 386 63388032
Bradycardia 23.96 9.76 50 100554 73177 63315241
Haemoglobin decreased 23.88 9.76 134 100470 145351 63243067
Carpal tunnel syndrome 23.87 9.76 80 100524 20737 63367681
Feeling hot 23.87 9.76 149 100455 50205 63338213
Incorrect product administration duration 23.84 9.76 55 100549 11491 63376927
Insulin-like growth factor increased 23.81 9.76 16 100588 903 63387515
Loss of personal independence in daily activities 23.74 9.76 77 100527 97213 63291205
Gastrointestinal haemorrhage 23.67 9.76 59 100545 81117 63307301
Libido decreased 23.63 9.76 25 100579 2647 63385771
Bone density abnormal 23.55 9.76 28 100576 3370 63385048
Endometrial hypertrophy 23.45 9.76 11 100593 306 63388112
Meniscus injury 23.22 9.76 41 100563 7073 63381345
Live birth 23.15 9.76 6 100598 25624 63362794
Suicide attempt 23.12 9.76 38 100566 60880 63327538
Hyponatraemia 23.06 9.76 95 100509 111805 63276613
Vulvovaginal swelling 22.98 9.76 13 100591 538 63387880
Hypoxia 22.97 9.76 37 100567 59755 63328663
Vomiting 22.85 9.76 694 99910 558923 62829495
Psoriasis 22.67 9.76 224 100380 86733 63301685
Pneumonia 22.65 9.76 551 100053 456216 62932202
Uterine leiomyoma 22.61 9.76 47 100557 9151 63379267
Breast mass 22.50 9.76 43 100561 7879 63380539
Sinus rhythm 22.41 9.76 15 100589 841 63387577
Memory impairment 22.26 9.76 258 100346 104000 63284418
Cystocele 22.22 9.76 17 100587 1177 63387241
Sinusitis 22.09 9.76 492 100112 226161 63162257
Pleural effusion 21.90 9.76 75 100529 93135 63295283
Uterine polyp 21.44 9.76 21 100583 2029 63386389
Ventricular dyskinesia 21.36 9.76 8 100596 124 63388294
Breast discomfort 21.29 9.76 12 100592 493 63387925
Metabolic acidosis 21.26 9.76 24 100580 45045 63343373
Neoplasm progression 21.20 9.76 16 100588 36412 63352006
Breast calcifications 21.20 9.76 17 100587 1261 63387157
Impaired healing 21.17 9.76 87 100517 102455 63285963
Chronic sinusitis 21.04 9.76 56 100548 12787 63375631
Hypokalaemia 20.85 9.76 89 100515 103715 63284703
Altered state of consciousness 20.79 9.76 7 100597 25223 63363195
Stress urinary incontinence 20.77 9.76 22 100582 2333 63386085
Drug ineffective 20.74 9.76 1922 98682 1042843 62345575
Gastrointestinal disorder 20.40 9.76 123 100481 131116 63257302
Atrophic vulvovaginitis 20.17 9.76 19 100585 1749 63386669
Histamine intolerance 20.16 9.76 6 100598 43 63388375
Pulmonary fibrosis 20.12 9.76 20 100584 39789 63348629
Oral herpes 19.86 9.76 88 100516 25986 63362432
Vessel puncture site bruise 19.81 9.76 11 100593 439 63387979
Hiatus hernia 19.68 9.76 77 100527 21517 63366901
Interstitial lung disease 19.65 9.76 43 100561 61865 63326553
Device expulsion 19.49 9.76 16 100588 34906 63353512
Intervertebral disc degeneration 19.43 9.76 62 100542 15670 63372748
Burning sensation 19.31 9.76 150 100454 54257 63334161
Product availability issue 19.29 9.76 28 100576 4093 63384325
Muscle fatigue 19.23 9.76 22 100582 2542 63385876
Breast cancer female 19.14 9.76 56 100548 13503 63374915
Dermal absorption impaired 19.06 9.76 6 100598 53 63388365
Expulsion of medication 19.04 9.76 5 100599 21 63388397
Corticosteroid binding globulin increased 19.03 9.76 4 100600 4 63388414
Lymphogranuloma venereum 19.03 9.76 4 100600 4 63388414
Vaginal disorder 19.01 9.76 13 100591 755 63387663
Hypomagnesaemia 18.92 9.76 11 100593 28726 63359692
Retinal vein occlusion 18.86 9.76 20 100584 2123 63386295
Application site infection 18.77 9.76 6 100598 56 63388362
Withdrawal bleed 18.49 9.76 6 100598 59 63388359
Intestinal polyp 18.49 9.76 17 100587 1518 63386900
Thyroxine decreased 18.44 9.76 12 100592 641 63387777
Product colour issue 18.38 9.76 12 100592 645 63387773
Paraesthesia 18.33 9.76 350 100254 156616 63231802
Anaemia 18.31 9.76 341 100263 293089 63095329
Vitamin D decreased 18.16 9.76 46 100558 10196 63378222
Intentional self-injury 18.13 9.76 9 100595 25678 63362740
Neutrophil count decreased 18.05 9.76 39 100565 56367 63332051
Palmar-plantar erythrodysaesthesia syndrome 17.92 9.76 7 100597 23008 63365410
Injection site inflammation 17.83 9.76 26 100578 3817 63384601
Ill-defined disorder 17.74 9.76 68 100536 81687 63306731
Product taste abnormal 17.68 9.76 19 100585 2048 63386370
Right ventricular failure 17.62 9.76 3 100601 17185 63371233
Breast hyperplasia 17.61 9.76 9 100595 303 63388115
International normalised ratio increased 17.58 9.76 29 100575 46396 63342022
Periorbital oedema 17.58 9.76 32 100572 5652 63382766
Prescribed overdose 17.44 9.76 17 100587 34136 63354282
Low density lipoprotein increased 17.44 9.76 34 100570 6323 63382095
Thermal burn 17.40 9.76 33 100571 6013 63382405
Rectocele 17.36 9.76 14 100590 1047 63387371
Product prescribing error 17.29 9.76 85 100519 26204 63362214
Respiratory distress 17.22 9.76 17 100587 33934 63354484
Atypical haemolytic uraemic syndrome 17.16 9.76 12 100592 723 63387695
Osteoporosis 17.09 9.76 152 100452 57186 63331232
Pregnancy 16.96 9.76 20 100584 36816 63351602
Shock 16.89 9.76 8 100596 23455 63364963
Emotional disorder 16.77 9.76 53 100551 13326 63375092
Head discomfort 16.68 9.76 53 100551 13362 63375056
Craniopharyngioma 16.57 9.76 7 100597 151 63388267
Pituitary tumour 16.56 9.76 13 100591 935 63387483
Prosopagnosia 16.55 9.76 5 100599 38 63388380
Endometriosis 16.51 9.76 30 100574 5290 63383128
Poor quality sleep 16.51 9.76 69 100535 19866 63368552
Creatinine renal clearance decreased 16.38 9.76 3 100601 16305 63372113
Abnormal dreams 16.37 9.76 45 100559 10471 63377947
Bacterial vulvovaginitis 16.30 9.76 12 100592 784 63387634
Drug resistance 16.24 9.76 8 100596 22925 63365493
Breast disorder 16.15 9.76 20 100584 2510 63385908
Hip arthroplasty 16.04 9.76 32 100572 47614 63340804
Ovarian atrophy 16.02 9.76 6 100598 93 63388325
Pelvic infection 16.01 9.76 9 100595 368 63388050
COVID-19 15.99 9.76 260 100344 112843 63275575
Spinal osteoarthritis 15.81 9.76 59 100545 16127 63372291
Acute respiratory distress syndrome 15.50 9.76 9 100595 23525 63364893
Uterine haemorrhage 15.46 9.76 25 100579 4016 63384402
Dyspnoea 15.46 9.76 874 99730 660439 62727979
Soft tissue swelling 15.42 9.76 14 100590 1230 63387188
Infusion site erythema 15.32 9.76 47 100557 11632 63376786
Pericardial effusion 15.30 9.76 15 100589 30043 63358375
Blood pressure increased 15.22 9.76 350 100254 161712 63226706
Myalgia 15.20 9.76 321 100283 146208 63242210
Back pain 15.19 9.76 536 100068 263609 63124809
Inflammation 15.05 9.76 73 100531 82200 63306218
Blood pressure systolic abnormal 14.96 9.76 51 100553 13335 63375083
Aptyalism 14.95 9.76 10 100594 560 63387858
Drug reaction with eosinophilia and systemic symptoms 14.91 9.76 19 100585 33817 63354601
Umbilical hernia 14.88 9.76 21 100583 2993 63385425
Transfusion 14.86 9.76 3 100601 15214 63373204
Periodontitis 14.83 9.76 22 100582 3281 63385137
Mediastinal effusion 14.75 9.76 5 100599 57 63388361
Urinary incontinence 14.72 9.76 94 100510 31920 63356498
Device colour issue 14.66 9.76 4 100600 20 63388398
Expired product administered 14.51 9.76 31 100573 6150 63382268
Melaena 14.51 9.76 16 100588 30349 63358069
Product outer packaging issue 14.50 9.76 4 100600 21 63388397
Myelosuppression 14.33 9.76 10 100594 23693 63364725
Tachycardia 14.32 9.76 119 100485 118037 63270381
Product design issue 14.27 9.76 3 100601 3 63388415
Vaginal prolapse 14.21 9.76 9 100595 459 63387959
Cold urticaria 14.18 9.76 6 100598 130 63388288
Tenderness 14.14 9.76 72 100532 22506 63365912
Poikiloderma 14.08 9.76 7 100597 222 63388196
Foetal exposure during pregnancy 14.03 9.76 18 100586 31944 63356474
Irritable bowel syndrome 14.01 9.76 75 100529 82337 63306081
Injection site pain 14.00 9.76 286 100318 129514 63258904
Inappropriate schedule of product administration 13.96 9.76 237 100367 103728 63284690
Thyrotoxic periodic paralysis 13.91 9.76 4 100600 25 63388393
Amnesia 13.91 9.76 142 100462 55443 63332975
Retinal vein thrombosis 13.83 9.76 9 100595 481 63387937
Trans-sexualism 13.81 9.76 3 100601 4 63388414
Mood altered 13.78 9.76 53 100551 14690 63373728
Application site pustules 13.78 9.76 4 100600 26 63388392
Poor venous access 13.70 9.76 53 100551 14732 63373686
Budd-Chiari syndrome 13.69 9.76 5 100599 72 63388346
Intentional product use issue 13.67 9.76 133 100471 127759 63260659
Vulvovaginal inflammation 13.57 9.76 11 100593 828 63387590
Scar 13.26 9.76 50 100554 13732 63374686
Neck pain 13.25 9.76 168 100436 69150 63319268
Hepatic cytolysis 13.18 9.76 4 100600 15403 63373015
Oestrogen deficiency 13.10 9.76 6 100598 158 63388260
Weight increased 13.02 9.76 521 100083 260271 63128147
Medication error 13.02 9.76 41 100563 52243 63336175
Obesity 13.01 9.76 17 100587 29935 63358483
Device physical property issue 13.00 9.76 16 100588 1996 63386422
Lip swelling 12.94 9.76 89 100515 30974 63357444
Post procedural cellulitis 12.93 9.76 5 100599 85 63388333
Vertebrobasilar insufficiency 12.86 9.76 6 100598 165 63388253
Cor pulmonale acute 12.83 9.76 8 100596 397 63388021
Electrolyte imbalance 12.77 9.76 8 100596 20068 63368350
Pituitary tumour recurrent 12.77 9.76 5 100599 88 63388330
Chest discomfort 12.76 9.76 245 100359 109724 63278694
Product administered at inappropriate site 12.76 9.76 20 100584 3129 63385289
Application site nodule 12.75 9.76 3 100601 7 63388411
Respiratory arrest 12.73 9.76 20 100584 32625 63355793
Endometrial disorder 12.62 9.76 10 100594 729 63387689
Breast cyst 12.61 9.76 15 100589 1806 63386612
Pain 12.57 9.76 1007 99597 739621 62648797
Infusion site swelling 12.52 9.76 39 100565 9731 63378687
Limb injury 12.46 9.76 76 100528 25401 63363017
Heliotrope rash 12.35 9.76 6 100598 181 63388237
Premature delivery 12.34 9.76 18 100586 30263 63358155
Neck injury 12.33 9.76 16 100588 2105 63386313
Sedation 12.28 9.76 27 100577 38782 63349636
Pulmonary embolism 12.22 9.76 256 100348 116428 63271990
Application site laceration 12.20 9.76 3 100601 9 63388409
Blood oestrogen abnormal 12.20 9.76 3 100601 9 63388409
Breast swelling 12.16 9.76 13 100591 1393 63387025
Adnexa uteri pain 12.15 9.76 8 100596 436 63387982
Muscle tightness 12.14 9.76 44 100560 11856 63376562
Blood pressure abnormal 12.11 9.76 52 100552 15146 63373272
Application site scab 12.08 9.76 6 100598 190 63388228
Liver disorder 12.07 9.76 44 100560 53643 63334775
Product use complaint 11.86 9.76 17 100587 2457 63385961
Hypogonadism 11.83 9.76 5 100599 108 63388310
Product storage error 11.79 9.76 51 100553 14905 63373513
Tandem gait test abnormal 11.77 9.76 4 100600 46 63388372
Limb discomfort 11.71 9.76 84 100520 29632 63358786
Gingival recession 11.70 9.76 13 100591 1454 63386964
External ear disorder 11.69 9.76 4 100600 47 63388371
Intercepted product prescribing error 11.69 9.76 6 100598 204 63388214
Eye irritation 11.68 9.76 67 100537 21904 63366514
Candida infection 11.68 9.76 81 100523 28270 63360148
XIth nerve injury 11.61 9.76 4 100600 48 63388370
Disseminated intravascular coagulation 11.57 9.76 8 100596 19043 63369375
Exposure keratitis 11.54 9.76 4 100600 49 63388369
Eosinophilic pleural effusion 11.54 9.76 4 100600 49 63388369
Tracheal pain 11.47 9.76 4 100600 50 63388368
Ultrasound liver abnormal 11.47 9.76 4 100600 50 63388368
Rotator cuff syndrome 11.39 9.76 47 100557 13455 63374963
Pelvic pain 11.35 9.76 47 100557 13472 63374946
Parotid gland enlargement 11.31 9.76 10 100594 848 63387570
Encephalopathy 11.31 9.76 28 100576 38592 63349826
Uterine disorder 11.31 9.76 19 100585 3150 63385268
Suspected product quality issue 11.30 9.76 6 100598 219 63388199
Product dispensing error 11.29 9.76 39 100565 10266 63378152
Agranulocytosis 11.19 9.76 14 100590 25120 63363298
Pain in extremity 11.18 9.76 637 99967 330849 63057569
Blood testosterone decreased 11.12 9.76 4 100600 55 63388363
Dry eye 11.11 9.76 106 100498 40655 63347763
Acne 11.08 9.76 69 100535 23224 63365194
Alanine aminotransferase abnormal 11.05 9.76 23 100581 4481 63383937
Musculoskeletal discomfort 11.04 9.76 57 100547 17910 63370508
Hyperglycaemia 11.02 9.76 32 100572 41835 63346583
Low turnover osteopathy 11.02 9.76 22 100582 4163 63384255
Respiratory depression 10.99 9.76 47 100557 13668 63374750
Meningioma surgery 10.99 9.76 4 100600 57 63388361
Procedural pain 10.97 9.76 65 100539 21504 63366914
Product physical consistency issue 10.96 9.76 9 100595 690 63387728
Pneumonia aspiration 10.95 9.76 24 100580 34516 63353902
Full blood count abnormal 10.94 9.76 21 100583 31696 63356722
Xanthoma 10.93 9.76 4 100600 58 63388360
Posterior reversible encephalopathy syndrome 10.91 9.76 7 100597 17338 63371080
Frontotemporal dementia 10.89 9.76 7 100597 366 63388052
Tachypnoea 10.86 9.76 7 100597 17295 63371123
Muscle atrophy 10.85 9.76 30 100574 7003 63381415
Carpal tunnel decompression 10.83 9.76 10 100594 898 63387520
Application site haemorrhage 10.81 9.76 11 100593 1113 63387305
Transferrin decreased 10.79 9.76 6 100598 240 63388178
Adenomyosis 10.77 9.76 8 100596 530 63387888
Breast disorder female 10.76 9.76 5 100599 136 63388282
Neck surgery 10.76 9.76 14 100590 1846 63386572
Orthostatic hypotension 10.76 9.76 26 100578 36134 63352284
Product prescribing issue 10.74 9.76 17 100587 2682 63385736
Cystitis interstitial 10.73 9.76 13 100591 1595 63386823
Acute hepatic failure 10.73 9.76 8 100596 18319 63370099
Gingival ulceration 10.62 9.76 10 100594 920 63387498
Hyperlipidaemia 10.61 9.76 60 100544 19511 63368907
Impatience 10.59 9.76 7 100597 384 63388034
Product residue present 10.57 9.76 21 100583 3958 63384460
Atrial fibrillation 10.57 9.76 126 100478 116510 63271908
Hepatic rupture 10.57 9.76 4 100600 64 63388354
Hypervolaemia 10.52 9.76 18 100586 28395 63360023
Neurotoxicity 10.50 9.76 7 100597 16983 63371435
Productive cough 10.48 9.76 58 100546 63150 63325268
Spinal disorder 10.43 9.76 37 100567 9865 63378553
Essential hypertension 10.42 9.76 24 100580 5009 63383409
Stress fracture 10.40 9.76 32 100572 7931 63380487
Blister 10.37 9.76 144 100460 129670 63258748
Accidental overdose 10.36 9.76 13 100591 23296 63365122
Eye haematoma 10.34 9.76 4 100600 68 63388350
Leukopenia 10.30 9.76 176 100428 77114 63311304
Lip injury 10.30 9.76 10 100594 956 63387462
Mammogram abnormal 10.30 9.76 9 100595 752 63387666
Blood corticotrophin increased 10.24 9.76 4 100600 70 63388348
Menopause 10.16 9.76 17 100587 2808 63385610
Upper gastrointestinal haemorrhage 10.08 9.76 9 100595 18843 63369575
Body height decreased 10.06 9.76 37 100567 10041 63378377
Hyperthyroidism 10.05 9.76 48 100556 14625 63373793
Iron deficiency anaemia 10.04 9.76 60 100544 19909 63368509
Peliosis hepatis 10.03 9.76 4 100600 74 63388344
Withdrawal syndrome 10.00 9.76 60 100544 19937 63368481
Spider naevus 9.96 9.76 5 100599 162 63388256
Seasonal allergy 9.93 9.76 62 100542 20888 63367530
Increased tendency to bruise 9.92 9.76 38 100566 10514 63377904
Benign breast neoplasm 9.91 9.76 11 100593 1229 63387189
Vaginal ulceration 9.90 9.76 7 100597 429 63387989
Tongue erythema 9.87 9.76 7 100597 431 63387987
Facial asymmetry 9.86 9.76 9 100595 796 63387622
Toothache 9.85 9.76 58 100546 19141 63369277
Repetitive strain injury 9.85 9.76 5 100599 166 63388252
Fall 9.79 9.76 515 100089 391819 62996599

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 140.91 40.55 26 1020 1410 34954475
Off label use 68.06 40.55 72 974 419452 34536433
Invasive ductal breast carcinoma 60.24 40.55 8 1038 45 34955840
Keratoconus 53.25 40.55 8 1038 119 34955766
Foetal exposure during pregnancy 50.52 40.55 24 1022 38077 34917808
Product use issue 49.68 40.55 28 1018 63188 34892697
Gynaecomastia 47.80 40.55 16 1030 10164 34945721
Prolactin-producing pituitary tumour 45.61 40.55 6 1040 31 34955854
Hyperprolactinaemia 43.54 40.55 10 1036 1586 34954299
Oestradiol increased 42.04 40.55 6 1040 61 34955824
Premature baby 40.92 40.55 17 1029 19616 34936269

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 1415.18 10.57 357 73872 2347 79667812
Meningioma 532.33 10.57 186 74043 4112 79666047
Application site rash 415.77 10.57 130 74099 2002 79668157
Hot flush 359.93 10.57 342 73887 54535 79615624
Vulvovaginal discomfort 264.46 10.57 89 74140 1749 79668410
Application site pruritus 257.75 10.57 106 74123 3704 79666455
Application site erythema 240.34 10.57 110 74119 5000 79665159
Product quality issue 208.29 10.57 204 74025 33736 79636423
Death 175.04 10.57 162 74067 566352 79103807
Application site irritation 172.81 10.57 64 74165 1680 79668479
Vulvovaginal pain 161.39 10.57 65 74164 2150 79668009
Ovarian hyperstimulation syndrome 158.97 10.57 74 74155 3497 79666662
Vaginal haemorrhage 141.12 10.57 135 74094 21682 79648477
Toxicity to various agents 135.54 10.57 116 74113 421424 79248735
Acute kidney injury 132.31 10.57 174 74055 519230 79150929
Menopausal symptoms 130.70 10.57 54 74175 1909 79668250
Pneumonia viral 121.35 10.57 86 74143 9072 79661087
Vulvovaginal burning sensation 116.26 10.57 47 74182 1570 79668589
Hysterectomy 112.24 10.57 71 74158 6201 79663958
Colitis microscopic 111.07 10.57 87 74142 10681 79659478
Migraine 110.91 10.57 249 73980 87244 79582915
Headache 109.30 10.57 1006 73223 652766 79017393
Vulvovaginal dryness 104.98 10.57 48 74181 2176 79667983
Febrile neutropenia 101.41 10.57 44 74185 230955 79439204
Application site reaction 97.69 10.57 34 74195 742 79669417
Drug abuse 97.38 10.57 17 74212 162674 79507485
Neutropenia 95.08 10.57 77 74152 287633 79382526
Breast tenderness 94.80 10.57 45 74184 2223 79667936
Vaginal discharge 94.10 10.57 68 74161 7395 79662764
Soft tissue disorder 92.36 10.57 51 74178 3464 79666695
Salpingo-oophorectomy unilateral 91.52 10.57 33 74196 801 79669358
Bronchitis 90.91 10.57 298 73931 130346 79539813
Product physical issue 89.27 10.57 53 74176 4132 79666027
Blood oestrogen decreased 88.46 10.57 22 74207 135 79670024
Product complaint 87.08 10.57 83 74146 13266 79656893
Thrombocytopenia 82.75 10.57 75 74154 265184 79404975
Fibromyalgia 78.07 10.57 180 74049 64160 79605999
Glaucoma 77.77 10.57 94 74135 19667 79650492
Application site vesicles 77.28 10.57 34 74195 1406 79668753
Device adhesion issue 76.97 10.57 59 74170 7016 79663143
Sinusitis fungal 75.18 10.57 39 74190 2335 79667824
Postmenopausal haemorrhage 74.84 10.57 34 74195 1518 79668641
Feeling abnormal 73.97 10.57 319 73910 158880 79511279
Product substitution issue 72.71 10.57 92 74137 20164 79649995
Skin reaction 72.52 10.57 82 74147 15986 79654173
Diverticulitis 72.47 10.57 143 74086 45793 79624366
Oestrogen receptor assay positive 72.28 10.57 22 74207 308 79669851
Cardiac arrest 72.06 10.57 35 74194 172061 79498098
Application site pain 70.93 10.57 48 74181 4699 79665460
Wrong technique in product usage process 69.94 10.57 188 74041 73687 79596472
Breast cancer 69.55 10.57 118 74111 33663 79636496
Hyperkalaemia 68.35 10.57 12 74217 114386 79555773
Application site burn 68.35 10.57 27 74202 848 79669311
Sepsis 67.71 10.57 91 74138 269337 79400822
Pancytopenia 67.46 10.57 35 74194 165710 79504449
Application site urticaria 65.03 10.57 19 74210 229 79669930
Depression 63.79 10.57 382 73847 216408 79453751
Multiple organ dysfunction syndrome 62.95 10.57 17 74212 120229 79549930
Cardiac failure 62.57 10.57 33 74196 154809 79515350
Hypotension 62.43 10.57 206 74023 440111 79230048
Device use issue 61.33 10.57 36 74193 2748 79667411
Sinusitis 61.08 10.57 350 73879 195151 79475008
Progesterone receptor assay positive 60.65 10.57 18 74211 230 79669929
Vulvovaginal pruritus 60.52 10.57 35 74194 2598 79667561
Device material issue 60.51 10.57 18 74211 232 79669927
Thyroid disorder 60.41 10.57 70 74159 14009 79656150
Vaginal infection 59.55 10.57 47 74182 5833 79664326
Breast cancer in situ 59.54 10.57 25 74204 921 79669238
Embolism venous 58.93 10.57 41 74188 4198 79665961
Pemphigus 58.29 10.57 11 74218 99571 79570588
Completed suicide 57.79 10.57 87 74142 245680 79424479
Butterfly rash 56.99 10.57 29 74200 1667 79668492
General physical health deterioration 56.81 10.57 106 74123 275132 79395027
Respiratory symptom 56.66 10.57 42 74187 4749 79665410
Fungal infection 56.48 10.57 122 74107 41626 79628533
Pyrexia 56.00 10.57 386 73843 678323 78991836
Sputum increased 55.81 10.57 41 74188 4572 79665587
Hand deformity 55.72 10.57 14 74215 103905 79566254
Oestradiol increased 55.34 10.57 14 74215 93 79670066
Bladder prolapse 55.30 10.57 27 74202 1420 79668739
Platelet count decreased 54.98 10.57 60 74169 194604 79475555
Incorrect dose administered by product 53.94 10.57 16 74213 204 79669955
Ophthalmic vein thrombosis 52.57 10.57 16 74213 224 79669935
Anti-cyclic citrullinated peptide antibody positive 49.06 10.57 9 74220 83134 79587025
Blood cholesterol increased 48.69 10.57 180 74049 83540 79586619
Cardio-respiratory arrest 48.66 10.57 20 74209 108490 79561669
Incorrect dose administered by device 48.64 10.57 39 74190 4950 79665209
Vaginal odour 47.33 10.57 17 74212 408 79669751
Osteopenia 47.22 10.57 71 74158 18293 79651866
Hormone level abnormal 47.05 10.57 27 74202 1975 79668184
Intentional overdose 46.76 10.57 20 74209 105940 79564219
Malignant neoplasm progression 46.65 10.57 35 74194 135955 79534204
Female genital tract fistula 46.47 10.57 41 74188 5934 79664225
Product dose omission issue 45.83 10.57 390 73839 247147 79423012
Respiratory failure 45.53 10.57 61 74168 180850 79489309
Hypoglycaemia 45.11 10.57 19 74210 101575 79568584
Septic shock 44.23 10.57 30 74199 122771 79547388
Pericarditis 43.93 10.57 21 74208 104215 79565944
Prolactin-producing pituitary tumour 43.66 10.57 12 74217 114 79670045
Colitis ischaemic 43.27 10.57 62 74167 15297 79654862
Fibrocystic breast disease 43.15 10.57 18 74211 652 79669507
Renal impairment 43.06 10.57 50 74179 157733 79512426
Nasal polyps 43.01 10.57 43 74186 7284 79662875
Mucosal inflammation 42.87 10.57 9 74220 75571 79594588
Renal failure 41.80 10.57 77 74152 200891 79469268
Muscle spasms 41.63 10.57 292 73937 174438 79495721
Placenta accreta 41.58 10.57 13 74216 200 79669959
Herpes zoster 41.28 10.57 184 74045 92899 79577260
Vulvovaginal mycotic infection 40.96 10.57 34 74195 4532 79665627
Diverticulum 40.32 10.57 59 74170 14837 79655322
Insomnia 40.10 10.57 376 73853 244794 79425365
Overdose 39.73 10.57 69 74160 184137 79486022
Wound 39.72 10.57 30 74199 116149 79554010
Disease recurrence 39.49 10.57 110 74119 43999 79626160
Bradycardia 39.14 10.57 41 74188 135516 79534643
Hepatic function abnormal 38.90 10.57 10 74219 73097 79597062
Rheumatoid factor positive 38.67 10.57 5 74224 59834 79610325
Breast cancer female 37.92 10.57 50 74179 11411 79658748
Eczema 37.74 10.57 103 74126 40715 79629444
Vulvovaginal injury 37.68 10.57 13 74216 276 79669883
Oral pain 37.51 10.57 88 74141 31710 79638449
Gastrooesophageal reflux disease 37.50 10.57 194 74035 104052 79566107
Influenza like illness 37.45 10.57 149 74080 71558 79598601
Arthritis 37.39 10.57 208 74021 114672 79555487
Rectal prolapse 37.34 10.57 24 74205 2154 79668005
Carpal tunnel syndrome 37.30 10.57 66 74163 19462 79650697
Osteoporosis 37.22 10.57 123 74106 53989 79616170
Anaemia 37.17 10.57 252 73977 444763 79225396
Gastrointestinal haemorrhage 36.97 10.57 50 74179 147669 79522490
Arthralgia 36.73 10.57 741 73488 571062 79099097
Lactic acidosis 36.72 10.57 10 74219 70349 79599810
Delirium 35.73 10.57 17 74212 84610 79585549
Vaginal erosion 35.66 10.57 7 74222 10 79670149
Disease progression 35.43 10.57 74 74155 184288 79485871
Liver function test abnormal 35.31 10.57 136 74093 64339 79605820
Blood creatinine increased 34.43 10.57 57 74172 155000 79515159
Bone density abnormal 34.35 10.57 26 74203 3034 79667125
Keratoconus 34.34 10.57 10 74219 119 79670040
Drug interaction 34.22 10.57 236 73993 414947 79255212
Application site scar 34.22 10.57 11 74218 186 79669973
Product odour abnormal 33.94 10.57 19 74210 1325 79668834
Glossodynia 33.67 10.57 28 74201 103309 79566850
Uterine polyp 33.63 10.57 20 74209 1564 79668595
Hypoxia 33.60 10.57 28 74201 103215 79566944
Breast enlargement 33.57 10.57 20 74209 1569 79668590
Pseudoprecocious puberty 33.45 10.57 6 74223 3 79670156
Decreased appetite 33.22 10.57 185 74044 342233 79327926
Blood oestrogen increased 33.08 10.57 9 74220 82 79670077
Pneumonia 33.06 10.57 425 73804 659821 79010338
Pain in extremity 32.94 10.57 499 73730 364039 79306120
Spinal stenosis 32.29 10.57 55 74174 15736 79654423
Cholestasis 32.16 10.57 5 74224 52104 79618055
Vulvovaginal erythema 31.78 10.57 11 74218 236 79669923
Product shape issue 31.77 10.57 8 74221 52 79670107
Spinal operation 31.71 10.57 38 74191 7879 79662280
Duodenal ulcer perforation 31.69 10.57 11 74218 66200 79603959
Vision blurred 31.36 10.57 187 74042 105711 79564448
Oral herpes 31.32 10.57 75 74154 27379 79642780
Palpitations 30.98 10.57 213 74016 126397 79543762
Endometrial cancer 30.87 10.57 21 74208 2073 79668086
Tricuspid valve incompetence 30.64 10.57 61 74168 19651 79650508
Memory impairment 30.38 10.57 193 74036 111541 79558618
Injection site pain 30.34 10.57 216 74013 129622 79540537
Endometrial cancer stage I 30.07 10.57 10 74219 189 79669970
Intermenstrual bleeding 29.97 10.57 32 74197 5852 79664307
Breast mass 29.68 10.57 34 74195 6720 79663439
Coma 29.55 10.57 30 74199 100619 79569540
Diastolic dysfunction 29.52 10.57 43 74186 10768 79659391
Helicobacter infection 29.43 10.57 14 74215 69690 79600469
Systemic lupus erythematosus 29.32 10.57 42 74187 121107 79549052
Interstitial lung disease 29.32 10.57 37 74192 112563 79557596
Bone marrow failure 29.16 10.57 6 74223 51101 79619058
Sleep apnoea syndrome 28.83 10.57 87 74142 36391 79633768
Chronic sinusitis 28.81 10.57 47 74182 12979 79657180
Endometrial stromal sarcoma 28.67 10.57 6 74223 14 79670145
Metabolic acidosis 28.61 10.57 21 74208 82508 79587651
Paraesthesia 28.60 10.57 270 73959 176053 79494106
Periodontal disease 28.16 10.57 19 74210 1851 79668308
Back pain 28.09 10.57 418 73811 303762 79366397
Feeling hot 27.94 10.57 120 74109 59614 79610545
Product size issue 27.85 10.57 14 74215 784 79669375
Endometrial hyperplasia 27.75 10.57 13 74216 623 79669536
Endometrial hypertrophy 26.83 10.57 9 74220 175 79669984
Neutrophil count decreased 26.47 10.57 29 74200 93930 79576229
Injection site inflammation 26.46 10.57 25 74204 3951 79666208
Head discomfort 26.40 10.57 48 74181 14454 79655705
Anxiety 26.36 10.57 350 73879 248162 79421997
Tinnitus 26.34 10.57 96 74133 44237 79625922
Burning sensation 26.06 10.57 116 74113 58516 79611643
Weight increased 25.93 10.57 382 73847 277004 79393155
Hiatus hernia 25.86 10.57 63 74166 23249 79646910
Stress 25.80 10.57 144 74085 79468 79590691
Porphyria non-acute 25.73 10.57 13 74216 736 79669423
Vitamin D decreased 25.57 10.57 38 74191 9687 79660472
Therapeutic response unexpected 25.51 10.57 57 74172 19889 79650270
White blood cell count decreased 25.33 10.57 90 74139 188198 79481961
Altered state of consciousness 25.31 10.57 5 74224 43817 79626342
Confusional state 25.09 10.57 183 74046 317814 79352345
Arthropathy 24.95 10.57 83 74146 177028 79493131
Meniscus injury 24.70 10.57 31 74198 6737 79663422
Dermatitis contact 24.66 10.57 40 74189 10993 79659166
Pneumonia aspiration 24.59 10.57 16 74213 66951 79603208
Melaena 24.55 10.57 13 74216 60877 79609282
Photosensitivity reaction 24.41 10.57 58 74171 21069 79649090
Haemoglobin decreased 24.35 10.57 115 74114 222004 79448155
Breast pain 24.22 10.57 34 74195 8231 79661928
Respiratory distress 24.20 10.57 12 74217 58327 79611832
Histamine intolerance 24.10 10.57 6 74223 37 79670122
International normalised ratio increased 24.03 10.57 26 74203 84695 79585464
Vessel puncture site bruise 24.01 10.57 11 74218 501 79669658
Psoriasis 23.89 10.57 154 74075 89433 79580726
Prosopagnosia 23.83 10.57 6 74223 39 79670120
Vaginal disorder 23.43 10.57 11 74218 530 79669629
Osteoarthritis 23.23 10.57 150 74079 87159 79583000
Shock 23.08 10.57 6 74223 43542 79626617
Dyspareunia 22.94 10.57 17 74212 1921 79668238
Blood pressure systolic abnormal 22.87 10.57 50 74179 17197 79652962
Uterine haemorrhage 22.74 10.57 20 74209 2883 79667276
Uterine leiomyoma 22.70 10.57 29 74200 6414 79663745
Hypothalamo-pituitary disorder 22.58 10.57 14 74215 1180 79668979
Lung disorder 22.54 10.57 25 74204 80532 79589627
Application site dermatitis 22.51 10.57 8 74221 186 79669973
Emphysema 22.46 10.57 48 74181 16252 79653907
Intervertebral disc degeneration 22.35 10.57 47 74182 15738 79654421
Product packaging issue 22.17 10.57 14 74215 1219 79668940
Hyponatraemia 21.98 10.57 88 74141 177760 79492399
Pleural effusion 21.91 10.57 66 74163 145196 79524963
Application site hypersensitivity 21.60 10.57 9 74220 325 79669834
Invasive ductal breast carcinoma 21.52 10.57 27 74202 5865 79664294
Application site ulcer 21.47 10.57 7 74222 124 79670035
Stress urinary incontinence 21.42 10.57 16 74213 1830 79668329
Muscle tightness 21.33 10.57 41 74188 12873 79657286
Crying 21.15 10.57 58 74171 22985 79647174
Corticosteroid binding globulin increased 21.15 10.57 4 74225 4 79670155
Thyroxine decreased 21.12 10.57 12 74217 861 79669298
Limb discomfort 21.11 10.57 73 74156 32777 79637382
Procedural pain 21.09 10.57 58 74171 23026 79647133
Nausea 21.00 10.57 1090 73139 956106 78714053
Prostate cancer 20.97 10.57 3 74226 33265 79636894
Periorbital oedema 20.91 10.57 32 74197 8370 79661789
Respiratory arrest 20.79 10.57 14 74215 57536 79612623
Hyperglycaemia 20.61 10.57 21 74208 70314 79599845
Dehydration 20.46 10.57 141 74088 248046 79422113
Therapy non-responder 20.42 10.57 34 74195 92271 79577888
Body height decreased 20.41 10.57 32 74197 8548 79661611
Oestradiol decreased 20.26 10.57 4 74225 6 79670153
Mood swings 20.24 10.57 52 74177 19828 79650331
Skin irritation 20.20 10.57 37 74192 11203 79658956
Poor venous access 20.08 10.57 49 74180 18100 79652059
Tachypnoea 19.96 10.57 3 74226 32060 79638099
Acute respiratory distress syndrome 19.95 10.57 8 74221 44059 79626100
Lymphogranuloma venereum 19.88 10.57 4 74225 7 79670152
Pituitary tumour 19.81 10.57 13 74216 1209 79668950
Vulvovaginal swelling 19.72 10.57 9 74220 406 79669753
Poor quality sleep 19.69 10.57 56 74173 22666 79647493
Cystocele 19.68 10.57 11 74218 765 79669394
Intestinal polyp 19.57 10.57 16 74213 2088 79668071
Application site erosion 19.49 10.57 8 74221 278 79669881
Night sweats 19.46 10.57 98 74131 51997 79618162
Atrophic vulvovaginitis 19.44 10.57 13 74216 1248 79668911
Ovarian atrophy 19.39 10.57 6 74223 89 79670070
Rhabdomyolysis 19.30 10.57 42 74187 103089 79567070
Insulin-like growth factor increased 18.94 10.57 15 74214 1871 79668288
Thermal burn 18.86 10.57 28 74201 7132 79663027
Encephalopathy 18.77 10.57 21 74208 67376 79602783
Retinal vein occlusion 18.58 10.57 19 74210 3304 79666855
Application site inflammation 18.58 10.57 9 74220 465 79669694
Atrial fibrillation 18.58 10.57 108 74121 197778 79472381
Drug resistance 18.57 10.57 8 74221 42205 79627954
Product taste abnormal 18.50 10.57 16 74213 2255 79667904
Incorrect product administration duration 18.44 10.57 37 74192 11985 79658174
Infusion related reaction 18.39 10.57 132 74097 230105 79440054
Breast calcifications 18.37 10.57 11 74218 871 79669288
Ovarian failure 18.29 10.57 10 74219 666 79669493
Fatigue 18.26 10.57 1048 73181 928679 78741480
Skin burning sensation 18.19 10.57 39 74190 13233 79656926
Sleep disorder due to general medical condition, insomnia type 18.00 10.57 9 74220 43547 79626612
Drug reaction with eosinophilia and systemic symptoms 17.91 10.57 20 74209 64224 79605935
Gender dysphoria 17.87 10.57 5 74224 51 79670108
Expulsion of medication 17.78 10.57 5 74224 52 79670107
Electrocardiogram QT prolonged 17.59 10.57 36 74193 90350 79579809
Hyperhidrosis 17.59 10.57 217 74012 151275 79518884
Low density lipoprotein increased 17.59 10.57 30 74199 8592 79661567
Hypomagnesaemia 17.51 10.57 11 74218 46900 79623259
Soft tissue swelling 17.39 10.57 13 74216 1488 79668671
Tenderness 17.39 10.57 55 74174 23587 79646572
Neck pain 17.34 10.57 125 74104 75292 79594867
Subdural haematoma 17.31 10.57 4 74225 31430 79638729
Wrong technique in device usage process 17.23 10.57 20 74209 4008 79666151
Application site dryness 17.23 10.57 7 74222 237 79669922
Pelvic infection 17.22 10.57 8 74221 376 79669783
Mediastinal effusion 17.21 10.57 5 74224 59 79670100
Endometriosis 17.03 10.57 19 74210 3649 79666510
Spinal osteoarthritis 16.95 10.57 44 74185 16883 79653276
Dermal absorption impaired 16.94 10.57 4 74225 19 79670140
Uterine disorder 16.88 10.57 15 74214 2192 79667967
Atypical haemolytic uraemic syndrome 16.78 10.57 11 74218 1021 79669138
Transposition of the great vessels 16.77 10.57 5 74224 65 79670094
Ventricular dyskinesia 16.76 10.57 8 74221 400 79669759
Exposure during pregnancy 16.69 10.57 44 74185 101088 79569071
Stress fracture 16.58 10.57 25 74204 6455 79663704
Haematuria 16.52 10.57 24 74205 68812 79601347
Breast discomfort 16.47 10.57 8 74221 416 79669743
Upper gastrointestinal haemorrhage 16.44 10.57 9 74220 41371 79628788
Urinary tract infection 16.34 10.57 352 73877 274160 79395999
Rectocele 16.23 10.57 9 74220 616 79669543
Meningioma benign 16.04 10.57 7 74222 284 79669875
Muscle fatigue 15.95 10.57 18 74211 3501 79666658
Hepatic cytolysis 15.88 10.57 3 74226 27148 79643011
Oestrone increased 15.86 10.57 3 74226 3 79670156
Pruritus 15.82 10.57 480 73749 394168 79275991
Folliculitis 15.70 10.57 17 74212 55363 79614796
Iron deficiency anaemia 15.59 10.57 56 74173 25616 79644543
Cytokine release syndrome 15.55 10.57 7 74222 35991 79634168
Disseminated intravascular coagulation 15.44 10.57 7 74222 35835 79634324
Poor quality product administered 15.43 10.57 18 74211 3627 79666532
Trans-sexualism 15.40 10.57 3 74226 4 79670155
Injection site bruising 15.22 10.57 77 74152 40925 79629234
Swelling face 15.22 10.57 116 74113 71096 79599063
Exposure via skin contact 15.21 10.57 7 74222 322 79669837
Neck surgery 15.19 10.57 13 74216 1806 79668353
Toothache 15.19 10.57 47 74182 19923 79650236
Palmar-plantar erythrodysaesthesia syndrome 15.02 10.57 6 74223 33128 79637031
Heliotrope rash 14.97 10.57 6 74223 196 79669963
Dizziness 14.84 10.57 615 73614 525826 79144333
Tooth fracture 14.80 10.57 33 74196 11497 79658662
Application site exfoliation 14.70 10.57 8 74221 528 79669631
Breast cyst 14.59 10.57 11 74218 1276 79668883
Vulvovaginal inflammation 14.56 10.57 8 74221 538 79669621
Poor quality device used 14.51 10.57 14 74215 2271 79667888
Neoplasm progression 14.50 10.57 16 74213 51666 79618493
Pericardial effusion 14.48 10.57 13 74216 46224 79623935
Hormone receptor positive breast cancer 14.48 10.57 7 74222 360 79669799
Full blood count abnormal 14.42 10.57 10 74219 40464 79629695
Hypokalaemia 14.39 10.57 77 74152 143963 79526196
Blood pressure diastolic decreased 14.36 10.57 61 74168 30155 79640004
Limb injury 14.33 10.57 60 74169 29468 79640691
Illness 14.32 10.57 83 74146 46428 79623731
Liver injury 14.32 10.57 19 74210 56595 79613564
Myelosuppression 14.29 10.57 10 74219 40286 79629873
Cardiogenic shock 14.09 10.57 11 74218 41903 79628256
Paranasal sinus inflammation 14.09 10.57 6 74223 229 79669930
Myalgia 14.08 10.57 247 73982 185394 79484765
Pain in jaw 13.98 10.57 82 74147 46069 79624090
Pulmonary embolism 13.97 10.57 231 73998 171423 79498736
Haemoptysis 13.96 10.57 19 74210 55980 79614179
Visual impairment 13.91 10.57 139 74090 91992 79578167
Cystitis interstitial 13.89 10.57 11 74218 1372 79668787
Poikiloderma 13.86 10.57 7 74222 396 79669763
Pneumonitis 13.85 10.57 22 74207 60838 79609321
Bacterial vulvovaginitis 13.79 10.57 8 74221 597 79669562
Abdominal distension 13.72 10.57 171 74058 119479 79550680
Breast disorder 13.69 10.57 13 74216 2068 79668091
Frontotemporal dementia 13.67 10.57 8 74221 607 79669552
Tachycardia 13.67 10.57 103 74126 177665 79492494
Candida infection 13.65 10.57 71 74158 38143 79632016
Maternal exposure during pregnancy 13.64 10.57 73 74156 136465 79533694
Type 2 diabetes mellitus 13.62 10.57 20 74209 57102 79613057
Benign breast neoplasm 13.56 10.57 9 74220 853 79669306
Application site discolouration 13.54 10.57 9 74220 855 79669304
COVID-19 13.50 10.57 214 74015 157460 79512699
Jaundice 13.40 10.57 18 74211 53331 79616828
Electrolyte imbalance 13.35 10.57 6 74223 30875 79639284
Tumour lysis syndrome 13.27 10.57 3 74226 23936 79646223
Vaginal ulceration 13.10 10.57 6 74223 273 79669886
Orthostatic hypotension 13.07 10.57 20 74209 56144 79614015
Neurotoxicity 13.02 10.57 7 74222 32511 79637648
Nipple pain 12.97 10.57 9 74220 917 79669242
Intentional self-injury 12.95 10.57 7 74222 32412 79637747
Right ventricular failure 12.92 10.57 3 74226 23494 79646665
Breast hyperplasia 12.90 10.57 5 74224 149 79670010
Retinal vein thrombosis 12.87 10.57 8 74221 677 79669482
Libido decreased 12.87 10.57 20 74209 5301 79664858
Vertigo 12.84 10.57 109 74120 68973 79601186
Repetitive strain injury 12.81 10.57 5 74224 152 79670007
Spider naevus 12.78 10.57 5 74224 153 79670006
Spinal disorder 12.76 10.57 29 74200 10231 79659928
Cor pulmonale acute 12.76 10.57 8 74221 688 79669471
Gastroenteritis 12.65 10.57 64 74165 34018 79636141
Urinary incontinence 12.60 10.57 73 74156 40836 79629323
Agranulocytosis 12.57 10.57 14 74215 45016 79625143
Vertebrobasilar insufficiency 12.48 10.57 6 74223 305 79669854
Testicular cancer metastatic 12.48 10.57 4 74225 67 79670092
Intercepted product prescribing error 12.46 10.57 6 74223 306 79669853
Hypocalcaemia 12.38 10.57 17 74212 49907 79620252
Inflammatory myofibroblastic tumour 12.34 10.57 5 74224 168 79669991
Post procedural cellulitis 12.32 10.57 4 74225 70 79670089
Pre-existing condition improved 12.21 10.57 20 74209 5543 79664616
Application site swelling 12.18 10.57 8 74221 745 79669414
Testicular mass 12.16 10.57 4 74225 73 79670086
Pulmonary congestion 12.14 10.57 5 74224 27095 79643064
Dry eye 12.09 10.57 67 74162 36864 79633295
Obesity 12.09 10.57 9 74220 35116 79635043
Precocious puberty 12.05 10.57 6 74223 329 79669830
Emotional disorder 12.02 10.57 35 74194 14352 79655807
Growth accelerated 11.98 10.57 3 74226 19 79670140
Unresponsive to stimuli 11.92 10.57 21 74208 55767 79614392
Hyperprolactinaemia 11.91 10.57 18 74211 4658 79665501
Atypical femur fracture 11.85 10.57 19 74210 5170 79664989
Withdrawal syndrome 11.83 10.57 53 74176 26801 79643358
Pituitary tumour recurrent 11.81 10.57 5 74224 188 79669971
Irritability 11.76 10.57 72 74157 41072 79629087
Intraductal proliferative breast lesion 11.73 10.57 13 74216 2478 79667681
Chest discomfort 11.68 10.57 187 74042 137857 79532302
Breast injury 11.68 10.57 4 74225 83 79670076
Eyelid pain 11.68 10.57 6 74223 352 79669807
Blood bilirubin increased 11.56 10.57 28 74201 66204 79603955
Eye swelling 11.49 10.57 52 74177 26416 79643743
Deep vein thrombosis 11.47 10.57 167 74062 120752 79549407
Myelodysplastic syndrome 11.45 10.57 7 74222 30294 79639865
External ear disorder 11.42 10.57 4 74225 89 79670070
Diabetic ketoacidosis 11.42 10.57 9 74220 34113 79636046
Feeling cold 11.41 10.57 55 74174 28674 79641485
Uterine haematoma 11.37 10.57 3 74226 24 79670135
Product administration interrupted 11.37 10.57 16 74213 3883 79666276
Injection site erythema 11.33 10.57 117 74112 78080 79592079
Pulmonary oedema 11.32 10.57 43 74186 88211 79581948
Increased tendency to bruise 11.31 10.57 28 74201 10436 79659723
Blood pressure increased 11.31 10.57 267 73962 211093 79459066
Rash maculo-papular 11.20 10.57 22 74207 56056 79614103
Cerebral haemorrhage 11.20 10.57 23 74206 57650 79612509
Lip injury 11.19 10.57 9 74220 1147 79669012
Cardiac failure congestive 11.19 10.57 82 74147 142320 79527839
Transferrin decreased 11.18 10.57 6 74223 385 79669774
Product outer packaging issue 11.16 10.57 3 74226 26 79670133
Surgery 11.10 10.57 60 74169 32706 79637453
Uterine cervix stenosis 11.07 10.57 5 74224 220 79669939
Iron binding capacity total decreased 11.07 10.57 6 74223 393 79669766
Deep dissecting haematoma 11.06 10.57 3 74226 27 79670132
Product colour issue 11.05 10.57 8 74221 872 79669287
Acute myocardial infarction 10.91 10.57 36 74193 77000 79593159
Budd-Chiari syndrome 10.91 10.57 4 74225 102 79670057
Migraine with aura 10.86 10.57 13 74216 2692 79667467
Incorrect dose administered 10.80 10.57 114 74115 76516 79593643
Hospitalisation 10.79 10.57 48 74181 94188 79575971
Hepatic rupture 10.76 10.57 4 74225 106 79670053
Gait disturbance 10.76 10.57 261 73968 207245 79462914
Oropharyngeal pain 10.75 10.57 152 74077 109201 79560958
Spondylolisthesis 10.73 10.57 14 74215 3161 79666998
Multiple use of single-use product 10.70 10.57 8 74221 916 79669243
Sedation 10.68 10.57 20 74209 51875 79618284

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 estrogens
CHEBI has role CHEBI:62872 quinoline oxidase inhibitors
CHEBI has role CHEBI:75771 Mus musculus metabolites
CHEBI has role CHEBI:77746 Homo sapiens metabolite
CHEBI has role CHEBI:83056 Daphnia magna metabolites
CHEBI has role CHEBI:176497 geroprotectors

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




๐Ÿถ Veterinary Drug Use

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

๐Ÿถ 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
1MG;0.5MG;40MG MYFEMBREE MYOVANT SCIENCES N214846 May 26, 2021 RX TABLET ORAL 9346822 Feb. 17, 2024 MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) IN PREMENOPAUSAL WOMEN
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 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 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 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 11497709 Nov. 21, 2032 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG 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 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 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 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
0.5MG;100MG BIJUVA MAYNE PHARMA N210132 Dec. 28, 2021 DISCN CAPSULE ORAL 10206932 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA MAYNE PHARMA N210132 Dec. 28, 2021 DISCN CAPSULE ORAL 10675288 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA MAYNE PHARMA N210132 Dec. 28, 2021 DISCN CAPSULE ORAL 11033626 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA MAYNE PHARMA N210132 Dec. 28, 2021 DISCN CAPSULE ORAL 8846648 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA MAYNE PHARMA N210132 Dec. 28, 2021 DISCN CAPSULE ORAL 8846649 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA MAYNE PHARMA N210132 Dec. 28, 2021 DISCN CAPSULE ORAL 8933059 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA MAYNE PHARMA N210132 Dec. 28, 2021 DISCN CAPSULE ORAL 9114145 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA MAYNE PHARMA N210132 Dec. 28, 2021 DISCN CAPSULE ORAL 9114146 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA MAYNE PHARMA N210132 Dec. 28, 2021 DISCN 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 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 10471072 June 18, 2033 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10471072 June 18, 2033 TREATMENT OF DYSPAREUNIA
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10568891 June 18, 2033 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10568891 June 18, 2033 TREATMENT OF DYSPAREUNIA
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10668082 June 18, 2033 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10668082 June 18, 2033 TREATMENT OF DYSPAREUNIA
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10888516 June 18, 2033 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10888516 June 18, 2033 TREATMENT OF DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10471072 June 18, 2033 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10471072 June 18, 2033 TREATMENT OF DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10568891 June 18, 2033 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10568891 June 18, 2033 TREATMENT OF DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10668082 June 18, 2033 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10668082 June 18, 2033 TREATMENT OF DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10888516 June 18, 2033 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10888516 June 18, 2033 TREATMENT OF DYSPAREUNIA
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10258630 Dec. 20, 2033 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10258630 Dec. 20, 2033 TREATMENT OF DYSPAREUNIA
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10398708 Dec. 20, 2033 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10398708 Dec. 20, 2033 TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 9180091 Dec. 20, 2033 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 9180091 Dec. 20, 2033 TREATMENT OF DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10258630 Dec. 20, 2033 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10258630 Dec. 20, 2033 TREATMENT OF DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10398708 Dec. 20, 2033 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 10398708 Dec. 20, 2033 TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 9180091 Dec. 20, 2033 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG IMVEXXY MAYNE PHARMA N208564 May 29, 2018 RX INSERT VAGINAL 9180091 Dec. 20, 2033 TREATMENT OF DYSPAREUNIA
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 MYOVANT SCIENCES N214846 May 26, 2021 RX TABLET ORAL 11033551 Sept. 29, 2037 MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) IN PREMENOPAUSAL WOMEN
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
0.1% ESTRADIOL CHEMO RESEARCH SL A211783 Aug. 10, 2022 RX GEL TRANSDERMAL April 8, 2023 COMPETITIVE GENERIC THERAPY
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE ORIAHNN (COPACKAGED) ABBVIE N213388 May 29, 2020 RX CAPSULE ORAL May 29, 2023 NEW PRODUCT
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE ORIAHNN (COPACKAGED) ABBVIE N213388 May 29, 2020 RX CAPSULE ORAL July 23, 2023 NEW CHEMICAL ENTITY
1MG;0.5MG;40MG MYFEMBREE MYOVANT SCIENCES N214846 May 26, 2021 RX TABLET ORAL May 26, 2024 NEW PRODUCT
1MG;0.5MG;40MG MYFEMBREE MYOVANT SCIENCES N214846 May 26, 2021 RX TABLET ORAL Aug. 5, 2025 FOR THE MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS
1MG;0.5MG;40MG MYFEMBREE MYOVANT SCIENCES N214846 May 26, 2021 RX TABLET ORAL Dec. 18, 2025 NEW CHEMICAL ENTITY
1MG;0.5MG;40MG MYFEMBREE MYOVANT SCIENCES 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
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
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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Estring HUMAN PRESCRIPTION DRUG LABEL 1 0013-1042 SYSTEM 2 mg VAGINAL NDA 27 sections
Estring HUMAN PRESCRIPTION DRUG LABEL 1 0013-2150 RING 2 mg VAGINAL NDA 27 sections
Estring HUMAN PRESCRIPTION DRUG LABEL 1 0013-2150 RING 2 mg VAGINAL NDA 27 sections
Alora HUMAN PRESCRIPTION DRUG LABEL 1 0023-5885 PATCH 0.03 mg TRANSDERMAL NDA 35 sections
Alora HUMAN PRESCRIPTION DRUG LABEL 1 0023-5886 PATCH 0.05 mg TRANSDERMAL NDA 35 sections
Alora HUMAN PRESCRIPTION DRUG LABEL 1 0023-5887 PATCH 0.08 mg TRANSDERMAL NDA 35 sections
Alora HUMAN PRESCRIPTION DRUG LABEL 1 0023-5888 PATCH 0.10 mg TRANSDERMAL NDA 35 sections
ELESTRIN HUMAN PRESCRIPTION DRUG LABEL 1 0037-4801 GEL, METERED 0.52 mg TOPICAL NDA 33 sections
ELESTRIN HUMAN PRESCRIPTION DRUG LABEL 1 0037-4801 GEL, METERED 0.52 mg TOPICAL NDA 33 sections
Vivelle-Dot HUMAN PRESCRIPTION DRUG LABEL 1 0078-0343 PATCH, EXTENDED RELEASE 0.04 mg TRANSDERMAL NDA 33 sections
Vivelle-Dot HUMAN PRESCRIPTION DRUG LABEL 1 0078-0343 PATCH, EXTENDED RELEASE 0.04 mg TRANSDERMAL NDA 33 sections
Vivelle-Dot HUMAN PRESCRIPTION DRUG LABEL 1 0078-0344 PATCH, EXTENDED RELEASE 0.05 mg TRANSDERMAL NDA 33 sections
Vivelle-Dot HUMAN PRESCRIPTION DRUG LABEL 1 0078-0344 PATCH, EXTENDED RELEASE 0.05 mg TRANSDERMAL NDA 33 sections
Vivelle-Dot HUMAN PRESCRIPTION DRUG LABEL 1 0078-0345 PATCH, EXTENDED RELEASE 0.08 mg TRANSDERMAL NDA 33 sections
Vivelle-Dot HUMAN PRESCRIPTION DRUG LABEL 1 0078-0345 PATCH, EXTENDED RELEASE 0.08 mg TRANSDERMAL NDA 33 sections
Vivelle-Dot HUMAN PRESCRIPTION DRUG LABEL 1 0078-0346 PATCH, EXTENDED RELEASE 0.10 mg TRANSDERMAL NDA 33 sections
Vivelle-Dot HUMAN PRESCRIPTION DRUG LABEL 1 0078-0346 PATCH, EXTENDED RELEASE 0.10 mg TRANSDERMAL NDA 33 sections
Vivelle-Dot HUMAN PRESCRIPTION DRUG LABEL 1 0078-0365 PATCH, EXTENDED RELEASE 0.03 mg TRANSDERMAL NDA 33 sections
Vivelle-Dot HUMAN PRESCRIPTION DRUG LABEL 1 0078-0365 PATCH, EXTENDED RELEASE 0.03 mg TRANSDERMAL NDA 33 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0093-3223 INSERT 10 ug VAGINAL ANDA 29 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0093-3223 INSERT 10 ug VAGINAL ANDA 29 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0093-3541 CREAM 0.10 mg VAGINAL ANDA 25 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
Estradiol Vaginal HUMAN PRESCRIPTION DRUG LABEL 1 0115-1518 CREAM 0.10 mg VAGINAL ANDA 23 sections
Vagifem HUMAN PRESCRIPTION DRUG LABEL 1 0169-5176 INSERT 10 ug VAGINAL NDA 31 sections
Vagifem HUMAN PRESCRIPTION DRUG LABEL 1 0169-5176 INSERT 10 ug VAGINAL NDA 31 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-3349 PATCH 0.03 mg TRANSDERMAL ANDA 30 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-3350 PATCH 0.05 mg TRANSDERMAL ANDA 30 sections
Estradiol HUMAN PRESCRIPTION DRUG LABEL 1 0378-3351 PATCH 0.08 mg TRANSDERMAL ANDA 30 sections