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 indicated as a tablet to reduce the risk of NSAID induced gastric ulcers but not duodenal ulcers in high risk patients.[L7616] Misoprostol is also formulated in combination with diclofenac to treat symptoms of osteoarthritis or rheumatoid arthritis in patients with a high risk of developing gastric ulcers.[L7619] Misoprostol is used off label for the management of miscarriages, prevention of post partum hemorrhage, and is also used alone or in combination with mifepristone in other countries for first trimester abortions.[A181589,A181583,A181697]
Marketing Status approved
ATC Code A02BB01; G02AD06
DrugBank ID DB00929
KEGG ID D00419
MeSH ID D016595
PubChem ID 5282381
TTD Drug ID D09ANG
NDC Product Code 24584-1051; 10135-745; 60592-234; 43393-023; 60687-746; 71335-0460; 72789-128; 43063-707; 59762-5008; 60687-735; 70954-443; 65035-103; 0025-1461; 71335-9631; 63629-7929; 38779-2778; 40032-161; 42571-254; 43393-020; 43393-022; 63704-008; 68084-040; 72789-121; 68245-0001; 59762-5007; 68084-041; 43386-160; 43386-161; 0025-1451; 42571-253; 54348-148; 68071-2904; 70954-444; 72789-300; 40016-002; 10135-746; 40032-160; 72789-111
UNII 0E43V0BB57
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Vulvovaginal erythema23.03.06.017; 21.08.02.0110.000617%Not Available
Foetal growth restriction18.03.01.0020.000925%
Myocardial necrosis marker increased13.04.01.013--Not Available
Neonatal asphyxia22.11.02.006; 18.04.15.0050.001233%Not Available
Neonatal respiratory distress syndrome18.04.10.003; 22.11.02.0100.000925%Not Available
Normal newborn18.08.06.0010.002404%Not Available
Obstructed labour18.07.01.0080.000925%Not Available
Post abortion haemorrhage24.07.03.027; 18.01.03.0040.004932%Not Available
Retained products of conception18.01.03.006; 12.02.14.0060.001233%Not Available
Speech disorder developmental19.19.01.003; 17.02.08.0110.000617%Not Available
Ruptured ectopic pregnancy18.02.02.0050.000925%Not Available
Cerebral ventricle dilatation17.11.01.0130.000925%Not Available
Meconium in amniotic fluid18.05.01.0070.000925%Not Available
Foetal heart rate disorder02.03.02.025; 18.03.02.0140.000925%Not Available
Stress cardiomyopathy02.04.01.012; 24.04.04.0260.001233%Not Available
Blood loss anaemia24.07.01.088; 01.03.02.0180.002466%Not Available
Drug effective for unapproved indication12.09.02.001; 08.06.01.0370.001356%Not Available
Drug ineffective for unapproved indication12.09.02.002; 08.06.01.0380.051911%Not Available
Female reproductive tract disorder21.10.05.020--Not Available
Haemoperitoneum24.07.02.065; 12.01.17.007; 07.07.02.0070.001541%Not Available
Heavy menstrual bleeding21.01.03.005--Not Available
Hypoxic ischaemic encephalopathy neonatal24.04.06.048; 22.02.02.016; 18.04.04.017; 17.13.02.0160.000617%Not Available
Intermenstrual bleeding21.01.01.0150.012454%Not Available
Neonatal seizure18.04.04.019; 17.12.03.0380.001233%Not Available
Orbital apex syndrome17.04.01.006; 06.05.02.0290.000617%Not Available
Precipitate labour18.07.01.0100.000617%Not Available
Uterine tachysystole18.07.02.013; 21.07.03.0070.001541%Not Available
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ADReCS-Target
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