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 8920.59 14.64 1434 20565 1697 63465326
Haemorrhage 4565.16 14.64 1407 20592 59615 63407408
Pregnancy 1546.78 14.64 552 21447 36284 63430739
Endometritis 930.91 14.64 178 21821 840 63466183
Heavy menstrual bleeding 657.52 14.64 243 21756 17530 63449493
Anaemia 521.07 14.64 571 21428 292859 63174164
Muscle spasms 363.32 14.64 352 21647 155798 63311225
Induced abortion failed 312.59 14.64 57 21942 195 63466828
Exposure during pregnancy 275.49 14.64 303 21696 155244 63311779
Uterine rupture 204.73 14.64 52 21947 1034 63465989
Drug ineffective for unapproved indication 201.26 14.64 133 21866 33930 63433093
Retained products of conception 184.25 14.64 33 21966 99 63466924
Vaginal haemorrhage 161.57 14.64 107 21892 27380 63439643
Post abortion haemorrhage 156.58 14.64 27 21972 60 63466963
Ectopic pregnancy 156.44 14.64 51 21948 2516 63464507
Pelvic inflammatory disease 147.40 14.64 44 21955 1618 63465405
Ruptured ectopic pregnancy 147.36 14.64 34 21965 442 63466581
Intermenstrual bleeding 140.34 14.64 64 21935 7862 63459161
Pelvic pain 132.27 14.64 73 21926 13446 63453577
Abortion induced incomplete 120.80 14.64 19 21980 16 63467007
Syncope 118.53 14.64 173 21826 117212 63349811
Bloody discharge 111.74 14.64 35 21964 1516 63465507
Uterine haemorrhage 102.28 14.64 42 21957 3999 63463024
Foetal exposure during pregnancy 101.47 14.64 86 21913 31876 63435147
International normalised ratio fluctuation 95.66 14.64 35 21964 2443 63464580
Abdominal pain 94.04 14.64 268 21731 293188 63173835
Complication of device insertion 91.34 14.64 47 21952 7517 63459506
Foetal death 87.84 14.64 52 21947 10928 63456095
Postpartum haemorrhage 87.83 14.64 31 21968 1950 63465073
Post abortion infection 85.66 14.64 13 21986 6 63467017
Lyme disease 84.42 14.64 35 21964 3414 63463609
Foetal methotrexate syndrome 84.31 14.64 17 21982 110 63466913
Stillbirth 78.79 14.64 41 21958 6709 63460314
Small for dates baby 78.31 14.64 34 21965 3717 63463306
Haemorrhage in pregnancy 73.60 14.64 27 21972 1898 63465125
Pyrexia 67.10 14.64 331 21668 470147 62996876
Gestational diabetes 65.17 14.64 39 21960 8357 63458666
Wrist deformity 63.82 14.64 25 21974 2105 63464918
Maternal exposure during pregnancy 62.79 14.64 193 21806 219869 63247154
Dizziness 62.36 14.64 304 21695 429621 63037402
Pain 61.94 14.64 453 21546 740175 62726848
Maternal exposure during delivery 60.93 14.64 22 21977 1478 63465545
Peripheral swelling 60.10 14.64 10 21989 265932 63201091
Arteriospasm coronary 57.78 14.64 28 21971 3940 63463083
Fatigue 55.75 14.64 143 21856 887885 62579138
Post abortion complication 55.09 14.64 9 21990 12 63467011
Uterine perforation 53.15 14.64 32 21967 6931 63460092
Uterine tenderness 52.19 14.64 9 21990 20 63467003
Vaginal odour 51.23 14.64 15 21984 515 63466508
Systemic lupus erythematosus 49.14 14.64 7 21992 208911 63258112
Chills 47.94 14.64 115 21884 113263 63353760
Meconium in amniotic fluid 45.13 14.64 12 21987 287 63466736
Alopecia 41.11 14.64 34 21965 337502 63129521
Embedded device 40.20 14.64 21 21978 3462 63463561
Therapeutic product effect decreased 39.96 14.64 9 21990 193178 63273845
Uterine hypotonus 39.90 14.64 9 21990 105 63466918
Procedural pain 39.74 14.64 43 21956 21526 63445497
Uterine hyperstimulation 39.13 14.64 8 21991 56 63466967
Sinusitis 38.80 14.64 15 21984 226638 63240385
Uterine tachysystole 38.60 14.64 7 21992 23 63467000
Pelvic infection 37.90 14.64 11 21988 366 63466657
Induced abortion haemorrhage 37.65 14.64 6 21993 6 63467017
Joint swelling 37.49 14.64 35 21964 327631 63139392
Toxic shock syndrome 36.65 14.64 13 21986 829 63466194
Microcephaly 35.26 14.64 13 21986 927 63466096
Adactyly 34.89 14.64 7 21992 44 63466979
Uterine atony 34.69 14.64 9 21990 195 63466828
Abnormal palmar/plantar creases 34.62 14.64 7 21992 46 63466977
Cerebral ventricle dilatation 34.11 14.64 13 21986 1016 63466007
Abortion induced 33.40 14.64 28 21971 10214 63456809
Death 33.17 14.64 49 21950 374332 63092691
Post procedural discomfort 33.11 14.64 13 21986 1101 63465922
Dysmorphism 32.82 14.64 16 21983 2280 63464743
Product use in unapproved indication 32.11 14.64 135 21864 178945 63288078
Infusion related reaction 32.08 14.64 23 21976 245498 63221525
Glossodynia 32.02 14.64 11 21988 178865 63288158
Arthropathy 32.00 14.64 21 21978 234771 63232252
Product dose omission issue 31.88 14.64 21 21978 234292 63232731
Off label use 31.83 14.64 365 21634 674097 62792926
Uterine dilation and curettage 31.40 14.64 12 21987 945 63466078
Craniosynostosis 31.03 14.64 8 21991 169 63466854
Intentional product use issue 30.73 14.64 4 21995 127888 63339135
Abortion infected 30.44 14.64 6 21993 34 63466989
Abdominal discomfort 30.41 14.64 40 21959 320845 63146178
Febrile neutropenia 30.23 14.64 3 21996 118446 63348577
Product complaint 29.89 14.64 29 21970 12780 63454243
Pre-eclampsia 29.85 14.64 25 21974 9108 63457915
Lower respiratory tract infection 29.80 14.64 5 21994 132302 63334721
Treatment failure 29.66 14.64 16 21983 199027 63267996
Respiratory disorder neonatal 28.34 14.64 12 21987 1233 63465790
Vomiting 28.26 14.64 307 21692 559310 62907713
Oral fibroma 28.11 14.64 6 21993 53 63466970
Toxicity to various agents 27.57 14.64 27 21972 247223 63219800
Microgenia 27.44 14.64 5 21994 17 63467006
Discomfort 27.14 14.64 12 21987 167362 63299661
Drug ineffective 26.28 14.64 234 21765 1044531 62422492
Neutropenia 26.17 14.64 14 21985 174991 63292032
Iron deficiency 26.16 14.64 21 21978 7209 63459814
Confusional state 26.14 14.64 26 21973 236354 63230669
COVID-19 26.09 14.64 4 21995 113099 63353924
Abortion 25.85 14.64 14 21985 2482 63464541
Arthralgia 25.68 14.64 106 21893 569604 62897419
Endometritis bacterial 25.64 14.64 4 21995 3 63467020
Maternal drugs affecting foetus 25.11 14.64 18 21981 5224 63461799
Congenital multiplex arthrogryposis 24.71 14.64 5 21994 33 63466990
Arnold-Chiari malformation 24.22 14.64 9 21990 656 63466367
Weight increased 24.20 14.64 33 21966 260759 63206264
Uterine spasm 24.01 14.64 9 21990 672 63466351
Contraindicated product administered 24.00 14.64 24 21975 217624 63249399
Nasopharyngitis 23.76 14.64 32 21967 254225 63212798
General physical health deterioration 23.62 14.64 21 21978 201381 63265642
Hepatic enzyme increased 22.66 14.64 22 21977 202306 63264717
Uterine hypertonus 22.57 14.64 7 21992 293 63466730
Tongue oedema 22.55 14.64 16 21983 4570 63462453
Maternal exposure timing unspecified 22.34 14.64 19 21980 7068 63459955
Diarrhoea 22.25 14.64 151 21848 715215 62751808
Congenital joint malformation 22.09 14.64 4 21995 13 63467010
Helicobacter infection 22.05 14.64 3 21996 92782 63374241
Oligohydramnios 22.00 14.64 18 21981 6348 63460675
Movement disorder 21.92 14.64 32 21967 21629 63445394
Dyspnoea 21.87 14.64 137 21862 661176 62805847
Vaginal discharge 21.79 14.64 21 21978 9177 63457846
Victim of homicide 21.74 14.64 5 21994 64 63466959
Headache 21.55 14.64 130 21869 633111 62833912
Blister 21.53 14.64 9 21990 129805 63337218
Completed suicide 21.27 14.64 12 21987 145661 63321362
Uterine cervical laceration 21.25 14.64 4 21995 17 63467006
Infantile haemangioma 21.00 14.64 5 21994 75 63466948
Acute kidney injury 20.93 14.64 37 21962 263378 63203645
Stomatitis 20.88 14.64 11 21988 138714 63328309
Premature separation of placenta 20.85 14.64 11 21988 1850 63465173
Pruritus 20.46 14.64 61 21938 361392 63105631
Foetal heart rate disorder 20.26 14.64 5 21994 88 63466935
Injection site pain 19.97 14.64 10 21989 129790 63337233
Pregnancy with contraceptive device 19.96 14.64 15 21984 4679 63462344
Hyponatraemia 19.81 14.64 7 21992 111893 63355130
Low set ears 19.06 14.64 6 21993 264 63466759
Fall 18.92 14.64 71 21928 392263 63074760
Anonychia 18.83 14.64 3 21996 3 63467020
Tachycardia 18.82 14.64 86 21913 118070 63348953
Polyhydramnios 18.80 14.64 11 21988 2260 63464763
Spina bifida 18.63 14.64 8 21991 851 63466172
Micrognathia 18.60 14.64 6 21993 286 63466737
Caesarean section 18.47 14.64 26 21973 17006 63450017
Duodenal ulcer perforation 18.15 14.64 4 21995 87205 63379818
Gross motor delay 18.02 14.64 5 21994 141 63466882
Adverse drug reaction 17.98 14.64 3 21996 79711 63387312
Congenital choroid plexus cyst 17.97 14.64 6 21993 319 63466704
Uterine disorder 17.80 14.64 12 21987 3157 63463866
Device difficult to use 17.68 14.64 22 21977 12774 63454249
Anaphylactoid syndrome of pregnancy 17.63 14.64 4 21995 48 63466975
Retained placenta or membranes 17.62 14.64 6 21993 339 63466684
Hospitalisation 17.51 14.64 4 21995 85077 63381946
Microphthalmos 17.50 14.64 5 21994 157 63466866
Psoriatic arthropathy 17.49 14.64 5 21994 91515 63375508
Foetal exposure during delivery 17.44 14.64 5 21994 159 63466864
Ectrodactyly 17.30 14.64 3 21996 7 63467016
Third stage postpartum haemorrhage 17.30 14.64 3 21996 7 63467016
Uterine infection 17.14 14.64 6 21993 368 63466655
Rash 17.10 14.64 119 21880 560752 62906271
Synostosis 16.99 14.64 4 21995 57 63466966
Prominent epicanthal folds 16.99 14.64 4 21995 57 63466966
Cough 16.85 14.64 49 21950 292694 63174329
Condition aggravated 16.77 14.64 77 21922 402140 63064883
Abnormal labour 16.56 14.64 4 21995 64 63466959
Congenital pneumonia 16.51 14.64 3 21996 10 63467013
Abortion complete 16.51 14.64 3 21996 10 63467013
Limb reduction defect 16.38 14.64 6 21993 420 63466603
Gastrointestinal disorder 16.22 14.64 13 21986 131226 63335797
Weight decreased 16.17 14.64 46 21953 276752 63190271
Premature baby 15.94 14.64 27 21972 20708 63446315
Breast tenderness 15.90 14.64 10 21989 2340 63464683
Amniotic cavity infection 15.69 14.64 8 21991 1255 63465768
Uterine contractions abnormal 15.63 14.64 5 21994 232 63466791
Disease progression 15.37 14.64 12 21987 122746 63344277
Dysmenorrhoea 15.36 14.64 12 21987 3961 63463062
Anaphylactic reaction 15.24 14.64 54 21945 66046 63400977
Anaemia of pregnancy 15.23 14.64 4 21995 91 63466932
Uterine cervix stenosis 14.99 14.64 5 21994 265 63466758
Disseminated intravascular coagulation 14.90 14.64 25 21974 19026 63447997
Purpura senile 14.75 14.64 6 21993 557 63466466
Induced labour 14.72 14.64 7 21992 944 63466079

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 272.51 16.78 127 5179 37974 34913651
Maternal exposure during pregnancy 81.64 16.78 30 5276 4888 34946737
Anencephaly 70.54 16.78 13 5293 126 34951499
Nail bed bleeding 57.40 16.78 13 5293 370 34951255
Premature baby 56.78 16.78 36 5270 19597 34932028
Congenital hydrocephalus 55.13 16.78 10 5296 88 34951537
Pulmonary hypoplasia 48.92 16.78 12 5294 485 34951140
Poor weight gain neonatal 46.54 16.78 7 5299 15 34951610
Congenital megaureter 44.38 16.78 9 5297 149 34951476
Neonatal respiratory arrest 44.37 16.78 7 5299 23 34951602
Renal aplasia 43.77 16.78 12 5294 754 34950871
Micrognathia 43.52 16.78 10 5296 304 34951321
Stillbirth 43.01 16.78 9 5297 175 34951450
Meningocele 42.54 16.78 7 5299 32 34951593
Congenital cystic kidney disease 40.77 16.78 10 5296 404 34951221
Foetal growth restriction 39.81 16.78 17 5289 4100 34947525
Moebius II syndrome 38.97 16.78 5 5301 0 34951625
Atrial septal defect 35.91 16.78 19 5287 7373 34944252
Congenital cystic lung 35.38 16.78 8 5298 226 34951399
Anomaly of external ear congenital 34.92 16.78 7 5299 109 34951516
Respiratory disorder neonatal 34.84 16.78 12 5294 1618 34950007
Newborn persistent pulmonary hypertension 34.29 16.78 7 5299 120 34951505
Intervertebral disc compression 33.30 16.78 8 5298 296 34951329
Heart disease congenital 32.72 16.78 11 5295 1379 34950246
Spinal osteoarthritis 32.45 16.78 18 5288 7665 34943960
Pleuritic pain 32.19 16.78 14 5292 3527 34948098
External auditory canal atresia 31.59 16.78 7 5299 180 34951445
Ventricular septal defect 30.55 16.78 14 5292 3987 34947638
Genitalia external ambiguous 30.12 16.78 7 5299 224 34951401
Haemangioma congenital 29.07 16.78 8 5298 510 34951115
Congenital diaphragmatic hernia 29.00 16.78 7 5299 264 34951361
Maternal drugs affecting foetus 27.56 16.78 13 5293 3952 34947673
Interstitial lung disease 27.23 16.78 41 5265 65241 34886384
Paternal exposure before pregnancy 27.17 16.78 5 5301 48 34951577
Thrombocytosis 27.11 16.78 13 5293 4099 34947526
Grip strength decreased 27.10 16.78 12 5294 3157 34948468
Congenital pulmonary valve atresia 26.55 16.78 5 5301 55 34951570
Patent ductus arteriosus 26.44 16.78 12 5294 3342 34948283
Retroperitoneal fibrosis 26.26 16.78 7 5299 395 34951230
Cleft lip and palate 24.60 16.78 8 5298 904 34950721
Red blood cell sedimentation rate increased 24.50 16.78 16 5290 9146 34942479
Anal fissure 23.63 16.78 12 5294 4278 34947347
Congenital tricuspid valve atresia 23.35 16.78 5 5301 109 34951516
Blood albumin decreased 23.10 16.78 18 5288 13554 34938071
Double outlet right ventricle 22.93 16.78 5 5301 119 34951506
Talipes 22.16 16.78 9 5297 1914 34949711
Off label use 21.89 16.78 19 5287 419505 34532120
Rash macular 21.79 16.78 17 5289 12825 34938800
Hyperbilirubinaemia neonatal 21.66 16.78 7 5299 775 34950850
Kidney duplex 21.51 16.78 6 5300 402 34951223
Joint effusion 21.48 16.78 12 5294 5181 34946444
Rheumatoid arthritis 20.35 16.78 27 5279 38211 34913414
Arachnoid cyst 19.65 16.78 5 5301 235 34951390
Death 19.60 16.78 19 5287 398030 34553595
Congenital central nervous system anomaly 19.01 16.78 6 5300 616 34951009
Craniofacial deformity 18.56 16.78 4 5302 90 34951535
Epilepsy congenital 18.55 16.78 3 5303 12 34951613
Nodule 18.45 16.78 12 5294 6807 34944818
C-reactive protein increased 18.44 16.78 31 5275 54067 34897558
Cerebellar hypoplasia 18.36 16.78 3 5303 13 34951612
Gastric ulcer haemorrhage 18.27 16.78 11 5295 5455 34946170
Pleural effusion 18.20 16.78 39 5267 81507 34870118
Pain in jaw 17.38 16.78 15 5291 13025 34938600
Skin discolouration 16.95 16.78 17 5289 17828 34933797

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 9165.89 14.55 1423 21028 1641 79720296
Haemorrhage 4235.57 14.55 1392 21059 89726 79632211
Pregnancy 1787.64 14.55 542 21909 26309 79695628
Endometritis 968.93 14.55 172 22279 636 79721301
Heavy menstrual bleeding 734.74 14.55 236 22215 13775 79708162
Anaemia 429.46 14.55 574 21877 444441 79277496
Muscle spasms 382.07 14.55 347 22104 174383 79547554
Exposure during pregnancy 314.00 14.55 246 22205 100886 79621051
Induced abortion failed 247.89 14.55 44 22407 162 79721775
Uterine rupture 198.31 14.55 45 22406 676 79721261
Retained products of conception 192.63 14.55 33 22418 93 79721844
Ectopic pregnancy 186.38 14.55 51 22400 1692 79720245
Post abortion haemorrhage 170.86 14.55 28 22423 54 79721883
Vaginal haemorrhage 166.03 14.55 93 22358 21724 79700213
Pelvic inflammatory disease 164.16 14.55 44 22407 1348 79720589
Pelvic pain 147.26 14.55 73 22378 13308 79708629
Ruptured ectopic pregnancy 146.54 14.55 32 22419 399 79721538
Intermenstrual bleeding 139.36 14.55 55 22396 5829 79716108
Pain 131.41 14.55 465 21986 703337 79018600
Bloody discharge 110.95 14.55 35 22416 1918 79720019
Uterine haemorrhage 108.74 14.55 38 22413 2865 79719072
Maternal exposure during pregnancy 108.38 14.55 161 22290 136377 79585560
Abortion induced incomplete 105.30 14.55 16 22435 13 79721924
Complication of device insertion 105.23 14.55 46 22405 6304 79715633
Drug ineffective for unapproved indication 96.75 14.55 94 22357 51144 79670793
Syncope 93.29 14.55 175 22276 179274 79542663
Lyme disease 92.46 14.55 35 22416 3315 79718622
International normalised ratio fluctuation 91.41 14.55 35 22416 3419 79718518
Foetal death 88.84 14.55 44 22407 8000 79713937
Haemorrhage in pregnancy 87.27 14.55 27 22424 1387 79720550
Postpartum haemorrhage 84.07 14.55 27 22424 1568 79720369
Post abortion infection 81.25 14.55 12 22439 6 79721931
Abdominal pain 75.47 14.55 261 22190 389308 79332629
Gestational diabetes 71.22 14.55 35 22416 6258 79715679
Wrist deformity 69.02 14.55 25 22426 2092 79719845
Stillbirth 66.67 14.55 29 22422 3926 79718011
Dizziness 63.87 14.55 305 22146 526136 79195801
Maternal exposure during delivery 63.70 14.55 21 22430 1325 79720612
Uterine tenderness 61.47 14.55 10 22441 18 79721919
Uterine perforation 59.47 14.55 31 22420 6272 79715665
Vaginal odour 57.59 14.55 15 22436 410 79721527
Meconium in amniotic fluid 52.06 14.55 11 22440 116 79721821
Arteriospasm coronary 46.69 14.55 27 22424 6689 79715248
Death 46.18 14.55 55 22396 566459 79155478
Post abortion complication 44.90 14.55 7 22444 8 79721929
Procedural pain 44.78 14.55 43 22408 23041 79698896
Uterine hypotonus 43.88 14.55 9 22442 81 79721856
Uterine tachysystole 43.24 14.55 7 22444 12 79721925
Pyrexia 42.38 14.55 331 22120 678378 79043559
Toxicity to various agents 42.34 14.55 34 22417 421506 79300431
Embedded device 42.21 14.55 20 22431 3299 79718638
Nail bed bleeding 41.92 14.55 13 22438 673 79721264
Uterine dilation and curettage 40.04 14.55 12 22439 553 79721384
Induced abortion haemorrhage 38.90 14.55 6 22445 6 79721931
Acute kidney injury 38.63 14.55 54 22397 519350 79202587
Febrile neutropenia 38.31 14.55 9 22442 230990 79490947
Completed suicide 38.04 14.55 11 22440 245756 79476181
Pre-eclampsia 37.84 14.55 24 22427 7017 79714920
Abortion induced 37.63 14.55 24 22427 7085 79714852
Post procedural discomfort 36.61 14.55 13 22438 1027 79720910
Endometritis bacterial 32.94 14.55 5 22446 4 79721933
Abortion infected 32.65 14.55 6 22445 28 79721909
Uterine atony 32.37 14.55 8 22443 176 79721761
Intentional product use issue 31.89 14.55 3 22448 152109 79569828
Vomiting 31.23 14.55 305 22146 665523 79056414
Toxic shock syndrome 30.72 14.55 12 22439 1237 79720700
Chills 30.61 14.55 107 22344 160127 79561810
Maternal drugs affecting foetus 30.53 14.55 13 22438 1670 79720267
Vaginal discharge 29.45 14.55 21 22430 7442 79714495
Dyspnoea 29.33 14.55 133 22318 856892 78865045
Pain in jaw 29.06 14.55 49 22402 46102 79675835
Peripheral swelling 27.99 14.55 21 22430 269596 79452341
Therapeutic product effect decreased 27.93 14.55 6 22445 163857 79558080
Fatigue 26.86 14.55 153 22298 929574 78792363
Pregnancy with contraceptive device 26.23 14.55 15 22436 3639 79718298
Product dose omission issue 26.06 14.55 19 22432 247518 79474419
Abortion 25.94 14.55 11 22440 1399 79720538
Uterine hyperstimulation 25.25 14.55 5 22446 37 79721900
Small for dates baby 24.85 14.55 8 22443 468 79721469
Uterine hypertonus 24.71 14.55 7 22444 264 79721673
General physical health deterioration 24.27 14.55 25 22426 275213 79446724
Uterine spasm 23.90 14.55 8 22443 529 79721408
Premature separation of placenta 23.85 14.55 10 22441 1236 79720701
Confusional state 23.66 14.55 33 22418 317964 79403973
Abnormal labour 22.92 14.55 4 22447 13 79721924
Iron deficiency 22.87 14.55 21 22430 10633 79711304
COVID-19 22.71 14.55 8 22443 157666 79564271
Hyponatraemia 22.43 14.55 11 22440 177837 79544100
Product complaint 22.43 14.55 23 22428 13326 79708611
Pelvic infection 22.30 14.55 7 22444 377 79721560
Neutropenia 22.27 14.55 29 22422 287681 79434256
Uterine cervical laceration 22.07 14.55 4 22447 17 79721920
Infusion related reaction 21.35 14.55 20 22431 230217 79491720
Uterine disorder 21.24 14.55 11 22440 2196 79719741
Polyhydramnios 20.76 14.55 10 22441 1710 79720227
Device difficult to use 20.59 14.55 22 22429 13363 79708574
Diarrhoea 20.30 14.55 155 22296 880334 78841603
Retained placenta or membranes 20.16 14.55 6 22445 270 79721667
Foetal exposure during pregnancy 19.93 14.55 15 22436 5775 79716162
Uterine infection 19.76 14.55 6 22445 289 79721648
Injection site pain 19.73 14.55 6 22445 129832 79592105
Lower respiratory tract infection 19.59 14.55 6 22445 129214 79592723
Normal newborn 19.34 14.55 16 22435 7056 79714881
Uterine cervical pain 19.03 14.55 4 22447 41 79721896
Anaphylactoid syndrome of pregnancy 18.78 14.55 4 22447 44 79721893
Stomatitis 18.62 14.55 9 22442 146748 79575189
Movement disorder 18.59 14.55 30 22421 27229 79694708
Abortion complete 18.23 14.55 3 22448 6 79721931
Breast tenderness 18.15 14.55 10 22441 2258 79719679
Sinusitis 18.10 14.55 17 22434 195484 79526453
Victim of homicide 18.07 14.55 5 22446 173 79721764
Third stage postpartum haemorrhage 17.92 14.55 3 22448 7 79721930
Pericarditis 17.39 14.55 4 22447 104232 79617705
Tongue oedema 17.20 14.55 15 22436 7102 79714835
Disease progression 17.10 14.55 16 22435 184346 79537591
Abortion spontaneous 16.84 14.55 30 22421 29477 79692460
Weight decreased 16.83 14.55 48 22403 355150 79366787
Oligohydramnios 16.78 14.55 11 22440 3401 79718536
Treatment failure 16.77 14.55 14 22437 170472 79551465
Hysterectomy 16.76 14.55 14 22437 6258 79715679
Infection 16.75 14.55 121 22330 241591 79480346
Impaired work ability 16.73 14.55 24 22427 19657 79702280
Anaemia of pregnancy 16.69 14.55 4 22447 77 79721860
Gastrointestinal disorder 16.28 14.55 7 22444 122198 79599739
Joint swelling 16.00 14.55 36 22415 288610 79433327
Red blood cell sedimentation rate increased 15.90 14.55 38 22413 45904 79676033
Weight increased 15.87 14.55 34 22417 277352 79444585
Maternal exposure timing unspecified 15.62 14.55 13 22438 5779 79716158
Blood albumin decreased 15.61 14.55 26 22425 24217 79697720
Device dislocation 15.59 14.55 27 22424 25943 79695994
Bacterial vulvovaginitis 15.54 14.55 6 22445 599 79721338
Dysmenorrhoea 15.43 14.55 10 22441 3035 79718902
Disseminated intravascular coagulation 15.03 14.55 32 22419 35810 79686127
Hospitalisation 14.97 14.55 4 22447 94232 79627705
Cough 14.97 14.55 53 22398 366736 79355201
Caesarean section 14.86 14.55 18 22433 12517 79709420
Genital haemorrhage 14.75 14.55 13 22438 6242 79715695
Condition aggravated 14.67 14.55 82 22369 501042 79220895

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 | Suggest Off label Use Form| |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
0E43V0BB57 UNII
151578 RXNORM
44310 MMSL
445 MMSL
5121 MMSL
d00303 MMSL
001133 NDDF
387242007 SNOMEDCT_US
43684009 SNOMEDCT_US
C0377863 UMLSCUI
CHEMBL1201377 ChEMBL_ID
66792-31-2 SECONDARY_CAS_RN
6436406 PUBCHEM_CID
12Z0SU967A UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1411 TABLET, FILM COATED 200 ug ORAL NDA 33 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1411 TABLET, FILM COATED 200 ug ORAL NDA 33 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1411 TABLET, FILM COATED 200 ug ORAL NDA 33 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1421 TABLET, FILM COATED 200 ug ORAL NDA 33 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1421 TABLET, FILM COATED 200 ug ORAL NDA 33 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1421 TABLET, FILM COATED 200 ug ORAL NDA 33 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 0591-0397 TABLET, DELAYED RELEASE 200 ug ORAL ANDA 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
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 0591-0398 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 10135-745 TABLET 100 ug ORAL ANDA 20 sections
Misoprostol HUMAN PRESCRIPTION DRUG LABEL 1 10135-746 TABLET 200 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