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estradiol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| estrogens | 1057 | 50-28-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 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:
| Property | Value | Reference |
|---|---|---|
| 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):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| 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:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 23, 1975 | FDA | BRISTOL MYERS SQUIBB | |
| Nov. 25, 2011 | PMDA | Shiseido Company, Limited |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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:
| Source | Code | Description |
|---|---|---|
| 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
G03AB Progestogens and estrogens, sequential preparations 10 drugs
G03CA Natural and semisynthetic estrogens, plain 7 drugs
H01CC Anti-gonadotropin-releasing hormones 6 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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
| Species | Use | Relation |
|---|---|---|
| Cattle | To increase rate of weight gain | Indication |
| Cattle | To improve feed efficiency | Indication |
| Cattle | Synchronization of estrus/ovulation | Indication |
🐶 Veterinary products
| Product | Applicant | Ingredients |
|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 11.13 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |