Misoprostol 25microgram tablets
Requires a prescription from a doctor or prescriber
Official documents, adverse reaction reporting, and safety monitoring
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Official medicine documents
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Misoprostol
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Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
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Suspected adverse reactions reported for Misoprostol
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EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
1 branded products available
MHRA licensed products
View all licensed products for Misoprostol on the MHRA register
Angusta 25microgram tablets
Therapeutically similar medicines
Similarity based on WHO Anatomical Therapeutic Chemical (ATC) classification and NHS BNF section grouping. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
Clinical guidelines and formulary information
British National Formulary
Misoprostol
Source: British National Formulary, NICE. Joint Formulary Committee. Contains public sector information licensed under the Open Government Licence v3.0.
NICE clinical guidance(7)
Abortion care (NG140)
Inducing labour (NG207)
Abortion care (QS199)
Ectopic pregnancy and miscarriage: diagnosis and initial management (NG126)
Insertion of a double balloon catheter for induction of labour in pregnant women without previous caesarean section (HTG380)
Intrapartum care (NG235)
Intrapartum care for women with existing medical conditions or obstetric complications and their babies (NG121)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
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Supply & product information
Official product databases and supply status monitoring
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. emc (electronic medicines compendium) is operated by Datapharm Ltd. Shortage information sourced from NHS Specialist Pharmacy Service (SPS), sps.nhs.uk.
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF codes from NHS Business Services Authority (NHSBSA). ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
0.5090h
Mechanism
Misoprostol is a synthetic prostaglandin E1 analog that stimulates prostaglandin…
Food interactions
1 warning
Human targets
5 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
800µg
Half-life
800µg
[A181592]
Protein binding
90%
[L7616][L7619]
Its active metabolite, misoprostol acid, is 81-89% protein bound in serum.
[A181691]
Volume of distribution
8.0L/kg
The…
Metabolism
[A181574]…
Elimination
4.6%
[A181574][L7619]
Clearance
0.286L/kg
[A181610]…
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Misoprostol was granted FDA approval on 27 December 1988.[L7616]
[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]
Known interactions with other medications. Always consult a healthcare professional.
Showing 21 of 21 interactions
[L7613]
The intraperitoneal LD50 in rats is 40mg/kg and in mice is 70mg/kg.
[L7613]
Patients experiencing an overdose may present with sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, fever, palpitations, hypotension, and bradycardia.
[A181706][L7616][L7619]
Hemodialysis is not expected to be useful in the treatment of misoprostol overdose[L7616] but oral activated charcoal may help reduce absorption.
[L7619]
In the event of an overdose, treat symptoms with supportive therapy.
[L7616]
This may include removal of undissolved tablets from the vagina or buccal cavity, intravenous fluid replacement, acetaminophen, diazepam, haloperidol, or intramuscular diclofenac depending on the symptoms that present.
[A181706]
Misoprostol binds to smooth muscle cells in the uterine lining to increase the strength and frequency of contractions as well as degrade collagen and reduce cervical tone.[A181586]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[A181592]
For a 800µg sublingual dose of misoprostol, the AUC was 3.2094±1.0417h\*ng/mL, the Cmax was 2.4391±1.1567ng/mL, and a tmax of 0.712±0.415h.
[A181592]
For a 800µg buccal dose of misoprostol, the AUC was 2.0726±0.3578h\*ng/mL, the Cmax was 1.3611±0.3436ng/mL, and a tmax of 1.308±0.624h.
[A181592]
[A181592]
[L7616][L7619]
Its active metabolite, misoprostol acid, is 81-89% protein bound in serum.
[A181691]
The apparent volume of distribution of the active metabolite of misoprostol was in subjects with normal renal function was 13.6±8.0L/kg, with mild renal impairment was 17.3±23.0L/kg, with moderate renal impairment was 14.3±6.8L/kg, and with end stage renal disease was 11.0±9.6L/kg.
[A181610]
[A181574]
This metabolite is further reduced to dinor and tetranor metabolites (SC-41411), a prostaglandin F1 (PGF1) analog of SC-41411, and a ω-16-carboxylic acid derivative.
[A181574]
However, the majority of these metabolites are not well described in the literature.
[A181574]
[A181574][L7619]
[A181610]
Misoprostol's active metabolite, misoprostol acid, has a total body clearance of 0.286L/kg/min.
[A181610]
Subjects with mild renal impairment had a total body clearance of 0.226±0.073L/kg/min, subjects with moderate renal impairment had a total body clearance of 0.270±0.103L/kg/min, and subjects with end stage renal disease had a total body clearance of 0.105±0.052L/kg/min.
[A181610]
Proteins and enzymes this drug interacts with in the body
PMID:7883006 PMID:7981210 PMID:8117308 PMID:8135729 PMID:8307176
The activity of this receptor can couple to both the inhibition of adenylate cyclase mediated by G(i) proteins, and to an elevation of intracellular calcium .
PMID:7883006 PMID:7981210 PMID:8117308 PMID:8135729
Required for normal development of fever in response to pyrinogens, including IL1B, prostaglandin E2 and bacterial lipopolysaccharide (LPS). Required for normal potentiation of platelet aggregation by prostaglandin E2, and thus plays a role in the regulation of blood coagulation. Required for increased HCO3(-) secretion in the duodenum in response to mucosal acidification, and thereby contributes to the protection of the mucosa against acid-induced ulceration.
Not required for normal kidney function, normal urine volume and osmolality (By similarity)
Implicated the smooth muscle contractile response to PGE2 in various tissues
May play an important role in regulating renal hemodynamics, intestinal epithelial transport, adrenal aldosterone secretion, and uterine function
ATC G02AD06
ATC A02BB01
ATC M01AE56
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Misoprostol
Additional database identifiers
Drugs Product Database (DPD)
1859
ChemSpider
4445541
BindingDB
85606
HUGO Gene Nomenclature Committee (HGNC)
HGNC:9595
GenAtlas
PTGER3
GeneCards
PTGER3
GenBank Gene Database
S69200
Guide to Pharmacology
342
UniProt Accession
PE2R3_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:9594
GenAtlas
PTGER2
GeneCards
PTGER2
GenBank Gene Database
U19487
GenBank Protein Database
632650
Guide to Pharmacology
341
UniProt Accession
PE2R2_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:9593
GenAtlas
PTGER1
GeneCards
PTGER1
GenBank Gene Database
L22647
GenBank Protein Database
410209
Guide to Pharmacology
340
UniProt Accession
PE2R1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:9602
GenAtlas
PTGIR
GeneCards
PTGIR
GenBank Gene Database
L29016
GenBank Protein Database
495043
Guide to Pharmacology
345
UniProt Accession
PI2R_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:9596
GenAtlas
PTGER4
GeneCards
PTGER4
GenBank Gene Database
BC113523
Guide to Pharmacology
343
UniProt Accession
PE2R4_HUMAN
International reference pricing
Reference pricing from DrugBank. Prices are indicative and may not reflect current UK costs.
Source: DrugBank. Used under CC BY-NC 4.0 academic licence for non-commercial purposes.
Patent information
All patents expired, 2 expired
Source: DrugBank · CC BY-NC 4.0. Patent data sourced from national patent offices. Expiry dates may not reflect extensions, regulatory exclusivity periods, or legal challenges.
DrugBank citations
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