All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

misoprostol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
prostaglandins	1817	59122-46-2

Description:

Molecule

Description

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:

Dose	Unit	Route
0.80	mg	O
0.20	mg	O
0.20	mg	V

ADMET properties:

Property	Value	Reference
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 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	80 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
Dec. 27, 1988	FDA	GD SEARLE LLC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
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
Prominent epicanthal folds	16.99	14.64	4	21995	57	63466966
Synostosis	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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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

🐶 Veterinary Drug Use

None

🐶 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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Prostaglandin E2 receptor EP3 subtype	GPCR	P43115	PE2R3_HUMAN	AGONIST	Ki	8.10		IUPHAR	CHEMBL
Prostaglandin E2 receptor EP2 subtype	GPCR	P43116	PE2R2_HUMAN	AGONIST	Ki	7.50		IUPHAR
Prostaglandin E2 receptor EP4 subtype	GPCR	P35408	PE2R4_HUMAN	AGONIST	Ki	7.60		IUPHAR
Prostaglandin F2-alpha receptor	GPCR	P43088	PF2R_HUMAN		Ki	5.03		PDSP

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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