Side Effects of ulipristal: A Synthesis of Findings from 29 Studies

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Original Abstract of the Article

Key Research Findings

Ulipristal acetate (UPA) is an oral selective progesterone receptor modulator (SPRM) that has been found to be effective in treating uterine fibroids. Several Phase III clinical trials, known as the PEARL studies, demonstrated UPA's ability to significantly reduce fibroid volume and menstrual bleeding, leading to improvements in quality of life. 8 , 16 , 21 , 13 Furthermore, UPA has also proven effective as an emergency contraceptive agent, with a demonstrated ability to prevent unintended pregnancies. 17 , 19 , 26 , 22

However, post-marketing surveillance revealed a concerning potential for UPA to cause liver injury and failure, leading to restrictions on its long-term use. 2 , 4 , 3 , 7

Reasons for Side Effects

One of the potential factors contributing to UPA's side effects is its ability to interact with other steroid receptors. 2

Common Side Effects

Menstrual Irregularities

While UPA is known to reduce menstrual flow, some patients may experience irregular menstrual cycles. 8 , 5 , 29

Liver Damage

UPA has been associated with a potential risk of liver injury and failure. 2 , 4 , 3 , 7

Others

Additional side effects reported with UPA include nausea, vomiting, headache, dizziness, breast pain, and weight gain. 23 , 18 , 20 , 9

Side Effect Management

Menstrual Irregularities

If you experience menstrual irregularities, it's important to consult your doctor. 5 , 29

Liver Damage

If you notice any signs or symptoms suggestive of liver damage, seek immediate medical attention. 2 , 4 , 3 , 7

Others

If you experience any other side effects, it's essential to discuss them with your doctor. 23 , 18 , 20 , 9

Comparison Between Studies

Commonalities

Numerous studies consistently demonstrate the effectiveness of UPA in treating uterine fibroids. 8 , 16 , 21 , 13 , 24 , 15 , 12 , 10 , 6

Differences

Variations exist among studies regarding the effectiveness of UPA and the incidence of side effects. 8 , 16 , 21 , 13 , 24 , 15 , 12 , 10 , 6 , 2 , 4 , 3 , 7

Real-life Application Considerations

While UPA is a promising drug for treating uterine fibroids, its potential to cause liver damage necessitates cautious approach regarding its long-term use. 2 , 4 , 3 , 7

Limitations of Current Research

The long-term implications of UPA remain incompletely understood. 2 , 4 , 3 , 7

Future Research Directions

Further research is crucial to fully assess the long-term safety and effectiveness of UPA. 2 , 4 , 3 , 7

Conclusion

Ulipristal acetate is a potentially valuable treatment option for uterine fibroids, but its potential to cause liver damage requires careful monitoring and consideration of long-term use. 2 , 4 , 3 , 7 If you are considering UPA, it is essential to discuss its risks and benefits with your doctor.

Keywords
Benefit Keywords
Reduced lesion size
Reduced lesion weight
Reduced proliferation
1
Uterine fibroid treatment
2
Fertility preservation
Fibroid volume reduction
3
Effective treatment
Reduced surgery
6
Uterine fibroid treatment
7
Bleeding control
Fibroid volume reduction
Menstrual cycle regulation
8
Pregnancy prevention
9
Leiomyoma treatment
Progesterone antagonist
10
Fibroid reduction
Hysteroscopic myomectomy efficacy
11
Prolonged clinical effect
Shrinking of uterine leiomyomas
12
Fibroid treatment
13
Conservative medical treatment
14
Controls bleeding
Reduces fibroid size
Safe and tolerable
15
Fibroid treatment
16
Emergency contraception
17
Unintended pregnancy prevention
18
Effective emergency contraception
Safe emergency contraception
19
Unwanted pregnancy prevention
20
Fibroid treatment
21
Efficacy
Emergency contraception
Safety
22
LNG less nausea
23
Fibroid treatment
24
Pregnancy prevention
25
Emergency contraception
26
Unwanted pregnancy prevention
27
Endometrial pattern normalization
28
Risk Keywords
Endometrial atrophy
Endometrial hyperplasia
Follicle accumulation
1
Hepatic failure
Hepatic injury
2
Liver injury
3
Antibiotic resistance
Fungemia
Hepatotoxicity
Increased risk of malignancies
Meningioma
QT prolongation
4
Common adverse symptoms
High discontinuation rate
5
Side effects
6
Side effects
7
Mild side effects
9
Limited clinical results
Side effects
12
Endometrial-related changes
13
Climacteric side effects
Fibroid relapse
14
Endometrial effects
16
Side effects
17
Side effects
18
Mild side effects
19
Nausea and vomiting
23
Side effects
25
Abnormal uterine bleeding
Uterine myomas
28
Abnormal uterine bleeding
Hysterectomy
29
Literature analysis of 29 papers
Positive Content
25
Neutral Content
1
Negative Content
3
Article Type
0
1
2
19
29
2.

The Selective Progesterone Receptor Modulator Ulipristal Acetate Inhibits the Activity of the Glucocorticoid Receptor.

Author: SmallBenjamin, MillardCharles E F, KisangaEdwina P, BurmanAndreanna, AnamAnika, FlanneryClare, Al-HendyAyman, WhirledgeShannon

Uterine fibroid treatment
Hepatic failure
Hepatic injury

This abstract discusses the selective progesterone modulator ulipristal acetate (ulipristal) as a therapeutic option for uterine fibroids, highlighting potential safety concerns related to hepatic injury and failure, and suggesting that cross-reactivity with other steroid receptors may contribute to these side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Risk-efficacy balance of ulipristal acetate compared to surgical alternatives.

Author: MiddelkoopMei-An, BetPierre M, DrenthJoost P H, HuirneJudith A F, HehenkampWouter J K

Fertility preservation
Fibroid volume reduction
Liver injury

Ulipristal is a potential conservative long-term treatment for uterine fibroids, decreasing fibroid volume with acceptable side effects and preserving fertility. However, it is currently under investigation for potential drug-induced liver injury.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

6.

Ulipristal acetate in symptomatic uterine fibroids. A real-world experience in a multicentric Italian study.

Author: GiarrèGiovanna, FranchiniMario, CastellacciEleonora, MaluneMaria Elena, Di Spiezio SardoAttilio, SacconeGabriele, AngioniStefano

Effective treatment
Reduced surgery
Side effects

Uterine fibroids are noncancerous growths in the uterus that can cause heavy bleeding and pain. This study looked at the effectiveness and safety of ulipristal acetate (UPA), a medication used to treat uterine fibroids, in premenopausal women. The study found that UPA was effective in reducing the number of women who needed surgery to treat their fibroids, and it was generally well tolerated.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

7.

Liver function, tolerability and satisfaction during treatment with ulipristal acetate in women with fibroids: a single center experience.

Author: Del FornoSimona, Degli EspostiEugenia, SalucciPaolo, LeonardiDeborah, IodiceRaffaella, ArenaAlessandro, RaimondoDiego, ParadisiRoberto, SeracchioliRenato

Uterine fibroid treatment
Side effects

This cross-sectional study evaluated liver function and tolerability in women treated with ulipristal acetate (UPA) for symptomatic uterine fibroids.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

8.

Esmya<sup>&#174;</sup> and the PEARL studies: A review.

Author: PowellMartin, DuttaDeborata

Bleeding control
Fibroid volume reduction
Menstrual cycle regulation

Ulipristal acetate is effective in treating heavy menstrual bleeding associated with uterine fibroids, with a favorable side-effect profile compared to leuprorelin acetate. It decreased fibroid volume and improved bleeding control.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

9.

The safety of available and emerging options for emergency contraception.

Author: LeeJessica K, SchwarzEleanor Bimla

Pregnancy prevention
Mild side effects

This review summarizes the available literature on the safety of emergency contraception (EC). All currently available methods of EC, including ulipristal acetate pills, levonorgestrel pills, and the copper IUD, have a favorable safety profile. The copper IUD is the most effective method of EC.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

10.

Drug safety evaluation of ulipristal acetate in the treatment of uterine fibroids.

Author: TafiEmanuela, ScalaCarolina, Leone Roberti MaggioreUmberto, BizzarriNicolò, CandianiMassimo, VenturiniPier Luigi, FerreroSimone

Leiomyoma treatment
Progesterone antagonist

Ulipristal acetate, a new type of drug, shows potential in treating uterine fibroids. It effectively blocks the effects of progesterone, the hormone responsible for fibroid growth.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

11.

Hysteroscopic myomectomy outcomes after 3-month treatment with either Ulipristal Acetate or GnRH analogues: a retrospective comparative study.

Author: SanchoJavier Monleón, DelgadoVerónica Serrano de la Cruz, ValeroMaria José Nuñez, SoterasMarta Gurrea, AmateVicente Payá, CarrascosaAntonio Abad

Fibroid reduction
Hysteroscopic myomectomy efficacy

Ulipristal acetate (UPA) is a safe and effective alternative to GnRH analogues for pre-treatment before hysteroscopic myomectomy.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

13.

Ulipristal acetate for uterine fibroids: a systematic review and meta-analysis.

Author: KalampokasTheodoros, KamathMohan, BoutasIoannis, KalampokasEmmanouil

Fibroid treatment
Endometrial-related changes

This systematic review evaluated the efficacy of ulipristal acetate (UA) for the management of uterine fibroids. Short-term use of UA seems to be an effective and safe method of treating uterine fibroids.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

14.

Therapeutic drugs in the treatment of symptomatic uterine fibroids.

Author: HoellenFriederike, GriesingerGeorg, BohlmannMichael K

Conservative medical treatment
Climacteric side effects
Fibroid relapse

GnRH agonists are often used to treat uterine fibroids but can cause severe side effects and fibroid relapse. Other treatments, such as oral contraceptives or progestins, do not significantly reduce fibroid volume.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

15.

[Ulipristal acetate, 5mg: a new alternative].

Author: Monleón SanchoJavier, RomagueraEugenia, RomeroAinhoa, HiguerasGema, MorcilloInmaculada, FusterSonia

Controls bleeding
Reduces fibroid size
Safe and tolerable

This study explores the efficacy and safety of ulipristal acetate (UA) for treating fibroids. UA inhibits the proliferation and induces apoptosis and cell death pathways in leiomyoma cells, resulting in smaller fibroids and lower uterine volumes. Clinical trials have shown that UA is effective in controlling bleeding and decreasing fibroid size with fewer side effects than leuprolide acetate.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : Spanish

16.

Ulipristal acetate: a novel option for the medical management of symptomatic uterine fibroids.

Author: TalaulikarVikram S, ManyondaIsaac T

Fibroid treatment
Endometrial effects

This review discusses the treatment of uterine fibroids, highlighting the emergence of ulipristal acetate (UA), a selective progesterone receptor modulator (SPRM). UA has shown promise in reducing fibroid size and symptoms, offering a uterus-sparing alternative to surgery. However, further research is needed to address concerns regarding its long-term impact.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

17.

Ulipristal acetate as an emergency contraceptive agent.

Author: MartinezAlan M, ThomasMichael A

Emergency contraception
Side effects

Ulipristal acetate (UPA), a selective progesterone receptor modulator, is a new oral tablet for emergency contraception (EC). It can be used up to 120 hours after unprotected intercourse with no increase in adverse effects or decrease in efficacy.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

18.

Nowadays which emergency contraception? Comparison between past and present: latest news in terms of clinical efficacy, side effects and contraindications.

Author: GizzoSalvatore, FanelliTiziana, Di GangiStefania, SaccardiCarlo, PatrelliTito Silvio, ZambonAlessandra, OmarAnis, D'AntonaDonato, NardelliGiovanni Battista

Unintended pregnancy prevention
Side effects

This review discusses emergency contraception (EC) and its use in preventing unwanted pregnancies. It clarifies the available methods, action windows, adverse events, and contraindications of EC. The authors highlight the importance of addressing confusion about EC to increase its utilization.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

19.

Update on emergency contraception.

Author: FinePaul M

Effective emergency contraception
Safe emergency contraception
Mild side effects

This article discusses the efficacy and safety of ulipristal acetate, a new emergency contraceptive, compared to levonorgestrel. Ulipristal acetate has been shown to be more effective than levonorgestrel, particularly when taken beyond 72 hours after unprotected intercourse. Side effects are mild and similar to those of levonorgestrel.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

20.

Emergency contraception: clinical outcomes.

Author: GlasierAnna

Unwanted pregnancy prevention

This review discusses the safety and efficacy of three commonly used methods of emergency contraception: levonorgestrel (LNG-EC), ulipristal acetate (UPA), and the copper intrauterine device.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

21.

Influence of ulipristal acetate therapy compared with uterine artery embolization on fibroid volume and vascularity indices assessed by three-dimensional ultrasound: prospective observational study.

Author: CzuczwarP, WozniakS, SzkodziakP, MilartP, WozniakowskaE, WronaW, PaszkowskiT

Fibroid treatment

This prospective case-control study of 34 premenopausal women with symptomatic uterine fibroids compared the effects of ulipristal acetate (UPA) and uterine artery embolization (UAE) on fibroid volume and vascularity. Both treatments resulted in a significant decrease in fibroid volume, with similar percentages of reduction. UAE resulted in a greater percentage reduction in vascularization indices compared to UPA.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

22.

The rationale for use of Ulipristal Acetate as first line in emergency contraception: biological and clinical evidence.

Author: GlasierAnna

Efficacy
Emergency contraception
Safety

Ulipristal acetate (UPA) is an emergency contraceptive (EC) that was licensed in Europe in 2009. This review discusses the rationale for using UPA for EC, based on data on efficacy, safety, and side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

23.

Prevention and management of nausea and vomiting with emergency contraception: a systematic review.

Author: RodriguezMaria I, GodfreyEmily M, WardenMeredith, CurtisKathryn M

LNG less nausea
Nausea and vomiting

The evidence does not support routine use of antiemetics with emergency contraception pill use. Data to guide management of emesis with emergency contraception are limited to expert opinion and package labeling.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

24.

Application of ulipristal acetate in female patients with uterine fibroids.

Author: GrzechocinskaBarbara, GadomskaHalina, ZygulaAleksandra, WielgosMiroslaw

Fibroid treatment

This study aims to evaluate the efficacy and safety of oral ulipristal acetate for treating women with symptomatic uterine fibroids.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

25.

Emerging options for emergency contraception.

Author: KoyamaAtsuko, HagopianLaura, LindenJudith

Pregnancy prevention
Side effects

Emergency contraception (EC) is an effective method of preventing pregnancy, with various options available, including IUDs and pills. Most pills have no contraindications except for ulipristal acetate and mifepristone. This article reviews the mechanisms, efficacy, safety, and patient preferences of EC.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

27.

Emergency contraception: clinical outcomes.

Author: GlasierAnna

Unwanted pregnancy prevention

This review discusses the safety and efficacy of three commonly used methods of emergency contraception: levonorgestrel (LNG-EC), ulipristal acetate (UPA), and the copper intrauterine device.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

28.

Hysteroscopic Patterns in Women on Treatment With Ulipristal Acetate 5 mg/day: A Preliminary Study.

Author: BettocchiStefano, BaranowskiWlodzimierz E, DoniecJacek, CeciOronzo, RestaLeonardo, FascillaFabiana Divina, MitolaPaola Carmela, TinelliRaffaele, CicinelliEttore

Endometrial pattern normalization
Abnormal uterine bleeding
Uterine myomas

In most women on UPA and with thickened endometrium at TVS, the hysteroscopy showed benign and characteristics aspects related to the ambivalent effects of UPA on progesterone receptor.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

29.

Abnormal excessive per vagina (PV) bleeding on Esmya-selective progesterone receptor modulator (SPRM) in a symptomatic patient with uterine fibroid.

Author: Matytsina-QuinlanLyubov, MatytsinaLaura

Abnormal uterine bleeding
Hysterectomy

This case report describes a woman who experienced excessive vaginal bleeding after starting Esmya, a selective progesterone receptor modulator (SPRM), for uterine fibroids. This highlights the potential for abnormal uterine bleeding (AUB) with SPRM use.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

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