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

Stem definitionDrug idCAS RN
prostaglandins 1817 59122-46-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • misoprostol
  • cytotec
  • isprelor
  • misoprost
  • misoprostil
A synthetic analog of natural prostaglandin E1. It produces a dose-related inhibition of gastric acid and pepsin secretion, and enhances mucosal resistance to injury. It is an effective anti-ulcer agent and also has oxytocic properties.
  • Molecular weight: 382.54
  • Formula: C22H38O5
  • CLOGP: 3.07
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 83.83
  • ALOGS: -4.37
  • ROTB: 14

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.80 mg O
0.20 mg O
0.20 mg V

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.03 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 80 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Dec. 27, 1988 FDA GD SEARLE LLC

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
Abortion incomplete 8675.84 14.39 1433 19340 1693 50582658
Haemorrhage 4482.99 14.39 1399 19374 52042 50532309
Pregnancy 1570.34 14.39 551 20222 29026 50555325
Endometritis 908.52 14.39 178 20595 797 50583554
Heavy menstrual bleeding 642.01 14.39 241 20532 15296 50569055
Anaemia 502.05 14.39 565 20208 251891 50332460
Muscle spasms 364.55 14.39 345 20428 125208 50459143
Induced abortion failed 275.23 14.39 52 20721 183 50584168
Exposure during pregnancy 229.47 14.39 265 20508 120750 50463601
Drug ineffective for unapproved indication 222.02 14.39 127 20646 21154 50563197
Uterine rupture 191.75 14.39 51 20722 1024 50583327
Retained products of conception 181.00 14.39 33 20740 90 50584261
Ectopic pregnancy 152.88 14.39 51 20722 2276 50582075
Ruptured ectopic pregnancy 145.70 14.39 34 20739 388 50583963
Pelvic inflammatory disease 143.87 14.39 44 20729 1478 50582873
Vaginal haemorrhage 137.46 14.39 99 20674 24452 50559899
Intermenstrual bleeding 126.82 14.39 60 20713 6754 50577597
Pelvic pain 114.45 14.39 66 20707 11147 50573204
Syncope 110.62 14.39 171 20602 102831 50481520
Abdominal pain 99.07 14.39 265 20508 235963 50348388
Uterine haemorrhage 98.85 14.39 41 20732 3374 50580977
Abortion induced incomplete 92.63 14.39 15 20758 13 50584338
Post abortion infection 83.46 14.39 13 20760 6 50584345
Foetal exposure during pregnancy 82.57 14.39 77 20696 27282 50557069
Pyrexia 73.15 14.39 329 20444 379874 50204477
Foetal death 72.61 14.39 44 20729 8136 50576215
Postpartum haemorrhage 71.59 14.39 27 20746 1727 50582624
Haemorrhage in pregnancy 68.64 14.39 26 20747 1683 50582668
Pain 68.45 14.39 438 20335 578465 50005886
Fatigue 65.99 14.39 119 20654 707482 49876869
Stillbirth 63.32 14.39 36 20737 5916 50578435
Gestational diabetes 63.30 14.39 39 20734 7426 50576925
Small for dates baby 62.58 14.39 30 20743 3475 50580876
Complication of device insertion 60.16 14.39 35 20738 6006 50578345
Dizziness 57.98 14.39 288 20485 346081 50238270
Foetal methotrexate syndrome 57.44 14.39 12 20761 78 50584273
Maternal exposure during pregnancy 55.86 14.39 168 20605 159610 50424741
Arteriospasm coronary 54.38 14.39 27 20746 3375 50580976
Peripheral swelling 53.32 14.39 10 20763 205926 50378425
Product use in unapproved indication 51.54 14.39 133 20640 115686 50468665
Uterine perforation 48.09 14.39 31 20742 6384 50577967
Post abortion complication 47.48 14.39 8 20765 11 50584340
Vaginal odour 47.00 14.39 14 20759 429 50583922
Maternal exposure during delivery 46.62 14.39 17 20756 989 50583362
Wrist deformity 46.62 14.39 20 20753 1789 50582562
Chills 46.11 14.39 114 20659 96573 50487778
Uterine tenderness 45.28 14.39 8 20765 17 50584334
Death 39.80 14.39 45 20728 325334 50259017
Uterine hypotonus 38.87 14.39 9 20764 99 50584252
Pelvic infection 38.72 14.39 11 20762 284 50584067
Procedural pain 38.05 14.39 37 20736 13795 50570556
Embedded device 38.04 14.39 20 20753 2817 50581534
Uterine tachysystole 37.41 14.39 7 20766 23 50584328
Induced abortion haemorrhage 36.64 14.39 6 20767 6 50584345
Systemic lupus erythematosus 36.02 14.39 7 20766 140615 50443736
Microcephaly 34.90 14.39 13 20760 803 50583548
Uterine atony 33.72 14.39 9 20764 183 50584168
Product dose omission issue 33.21 14.39 17 20756 183821 50400530
Toxic shock syndrome 33.18 14.39 11 20762 481 50583870
Cerebral ventricle dilatation 33.15 14.39 13 20760 924 50583427
Uterine hyperstimulation 32.69 14.39 7 20766 52 50584299
Therapeutic product effect decreased 32.36 14.39 8 20765 136042 50448309
Sinusitis 31.98 14.39 15 20758 170543 50413808
Dysmorphism 31.13 14.39 16 20757 2151 50582200
Off label use 30.13 14.39 312 20461 474114 50110237
Toxicity to various agents 29.85 14.39 26 20747 212473 50371878
Alopecia 29.82 14.39 34 20739 245013 50339338
Respiratory disorder neonatal 29.62 14.39 12 20761 929 50583422
Abortion induced 29.54 14.39 27 20746 9317 50575034
Febrile neutropenia 29.35 14.39 3 20770 97664 50486687
Drug ineffective 29.27 14.39 207 20566 819126 49765225
Post procedural discomfort 29.15 14.39 12 20761 968 50583383
Joint swelling 28.81 14.39 35 20738 245251 50339100
Adactyly 28.21 14.39 6 20767 43 50584308
Abnormal palmar/plantar creases 28.09 14.39 6 20767 44 50584307
Congenital multiplex arthrogryposis 27.88 14.39 5 20768 12 50584339
Oral fibroma 27.10 14.39 6 20767 53 50584298
Uterine dilation and curettage 27.04 14.39 11 20762 861 50583490
Neutropenia 26.25 14.39 14 20759 147951 50436400
Abortion 25.74 14.39 14 20759 2110 50582241
Completed suicide 25.65 14.39 11 20762 131878 50452473
Abortion infected 25.57 14.39 5 20768 22 50584329
Arnold-Chiari malformation 25.39 14.39 9 20764 482 50583869
Craniosynostosis 25.29 14.39 7 20766 164 50584187
Endometritis bacterial 24.96 14.39 4 20769 3 50584348
Pre-eclampsia 24.95 14.39 23 20750 8021 50576330
Bloody discharge 23.89 14.39 11 20762 1163 50583188
Lower respiratory tract infection 23.83 14.39 5 20768 95196 50489155
Acute kidney injury 23.29 14.39 36 20737 228022 50356329
Product complaint 23.15 14.39 26 20747 11440 50572911
Meconium in amniotic fluid 22.66 14.39 7 20766 243 50584108
Uterine hypertonus 22.53 14.39 7 20766 248 50584103
Contraindicated product administered 22.43 14.39 17 20756 148941 50435410
Vaginal discharge 22.40 14.39 18 20755 5222 50579129
Confusional state 22.39 14.39 26 20747 185902 50398449
Infusion related reaction 22.32 14.39 22 20751 169535 50414816
Abdominal discomfort 22.31 14.39 38 20735 231603 50352748
Diarrhoea 22.27 14.39 146 20627 588330 49996021
Post abortion haemorrhage 22.02 14.39 5 20768 50 50584301
Injection site pain 22.01 14.39 9 20764 111015 50473336
Intentional product use issue 21.53 14.39 3 20770 76915 50507436
Infantile haemangioma 21.43 14.39 5 20768 57 50584294
Congenital joint malformation 21.41 14.39 4 20769 13 50584338
Victim of homicide 21.19 14.39 5 20768 60 50584291
Maternal exposure timing unspecified 21.17 14.39 15 20758 3605 50580746
Fall 21.03 14.39 69 20704 334863 50249488
Arthralgia 20.83 14.39 101 20672 438601 50145750
Maternal drugs affecting foetus 20.77 14.39 17 20756 5060 50579291
Microgenia 20.76 14.39 4 20769 16 50584335
Dyspnoea 20.64 14.39 136 20637 547472 50036879
Weight increased 20.49 14.39 32 20741 201859 50382492
Glossodynia 20.40 14.39 11 20762 115558 50468793
Hyponatraemia 20.38 14.39 7 20766 96132 50488219
Tongue oedema 20.38 14.39 15 20758 3824 50580527
Treatment failure 20.35 14.39 16 20757 137621 50446730
Hepatic enzyme increased 20.28 14.39 16 20757 137364 50446987
Arthropathy 20.20 14.39 21 20752 157885 50426466
Discomfort 19.59 14.39 10 20763 108370 50475981
Pruritus 19.52 14.39 56 20717 283512 50300839
Foetal heart rate disorder 19.41 14.39 5 20768 88 50584263
Device difficult to use 19.25 14.39 22 20751 9864 50574487
Nasopharyngitis 19.18 14.39 31 20742 192896 50391455
Spina bifida 18.93 14.39 8 20765 689 50583662
Rash 18.91 14.39 104 20669 437367 50146984
Micrognathia 18.73 14.39 6 20767 235 50584116
Polyhydramnios 18.24 14.39 11 20762 2014 50582337
Tachycardia 18.07 14.39 85 20688 99678 50484673
Low set ears 18.06 14.39 6 20767 264 50584087
Uterine spasm 18.05 14.39 7 20766 483 50583868
Uterine disorder 17.88 14.39 12 20761 2643 50581708
Gross motor delay 17.79 14.39 5 20768 124 50584227
Retained placenta or membranes 17.66 14.39 6 20767 283 50584068
Drug intolerance 17.59 14.39 40 20733 219064 50365287
International normalised ratio fluctuation 17.45 14.39 11 20762 2179 50582172
Premature separation of placenta 17.45 14.39 10 20763 1668 50582683
Pregnancy with contraceptive device 17.41 14.39 14 20759 4065 50580286
Anaphylactoid syndrome of pregnancy 17.27 14.39 4 20769 44 50584307
Cough 17.07 14.39 47 20726 241217 50343134
General physical health deterioration 17.05 14.39 20 20753 142414 50441937
Foetal exposure during delivery 17.03 14.39 4 20769 47 50584304
Headache 17.02 14.39 130 20643 506405 50077946
Congenital choroid plexus cyst 16.97 14.39 6 20767 319 50584032
Microphthalmos 16.92 14.39 5 20768 149 50584202
Vomiting 16.87 14.39 274 20499 460484 50123867
Third stage postpartum haemorrhage 16.79 14.39 3 20770 7 50584344
Abortion complete 16.79 14.39 3 20770 7 50584344
Synostosis 16.32 14.39 4 20769 57 50584294
Pneumonia 16.32 14.39 90 20683 378311 50206040
Thrombocytopenia 16.30 14.39 17 20756 127656 50456695
Hospitalisation 16.13 14.39 4 20769 67933 50516418
Congenital pneumonia 16.00 14.39 3 20770 10 50584341
Stomatitis 15.99 14.39 11 20762 101333 50483018
Lyme disease 15.95 14.39 11 20762 2532 50581819
Limb reduction defect 15.95 14.39 6 20767 381 50583970
Movement disorder 15.79 14.39 27 20746 17605 50566746
Weight decreased 15.73 14.39 43 20730 221202 50363149
Dysmenorrhoea 15.50 14.39 12 20761 3298 50581053
Breast tenderness 15.43 14.39 10 20763 2078 50582273
Uterine contractions abnormal 15.03 14.39 5 20768 221 50584130
Amniotic cavity infection 15.03 14.39 8 20765 1155 50583196
Premature baby 15.02 14.39 27 20746 18310 50566041
Uterine cervix stenosis 14.94 14.39 5 20768 225 50584126
Uterine cervical laceration 14.71 14.39 3 20770 17 50584334

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
Foetal exposure during pregnancy 235.19 15.08 112 4561 33755 29536099
Maternal exposure during pregnancy 85.64 15.08 30 4643 4093 29565761
Anencephaly 70.02 15.08 13 4660 126 29569728
Premature baby 52.07 15.08 33 4640 17247 29552607
Pulmonary hypoplasia 50.28 15.08 12 4661 414 29569440
Congenital hydrocephalus 48.59 15.08 9 4664 86 29569768
Poor weight gain neonatal 46.26 15.08 7 4666 15 29569839
Congenital megaureter 45.43 15.08 9 4664 126 29569728
Renal aplasia 44.96 15.08 12 4661 654 29569200
Neonatal respiratory arrest 44.09 15.08 7 4666 23 29569831
Micrognathia 43.31 15.08 10 4663 298 29569556
Stillbirth 42.95 15.08 9 4664 169 29569685
Meningocele 42.26 15.08 7 4666 32 29569822
Congenital cystic kidney disease 40.79 15.08 10 4663 387 29569467
Foetal growth restriction 40.61 15.08 17 4656 3749 29566105
Moebius II syndrome 38.77 15.08 5 4668 0 29569854
Respiratory disorder neonatal 35.95 15.08 12 4661 1413 29568441
Congenital cystic lung 35.20 15.08 8 4665 222 29569632
Newborn persistent pulmonary hypertension 34.89 15.08 7 4666 105 29569749
Anomaly of external ear congenital 34.89 15.08 7 4666 105 29569749
Intervertebral disc compression 34.01 15.08 8 4665 259 29569595
Heart disease congenital 33.17 15.08 11 4662 1269 29568585
Cleft lip and palate 32.50 15.08 8 4665 315 29569539
External auditory canal atresia 31.42 15.08 7 4666 177 29569677
Genitalia external ambiguous 30.40 15.08 7 4666 206 29569648
Haemangioma congenital 29.04 15.08 8 4665 491 29569363
Congenital diaphragmatic hernia 28.75 15.08 7 4666 263 29569591
Retroperitoneal fibrosis 28.11 15.08 7 4666 289 29569565
Maternal drugs affecting foetus 27.29 15.08 13 4660 3880 29565974
Paternal exposure before pregnancy 26.97 15.08 5 4668 48 29569806
Interstitial lung disease 26.89 15.08 39 4634 57679 29512175
Patent ductus arteriosus 26.77 15.08 12 4661 3119 29566735
Congenital pulmonary valve atresia 26.35 15.08 5 4668 55 29569799
Congenital tricuspid valve atresia 23.20 15.08 5 4668 108 29569746
Double outlet right ventricle 23.15 15.08 5 4668 109 29569745
Talipes 22.42 15.08 9 4664 1783 29568071
Kidney duplex 21.27 15.08 6 4667 402 29569452
Atrial septal defect 20.52 15.08 13 4660 6776 29563078
Arachnoid cyst 20.18 15.08 5 4668 202 29569652
Gastric ulcer haemorrhage 18.95 15.08 11 4662 4903 29564951
Cerebellar hypoplasia 18.64 15.08 3 4670 11 29569843
Craniofacial deformity 18.49 15.08 4 4669 88 29569766
Hyperbilirubinaemia neonatal 17.73 15.08 6 4667 736 29569118
Spinal deformity 16.72 15.08 5 4668 412 29569442
Low set ears 16.48 15.08 5 4668 432 29569422
Death 16.40 15.08 18 4655 342066 29227788
Vesicoureteric reflux 16.36 15.08 4 4669 153 29569701
Congenital central nervous system anomaly 16.29 15.08 5 4668 450 29569404
Congenital bowing of long bones 16.26 15.08 3 4670 28 29569826
Foetal distress syndrome 15.99 15.08 6 4667 993 29568861
Neonatal respiratory distress syndrome 15.95 15.08 9 4664 3801 29566053
Congenital nose malformation 15.36 15.08 4 4669 198 29569656
Delayed fontanelle closure 15.35 15.08 3 4670 39 29569815
Hypertelorism 15.27 15.08 5 4668 554 29569300

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
Abortion incomplete 8969.85 14.49 1422 19388 1639 64476283
Haemorrhage 4221.42 14.49 1387 19423 77964 64399958
Pregnancy 1845.78 14.49 541 20269 20324 64457598
Endometritis 954.75 14.49 172 20638 594 64477328
Heavy menstrual bleeding 733.57 14.49 235 20575 11842 64466080
Anaemia 430.27 14.49 567 20243 378113 64099809
Muscle spasms 391.42 14.49 340 20470 140683 64337239
Exposure during pregnancy 281.71 14.49 219 20591 77456 64400466
Induced abortion failed 219.12 14.49 40 20770 151 64477771
Retained products of conception 190.30 14.49 33 20777 85 64477837
Uterine rupture 187.44 14.49 44 20766 669 64477253
Ectopic pregnancy 184.97 14.49 51 20759 1513 64476409
Pelvic inflammatory disease 162.63 14.49 44 20766 1214 64476708
Vaginal haemorrhage 143.37 14.49 85 20725 19259 64458663
Ruptured ectopic pregnancy 140.34 14.49 31 20779 353 64477569
Pain 136.09 14.49 439 20371 553072 63924850
Pelvic pain 131.07 14.49 66 20744 10844 64467078
Intermenstrual bleeding 125.59 14.49 51 20759 5074 64472848
Drug ineffective for unapproved indication 117.55 14.49 90 20720 31043 64446879
Uterine haemorrhage 104.27 14.49 37 20773 2542 64475380
Maternal exposure during pregnancy 99.57 14.49 138 20672 95746 64382176
Syncope 90.01 14.49 173 20637 157462 64320460
Abdominal pain 84.01 14.49 256 20554 312119 64165803
Abortion induced incomplete 83.55 14.49 13 20797 11 64477911
Haemorrhage in pregnancy 82.13 14.49 26 20784 1254 64476668
Foetal death 80.52 14.49 39 20771 5891 64472031
Post abortion infection 79.61 14.49 12 20798 6 64477916
Complication of device insertion 71.20 14.49 34 20776 4978 64472944
Postpartum haemorrhage 71.04 14.49 24 20786 1423 64476499
Gestational diabetes 70.63 14.49 35 20775 5555 64472367
Dizziness 63.05 14.49 290 20520 429873 64048049
Stillbirth 58.89 14.49 27 20783 3606 64474316
Uterine perforation 57.82 14.49 31 20779 5789 64472133
Vaginal odour 54.54 14.49 14 20796 313 64477609
Uterine tenderness 54.53 14.49 9 20801 15 64477907
Maternal exposure during delivery 52.67 14.49 17 20793 873 64477049
Wrist deformity 51.37 14.49 20 20790 1780 64476142
Pyrexia 49.15 14.49 328 20482 558316 63919606
Death 48.07 14.49 51 20759 482654 63995268
Arteriospasm coronary 45.74 14.49 26 20784 5439 64472483
Uterine hypotonus 43.28 14.49 9 20801 75 64477847
Embedded device 43.19 14.49 20 20790 2732 64475190
Completed suicide 42.70 14.49 10 20800 224404 64253518
Toxicity to various agents 42.61 14.49 33 20777 363480 64114442
Uterine tachysystole 42.29 14.49 7 20803 12 64477910
Procedural pain 42.06 14.49 37 20773 15471 64462451
Fatigue 40.86 14.49 116 20694 748614 63729308
Peripheral swelling 40.43 14.49 9 20801 209144 64268778
Acute kidney injury 39.85 14.49 52 20758 449188 64028734
Post abortion complication 38.60 14.49 6 20804 5 64477917
Induced abortion haemorrhage 38.08 14.49 6 20804 6 64477916
Uterine dilation and curettage 35.81 14.49 11 20799 480 64477442
Abortion induced 34.55 14.49 23 20787 6365 64471557
Febrile neutropenia 34.45 14.49 9 20801 187648 64290274
Post procedural discomfort 32.91 14.49 12 20798 891 64477031
Pre-eclampsia 32.66 14.49 22 20788 6209 64471713
Endometritis bacterial 32.26 14.49 5 20805 4 64477918
Chills 31.77 14.49 107 20703 137157 64340765
Uterine atony 31.69 14.49 8 20802 167 64477755
Vaginal discharge 30.75 14.49 18 20792 3979 64473943
Toxic shock syndrome 29.44 14.49 11 20799 875 64477047
Abortion infected 28.03 14.49 5 20805 16 64477906
Product dose omission issue 27.87 14.49 14 20796 194733 64283189
Dyspnoea 26.32 14.49 131 20679 718543 63759379
Meconium in amniotic fluid 26.15 14.49 6 20804 82 64477840
Maternal drugs affecting foetus 26.13 14.49 12 20798 1608 64476314
Abortion 25.89 14.49 11 20799 1225 64476697
Uterine hypertonus 24.81 14.49 7 20803 226 64477696
Small for dates baby 24.41 14.49 8 20802 431 64477491
Bloody discharge 24.01 14.49 11 20799 1466 64476456
Device difficult to use 23.85 14.49 22 20788 9776 64468146
Pregnancy with contraceptive device 23.64 14.49 14 20796 3160 64474762
Product use in unapproved indication 23.52 14.49 116 20694 176502 64301420
Pelvic infection 22.77 14.49 7 20803 306 64477616
Therapeutic product effect decreased 22.21 14.49 5 20805 115346 64362576
Neutropenia 21.97 14.49 27 20783 239597 64238325
Uterine disorder 21.84 14.49 11 20799 1806 64476116
Vomiting 21.22 14.49 271 20539 550846 63927076
Polyhydramnios 20.85 14.49 10 20800 1477 64476445
Hyponatraemia 20.72 14.49 11 20799 148328 64329594
Retained placenta or membranes 20.64 14.49 6 20804 216 64477706
Confusional state 20.39 14.49 33 20777 261111 64216811
Maternal exposure timing unspecified 20.32 14.49 12 20798 2695 64475227
Premature separation of placenta 20.12 14.49 9 20801 1135 64476787
Injection site pain 19.23 14.49 6 20804 111402 64366520
Uterine hyperstimulation 19.16 14.49 4 20806 34 64477888
Joint swelling 18.98 14.49 25 20785 215357 64262565
Lyme disease 18.90 14.49 11 20799 2404 64475518
Anaphylactoid syndrome of pregnancy 18.58 14.49 4 20806 40 64477882
Diarrhoea 18.54 14.49 147 20663 722557 63755365
Post abortion haemorrhage 17.91 14.49 4 20806 48 64477874
Breast tenderness 17.83 14.49 10 20800 2039 64475883
Abortion complete 17.82 14.49 3 20807 6 64477916
General physical health deterioration 17.74 14.49 24 20786 204401 64273521
Hysterectomy 17.66 14.49 14 20796 5071 64472851
Third stage postpartum haemorrhage 17.51 14.49 3 20807 7 64477915
Victim of homicide 17.42 14.49 5 20805 172 64477750
Uterine spasm 17.30 14.49 6 20804 385 64477537
International normalised ratio fluctuation 16.84 14.49 11 20799 2950 64474972
Product complaint 16.78 14.49 20 20790 11934 64465988
Infusion related reaction 16.74 14.49 17 20793 164450 64313472
Weight decreased 16.46 14.49 43 20767 285696 64192226
Oligohydramnios 16.30 14.49 11 20799 3113 64474809
Drug interaction 16.26 14.49 61 20749 362022 64115900
Bacterial vulvovaginitis 16.21 14.49 6 20804 465 64477457
Abnormal labour 16.10 14.49 3 20807 13 64477909
Dysmenorrhoea 16.00 14.49 10 20800 2487 64475435
Uterine infection 15.88 14.49 5 20805 237 64477685
Tongue oedema 15.66 14.49 14 20796 5976 64471946
Uterine cervical laceration 15.43 14.49 3 20807 17 64477905
Gastrointestinal disorder 15.18 14.49 5 20805 89704 64388218
Hospitalisation 15.01 14.49 3 20807 75204 64402718
Lower respiratory tract infection 14.78 14.49 6 20804 94608 64383314
Fall 14.63 14.49 77 20733 416749 64061173
Genital haemorrhage 14.62 14.49 13 20797 5509 64472413

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A02BB01 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Prostaglandins
ATC G02AD06 GENITO URINARY SYSTEM AND SEX HORMONES
OTHER GYNECOLOGICALS
UTEROTONICS
Prostaglandins
ATC M01AE56 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
FDA CS M0017811 Prostaglandins E, Synthetic
FDA EPC N0000175785 Prostaglandin E1 Analog
CHEBI has role CHEBI:36063 oxytocic agents
CHEBI has role CHEBI:49201 anti-ulcer drugs
CHEBI has role CHEBI:50691 abortifacient drug
MeSH PA D000019 Abortifacient Agents
MeSH PA D000020 Abortifacient Agents, Nonsteroidal
MeSH PA D000897 Anti-Ulcer Agents
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D010120 Oxytocics
MeSH PA D012102 Reproductive Control Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Postpartum hemorrhage indication 47821001
Rheumatoid Arthritis in Patient at High Ulcer Risk indication
Prevention of NSAID-Induced Gastric Ulcer indication
Prevention of CMV Disease After Organ Transplant indication
Osteoarthritis in Patients at High Ulcer Risk indication
Ankylosing spondylitis off-label use 9631008 DOID:7147
Peptic ulcer off-label use 13200003 DOID:750
Duodenal ulcer disease off-label use 51868009 DOID:1724
Cervical ripening procedure off-label use 236959001
Pregnancy with abortive outcome off-label use 363681007
Gastric ulcer off-label use 397825006 DOID:10808
NSAID-Induced Gastric Ulcer off-label use
Alcoholism contraindication 7200002
Myocardial infarction contraindication 22298006 DOID:5844
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Dehydration contraindication 34095006
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Body fluid retention contraindication 43498006
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Gastrointestinal perforation contraindication 51875005
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Blood coagulation disorder contraindication 64779008 DOID:1247
Gastrointestinal hemorrhage contraindication 74474003
Liver function tests abnormal contraindication 166603001
Asthma contraindication 195967001 DOID:2841
Deliveries by cesarean contraindication 200144004
Non-infective meningitis contraindication 230155003
Cerebrovascular accident contraindication 230690007
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Drug-induced hepatitis contraindication 235876009
Edema contraindication 267038008
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Cardiovascular event risk contraindication 395112001
Smokes tobacco daily contraindication 449868002
Uterine Rupture in Pregnancy contraindication
Bloody Vomit contraindication
Gynecological Surgery contraindication




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
Prostaglandin E2 receptor EP3 subtype GPCR AGONIST Ki 8.10 IUPHAR CHEMBL
Prostaglandin E2 receptor EP2 subtype GPCR AGONIST Ki 7.50 IUPHAR
Prostaglandin E2 receptor EP4 subtype GPCR AGONIST Ki 7.60 IUPHAR
Prostaglandin F2-alpha receptor GPCR Ki 5.03 PDSP

External reference:

IDSource
4019313 VUID
N0000147506 NUI
D00419 KEGG_DRUG
4019313 VANDF
C0085174 UMLSCUI
CHEBI:63610 CHEBI
CHEMBL606 ChEMBL_ID
DB00929 DRUGBANK_ID
D016595 MESH_DESCRIPTOR_UI
5282381 PUBCHEM_CID
C047042 MESH_SUPPLEMENTAL_RECORD_UI
5154 INN_ID
66792-31-2 SECONDARY_CAS_RN
0E43V0BB57 UNII
6436406 PUBCHEM_CID
151578 RXNORM
44310 MMSL
445 MMSL
5121 MMSL
d00303 MMSL
001133 NDDF
387242007 SNOMEDCT_US
43684009 SNOMEDCT_US
C0377863 UMLSCUI
CHEMBL1201377 ChEMBL_ID
12Z0SU967A UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1411 TABLET, FILM COATED 200 ug ORAL NDA 30 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1421 TABLET, FILM COATED 200 ug ORAL NDA 30 sections
Cytotec HUMAN PRESCRIPTION DRUG LABEL 1 0025-1451 TABLET 100 ug ORAL NDA 28 sections
Cytotec HUMAN PRESCRIPTION DRUG LABEL 1 0025-1461 TABLET 200 ug ORAL NDA 28 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 0591-0397 TABLET, DELAYED RELEASE 200 ug ORAL ANDA 28 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 0591-0398 TABLET, DELAYED RELEASE 200 ug ORAL ANDA 28 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 0904-6806 TABLET 100 ug ORAL ANDA 22 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 0904-6807 TABLET 200 ug ORAL ANDA 22 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 10135-745 TABLET 100 ug ORAL ANDA 20 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 10135-746 TABLET 200 ug ORAL ANDA 20 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 10544-949 TABLET, DELAYED RELEASE 200 ug ORAL ANDA 24 sections
Diclofenac Sodium and MisoprostolDelayed-Release HUMAN PRESCRIPTION DRUG LABEL 2 10544-955 TABLET, DELAYED RELEASE 0.20 mg ORAL ANDA 30 sections
misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 12634-502 TABLET 200 ug ORAL NDA authorized generic 27 sections
CYTOTEC HUMAN PRESCRIPTION DRUG LABEL 1 12634-933 TABLET 200 ug ORAL NDA 13 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 16590-024 TABLET, FILM COATED 200 ug ORAL NDA 31 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 21695-425 TABLET, FILM COATED 200 ug ORAL NDA 30 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 33261-076 TABLET 200 ug ORAL ANDA 15 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 33261-754 TABLET 100 ug ORAL ANDA 15 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 40032-160 TABLET 100 ug ORAL ANDA 22 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 40032-161 TABLET 200 ug ORAL ANDA 22 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 42291-232 TABLET, DELAYED RELEASE 200 ug ORAL ANDA 27 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 42291-233 TABLET, DELAYED RELEASE 200 ug ORAL ANDA 27 sections
Diclofenac Sodium and Misoprostol Delayed-Release HUMAN PRESCRIPTION DRUG LABEL 2 42367-110 TABLET, DELAYED RELEASE 0.20 mg ORAL ANDA 30 sections
Diclofenac Sodium and Misoprostol Delayed-Release HUMAN PRESCRIPTION DRUG LABEL 2 42367-111 TABLET, DELAYED RELEASE 0.20 mg ORAL ANDA 30 sections
Diclofenac Sodium/Misoprostoldiclofenac-sodium-misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 42571-133 TABLET 200 ug ORAL ANDA 28 sections
Diclofenac Sodium/Misoprostoldiclofenac-sodium-misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 42571-134 TABLET 200 ug ORAL ANDA 28 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 43063-707 TABLET 200 ug ORAL ANDA 22 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 43063-707 TABLET 200 ug ORAL ANDA 22 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 43386-160 TABLET 100 ug ORAL ANDA 22 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 43386-161 TABLET 200 ug ORAL ANDA 22 sections