medroxyprogesterone ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
steroids, progestogens 1659 71-58-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • medroxyprogesterone
  • medroxyprogesterone acetate
  • medoxyprogesterone
  • medroxyprogesteron
  • depomedroxyprogesterone acetate
  • medroprogesterone acetate
  • hysron
A synthetic progestin that is derived from 17-hydroxyprogesterone. It is a long-acting contraceptive that is effective both orally or by intramuscular injection and has also been used to treat breast and endometrial neoplasms.
  • Molecular weight: 386.53
  • Formula: C24H34O4
  • CLOGP: 4.20
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 0
  • TPSA: 60.44
  • ALOGS: -5.24
  • ROTB: 3

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
1.67 mg P
5 mg O
7 mg P
1 g O
1 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ
S (Water solubility) 0.02 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 44 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.06 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 15 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAPK10,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PRKDC,STK33,TEK 21
kinase-selectivity-class EIF2AK3,GRK2 2
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
June 18, 1959 FDA PHARMACIA AND UPJOHN

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Unintended pregnancy 1945.73 10.89 494 42052 7143 90578758
Incorrect dose administered by device 904.27 10.89 254 42292 5483 90580418
Device leakage 846.07 10.89 274 42272 9717 90576184
Pregnancy with injectable contraceptive 705.93 10.89 110 42436 31 90585870
Syringe issue 575.62 10.89 165 42381 3837 90582064
Drug dose omission by device 551.07 10.89 200 42346 10031 90575870
Needle issue 436.88 10.89 184 42362 13750 90572151
Intermenstrual bleeding 433.03 10.89 163 42383 9060 90576841
Device occlusion 421.17 10.89 160 42386 9122 90576779
Heavy menstrual bleeding 319.26 10.89 167 42379 20363 90565538
Injection site abscess 268.82 10.89 73 42473 1381 90584520
Amenorrhoea 264.81 10.89 123 42423 11599 90574302
Vaginal haemorrhage 244.32 10.89 163 42383 31108 90554793
Breast cancer 213.06 10.89 187 42359 53574 90532327
Device mechanical issue 196.54 10.89 54 42492 1069 90584832
Device issue 193.14 10.89 138 42408 29399 90556502
Osteopenia 182.33 10.89 121 42425 22881 90563020
Device delivery system issue 159.60 10.89 51 42495 1727 90584174
Incorrect dose administered 143.39 10.89 181 42365 78749 90507152
Glossodynia 136.56 10.89 3 42543 321776 90264125
Depression 123.57 10.89 365 42181 300236 90285665
Contraindicated product administered 119.06 10.89 8 42538 320131 90265770
Menstruation irregular 115.20 10.89 62 42484 7998 90577903
Oestrogen receptor assay positive 113.36 10.89 30 42516 512 90585389
Pulmonary embolism 111.10 10.89 211 42335 130609 90455292
Product administration error 110.89 10.89 95 42451 26328 90559573
Fibrocystic breast disease 109.70 10.89 35 42511 1179 90584722
Poor quality device used 102.10 10.89 39 42507 2254 90583647
Abortion spontaneous 98.21 10.89 124 42422 53932 90531969
Systemic lupus erythematosus 97.23 10.89 25 42521 361871 90224030
Joint swelling 97.19 10.89 58 42488 503242 90082659
Hepatic enzyme increased 96.77 10.89 25 42521 360711 90225190
Injection site atrophy 95.91 10.89 29 42517 815 90585086
Treatment failure 94.08 10.89 15 42531 303913 90281988
Uterine perforation 93.91 10.89 53 42493 7501 90578400
Uterine haemorrhage 92.45 10.89 45 42501 4707 90581194
Wrong technique in device usage process 92.21 10.89 48 42498 5787 90580114
Pelvic pain 91.85 10.89 68 42478 15289 90570612
Synovitis 90.09 10.89 22 42524 329730 90256171
Progesterone receptor assay positive 89.68 10.89 23 42523 345 90585556
Wound 87.21 10.89 18 42528 302962 90282939
Meningioma 86.74 10.89 44 42502 5027 90580874
Breast cancer in situ 86.21 10.89 32 42514 1708 90584193
Helicobacter infection 83.36 10.89 6 42540 226844 90359057
Pericarditis 82.12 10.89 14 42532 270137 90315764
Clear cell renal cell carcinoma 81.75 10.89 30 42516 1550 90584351
Uterine leiomyoma 80.92 10.89 55 42491 10809 90575092
Folliculitis 79.33 10.89 4 42542 204349 90381552
Postmenopausal haemorrhage 79.19 10.89 33 42513 2397 90583504
Drug intolerance 79.04 10.89 57 42489 447534 90138367
Liquid product physical issue 78.61 10.89 29 42517 1521 90584380
Dysmenorrhoea 78.35 10.89 40 42506 4632 90581269
Emotional distress 77.82 10.89 91 42455 36571 90549330
Lower respiratory tract infection 76.16 10.89 13 42533 250646 90335255
Breast cancer female 76.03 10.89 60 42486 14826 90571075
Deep vein thrombosis 74.35 10.89 145 42401 91475 90494426
Rheumatoid arthritis 73.96 10.89 39 42507 362575 90223326
Breast calcifications 73.84 10.89 27 42519 1381 90584520
Infusion related reaction 72.38 10.89 54 42492 416726 90169175
Persistent genital arousal disorder 70.82 10.89 22 42524 678 90585223
Hot flush 70.18 10.89 111 42435 59377 90526524
Abdominal discomfort 69.48 10.89 73 42473 477255 90108646
Renal mass 68.24 10.89 30 42516 2485 90583416
Breast tenderness 67.15 10.89 30 42516 2582 90583319
Anxiety 64.41 10.89 302 42244 309470 90276431
Device breakage 64.09 10.89 53 42493 13991 90571910
Blister 64.04 10.89 20 42526 254978 90330923
Death 62.94 10.89 73 42473 456478 90129423
Injection site pain 61.14 10.89 200 42346 173499 90412402
Therapeutic product effect decreased 60.93 10.89 27 42519 277544 90308357
Genital haemorrhage 59.98 10.89 42 42504 8660 90577241
Stomatitis 59.86 10.89 27 42519 274671 90311230
Muscle injury 58.69 10.89 7 42539 176647 90409254
Uterine polyp 58.23 10.89 27 42519 2533 90583368
Injection site necrosis 57.88 10.89 23 42523 1478 90584423
Pyrexia 57.51 10.89 142 42404 660343 89925558
Infertility female 56.62 10.89 18 42528 599 90585302
Mobility decreased 55.65 10.89 24 42522 250710 90335191
Discomfort 55.19 10.89 30 42516 274305 90311596
Cerebrovascular accident 54.50 10.89 154 42392 123379 90462522
Confusional state 54.03 10.89 61 42485 386144 90199757
Liver injury 53.71 10.89 8 42538 170559 90415342
Device defective 53.15 10.89 28 42518 3458 90582443
Suppressed lactation 52.53 10.89 16 42530 461 90585440
Psoriatic arthropathy 52.05 10.89 21 42525 228314 90357587
Arthropathy 51.06 10.89 58 42488 366184 90219717
General physical health deterioration 50.87 10.89 55 42491 355060 90230841
Infertility 50.62 10.89 18 42528 849 90585052
Haemorrhage 50.55 10.89 105 42441 69264 90516637
Menstrual disorder 50.35 10.89 33 42513 6105 90579796
Poor quality product administered 49.49 10.89 28 42518 3980 90581921
Ill-defined disorder 49.18 10.89 13 42533 184878 90401023
Peripheral swelling 47.85 10.89 75 42471 413031 90172870
Cholecystitis chronic 46.76 10.89 38 42508 9788 90576113
Mood swings 46.64 10.89 53 42493 20649 90565252
Exposure via skin contact 45.95 10.89 39 42507 10666 90575235
Breast cancer metastatic 45.19 10.89 45 42501 15087 90570814
Scar 44.54 10.89 45 42501 15350 90570551
Infection 43.60 10.89 64 42482 362030 90223871
Gastrointestinal disorder 43.57 10.89 34 42512 256653 90329248
Pneumonia 42.01 10.89 156 42390 637903 89947998
Breast disorder 41.55 10.89 22 42524 2745 90583156
Musculoskeletal stiffness 41.28 10.89 47 42499 296485 90289416
Endometrial hyperplasia 41.26 10.89 16 42530 963 90584938
Hyperlipidaemia 40.71 10.89 52 42494 22864 90563037
Mood altered 40.52 10.89 45 42501 17099 90568802
C-reactive protein increased 39.23 10.89 18 42528 181371 90404530
Intentional product use issue 39.05 10.89 27 42519 216865 90369036
Suicidal ideation 38.55 10.89 98 42448 73757 90512144
Wound infection 38.54 10.89 3 42543 106399 90479502
Device use issue 38.09 10.89 23 42523 3690 90582211
Pregnancy test positive 38.04 10.89 10 42536 166 90585735
Device difficult to use 38.02 10.89 44 42502 17481 90568420
Abdominal pain lower 37.94 10.89 58 42488 30119 90555782
Coronary artery disease 37.27 10.89 61 42485 33562 90552339
Atrophic vulvovaginitis 37.10 10.89 18 42528 1869 90584032
Spinal osteoarthritis 36.48 10.89 45 42501 19103 90566798
Therapeutic product effect incomplete 36.44 10.89 23 42523 193873 90392028
Mammogram abnormal 36.36 10.89 14 42532 827 90585074
Device dislocation 36.10 10.89 58 42488 31424 90554477
Endometrial cancer 36.09 10.89 22 42524 3590 90582311
Abnormal uterine bleeding 36.00 10.89 18 42528 1994 90583907
Swelling 35.70 10.89 91 42455 418967 90166934
Ectopic pregnancy 35.65 10.89 21 42525 3220 90582681
Off label use 35.46 10.89 339 42207 1101913 89483988
Low turnover osteopathy 35.39 10.89 23 42523 4195 90581706
Product use issue 35.31 10.89 63 42483 329856 90256045
Exostosis of jaw 34.01 10.89 15 42531 1252 90584649
Diabetes mellitus 33.77 10.89 86 42460 64789 90521112
Breast mass 33.72 10.89 31 42515 9416 90576485
Device failure 33.51 10.89 27 42519 6870 90579031
Injection site panniculitis 33.32 10.89 5 42541 0 90585901
Scoliosis 33.31 10.89 30 42516 8877 90577024
Impaired healing 32.71 10.89 37 42509 234162 90351739
Delirium 32.60 10.89 5 42541 104354 90481547
Irritable bowel syndrome 32.12 10.89 30 42516 207418 90378483
Intervertebral disc degeneration 31.96 10.89 40 42506 17234 90568667
Injection site inflammation 31.49 10.89 22 42524 4519 90581382
Emotional disorder 31.44 10.89 37 42509 14960 90570941
Product complaint 31.16 10.89 35 42511 13465 90572436
Device physical property issue 30.57 10.89 18 42528 2758 90583143
Dyspareunia 30.51 10.89 18 42528 2768 90583133
Abortion missed 30.45 10.89 16 42530 1966 90583935
Bone density decreased 30.25 10.89 39 42507 17306 90568595
Toxicity to various agents 29.88 10.89 56 42490 287790 90298111
Type 2 diabetes mellitus 29.61 10.89 31 42515 203213 90382688
Acne 29.30 10.89 50 42496 28457 90557444
Lung disorder 29.25 10.89 17 42529 149866 90436035
Device malfunction 28.78 10.89 42 42504 20935 90564966
Injection site discolouration 28.36 10.89 28 42518 9292 90576609
Osteonecrosis 28.27 10.89 47 42499 26194 90559707
Device deployment issue 27.71 10.89 21 42525 4888 90581013
Breast hyperplasia 27.43 10.89 9 42537 332 90585569
Device connection issue 27.41 10.89 12 42534 984 90584917
Diverticulum 27.27 10.89 31 42515 12082 90573819
Stress urinary incontinence 27.26 10.89 16 42530 2436 90583465
Skin laceration 27.20 10.89 46 42500 25989 90559912
Dental caries 27.08 10.89 30 42516 11367 90574534
Alopecia 27.01 10.89 130 42416 494941 90090960
Acute kidney injury 26.94 10.89 70 42476 320317 90265584
Diarrhoea 26.81 10.89 297 42249 938893 89647008
Cervical dysplasia 26.71 10.89 19 42527 4015 90581886
Rash 26.33 10.89 243 42303 795857 89790044
Neutropenia 25.85 10.89 41 42505 224863 90361038
Embedded device 25.83 10.89 19 42527 4229 90581672
Product quality issue 25.81 10.89 89 42457 79236 90506665
Nasopharyngitis 25.80 10.89 101 42445 407003 90178898
Joint range of motion decreased 25.61 10.89 16 42530 135627 90450274
Gait inability 25.35 10.89 19 42527 146437 90439464
Femur fracture 24.93 10.89 62 42484 46020 90539881
Prescribed underdose 24.84 10.89 3 42543 75016 90510885
Withdrawal bleed 24.48 10.89 6 42540 74 90585827
Breast cyst 24.34 10.89 14 42532 2053 90583848
Product use complaint 24.23 10.89 17 42529 3516 90582385
Biopsy breast abnormal 23.90 10.89 5 42541 28 90585873
Prescribed overdose 23.88 10.89 8 42538 97617 90488284
Injection site indentation 23.88 10.89 8 42538 315 90585586
Deformity 23.83 10.89 29 42517 12141 90573760
Osteoporosis 23.71 10.89 99 42447 96432 90489469
Red blood cell sedimentation rate increased 23.55 10.89 5 42541 82590 90503311
Oligomenorrhoea 23.41 10.89 11 42535 1064 90584837
Eosinopenia 23.39 10.89 6 42540 90 90585811
Anaphylactic reaction 23.28 10.89 92 42454 87432 90498469
Pregnancy with implant contraceptive 23.27 10.89 17 42529 3744 90582157
Wheezing 23.25 10.89 48 42498 238032 90347869
Fracture nonunion 23.00 10.89 14 42532 2278 90583623
Accidental exposure to product 22.92 10.89 57 42489 42309 90543592
Uterine disorder 22.91 10.89 16 42530 3285 90582616
Vaginal odour 22.76 10.89 9 42537 571 90585330
Angina unstable 22.74 10.89 22 42524 7121 90578780
Procedural pain 22.57 10.89 49 42497 33311 90552590
Cerebral venous sinus thrombosis 22.54 10.89 14 42532 2362 90583539
Breast conserving surgery 22.39 10.89 11 42535 1174 90584727
Vulvovaginal dryness 22.35 10.89 16 42530 3415 90582486
Live birth 22.12 10.89 5 42541 79102 90506799
Peripheral venous disease 22.12 10.89 6 42540 83915 90501986
Resorption bone increased 22.09 10.89 11 42535 1208 90584693
Knee arthroplasty 21.83 10.89 6 42540 83176 90502725
Menometrorrhagia 21.79 10.89 11 42535 1244 90584657
Myocardial infarction 21.74 10.89 103 42443 105869 90480032
Postmortem blood drug level abnormal 21.68 10.89 7 42539 245 90585656
Fatigue 21.59 10.89 397 42149 1153626 89432275
Mastectomy 21.52 10.89 13 42533 2086 90583815
Cerebral infarction 21.45 10.89 42 42504 26554 90559347
Endometrial cancer stage I 21.41 10.89 7 42539 255 90585646
Osteomyelitis 21.28 10.89 43 42503 27803 90558098
Benign breast neoplasm 21.26 10.89 11 42535 1309 90584592
Incorrect route of product administration 21.23 10.89 62 42484 50564 90535337
Anger 21.08 10.89 29 42517 13691 90572210
Stress fracture 21.04 10.89 23 42523 8588 90577313
Liver disorder 20.64 10.89 16 42530 121253 90464648
Adnexa uteri pain 20.64 10.89 8 42538 481 90585420
Fibromyalgia 20.63 10.89 41 42505 206228 90379673
Panic attack 20.49 10.89 41 42505 26324 90559577
Meniscus injury 20.12 10.89 22 42524 8215 90577686
Hormone level abnormal 20.11 10.89 14 42532 2859 90583042
Lipoatrophy 19.94 10.89 7 42539 318 90585583
Muscle fatigue 19.89 10.89 14 42532 2910 90582991
Endometrial atrophy 19.88 10.89 5 42541 69 90585832
Urine leukocyte esterase 19.86 10.89 6 42540 168 90585733
Pulmonary fibrosis 19.85 10.89 13 42533 107490 90478411
Therapy non-responder 19.74 10.89 21 42525 136683 90449218
Libido decreased 19.64 10.89 14 42532 2968 90582933
Internal injury 19.51 10.89 7 42539 339 90585562
Thrombosis 19.48 10.89 77 42469 73174 90512727
Cervicitis 19.48 10.89 8 42538 560 90585341
Coronary artery occlusion 19.44 10.89 22 42524 8532 90577369
Intentional device misuse 19.24 10.89 9 42537 861 90585040
Adenomyosis 19.16 10.89 8 42538 584 90585317
Lower limb fracture 19.06 10.89 8 42538 85005 90500896
Toothache 19.02 10.89 36 42510 22194 90563707
Mitral valve prolapse 19.02 10.89 13 42533 2578 90583323
Injection site induration 18.98 10.89 24 42522 10444 90575457
Anhedonia 18.84 10.89 25 42521 11406 90574495
Uterine pain 18.83 10.89 7 42539 375 90585526
Thrombocytopenia 18.79 10.89 44 42502 208681 90377220
Medical device discomfort 18.79 10.89 12 42534 2124 90583777
Hyponatraemia 18.74 10.89 21 42525 133517 90452384
Oral infection 18.21 10.89 17 42529 5263 90580638
Fear 18.21 10.89 30 42516 16592 90569309
Placenta accreta 17.94 10.89 6 42540 235 90585666
Skin sensitisation 17.92 10.89 9 42537 1006 90584895
Wrong product administered 17.91 10.89 20 42526 7645 90578256
Foot fracture 17.90 10.89 39 42507 26567 90559334
Thyrotoxic periodic paralysis 17.88 10.89 4 42542 32 90585869
Injection site infection 17.83 10.89 12 42534 2320 90583581
Feeling abnormal 17.83 10.89 137 42409 167098 90418803
Expired product administered 17.81 10.89 19 42527 6903 90578998
Intentional overdose 17.80 10.89 11 42535 93823 90492078
Injection site swelling 17.64 10.89 65 42481 59774 90526127
Autoimmune disorder 17.57 10.89 7 42539 76737 90509164
Disease progression 17.57 10.89 29 42517 156586 90429315
Injection site erythema 17.55 10.89 92 42454 98410 90487491
Liver function test increased 17.46 10.89 9 42537 84846 90501055
Hip arthroplasty 17.37 10.89 7 42539 76201 90509700
Complication associated with device 17.27 10.89 32 42514 19417 90566484
Circumstance or information capable of leading to medication error 17.15 10.89 16 42530 4951 90580950
Device use error 17.14 10.89 19 42527 7202 90578699
Delayed puberty 17.13 10.89 5 42541 124 90585777
Sepsis 16.92 10.89 37 42509 179777 90406124
Pregnancy with contraceptive device 16.88 10.89 16 42530 5050 90580851
Gallbladder disorder 16.86 10.89 32 42514 19771 90566130
Seizure 16.81 10.89 126 42420 152503 90433398
Cardiac failure 16.74 10.89 16 42530 109480 90476421
Staphylococcal abscess 16.68 10.89 8 42538 810 90585091
Inflammation 16.60 10.89 37 42509 178555 90407346
Maternal exposure during pregnancy 16.60 10.89 100 42446 359963 90225938
Breast reconstruction 16.59 10.89 6 42540 297 90585604
Endometrial hypertrophy 16.39 10.89 6 42540 308 90585593
Neurofibroma 16.39 10.89 3 42543 7 90585894
Mitral valve incompetence 16.29 10.89 34 42512 22490 90563411
Large intestine polyp 16.20 10.89 21 42525 9365 90576536
Intramedullary rod insertion 16.18 10.89 11 42535 2161 90583740
Oestrogen deficiency 16.13 10.89 5 42541 153 90585748
Decidual cast 16.10 10.89 3 42543 8 90585893
Galactorrhoea 16.04 10.89 15 42531 4657 90581244
Ovarian cyst 16.02 10.89 29 42517 17289 90568612
Anaemia postoperative 16.00 10.89 11 42535 2202 90583699
Nail disorder 15.99 10.89 4 42542 59063 90526838
Impaired fasting glucose 15.89 10.89 6 42540 336 90585565
Uterine injury 15.85 10.89 4 42542 56 90585845
Complication of device removal 15.79 10.89 17 42529 6238 90579663
Meningioma benign 15.77 10.89 6 42540 343 90585558
Liver iron concentration abnormal 15.72 10.89 4 42542 58 90585843
Livedo reticularis 15.67 10.89 13 42533 3446 90582455
Glucose tolerance impaired 15.59 10.89 19 42527 7966 90577935
Bone loss 15.56 10.89 13 42533 3479 90582422
Product administered at inappropriate site 15.56 10.89 14 42532 4137 90581764
Lumbar spinal stenosis 15.53 10.89 16 42530 5581 90580320
Inappropriate schedule of product administration 15.52 10.89 122 42424 149811 90436090
Chlamydial infection 15.43 10.89 6 42540 364 90585537
Loss of libido 15.41 10.89 9 42537 1358 90584543
Modified radical mastectomy 15.38 10.89 3 42543 11 90585890
Adenoma benign 15.35 10.89 8 42538 966 90584935
Cholecystectomy 15.35 10.89 23 42523 11732 90574169
Drug abuse 15.15 10.89 10 42536 82337 90503564
Tic 15.01 10.89 10 42536 1901 90584000
Marital problem 14.90 10.89 5 42541 198 90585703
Menopausal symptoms 14.85 10.89 12 42534 3066 90582835
Breast necrosis 14.82 10.89 5 42541 201 90585700
Product administered by wrong person 14.76 10.89 4 42542 75 90585826
Nocturia 14.75 10.89 21 42525 10234 90575667
Injection site discomfort 14.74 10.89 16 42530 5924 90579977
Gingivitis 14.69 10.89 20 42526 9349 90576552
Blood oestrogen decreased 14.62 10.89 6 42540 419 90585482
Nervousness 14.56 10.89 42 42504 34014 90551887
Febrile neutropenia 14.56 10.89 33 42513 158316 90427585
Blepharospasm 14.54 10.89 4 42542 55441 90530460
Injection site cellulitis 14.52 10.89 9 42537 1512 90584389
Breast pain 14.49 10.89 21 42525 10397 90575504
Injection site reaction 14.39 10.89 83 42463 91997 90493904
Hyperkeratosis 14.37 10.89 17 42529 6911 90578990
Medical device pain 14.35 10.89 9 42537 1543 90584358
Irritability 14.31 10.89 43 42503 35619 90550282
Abdominal pain 14.27 10.89 263 42283 395458 90190443
Protein urine present 14.26 10.89 17 42529 6967 90578934
Hypothyroidism 14.25 10.89 56 42490 53071 90532830
Fine motor skill dysfunction 14.16 10.89 15 42531 5404 90580497
Post procedural cellulitis 14.11 10.89 4 42542 89 90585812
Cartilage injury 14.02 10.89 10 42536 2121 90583780
Cerebral palsy 14.02 10.89 5 42541 238 90585663
Pharyngeal oedema 13.95 10.89 24 42522 13747 90572154
Pituitary tumour recurrent 13.91 10.89 4 42542 94 90585807
Product packaging issue 13.89 10.89 9 42537 1632 90584269
Gastrooesophageal reflux disease 13.87 10.89 129 42417 166208 90419693
Ventricular hypertrophy 13.83 10.89 12 42534 3379 90582522
Myelosuppression 13.81 10.89 4 42542 53587 90532314
Pancytopenia 13.74 10.89 22 42524 120241 90465660
Uterine spasm 13.55 10.89 7 42539 830 90585071
Incorrect dose administered by product 13.52 10.89 5 42541 264 90585637
Aggression 13.51 10.89 35 42511 26633 90559268
Pollakiuria 13.44 10.89 40 42506 32965 90552936
Chromatopsia 13.43 10.89 6 42540 516 90585385
Anticonvulsant drug level increased 13.43 10.89 9 42537 1727 90584174
Dry mouth 13.42 10.89 43 42503 184016 90401885
Injection site abscess sterile 13.30 10.89 3 42543 25 90585876
Hospitalisation 13.21 10.89 25 42521 128075 90457826
Musculoskeletal pain 13.20 10.89 39 42507 171212 90414689
Pregnancy test urine positive 13.20 10.89 3 42543 26 90585875
Coma 13.12 10.89 9 42537 72623 90513278
Oedema 13.12 10.89 49 42497 200246 90385655
Goitre 13.05 10.89 16 42530 6751 90579150
Ovarian cancer 13.05 10.89 16 42530 6751 90579150
Thyroid disorder 13.04 10.89 27 42519 17758 90568143
Crystalluria 13.01 10.89 6 42540 556 90585345
Maternal drugs affecting foetus 13.00 10.89 14 42532 5141 90580760
Post procedural discomfort 12.97 10.89 8 42538 1333 90584568
Transient ischaemic attack 12.81 10.89 47 42499 43129 90542772
Drug exposure before pregnancy 12.61 10.89 7 42539 959 90584942
Polymenorrhoea 12.56 10.89 8 42538 1409 90584492
Occupational exposure to product 12.49 10.89 10 42536 2521 90583380
Haemorrhoids 12.47 10.89 34 42512 26668 90559233
Seborrhoeic keratosis 12.46 10.89 11 42535 3169 90582732
Bursitis 12.46 10.89 27 42519 131627 90454274
Arteriosclerosis 12.45 10.89 20 42526 10833 90575068
Blood urine present 12.40 10.89 26 42520 17252 90568649
Social anxiety disorder 12.33 10.89 6 42540 627 90585274
Lumbar radiculopathy 12.29 10.89 10 42536 2581 90583320
Throat tightness 12.26 10.89 36 42510 29448 90556453
Cholelithiasis 12.23 10.89 53 42493 52453 90533448
Taste disorder 11.98 10.89 7 42539 61539 90524362
Abscess 11.93 10.89 27 42519 18864 90567037
Nitrite urine present 11.89 10.89 7 42539 1072 90584829
Breast disorder female 11.88 10.89 4 42542 160 90585741
Uterine cervix stenosis 11.81 10.89 5 42541 378 90585523
Aortic valve incompetence 11.71 10.89 15 42531 6609 90579292
Condition aggravated 11.67 10.89 203 42343 595342 89990559
Postmortem blood drug level increased 11.64 10.89 6 42540 709 90585192
Syncope 11.63 10.89 104 42442 132559 90453342
Feelings of worthlessness 11.62 10.89 5 42541 393 90585508
Pain in jaw 11.61 10.89 49 42497 47936 90537965
Sinusitis 11.61 10.89 104 42442 342984 90242917
Dermatitis contact 11.61 10.89 22 42524 13573 90572328
Cerebrovascular disorder 11.59 10.89 10 42536 2796 90583105
Bacterial test 11.57 10.89 7 42539 1126 90584775
Gastroenteritis 11.50 10.89 35 42511 29194 90556707
Plantar fasciitis 11.47 10.89 12 42534 4262 90581639
Breast fibrosis 11.46 10.89 3 42543 49 90585852
Lip swelling 11.43 10.89 42 42504 38568 90547333
HIV test positive 11.40 10.89 3 42543 50 90585851
Bacterial vaginosis 11.40 10.89 8 42538 1655 90584246
Cervicobrachial syndrome 11.39 10.89 7 42539 1158 90584743
Palpitations 11.38 10.89 106 42440 136622 90449279
Renal impairment 11.38 10.89 20 42526 105401 90480500
Gingival bleeding 11.37 10.89 23 42523 14880 90571021
Hypercoagulation 11.37 10.89 9 42537 2233 90583668
Fat necrosis 11.35 10.89 6 42540 746 90585155
Crying 11.33 10.89 32 42514 25613 90560288
Tunnel vision 11.23 10.89 8 42538 1693 90584208
Melanocytic naevus 11.21 10.89 13 42533 5173 90580728
Hepatic cirrhosis 11.21 10.89 8 42538 63245 90522656
Hirsutism 11.20 10.89 8 42538 1702 90584199
Drug hypersensitivity 11.13 10.89 152 42394 463457 90122444
Osteonecrosis of jaw 11.13 10.89 42 42504 39061 90546840
Acne cystic 11.04 10.89 6 42540 789 90585112
Porphyria 10.95 10.89 4 42542 204 90585697
Carotid artery stenosis 10.92 10.89 13 42533 5321 90580580
Homicidal ideation 10.91 10.89 8 42538 1772 90584129
Recalled product administered 10.90 10.89 6 42540 809 90585092
Bradycardia 10.90 10.89 14 42532 83833 90502068

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Head titubation 117.90 35.12 18 852 451 42620014
Cogwheel rigidity 93.71 35.12 18 852 1783 42618682
Extrapyramidal disorder 70.67 35.12 22 848 16390 42604075
Sedation complication 68.12 35.12 15 855 2904 42617561
Serotonin syndrome 60.87 35.12 22 848 25823 42594642
Anticholinergic syndrome 59.08 35.12 12 858 1577 42618888
Exposure during pregnancy 39.03 35.12 12 858 8536 42611929
Porphyria non-acute 38.84 35.12 7 863 487 42619978
Sexually inappropriate behaviour 37.22 35.12 7 863 616 42619849

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Unintended pregnancy 1109.10 12.21 263 32852 4545 110551639
Pregnancy with injectable contraceptive 571.30 12.21 84 33031 31 110556153
Incorrect dose administered by device 488.41 12.21 148 32967 6666 110549518
Device leakage 392.05 12.21 156 32959 15892 110540292
Intermenstrual bleeding 281.94 12.21 98 33017 6836 110549348
Drug dose omission by device 259.68 12.21 113 33002 14403 110541781
Vaginal haemorrhage 245.58 12.21 129 32986 24945 110531239
Amenorrhoea 243.92 12.21 95 33020 9136 110547048
Needle issue 222.21 12.21 108 33007 17732 110538452
Heavy menstrual bleeding 212.68 12.21 102 33013 16263 110539921
Syringe issue 189.66 12.21 80 33035 9445 110546739
Injection site abscess 180.61 12.21 52 33063 1954 110554230
Device occlusion 156.91 12.21 81 33034 15104 110541080
Osteopenia 156.46 12.21 92 33023 22117 110534067
Depression 128.05 12.21 289 32826 317046 110239138
Device issue 123.92 12.21 94 33021 34441 110521743
Abortion spontaneous 120.12 12.21 92 33023 34190 110521994
Uterine perforation 115.04 12.21 51 33064 6789 110549395
Oestrogen receptor assay positive 109.48 12.21 25 33090 362 110555822
Injection site atrophy 108.30 12.21 26 33089 473 110555711
Menstruation irregular 106.51 12.21 46 33069 5751 110550433
Fibrocystic breast disease 94.54 12.21 25 33090 681 110555503
Breast cancer in situ 94.31 12.21 28 33087 1173 110555011
Breast cancer 90.40 12.21 82 33033 38460 110517724
Uterine haemorrhage 88.92 12.21 35 33080 3459 110552725
Device mechanical issue 87.68 12.21 30 33085 1994 110554190
Progesterone receptor assay positive 87.37 12.21 19 33096 217 110555967
Persistent genital arousal disorder 86.07 12.21 23 33092 653 110555531
Emotional distress 83.51 12.21 84 33031 44763 110511421
Pelvic pain 81.81 12.21 54 33061 15888 110540296
Uterine leiomyoma 78.84 12.21 41 33074 7759 110548425
Genital haemorrhage 78.73 12.21 40 33075 7212 110548972
Clear cell renal cell carcinoma 78.64 12.21 30 33085 2726 110553458
Pulmonary embolism 76.24 12.21 186 32929 214288 110341896
Death 74.65 12.21 60 33055 698809 109857375
Device delivery system issue 71.02 12.21 26 33089 2107 110554077
Postmenopausal haemorrhage 70.85 12.21 25 33090 1821 110554363
Renal mass 70.59 12.21 30 33085 3605 110552579
Poor quality device used 67.01 12.21 27 33088 2836 110553348
Product administration error 66.18 12.21 68 33047 37149 110519035
Breast cancer female 65.84 12.21 43 33072 12425 110543759
Meningioma 63.70 12.21 32 33083 5633 110550551
Uterine polyp 61.71 12.21 23 33092 1960 110554224
Anxiety 60.04 12.21 233 32882 344845 110211339
Hot flush 55.90 12.21 83 33032 65953 110490231
Device dislocation 54.70 12.21 57 33058 31647 110524537
Acute kidney injury 54.63 12.21 66 33049 635364 109920820
Injection site pain 54.59 12.21 146 32969 177776 110378408
Contraindicated product administered 53.31 12.21 6 33109 248261 110307923
Pyrexia 52.46 12.21 120 32995 898145 109658039
Wrong technique in device usage process 52.34 12.21 30 33085 6871 110549313
Treatment failure 49.86 12.21 11 33104 277223 110278961
Breast calcifications 48.12 12.21 16 33099 974 110555210
Menstrual disorder 47.93 12.21 25 33090 4759 110551425
Atrophic vulvovaginitis 46.37 12.21 17 33098 1383 110554801
Injection site necrosis 46.03 12.21 18 33097 1748 110554436
Cholecystitis chronic 45.90 12.21 31 33084 9469 110546715
Dysmenorrhoea 45.38 12.21 22 33093 3588 110552596
Hepatic enzyme increased 44.79 12.21 20 33095 320872 110235312
Cerebrovascular accident 44.22 12.21 137 32978 181147 110375037
Neutropenia 44.05 12.21 29 33086 374591 110181593
Device breakage 43.99 12.21 35 33080 13734 110542450
Mood swings 42.96 12.21 43 33072 22769 110533415
Pneumonia 42.86 12.21 128 32987 876586 109679598
Abnormal uterine bleeding 42.18 12.21 16 33099 1431 110554753
Dyspareunia 41.82 12.21 18 33097 2231 110553953
Pericarditis 40.83 12.21 8 33107 219106 110337078
Pregnancy test positive 40.45 12.21 9 33106 115 110556069
Lower respiratory tract infection 39.22 12.21 12 33103 243094 110313090
Abdominal pain lower 39.19 12.21 52 33063 37231 110518953
Scoliosis 38.66 12.21 27 33088 8706 110547478
Scar 37.79 12.21 35 33080 16846 110539338
Helicobacter infection 37.56 12.21 5 33110 181872 110374312
Exostosis of jaw 37.25 12.21 14 33101 1221 110554963
Wound 37.05 12.21 12 33103 234425 110321759
Low turnover osteopathy 37.00 12.21 16 33099 2006 110554178
Endometrial cancer 37.00 12.21 17 33098 2459 110553725
Incorrect dose administered 36.91 12.21 90 33025 103551 110452633
Synovitis 36.83 12.21 18 33097 274074 110282110
Deep vein thrombosis 36.24 12.21 108 33007 139779 110416405
Breast tenderness 35.96 12.21 17 33098 2623 110553561
Injection site panniculitis 35.57 12.21 5 33110 0 110556184
Mammogram abnormal 35.04 12.21 11 33104 557 110555627
Breast disorder 34.93 12.21 16 33099 2298 110553886
Embedded device 34.57 12.21 19 33096 4014 110552170
Stress urinary incontinence 34.40 12.21 15 33100 1918 110554266
Confusional state 33.93 12.21 55 33060 468625 110087559
Liquid product physical issue 33.73 12.21 14 33101 1586 110554598
Device failure 33.59 12.21 23 33092 7184 110549000
Procedural pain 33.45 12.21 47 33068 35518 110520666
Joint swelling 32.97 12.21 51 33064 442794 110113390
Endometrial hyperplasia 32.75 12.21 11 33104 691 110555493
Osteonecrosis 32.34 12.21 45 33070 33696 110522488
Vulvovaginal dryness 32.31 12.21 16 33099 2731 110553453
Infertility female 32.13 12.21 10 33105 492 110555692
Drug abuse 31.97 12.21 7 33108 177404 110378780
Porphyria non-acute 31.93 12.21 11 33104 746 110555438
Osteoporosis 31.37 12.21 76 33039 87076 110469108
Spinal osteoarthritis 30.79 12.21 34 33081 20149 110536035
Deformity 30.71 12.21 25 33090 10135 110546049
Injury 30.22 12.21 119 32996 177146 110379038
Benign breast neoplasm 30.20 12.21 11 33104 878 110555306
Device use issue 30.18 12.21 17 33098 3767 110552417
Device defective 30.02 12.21 17 33098 3805 110552379
Therapeutic product effect decreased 29.96 12.21 18 33097 244298 110311886
Mobility decreased 29.82 12.21 17 33098 237405 110318779
General physical health deterioration 29.77 12.21 51 33064 425244 110130940
Emotional disorder 29.58 12.21 30 33085 16130 110540054
Device difficult to use 29.24 12.21 32 33083 18773 110537411
Rheumatoid arthritis 29.17 12.21 28 33087 299585 110256599
Blister 28.96 12.21 16 33099 227360 110328824
Intervertebral disc degeneration 28.51 12.21 31 33084 18054 110538130
Diabetes mellitus 27.93 12.21 79 33036 99302 110456882
Stomatitis 27.80 12.21 24 33091 270218 110285966
Infertility 27.78 12.21 10 33105 772 110555412
Dental caries 27.66 12.21 26 33089 12747 110543437
Abortion missed 27.59 12.21 12 33103 1525 110554659
Hyperlipidaemia 27.42 12.21 43 33072 35805 110520379
Complication of device removal 27.03 12.21 17 33098 4603 110551581
Pregnancy with contraceptive device 27.02 12.21 16 33099 3891 110552293
Therapeutic product effect incomplete 26.74 12.21 17 33098 223788 110332396
Endometrial cancer stage I 26.64 12.21 7 33108 186 110555998
Toxicity to various agents 26.55 12.21 66 33049 480489 110075695
Toothache 26.52 12.21 34 33081 23541 110532643
Sepsis 26.02 12.21 36 33079 327310 110228874
Ectopic pregnancy 25.90 12.21 13 33102 2284 110553900
Cerebral venous sinus thrombosis 25.82 12.21 14 33101 2881 110553303
Uterine disorder 25.75 12.21 13 33102 2313 110553871
Intentional product use issue 25.52 12.21 22 33093 247884 110308300
C-reactive protein increased 25.42 12.21 17 33098 217902 110338282
Thrombocytopenia 25.18 12.21 41 33074 348844 110207340
Skin laceration 25.15 12.21 40 33075 33713 110522471
Febrile neutropenia 25.01 12.21 35 33080 316732 110239452
Medical device discomfort 24.71 12.21 12 33103 1964 110554220
Eosinopenia 24.60 12.21 6 33109 117 110556067
Systemic lupus erythematosus 24.49 12.21 24 33091 254314 110301870
Muscle injury 24.48 12.21 6 33109 140801 110415383
Off label use 24.15 12.21 311 32804 1499874 109056310
Injection site inflammation 24.09 12.21 16 33099 4755 110551429
Breast reconstruction 23.83 12.21 6 33109 134 110556050
Exposure via skin contact 23.33 12.21 24 33091 13123 110543061
Liver injury 23.24 12.21 8 33107 150405 110405779
Gallbladder disorder 23.14 12.21 30 33085 20999 110535185
Ill-defined disorder 23.12 12.21 9 33106 156844 110399340
Infusion related reaction 22.93 12.21 50 33065 381112 110175072
Oligomenorrhoea 22.78 12.21 9 33106 898 110555286
Breast mass 22.46 12.21 19 33096 8122 110548062
Head titubation 22.44 12.21 10 33105 1347 110554837
Ovarian cyst 22.17 12.21 24 33091 13906 110542278
Discomfort 22.16 12.21 19 33096 214688 110341496
Adenomyosis 22.06 12.21 7 33108 367 110555817
Internal injury 22.04 12.21 7 33108 368 110555816
Adnexa uteri pain 21.75 12.21 7 33108 384 110555800
Hyponatraemia 21.58 12.21 20 33095 217633 110338551
Urine leukocyte esterase 21.47 12.21 6 33109 202 110555982
Cardiac failure 21.40 12.21 15 33100 187611 110368573
Disease progression 21.29 12.21 25 33090 244009 110312175
Fracture nonunion 21.27 12.21 10 33105 1524 110554660
Resorption bone increased 21.27 12.21 10 33105 1524 110554660
Meniscus injury 21.11 12.21 18 33097 7775 110548409
Suicidal ideation 21.07 12.21 69 33046 93868 110462316
Cervical dysplasia 21.02 12.21 12 33103 2728 110553456
Skin sensitisation 20.95 12.21 9 33106 1110 110555074
Feeling abnormal 20.79 12.21 108 33007 180603 110375581
Drug intolerance 20.79 12.21 58 33057 406454 110149730
Maternal drugs affecting foetus 20.76 12.21 10 33105 1607 110554577
Femur fracture 20.74 12.21 43 33072 44426 110511758
Vaginal odour 20.53 12.21 7 33108 460 110555724
Ovarian cancer 20.42 12.21 14 33101 4382 110551802
Abdominal discomfort 20.29 12.21 56 33059 393802 110162382
Stress fracture 20.22 12.21 17 33098 7204 110548980
Osteomyelitis 20.22 12.21 38 33077 36562 110519622
Coronary artery disease 20.15 12.21 57 33058 71633 110484551
Oral infection 19.96 12.21 16 33099 6345 110549839
Mitral valve prolapse 19.83 12.21 11 33104 2367 110553817
Bradycardia 19.71 12.21 11 33104 155506 110400678
Gastrooesophageal reflux disease 19.64 12.21 106 33009 179870 110376314
Intentional device misuse 19.62 12.21 8 33107 866 110555318
Psoriatic arthropathy 19.60 12.21 18 33097 196743 110359441
Injection site indentation 19.42 12.21 6 33109 288 110555896
Bone density decreased 19.42 12.21 24 33091 16018 110540166
Menopausal symptoms 19.31 12.21 11 33104 2490 110553694
Urticaria 19.19 12.21 162 32953 318695 110237489
Muscle fatigue 19.18 12.21 13 33102 3994 110552190
Weight increased 19.16 12.21 201 32914 419443 110136741
Wound infection 19.10 12.21 3 33112 96462 110459722
Medical device pain 18.96 12.21 9 33106 1401 110554783
Renal failure 18.93 12.21 24 33091 226550 110329634
Throat tightness 18.79 12.21 35 33080 33454 110522730
Device use error 18.73 12.21 18 33097 9071 110547113
Injection site discolouration 18.71 12.21 18 33097 9085 110547099
Breast cyst 18.58 12.21 9 33106 1465 110554719
Lung disorder 18.50 12.21 16 33099 180031 110376153
Diverticulum 18.43 12.21 23 33092 15503 110540681
Postmortem blood drug level abnormal 18.38 12.21 7 33108 633 110555551
Endometrial atrophy 18.37 12.21 4 33111 46 110556138
Prolactin-producing pituitary tumour 18.29 12.21 5 33110 155 110556029
Injection site swelling 18.22 12.21 50 33065 61740 110494444
Goitre 18.19 12.21 15 33100 6189 110549995
Fine motor skill dysfunction 18.04 12.21 15 33100 6259 110549925
Fear 17.99 12.21 28 33087 23165 110533019
Uterine injury 17.92 12.21 4 33111 52 110556132
Pain in jaw 17.75 12.21 44 33071 51133 110505051
Modified radical mastectomy 17.73 12.21 3 33112 7 110556177
Lumbar spinal stenosis 17.72 12.21 15 33100 6418 110549766
Withdrawal bleed 17.71 12.21 4 33111 55 110556129
Diarrhoea 17.64 12.21 238 32877 1139267 109416917
Cartilage injury 17.60 12.21 9 33106 1645 110554539
Breast hyperplasia 17.52 12.21 5 33110 182 110556002
Liver iron concentration abnormal 17.51 12.21 4 33111 58 110556126
Injection site erythema 17.50 12.21 65 33050 94111 110462073
Decidual cast 17.45 12.21 3 33112 8 110556176
Cardiac arrest 17.33 12.21 20 33095 196733 110359451
Post procedural discomfort 17.20 12.21 8 33107 1189 110554995
Pregnancy with implant contraceptive 17.16 12.21 10 33105 2362 110553822
Hormone level abnormal 17.13 12.21 10 33105 2370 110553814
Bone disorder 17.02 12.21 26 33089 21166 110535018
Injection site reaction 16.99 12.21 62 33053 89008 110467176
Gastrointestinal disorder 16.93 12.21 29 33086 241923 110314261
Uterine pain 16.90 12.21 5 33110 207 110555977
Delayed puberty 16.90 12.21 5 33110 207 110555977
Gingivitis 16.80 12.21 18 33097 10313 110545871
Device connection issue 16.73 12.21 8 33107 1266 110554918
Pancytopenia 16.70 12.21 23 33092 209590 110346594
Staphylococcal abscess 16.64 12.21 8 33107 1281 110554903
Placenta accreta 16.56 12.21 5 33110 222 110555962
Delirium 16.48 12.21 10 33105 135015 110421169
Galactorrhoea 16.44 12.21 12 33103 4143 110552041
Lumbar radiculopathy 16.39 12.21 10 33105 2568 110553616
Acne 16.32 12.21 33 33082 33487 110522697
Oestrogen deficiency 16.21 12.21 4 33111 82 110556102
Cholecystectomy 16.13 12.21 18 33097 10791 110545393
Bacterial vaginosis 16 12.21 8 33107 1394 110554790
Foot fracture 15.99 12.21 28 33087 25518 110530666
Post procedural cellulitis 15.98 12.21 4 33111 87 110556097
Wrong product administered 15.92 12.21 18 33097 10942 110545242
Biopsy breast abnormal 15.81 12.21 3 33112 16 110556168
Insomnia 15.66 12.21 171 32944 360419 110195765
Blood oestrogen decreased 15.61 12.21 5 33110 270 110555914
Cholelithiasis 15.51 12.21 48 33067 63374 110492810
Cerebral infarction 15.34 12.21 42 33073 51796 110504388
Mitral valve incompetence 15.27 12.21 32 33083 33297 110522887
Complication associated with device 15.24 12.21 24 33091 20049 110536135
Premature menopause 15.09 12.21 7 33108 1035 110555149
Anaphylactic reaction 15.06 12.21 71 33044 114229 110441955
Uterine cervix stenosis 15.01 12.21 5 33110 306 110555878
Lipoatrophy 14.91 12.21 6 33109 628 110555556
Uterine spasm 14.89 12.21 6 33109 630 110555554
Respiratory failure 14.89 12.21 26 33089 215306 110340878
Hyperkeratosis 14.85 12.21 16 33099 9223 110546961
Bone loss 14.83 12.21 10 33105 3045 110553139
Interstitial lung disease 14.78 12.21 12 33103 139322 110416862
Panic attack 14.70 12.21 29 33086 28911 110527273
Cerebral palsy 14.65 12.21 5 33110 330 110555854
Sexually inappropriate behaviour 14.58 12.21 6 33109 665 110555519
Intentional overdose 14.58 12.21 11 33104 132490 110423694
Breast necrosis 14.57 12.21 4 33111 126 110556058
Drug exposure before pregnancy 14.43 12.21 6 33109 683 110555501
Pharyngeal oedema 14.40 12.21 21 33094 16407 110539777
Angina unstable 14.40 12.21 21 33094 16411 110539773
Musculoskeletal stiffness 14.24 12.21 40 33075 279782 110276402
Bacterial test 14.21 12.21 7 33108 1182 110555002
Infection 14.19 12.21 58 33057 362142 110194042
Liver disorder 14.18 12.21 13 33102 142230 110413954
Gastroenteritis 14.13 12.21 34 33081 38766 110517418
Hyperkalaemia 14.03 12.21 12 33103 135784 110420400
Glucose tolerance impaired 14.03 12.21 16 33099 9821 110546363
Lip swelling 13.96 12.21 40 33075 50627 110505557
Nitrite urine present 13.96 12.21 7 33108 1228 110554956
Septic shock 13.89 12.21 16 33099 157512 110398672
Peripheral swelling 13.85 12.21 68 33047 403966 110152218
Peripheral venous disease 13.84 12.21 4 33111 84113 110472071
Injection site infection 13.83 12.21 9 33106 2584 110553600
Multiple organ dysfunction syndrome 13.82 12.21 15 33100 151695 110404489
Livedo reticularis 13.47 12.21 12 33103 5494 110550690
Exposure during pregnancy 13.41 12.21 91 33024 167333 110388851
Device expulsion 13.39 12.21 29 33086 30862 110525322
Complication of pregnancy 13.37 12.21 5 33110 430 110555754
Morton's neuralgia 13.30 12.21 3 33112 41 110556143
Tunnel vision 13.28 12.21 8 33107 2007 110554177
Endometrial hypertrophy 13.24 12.21 4 33111 178 110556006
Poor quality product administered 13.15 12.21 11 33104 4630 110551554
Carpal tunnel syndrome 13.15 12.21 24 33091 22586 110533598
Cogwheel rigidity 13.12 12.21 10 33105 3688 110552496
Nervousness 13.11 12.21 32 33083 36819 110519365
Pituitary tumour recurrent 13.11 12.21 4 33111 184 110556000
Unwanted pregnancy 13.10 12.21 3 33112 44 110556140
Abortion induced 13.09 12.21 14 33101 8005 110548179
Cerebrovascular disorder 13.08 12.21 10 33105 3701 110552483
Anticonvulsant drug level increased 13.03 12.21 9 33106 2849 110553335
Myelosuppression 12.96 12.21 6 33109 94334 110461850
Menometrorrhagia 12.85 12.21 6 33109 900 110555284
Completed suicide 12.82 12.21 34 33081 242347 110313837
Thyrotoxic periodic paralysis 12.75 12.21 4 33111 202 110555982
Coma 12.69 12.21 10 33105 117859 110438325
Thyroid disorder 12.49 12.21 20 33095 16949 110539235
Nocturia 12.47 12.21 20 33095 16970 110539214
Red blood cell sedimentation rate increased 12.38 12.21 4 33111 78298 110477886
Osteonecrosis of jaw 12.36 12.21 37 33078 47980 110508204
Abdominal pain 12.34 12.21 219 32896 512770 110043414
Affective disorder 12.31 12.21 16 33099 11225 110544959
Atrial fibrillation 12.31 12.21 32 33083 229610 110326574
Pollakiuria 12.28 12.21 35 33080 44160 110512024
Progesterone decreased 12.27 12.21 3 33112 59 110556125

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC G03AA08 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 G03AC06 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
Progestogens
ATC G03DA02 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
PROGESTOGENS
Pregnen (4) derivatives
ATC G03FA12 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
PROGESTOGENS AND ESTROGENS IN COMBINATION
Progestogens and estrogens, fixed combinations
ATC G03FB06 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
PROGESTOGENS AND ESTROGENS IN COMBINATION
Progestogens and estrogens, sequential preparations
ATC L02AB02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ENDOCRINE THERAPY
HORMONES AND RELATED AGENTS
Progestogens
FDA CS M0447349 Progesterone Congeners
MeSH PA D000080066 Contraceptive Agents, Hormonal
MeSH PA D003271 Contraceptive Agents, Female
MeSH PA D003278 Contraceptives, Oral, Hormonal
MeSH PA D003280 Contraceptives, Oral, Synthetic
MeSH PA D012102 Reproductive Control Agents
CHEBI has role CHEBI:49323 contraceptive drug
CHEBI has role CHEBI:49326 synthetic oral contraceptive
CHEBI has role CHEBI:59826 progestin
CHEBI has role CHEBI:22586 antioxidant
CHEBI has role CHEBI:35222 inhibitor
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:49324 female contraceptive drug
CHEBI has role CHEBI:50113 androgen
CHEBI has role CHEBI:50249 anticoagulant
CHEBI has role CHEBI:50646 bone density conservation agent
CHEBI has role CHEBI:60809 adjuvant
CHEBI has role CHEBI:64946 anti-HIV agent
FDA EPC N0000175602 Progestin
MeSH PA D000970 Antineoplastic Agents
MeSH PA D003272 Contraceptive Agents, Male
MeSH PA D018931 Antineoplastic Agents, Hormonal

Related Drugs by ATC class:

G03AA Progestogens and estrogens, fixed combinations 17 drugs
G03AC Progestogens 9 drugs
G03DA Pregnen (4) derivatives 3 drugs
G03FA Progestogens and estrogens, fixed combinations 15 drugs
G03FB Progestogens and estrogens, sequential preparations 10 drugs
L02AB Progestogens 2 drugs

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

DiseaseRelationSNOMED_IDDOID
Contraception indication 13197004
Dysfunctional uterine bleeding indication 19155002
Atrophic vaginitis indication 52441000
Secondary physiologic amenorrhea indication 86030004
Secondary malignant neoplasm of kidney indication 94360002
Postmenopausal osteoporosis indication 102447009
Endometriosis indication 129103003
Menopausal flushing indication 198436008
Endometrial carcinoma indication 254878006 DOID:2871
Prevention of premature ovulation during controlled ovarian stimulation indication 732970000
Endometrial Hyperplasia Prevention indication
Polycystic ovaries off-label use 69878008
Precocious puberty off-label use 400179000
Endogenous Estrogen Production Test off-label use
Hyperlipoproteinemia contraindication 3744001 DOID:1168
Hypocalcemia contraindication 5291005
Alcoholism contraindication 7200002
Weight gain finding contraindication 8943002
Hypercholesterolemia contraindication 13644009
Myocardial infarction contraindication 22298006 DOID:5844
Fibroadenosis of breast contraindication 23260002 DOID:10352
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
Dementia contraindication 52448006
Hepatic porphyria contraindication 55056006 DOID:3133
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Hyperlipidemia contraindication 55822004 DOID:1168
Anorexia nervosa contraindication 56882008 DOID:8689
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
Diabetes mellitus contraindication 73211009 DOID:9351
Epilepsy contraindication 84757009 DOID:1826
Breast lump contraindication 89164003
Kidney disease contraindication 90708001 DOID:557
Uterine leiomyoma contraindication 95315005 DOID:13223
Deep venous thrombosis contraindication 128053003
Mammography abnormal contraindication 168750009
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
Chorea contraindication 271700006
Pregnancy, function contraindication 289908002
Hypertriglyceridemia contraindication 302870006
Osteopenia contraindication 312894000
Functional visual loss contraindication 313165001
Malignant tumor of ovary contraindication 363443007 DOID:2394
Thromboembolic disorder contraindication 371039008
Cardiovascular event risk contraindication 395112001
Disorder of coronary artery contraindication 414024009
Obesity contraindication 414916001 DOID:9970
Estrogen receptor positive tumor contraindication 416053008
Family history of malignant neoplasm of breast contraindication 429740004
Hypertensive urgency contraindication 443482000
Carcinoma of female breast contraindication 447782002
Smokes tobacco daily contraindication 449868002




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Progesterone receptor Nuclear hormone receptor AGONIST EC50 9.59 WOMBAT-PK CHEMBL
Histamine H2 receptor GPCR Ki 4.56 DRUG MATRIX
Glucocorticoid receptor Nuclear hormone receptor Ki 7.88 CHEMBL
Mineralocorticoid receptor Nuclear hormone receptor IC50 5.92 CHEMBL
Androgen receptor Nuclear hormone receptor EC50 8.20 WOMBAT-PK
Aldo-keto reductase family 1 member C1 Enzyme IC50 5.74 CHEMBL
Aldo-keto reductase family 1 member C2 Enzyme IC50 5.39 CHEMBL
Aldo-keto reductase family 1 member C3 Enzyme IC50 6.52 CHEMBL
Cytochrome P450 2C19 Enzyme IC50 5.70 DRUG MATRIX
Sex hormone-binding globulin Secreted Kd 6.20 CHEMBL
Estrogen receptor Nuclear hormone receptor IC50 6.03 CHEMBL
Androgen receptor Transcription factor IC50 7.45 CHEMBL
Progesterone receptor Transcription factor Ki 7.03 DRUG MATRIX
Androgen receptor Transcription factor EC50 8.21 CHEMBL

External reference:

IDSource
4019810 VUID
N0000147899 NUI
D00951 KEGG_DRUG
520-85-4 SECONDARY_CAS_RN
4017828 VANDF
4019810 VANDF
C0025147 UMLSCUI
CHEBI:6715 CHEBI
CHEMBL717 ChEMBL_ID
D008525 MESH_DESCRIPTOR_UI
10631 PUBCHEM_CID
2879 IUPHAR_LIGAND_ID
853 INN_ID
HSU1C9YRES UNII
DB00603 DRUGBANK_ID
1000112 RXNORM
5032 MMSL
7121 MMSL
d00284 MMSL
001295 NDDF
004938 NDDF
126112002 SNOMEDCT_US
126113007 SNOMEDCT_US
36621009 SNOMEDCT_US
D017258 MESH_DESCRIPTOR_UI
HSU1C9YRES INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Provera HUMAN PRESCRIPTION DRUG LABEL 1 0009-0051 TABLET 10 mg ORAL NDA 25 sections
Provera HUMAN PRESCRIPTION DRUG LABEL 1 0009-0065 TABLET 2.50 mg ORAL NDA 25 sections
Provera HUMAN PRESCRIPTION DRUG LABEL 1 0009-0287 TABLET 5 mg ORAL NDA 25 sections
Depo-Provera HUMAN PRESCRIPTION DRUG LABEL 1 0009-0746 INJECTION, SUSPENSION 150 mg INTRAMUSCULAR NDA 32 sections
Depo-SubQ Provera HUMAN PRESCRIPTION DRUG LABEL 1 0009-4709 INJECTION, SUSPENSION 104 mg SUBCUTANEOUS NDA 30 sections
Depo-Provera HUMAN PRESCRIPTION DRUG LABEL 1 0009-7376 INJECTION, SUSPENSION 150 mg INTRAMUSCULAR NDA 32 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1105 TABLET, SUGAR COATED 1.50 mg ORAL NDA 34 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1105 TABLET, SUGAR COATED 1.50 mg ORAL NDA 34 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1106 TABLET, SUGAR COATED 1.50 mg ORAL NDA 34 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1106 TABLET, SUGAR COATED 1.50 mg ORAL NDA 34 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1107 TABLET, SUGAR COATED 2.50 mg ORAL NDA 34 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1107 TABLET, SUGAR COATED 2.50 mg ORAL NDA 34 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1108 TABLET, SUGAR COATED 5 mg ORAL NDA 34 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 0046-1108 TABLET, SUGAR COATED 5 mg ORAL NDA 34 sections
Medroxyprogesterone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0548-5400 INJECTION, SUSPENSION, EXTENDED RELEASE 150 mg INTRAMUSCULAR ANDA 30 sections
Medroxyprogesterone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0548-5701 INJECTION, SUSPENSION, EXTENDED RELEASE 150 mg INTRAMUSCULAR ANDA 30 sections
Medroxyprogesterone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0555-0779 TABLET 10 mg ORAL ANDA 24 sections
Medroxyprogesterone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0555-0872 TABLET 2.50 mg ORAL ANDA 24 sections
Medroxyprogesterone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0555-0873 TABLET 5 mg ORAL ANDA 24 sections
Medroxyprogesterone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 10544-001 TABLET 5 mg ORAL ANDA 24 sections
Medroxyprogesterone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 10544-062 TABLET 10 mg ORAL ANDA 24 sections
Medroxyprogesterone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 21695-896 TABLET 10 mg ORAL ANDA 23 sections
Medroxyprogesterone Acetate Injectable Suspension HUMAN PRESCRIPTION DRUG LABEL 1 24201-150 INJECTION, SUSPENSION 150 mg INTRAMUSCULAR ANDA 29 sections
Medroxyprogesterone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 33261-534 TABLET 10 mg ORAL ANDA 24 sections
Medroxyprogesterone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 33261-609 TABLET 2.50 mg ORAL ANDA 24 sections
Medroxyprogesterone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 33261-740 TABLET 5 mg ORAL ANDA 24 sections
Medroxyprogesterone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 50090-0166 TABLET 10 mg ORAL ANDA 24 sections
Medroxyprogesterone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 50090-0490 TABLET 2.50 mg ORAL ANDA 24 sections
Medroxyprogesterone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 50090-0491 TABLET 5 mg ORAL ANDA 24 sections
Prempro HUMAN PRESCRIPTION DRUG LABEL 2 50090-0573 TABLET, SUGAR COATED 2.50 mg ORAL NDA 30 sections