Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Misoprostol
Drug ID BADD_D01477
Description Misoprostol is a prostaglandin analog used to reduce the risk of NSAID related ulcers, manage miscarriages, prevent post partum hemorrhage, and also for first trimester abortions.[L7616,L7619,A181589,A181583,A181697] The stimulation of prostaglandin receptors in the stomach reduces gastric acid secretion, while stimulating these receptors in the uterus and cervix can increase the strength and frequency of contractions and decrease cervical tone.[A181586] Misoprostol was granted FDA approval on 27 December 1988.[L7616]
Indications and Usage Misoprostol is also indicated for other uses that are not approved in Canada, including the medical termination of an intrauterine pregnancy used alone or in combination with methotrexate,as well as the induction of labour in a selected population of pregnant women with unfavourable cervices. This indication is avoided in women with prior uterine surgery or cesarean surgery due to an increased risk of possible uterine rupture. Misoprostol is also used for the prevention or treatment of serious postpartum hemorrhage.
Marketing Status Prescription
ATC Code A02BB01; G02AD06
DrugBank ID DB00929
KEGG ID D00419
MeSH ID D016595
PubChem ID 5282381
TTD Drug ID D09ANG
NDC Product Code 59762-5007; 0025-1451; 55289-248; 38779-2778; 43393-022; 70710-1006; 0904-6806; 40032-160; 0025-1461; 43063-707; 54348-148; 60592-234; 72789-121; 71335-0460; 70954-443; 72789-111; 72789-128; 40016-002; 43393-020; 40032-161; 70954-444; 65035-103; 43386-161; 68071-4843; 0904-6807; 70771-1496; 59762-5008; 68084-041; 63704-008; 24584-1051; 70710-1007; 63629-7929; 68245-0001; 70771-1497; 12634-502; 68084-040; 43386-160
Synonyms Misoprostol | Novo-Misoprostol | Novo Misoprostol | SC-29333 | SC 29333 | SC29333 | SC-30249 | SC 30249 | SC30249 | Apo-Misoprostol | Apo Misoprostol | Misoprostol, (11beta,13E,16R)-Isomer | Glefos | Misoprostol, (11alpha,13E)-Isomer | Misoprostol, (11alpha,13E,16R)-Isomer | Misoprostol, (11alpha,13Z)-(+-)-Isomer | Misoprostol, (11alpha.13E,16S)-Isomer | Misoprostol, (11beta,13E)-(+-)-Isomer | Misoprostol, (11beta,13E,16S)-Isomer | Cytotec
Chemical Information
Molecular Formula C22H38O5
CAS Registry Number 59122-46-2
SMILES CCCCC(C)(CC=CC1C(CC(=O)C1CCCCCCC(=O)OC)O)O
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Uterine contractions abnormal21.07.03.003; 18.07.02.0020.005651%Not Available
Erectile dysfunction19.08.04.001; 21.03.01.007--
Hepatobiliary disease09.01.08.003--Not Available
Congenital foot malformation15.11.07.002; 03.11.07.0020.002826%Not Available
Congenital hand malformation15.11.07.005; 03.11.07.0050.001474%Not Available
Skull malformation15.11.02.003; 03.11.02.0030.001106%Not Available
Muscle contracture15.03.01.0100.004239%Not Available
Gastrointestinal inflammation07.08.03.007--Not Available
Renal aplasia20.01.02.001; 03.06.01.0020.000737%Not Available
Dysmorphism15.11.06.001; 03.11.06.0010.001474%Not Available
Uterine hyperstimulation21.07.03.006; 18.07.02.0080.002826%Not Available
Anaphylactoid syndrome of pregnancy24.01.06.004; 22.06.02.004; 18.02.02.006; 10.01.07.005; 01.01.02.010--Not Available
Intellectual disability19.21.06.001; 17.03.07.0010.002826%Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.0040.002826%
Acute kidney injury20.01.03.016--
Vulvovaginal erythema23.03.06.017; 21.08.02.0110.002826%Not Available
Foetal growth restriction18.03.01.0020.005651%
Myocardial necrosis marker increased13.04.01.013--Not Available
Micrognathia03.11.05.007; 15.11.05.0070.002826%Not Available
Moebius II syndrome17.19.02.008; 03.10.01.0100.004239%Not Available
Neonatal anoxia22.11.02.005; 18.04.15.0040.000737%Not Available
Neonatal asphyxia18.04.15.005; 22.11.02.0060.004239%Not Available
Obstructed labour18.07.01.0080.004239%Not Available
Retained products of conception18.01.03.006; 12.02.14.0060.004239%Not Available
Ruptured ectopic pregnancy18.02.02.0050.002826%Not Available
Cerebral ventricle dilatation17.11.01.0130.004239%Not Available
Meconium in amniotic fluid18.05.01.0070.002826%Not Available
Retrognathia15.10.05.0080.002826%Not Available
Induced abortion haemorrhage24.07.03.024; 12.02.19.0020.008477%Not Available
Induced abortion failed12.02.19.001; 18.01.03.0030.016954%Not Available
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