Utovlan

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Utovlan

Quick Facts

Property Description
Active ingredient Norethisterone (Norethindrone)
Form Oral Tablet
Pharmacological class Progestogen (Synthetic Sex Hormone)
Origin Synthetic (19-nortestosterone derivative)

What Type of Medicine is Utovlan?

Utovlan is a specific trade name for a medicine whose sole active ingredient is Norethisterone. It is categorized within the pharmacological class of Progestogens. Norethisterone is a chemically manufactured hormonal preparation of synthetic origin as a 19-nortestosterone derivative. This compound is clinically recognized for its hormonal activity. Utovlan is typically positioned as a prescription-only medicine (POM) and is used in the UK market, differentiating its brand presence from other Norethisterone products available globally.

Composition and Form: Norethisterone as an Oral Tablet

The composition of this medicine centers exclusively on the active ingredient, Norethisterone, which is also known by the generic name norethindrone. The drug is formulated as a solid tablet for oral administration. This tablet form is standardized and designed for systemic absorption. Norethisterone functions as a progesterone receptor agonist, where its fundamental biological mechanism is the activation of the body’s progesterone receptors to achieve a hormonal effect.

General Purpose of Progestogen Therapy

The core function of Progestogen therapy is to modulate hormonal processes, providing control over the female reproductive system. By influencing hormonal signals, Norethisterone can stabilize and transform the tissue of the uterine lining (endometrium). This action is applied in managing and controlling aspects of the menstrual cycle, offering an established application in gynaecology. This capability is used when temporary hormonal adjustment is necessary, such as postponing menstruation for administrative or practical reasons.

Regulatory References

  1. European Medicines Agency (EMA) Summary of Product Characteristics

What side effects are possible with Utovlan?

Possible Side Effects and Safety Information

Regulatory documents classify the adverse reactions of Norethisterone (Utovlan) by frequency and the body's organ systems. These classifications distinguish between frequently observed reactions and those that are rare but clinically significant, structuring the drug's official safety profile.

Commonly Documented Adverse Reactions

The most commonly listed adverse reactions include changes in the menstrual cycle, such as breakthrough bleeding, spotting, and sometimes amenorrhoea (lack of periods). Other common effects involve the Nervous system (headache, dizziness), Gastrointestinal system (nausea), and Reproductive system (mastodynia or breast tenderness). Fluid retention, which can manifest as oedema and weight changes, is also frequently noted in the official prescribing information.

Serious Adverse Reactions and Constraints

The most serious events documented are rare but important, focusing primarily on Vascular disorders and Hepatobiliary disorders. These serious adverse reactions include thromboembolic events (such as Deep Vein Thrombosis, Pulmonary Embolism, and Stroke) and, very rarely, hepatic adenomas or hepatocellular carcinoma. The medicine is formally contraindicated in cases of active liver disease, a history of thromboembolic disease, or undiagnosed genital bleeding. Individuals with conditions susceptible to fluid retention, such as epilepsy or asthma, require careful observation, as noted in regulatory texts.

Overdose and Emergency Response

Utovlan (Norethisterone) is classified by regulatory authorities as a substance with low acute toxicity, meaning that overdosage is generally not associated with severe or life-threatening symptoms. Despite this classification, all cases of suspected overdosage require immediate professional attention.

Documented Manifestations

Regulatory prescribing information documents a specific profile of clinical manifestations that may present following an acute overdose. These signs are primarily hormonal and gastrointestinal. Officially documented symptoms include nausea and vomiting. Patients may also experience breast enlargement and the later appearance of vaginal bleeding. This symptom profile confirms that acute overexposure rarely leads to serious adverse effects requiring specific critical care beyond supportive measures.

Emergency Actions and Management

In all instances of suspected overexposure, government health authorities mandate that patients seek immediate emergency medical attention. Treatment for Utovlan overdose is universally described as symptomatic, focusing on managing the presenting clinical signs. The official label confirms that no specific antidote is known for Norethisterone.

For cases involving a large overdosage, regulatory documents specify that the procedure of gastric lavage may be employed by medical professionals if the patient is seen within approximately four hours of the ingestion event.

Therapeutic Uses of Utovlan

What Utovlan Treats: Main Uses and Benefits

Utovlan (Norethisterone) is commonly used to help manage symptoms related to abnormal uterine bleeding, including excessive menstrual flow (menorrhagia) and unscheduled episodes. Norethisterone is used to treat abnormal periods or bleeding, to manage symptoms related to secondary amenorrhoea, supporting cycle regularity, and for the management of endometriosis. It may assist with maintaining a sense of stability by supporting cycle regulation and contributes to easing the symptom load associated with heavy blood loss.

The medication may also provide supportive relief for symptoms related to specific gynecological disorders, such as endometriosis and painful periods (dysmenorrhoea). It is relevant for easing symptoms related to hormone-mediated discomfort and is commonly used to help manage distressing somatic and mood symptoms associated with Premenstrual Syndrome (PMS) and premenstrual tension. It is used in clinical scenarios requiring the temporary adjustment of the menstrual cycle, often for practical reasons.

“It provides support that helps ease the overall symptom burden, which contributes to improved comfort during periods of heightened symptoms.”

Quick Fact: Relevant for Symptomatic Management of Menstrual Cycle Disturbances and Abnormal Bleeding.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Official Eligibility and Restrictions for Utovlan Use

Utovlan (Norethisterone) eligibility is strictly defined by regulatory documents, focusing on patient status and pre-existing medical conditions. The medicine is primarily intended for use by post-menarchal females of reproductive potential who do not possess any specific health contraindications.

Use is absolutely prohibited (contraindicated) for several high-risk populations, as documented in official labeling. This includes individuals with known or suspected pregnancy and those with a history of venous or arterial thromboembolism (blood clots). The medicine is also contraindicated in patients with severe liver disease or liver tumors, known or suspected hormone-sensitive cancers (such as breast carcinoma), and those experiencing undiagnosed irregular vaginal bleeding. Individuals with porphyria or known hypersensitivity to the components must also not use this medicine.

For certain populations, use requires special care and close observation. This conditional use applies to patients with conditions that may be aggravated by fluid retention, such as epilepsy, asthma, cardiac dysfunction, and renal dysfunction. Additionally, the medicine is not indicated for children who have not yet reached menarche, and data on use in the geriatric population is not formally established.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

Utovlan (norethisterone) is metabolized primarily in the liver, and its plasma concentrations can be affected by co-administered substances. This information is based strictly on official regulatory labeling.


Documented Interaction Categories

Category Description and Examples
Enzyme-Inducing Agents Substances that increase the activity of liver enzymes (CYP450) may reduce norethisterone plasma levels, potentially lowering its efficacy. Examples include certain antiepileptics, antivirals (e.g., Ritonavir, Nelfinavir), and the herbal product St. John's Wort.
Reciprocal Exposure Changes Co-administration with certain drugs, such as the immunosuppressant Cyclosporin, has been documented to cause changes in the exposure of both medications. Norethisterone may increase plasma cyclosporin levels, while cyclosporin may decrease norethisterone levels.
Pharmacodynamic Effects The concurrent use of medications that also cause fluid retention may lead to an additive or aggravated effect.
Laboratory Test Interference Progestogens can influence the results of specific laboratory tests, including those related to hepatic, thyroid, and coagulation function. This requires consideration when interpreting results for individuals taking Utovlan.

Official Constraints and Considerations

No co-administered medicinal product is universally listed as an absolute contraindication for single-agent norethisterone use in regulatory labeling. The primary constraint involves the risk of reduced efficacy when combined with strong enzyme inducers, necessitating careful monitoring. Use with cyclosporin requires attention to the potential for increased cyclosporin exposure and its associated risks.

Mechanism of Action

Utovlan's mechanism centers on the synthetic hormone norethisterone, which exerts biological effects across the reproductive system. Its actions are strictly defined by two key mechanistic domains: hormone receptor activation and central regulatory feedback.

Modulating Hormone Receptor Activity

The core action of norethisterone is as an agonist for Progesterone Receptors (PRs) found in target tissues, primarily the uterine lining (endometrium). By binding to these receptors, the drug initiates specific genetic and cellular changes that promote the full structural maturation and development of the uterine lining.

Influencing Uterine Structural Integrity

This is a direct peripheral consequence of receptor binding in the endometrium. The drug modifies the cellular environment, leading to a robust, secretory-phase state that structurally reinforces the tissue, counteracting the signals for premature tissue breakdown. This mechanism influences the physiological state within the uterus, which underlies the drug's resultant physiological changes.

Influencing Central Hormonal Control

Norethisterone also engages in negative feedback within the Hypothalamic-Pituitary-Ovarian (HPO) axis, a key control system for reproductive signaling. This feedback suppresses the release of pituitary hormones (like FSH and LH), which consequently modifies the progression and timing of the menstrual cycle.

Dosage and Administration Information

How to Use Utovlan (Norethisterone)

Utovlan is administered strictly via the oral route as a 5 mg tablet, which is the established method of use. The precise dosing and duration depend entirely on the specific regimen outlined in the prescribing information.

Administration and Dosing Patterns

The dosage schedule involves various daily frequencies and total milligram amounts, which are tied to the intended clinical use. For example, a regimen to manage acute dysfunctional uterine bleeding typically requires a short course of 5 mg three times daily (15 mg total daily dose). In contrast, the use for conditions like Premenstrual Syndrome (PMS) often utilizes a dose of 5 mg once daily, restricted to specific days of the menstrual cycle (e.g., Days 16 to 25).

Treatment duration is defined based on the condition. The use for delaying menstruation has an upper limit of 14 days, beginning three days before the expected onset. For long-term management, such as endometriosis, treatment may be specified to continue for a minimum of six months.

Contextual Intake Conditions

Utovlan tablets should be swallowed whole with a drink of water and can be taken with or without food. To ensure consistent hormonal levels, it is a procedural requirement that the daily dose or doses are taken at approximately the same times each day. Instructions detail that if a dose is missed, it should be skipped if it is near the time for the next scheduled dose, and a double dose must not be taken to compensate. There are no specific high-level dose adjustments provided for patients with renal or hepatic impairment for these specific gynecological regimens.

Recent Clinical Evidence

Research Evidence / Overview of Studies

This section summarizes the published research that has evaluated Utovlan (norethisterone) for its approved uses. Studies examined whether Utovlan was associated with changes in symptoms related to conditions like heavy periods (menorrhagia), painful periods (dysmenorrhea), and endometriosis.

Research has explored whether Utovlan use was associated with patient-reported quality of life outcomes, particularly in women managing chronic menstrual disorders. The clinical significance of these findings is not yet entirely clear and requires further investigation.


Onset of Observed Changes and Study Scope

Studies have assessed the timeline for a reduction in bleeding associated with Utovlan use. The RCT reported that 75% of participants reported an observed change in symptoms within 48 hours when initiating treatment for heavy or irregular bleeding. The trial also collected data on the use of other pain and bleeding management medications during this period.

Studies have explored the basic activity of Utovlan, which is a synthetic progestogen that mimics the effect of the natural hormone progesterone. Research has included participants with severe manifestations of conditions like endometriosis, even following previous surgical or hormonal interventions.


Long-term Data and Combination Use

Long-term data has been collected through studies such as a three-year cohort study that tracked participants who used Utovlan. Researchers examined whether observed changes in symptoms were maintained over the study period and monitored participants' health status.

Research has also evaluated whether the combined use of Utovlan and other treatments (such as other hormonal therapies) resulted in different outcomes compared to either intervention alone. This combination approach has been examined in the context of different treatment protocols for menstrual disorders.

Frequently Asked Questions (FAQ)

Common questions about Utovlan (FAQ)


Q: Is Utovlan the same as a contraceptive pill?

No, Utovlan is not primarily a contraceptive pill, particularly when it is prescribed for short-term use, such as to delay menstruation. Official patient information leaflets emphasize that the drug will not prevent pregnancy. Regulatory documents state that if contraception is necessary, a non-hormonal barrier method is advised.


Q: Is it common to experience mood changes while taking Utovlan?

The active ingredient, Norethisterone, is associated with certain psychiatric side effects. Depressed mood or clinical depression is listed as an uncommon adverse effect in regulatory documents. Official warnings indicate that closer observation is often warranted for individuals with a history of clinical depression while taking this medication.


Q: Is Utovlan considered a type of hormone replacement therapy (HRT)?

Utovlan is classified as a progestogen, which is a type of synthetic female hormone. This progestogen is used as a necessary component in many combined Hormone Replacement Therapy (HRT) products. The single-ingredient formulation of Utovlan is, however, typically prescribed for gynaecological conditions.


Q: Is Utovlan safe to use if I have high blood pressure?

Official warnings note that hypertension (high blood pressure) is a documented risk factor for serious vascular events, such as blood clots. In cases where a significant increase in blood pressure occurs while using the medication, regulatory guidelines indicate that discontinuation of the drug may be warranted.


Q: What happens when I stop taking Utovlan?

After the treatment course is completed, official product information indicates that a withdrawal bleed typically occurs. This bleed resembles a normal period and usually begins within 2 to 4 days after the last tablet is taken.


Q: Does taking Utovlan impact my ability to drive or operate machinery?

Regulatory safety documents indicate that some users may experience adverse effects on the nervous system, such as dizziness or feeling drowsy (somnolence). Due to the possibility of these effects, caution is generally advised regarding the operation of machinery or driving.


Q: Do other medicines, like antibiotics, reduce the effectiveness of Utovlan?

Yes, official warnings note that the intended hormonal effect can be reduced by other medicines that induce liver enzymes. Examples of such interacting medicines include certain types of antibiotics (such as rifampicin) and some antiepileptic drugs.


Q: Why is Utovlan sometimes prescribed for conditions other than menstrual issues?

The medicine is officially indicated for a range of uses beyond simply regulating a period. Regulatory documents list approved conditions such as dysfunctional uterine bleeding, primary and secondary amenorrhea (lack of periods), premenstrual syndrome, and endometriosis.


Q: What are the signs that Utovlan is having the intended effect?

Official prescribing information notes that when Utovlan is used to treat heavy or dysfunctional uterine bleeding, the reduction of abnormal bleeding is typically seen within 1 to 3 days of starting treatment.


Q: What is the half-life of Utovlan?

The half-life is a measure of how quickly the body eliminates the medicine. According to official pharmacokinetic studies, the terminal elimination half-life of the active ingredient, Norethisterone, is measured to be approximately 5 to 12 hours after a single dose.


Q: Can Utovlan affect cholesterol levels?

Official data on progestin therapy suggests that it may have adverse effects on lipid and carbohydrate metabolism, which includes cholesterol levels. Regulatory documents indicate that women with pre-existing hyperlipidemias (high blood fats) may require clinical management considerations during treatment.


Q: Are there any known interactions between Utovlan and grapefruit?

Yes, regulatory warnings advise caution regarding grapefruit juice. Grapefruit juice acts on a certain enzyme (CYP3A4) in the body, which can increase the blood concentration of the active substance and potentially alter its effects.


Q: Can Utovlan be used by women who have gone through menopause?

Official product information states that Norethisterone is often used in combination with an estrogen as part of Hormone Replacement Therapy (HRT). This combination is specifically indicated for managing symptoms caused by estrogen deficiency in women who have been postmenopausal for more than one year.


Q: Are there any foods or drinks that should be avoided when taking Utovlan?

Regulatory documents indicate that certain foods and drinks may affect how this medicine is handled by the body. Specifically, grapefruit juice may increase the concentration of the active substance in the blood because it can influence the enzymes that process the medicine.


Q: Is it possible for Utovlan to delay ovulation?

Yes, official product information states that one of the effects of Norethisterone when taken at typical treatment doses is the suppression of ovulation. This happens through the drug's influence on the central hormonal control system, known as the pituitary gland.


Q: Are there different strengths or formulations of Utovlan available?

Utovlan itself is typically available as a 5 mg oral tablet, which is the standard formulation for its primary uses. However, the active ingredient, Norethisterone, is also found in other products, sometimes in different strengths or forms, particularly when used as a component of Hormone Replacement Therapy.


Q: What is the legal status of Utovlan in different countries (prescription vs. OTC)?

Based on regulatory standards globally, 5 mg tablets of Norethisterone, marketed under brand names like Utovlan, are consistently classified as a prescription-only medicine (POM). This means that access to the drug requires an authorization from a healthcare professional.


Q: Does Utovlan cause headaches or migraines?

Headache is listed as a commonly reported adverse effect of this medication. Official warnings also state that the development of a migraine, or an increase in the frequency or severity of existing headaches, is a signal that requires clinical reassessment.


Q: What type of monitoring is usually suggested while taking Utovlan?

Official guidance indicates that closer observation is generally warranted for patients with certain pre-existing conditions, such as asthma, epilepsy, or heart/kidney dysfunction. Monitoring is also advised to check for signs of serious adverse reactions, such as the development of blood clots or high blood pressure.


Q: What is the maximum duration of use cited in official documents for Utovlan?

The duration of use is specific to the condition being treated. For the postponement of menstruation, for example, official product information specifies a duration limit that is typically not longer than 10 to 14 days or a maximum of 20 days, depending on the regulatory document.


Q: What are the differences in how Utovlan works compared to combined hormonal pills?

Utovlan contains only the progestogen hormone, Norethisterone, which works by suppressing ovulation and altering the lining of the uterus and cervical mucus. Combined hormonal pills, in contrast, include both a progestogen and an estrogen component, meaning they utilize a broader mechanism of action.

How should Utovlan be stored and disposed of?

The official regulatory profile for Utovlan (norethisterone) mandates specific conditions to maintain product stability and ensure public safety.

Storage Requirements

Utovlan tablets must be stored below 25 C and kept in the original package to protect from light and moisture. This ensures the stability of the active ingredient and prevents degradation. Like all medicines, the product must be stored out of the sight and reach of children to prevent accidental ingestion.

Disposal Instructions

Unused or expired Utovlan must be disposed of properly. The most advisable method is utilizing a drug take-back program. If this option is unavailable, the medicine should be disposed of in household trash by first mixing the tablets with an undesirable substance (such as coffee grounds) and sealing the mixture in a container before discarding it. It is strictly prohibited to flush Utovlan down the toilet or dispose of it in wastewater.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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