Ulipristal 5mg tablets
Ulipristal is a selective progesterone receptor modulator used for the purposes of emergency contraception (Ella) and for the treatment of uterine fibroids (Fibristal).
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MHRA alerts for Ulipristal
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 Ulipristal
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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.
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Suspected adverse reactions reported for Ulipristal
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2 branded products available
WHO defined daily dose (DDD)
30 mg
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via the NHS dm+d supplementary mapping files (NHSBSA). Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(4)
Heavy menstrual bleeding: assessment and management (NG88)
Relugolix–estradiol–norethisterone acetate for treating moderate to severe symptoms of uterine fibroids (TA832)
Contraception (QS129)
Linzagolix for treating moderate to severe symptoms of uterine fibroids (TA996)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
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Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
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. 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.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 29 · Randomised trials: 19 · 2012–2026
Showing the 50 most relevant studies, sorted by most relevant.
Krzyżanowski J, Paszkowski T, Szkodziak P, et al.
2024
- Leiomyoma
- Uterine Neoplasms
- Norpregnadienes
Uterine fibroids, benign tumors originating from uterine smooth muscle cells, vary in prevalence depending on patient ethnicity, hormonal exposure, and genetics. Due to their high incidence, these neoplasms pose a significant burden on healthcare systems. Current treatment strategies range from routine monitoring in asymptomatic cases to surgical procedures such as myomectomy or hysterectomy in symptomatic patients, with an increasing trend toward uterus-preserving or non-surgical alternatives. This review examines the existing medical treatments for uterine fibroids and delves into the potential of emerging therapies. A scoping review of the literature was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Medical therapies are divided into hormonal and non-hormonal treatments; however, long-term, safe, and effective treatments in the treatment of uterine fibroids are limited. In addition to established therapies, there is an increasing number of studies investigating the effect of substances such as vitamin D or green tea extract on uterine fibroids. Some studies investigate acupuncture as a possible alternative therapy. While existing treatments offer symptomatic relief and preparation for surgery, our findings point to a significant need for further research into long-term solutions, especially owing to recent limitations in the use of ulipristal acetate due to risk of liver damage. Initial studies involving vitamin D and epigallocatechin gallate are encouraging; however, additional research is required to establish definitive therapeutic roles.
Abstract licence: CC BY-NC-ND
Lambrecht I, Van den Bosch T
2023
Steyn PS, Fleurant E, Smith EM, et al.
2025
- Contraceptives, Postcoital
- Contraception, Postcoital
- Menstrual Cycle
BackgroundEmergency contraception refers to contraceptive methods used following unprotected sexual intercourse.ObjectiveTo review the literature on safety of repeated use of emergency contraceptive pills (ECPs) in the same menstrual cycle.MethodsWe searched multiple databases from inception through February 2024 for articles on repeated ECP use. We assessed the risk of bias for each study and certainty of evidence for all outcomes.ResultsFrom 4565 articles identified, six met the inclusion criteria. Four studies of repeated levonorgestrel (LNG)-ECP use provided very low certainty evidence. Among women who became pregnant after at least one use of LNG-ECP in the conception cycle, women with ectopic pregnancy had increased odds of repeated LNG-ECP use in the conception cycle compared with women with intrauterine pregnancy (adjusted OR (aOR) 2.5, 95% CI 1.0 to 6.2). One non-comparative study reported few serious adverse events with repeated pericoital use of LNG-ECP, and two cohort studies of LNG-ECP failure found no differences in pregnancy, fetal/neonatal, infant or child outcomes comparing higher (2.25-9 mg LNG) and lower (0.75-1.5 mg LNG) doses in the conception cycle. Two studies of repeated ulipristal acetate (UPA) use provided very low certainty evidence. One non-comparative study observed no serious adverse events, no abnormal laboratory results and normal endometrial biopsies with UPA (30 mg, 4-6 doses/month). One randomised controlled trial in a clinical setting observed no serious adverse events with UPA (10 mg, 20 mg or 50 mg for 10 days) compared with placebo.ConclusionEvidence on the safety of repeated ECP use is limited and of very low certainty, but overall does not suggest safety concerns.
Abstract licence: CC BY
Lőczi L, Vezér M, Török M, et al.
2023
- Contraception, Postcoital
- Databases, Factual
- Health Personnel
IntroductionEmergency contraception is an effective and safe solution for preventing unwanted pregnancies. Many methods of emergency contraception are used, which have different mechanisms of action and time frames.ObjectiveProviding information to healthcare professionals and decision-makers based on the literature data about the target populations of emergency contraception, evidence-based modern methods, their effectiveness, and practical application for the purpose of reducing the incidence of unintended pregnancies.MethodsWe conducted a systematic literature search in MEDLINE (PubMed), Embase and Scopus databases based on relevant keywords, for publications that were published between 1960 and 2023.Results23 clinical professional publications were selected that examined the effectiveness of oral and long-term usable contraceptives as emergency contraceptives. Our research results were interpreted in terms of weight, breastfeeding, time elapsed since the intercourse and future contraceptive plans, which help to select the most appropriate emergency contraceptive for healthcare professionals.ConclusionBased on the literature data, our systematic review provides assistance for choosing between the available oral levonorgestrel, ulipristal acetate, and intrauterine contraceptive devices available in Hungary based on effectiveness, target population, and accessibility. We support the healthcare governance in creating up-to-date professional guidelines to improve the availability of emergency contraception and, consequently, enhance reproductive health. Orv Hetil. 2023; 164(44): 1736-1748.
Abstract licence: CC BY
Elena Rosato, Manuela Farris, Carlo Bastianelli
Frontiers in Pharmacology, 2016
S. Vitale, S. Ferrero, S. Caruso, et al.
Obstetrical & Gynecological Survey, 2020
Inge de Milliano, Moniek Twisk, Johannes C Ket, et al.
PLoS ONE, 2017
LIANA PLEȘ
FARMACIA, 2018
E. Comasco, H. Kopp Kallner, M. Bixo, et al.
The American journal of psychiatry, 2020
L. Whitaker, L. Middleton, J. Daniels, et al.
eClinicalMedicine, 2023
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study 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
6.3 hours
Mechanism
The exact mechanism of action of ulipristal has been heavily debated [FDA Label] [A18504, A175372, A175375, A175378].
Food interactions
1 warning
Human targets
3 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
60-90 minutes
Cmax, healthy subjects, single oral dose = 176 ± 89 ng/mL;
AUC(0-∞), healthy subjects,…
Half-life
6.3 hours
Protein binding
94%
Metabolism
Clearance
64.0L/h
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Ulipristal is currently recommended as first line therapy for emergency contraception, due to improved efficacy and similar side effect profile as compared to the traditional use of levonorgestrel or the Yuzpe regimen. The exact mechanism of action for ulipristal is still currently debated, though there is evidence that it functions by inhibiting ovulation. A recent systematic review proclaimed that the majority of available evidence demonstrates an inhibitory effect on ovulation rather than a post-fertilization effect on the endometrium, which has been heavily debated due to ethical concerns related to abortion (Rosato et al, 2016). Nevertheless, current and ongoing research into the agent's mechanism of action as an emergency contraceptive continue to provide potentially plausible evidence that ulipristal may, in fact, elicit activity on the endometrium that prevents embryo implantation [A175372][A175375][A175378].
[L35054][L52345]
In Canada and Europe, this drug is indicated for within 120 hours (five days) of unprotected sexual intercourse or contraceptive failure.
[L52345][L52355]
Known interactions with other medicines. Always consult a healthcare professional.
Showing 50 of 513 interactions
Conversely, some of the latest investigations pertaining to ulipristal's mechanism of action as an emergency contraceptive propose that it principally elicits its action by preventing embryo implantation, as opposed to preventing ovulation [A175372][A175375][A175378]. Although previous investigations have shown that ulipristal essentially has the ability to prevent ovulation equivalent to placebo (ie. null effect or ability) when administered during LH peaks one to two days before ovulation, the agent still demonstrates a stable and consistently high contraceptive effect of approximately >=80% when used at this time [A175372]. Subsequently, current studies attempt to investigate how ulipristal could elicit emergency contraception via ovulation prevention under circumstances where ovulation had already clearly been observed [A175372][A175375][A175378]. Endometrial biopsy samples studied from such circumstances in such investigations subsequently show that the administered ulipristal causes endometrial tissue to become inhospitable and unsuitable for embryo implantation where a variety of genes characteristic of receptive, pro-gestational endometrium are downregulated [A175372][A175375][A175378].
Nevertheless, most if not all proposed mechanisms commonly agree that ulipristal ultimately demonstrates its pharmacological effects by binding to human progesterone receptors and prevents natural, endogenous progesterone from occupying such receptors [A18504][F3772][A175372][A175375][A175378]. Regardless, however, considering current and on-going research into ulipristal's ability to prevent embryo implantation, the notion that the medication can elicit post-fertilization effects potentially raises alerts and/or ethical debates over the use of ulipristal owing to potential abortifacient activity [A18504][A175372][A175375][A175378], which is considered to be on par or equipotent to that of mifepristone [F3769]. Attention should be drawn to the fact that some prescribing information, however, such as the US FDA label for ulipristal indicated for emergency contraception, has included new supplementary commentary since 2018 that directly warns about ulipristal not being indicated for termination of existing pregnancies and suggesting that ulipristal use may confer alterations to the endometrium that may affect implantation and contribute to efficacy [FDA Label].
In the treatment of fibroids, ulipristal has been shown to exert direct actions on fibroids reducing their size through inhibition of cell proliferation and induction of apoptosis.
How the body processes this drug — absorption, distribution, metabolism, and elimination
Cmax, healthy subjects, single oral dose = 176 ± 89 ng/mL;
AUC(0-∞), healthy subjects, single oral dose = 556 ± 260 ng·h/mL;
Proteins and enzymes this drug interacts with in the body
PMID:27120390 PMID:37478846
Has a dual mode of action: as a transcription factor that binds to glucocorticoid response elements (GRE), both for nuclear and mitochondrial DNA, and as a modulator of other transcription factors .
PMID:28139699
Affects inflammatory responses, cellular proliferation and differentiation in target tissues. Involved in chromatin remodeling .
PMID:9590696
Plays a role in rapid mRNA degradation by binding to the 5' UTR of target mRNAs and interacting with PNRC2 in a ligand-dependent manner which recruits the RNA helicase UPF1 and the mRNA-decapping enzyme DCP1A, leading to RNA decay .
PMID:25775514
Could act as a coactivator for STAT5-dependent transcription upon growth hormone (GH) stimulation and could reveal an essential role of hepatic GR in the control of body growth (By similarity)
PMID:19022849
Transcription factor activity is modulated by bound coactivator and corepressor proteins like ZBTB7A that recruits NCOR1 and NCOR2 to the androgen response elements/ARE on target genes, negatively regulating androgen receptor signaling and androgen-induced cell proliferation .
PMID:20812024
Transcription activation is also down-regulated by NR0B2. Activated, but not phosphorylated, by HIPK3 and ZIPK/DAPK3
Enzymes involved in drug metabolism — important for understanding drug interactions
Proteins that carry this drug through the body
PMID:19021548
Major calcium and magnesium transporter in plasma, binds approximately 45% of circulating calcium and magnesium in plasma (By similarity).
Potentially has more than two calcium-binding sites and might additionally bind calcium in a non-specific manner (By similarity). The shared binding site between zinc and calcium at residue Asp-273 suggests a crosstalk between zinc and calcium transport in the blood (By similarity). The rank order of affinity is zinc > calcium > magnesium (By similarity).
Binds to the bacterial siderophore enterobactin and inhibits enterobactin-mediated iron uptake of E.coli from ferric transferrin, and may thereby limit the utilization of iron and growth of enteric bacteria such as E.coli .
PMID:6234017
Does not prevent iron uptake by the bacterial siderophore aerobactin PMID:6234017
Appears to function in modulating the activity of the immune system during the acute-phase reaction
ATC G03AD02
ATC G03XB02
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)
Ulipristal
Additional database identifiers
Drugs Product Database (DPD)
22109
ChemSpider
19349271
ZINC
ZINC000034089131
HUGO Gene Nomenclature Committee (HGNC)
HGNC:8910
GenAtlas
PGR
GeneCards
PGR
GenBank Gene Database
X51730
GenBank Protein Database
35652
Guide to Pharmacology
627
UniProt Accession
PRGR_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:7978
GenAtlas
NR3C1
GeneCards
NR3C1
GenBank Gene Database
X03225
GenBank Protein Database
31680
Guide to Pharmacology
625
UniProt Accession
GCR_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:644
GenAtlas
AR
GeneCards
AR
GenBank Gene Database
M20132
GenBank Protein Database
178628
Guide to Pharmacology
628
UniProt Accession
ANDR_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2637
GenAtlas
CYP3A4
GeneCards
CYP3A4
GenBank Gene Database
M18907
Guide to Pharmacology
1337
UniProt Accession
CP3A4_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2596
GenAtlas
CYP1A2
GeneCards
CYP1A2
GenBank Gene Database
Z00036
Guide to Pharmacology
1319
UniProt Accession
CP1A2_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:399
GenAtlas
ALB
GeneCards
ALB
GenBank Gene Database
V00494
GenBank Protein Database
28590
UniProt Accession
ALBU_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:8498
GenAtlas
ORM1
GeneCards
ORM1
GenBank Gene Database
X02544
GenBank Protein Database
757907
UniProt Accession
A1AG1_HUMAN
DrugBank citations
If you use DrugBank data in your research, please cite:
- DrugBank 6.02024Recommended citationKnox C., Wilson M., Klinger C.M., et alDrugBank 6.0: the DrugBank Knowledgebase for 2024Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
- DrugBank 5.02018Wishart D.S., Feunang Y.D., Guo A.C., et alDrugBank 5.0: a major update to the DrugBank database for 2018Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
- DrugBank 4.02014Law V., Knox C., Djoumbou Y., et alDrugBank 4.0: shedding new light on drug metabolismNucleic Acids Res. 2014 Jan 142(1):D1091-7
- DrugBank 3.02011Knox C., Law V., Jewison T., et alDrugBank 3.0: a comprehensive resource for 'omics' research on drugsNucleic Acids Res. 2011 Jan39(Database issue):D1035-41
- DrugBank 2.02008Wishart D.S., Knox C., Guo A.C., et alDrugBank: a knowledgebase for drugs, drug actions and drug targets.Nucleic Acids Research2008 Jan36(Database issue):D901-6
- DrugBank 1.02006Wishart D.S., Knox C., Guo A.C., et alDrugBank: a comprehensive resource for in silico drug discovery and exploration.Nucleic Acids Research2006 Jan 134(Database issue):D668-72