Veoza: Uses, Dosage & Side Effects
A non-hormonal neurokinin 3 (NK3) receptor antagonist for the treatment of moderate to severe menopausal hot flashes and night sweats
Veoza (fezolinetant) is a first-in-class, non-hormonal prescription medication approved for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. These symptoms, commonly known as hot flashes and night sweats, affect the majority of women during the menopausal transition and can significantly impair quality of life, sleep, and daily functioning. Veoza works by selectively blocking neurokinin 3 (NK3) receptors in the brain's thermoregulatory center, addressing the root neurological cause of VMS without involving hormonal pathways. It is taken as a single 45 mg tablet once daily by mouth and represents an important therapeutic option for women who cannot or prefer not to use hormone replacement therapy.
Quick Facts: Veoza
Key Takeaways
- Veoza (fezolinetant) is the first non-hormonal NK3 receptor antagonist approved for treating moderate to severe menopausal hot flashes and night sweats, providing an alternative for women who cannot or prefer not to use hormone replacement therapy.
- It works by blocking neurokinin B (NKB) signaling in the brain's thermoregulatory center, directly addressing the neurological mechanism that causes vasomotor symptoms during menopause without affecting estrogen levels.
- The recommended dose is one 45 mg tablet taken orally once daily, with or without food. Clinical trials showed significant reductions in both the frequency and severity of hot flashes.
- Liver function monitoring is mandatory: blood tests are required before starting treatment, monthly for the first three months, and periodically thereafter. Do not use Veoza if you have existing liver disease without medical guidance.
- Veoza must not be taken with moderate or strong CYP1A2 inhibitors (such as fluvoxamine, enoxacin, or ethinylestradiol-containing contraceptives) as these drugs can significantly increase fezolinetant levels in the blood.
What Is Veoza and What Is It Used For?
Veoza contains the active substance fezolinetant, a selective neurokinin 3 (NK3) receptor antagonist. It belongs to an entirely new class of medications developed specifically to treat vasomotor symptoms (VMS) of menopause, commonly experienced as hot flashes (sudden intense sensations of heat, typically in the face, neck, and chest) and night sweats (episodes of excessive sweating during sleep). These symptoms are the hallmark of the menopausal transition and affect up to 80% of women, with approximately 25% experiencing symptoms severe enough to significantly impair their quality of life.
The mechanism of action of Veoza is rooted in our evolving understanding of the neurobiology behind menopausal vasomotor symptoms. In the hypothalamus, a region of the brain responsible for body temperature regulation, there are specialized neurons called KNDy neurons (named after the neuropeptides they produce: kisspeptin, neurokinin B, and dynorphin). These neurons act as a thermostat, maintaining body temperature within a narrow comfortable range known as the thermoneutral zone.
Before menopause, estrogen helps keep the activity of KNDy neurons in check, maintaining a wide thermoneutral zone. When estrogen levels decline during the menopausal transition, KNDy neurons become overactive and produce excessive amounts of neurokinin B (NKB). This overproduction of NKB binds to neurokinin 3 (NK3) receptors on the same and neighboring neurons, triggering heat dissipation responses (vasodilation, sweating) even when the body is not actually overheating. The thermoneutral zone narrows dramatically, meaning even small fluctuations in core body temperature can trigger a full-blown hot flash or night sweat episode.
Fezolinetant specifically blocks the NK3 receptor, preventing NKB from activating these aberrant heat-dissipation pathways. By restoring normal thermoregulatory function at the neuronal level, Veoza reduces both the frequency and intensity of hot flashes and night sweats. Crucially, this mechanism does not involve the manipulation of estrogen or any other hormonal pathway, making Veoza a genuinely non-hormonal treatment option. This is particularly important for women who have contraindications to hormone replacement therapy (HRT), such as those with a history of hormone-sensitive cancers, thromboembolic disease, or certain cardiovascular conditions.
The clinical efficacy of fezolinetant was established in the SKYLIGHT clinical trial program, which included the pivotal SKYLIGHT 1 and SKYLIGHT 2 phase 3 randomized, double-blind, placebo-controlled trials. In these studies, women taking fezolinetant 45 mg daily experienced statistically significant and clinically meaningful reductions in both the frequency (number of episodes per day) and severity of moderate to severe VMS compared with placebo. These improvements were observed as early as the first week of treatment and were sustained throughout the study periods of up to 52 weeks.
Veoza represents a paradigm shift in the management of menopausal vasomotor symptoms. Unlike hormone replacement therapy (HRT), which works by supplementing declining estrogen levels, Veoza targets the neurological mechanism directly. This makes it suitable for women who cannot use hormones, such as breast cancer survivors, women with a history of blood clots, or those who simply prefer a non-hormonal approach. Veoza does not affect bone density, vaginal symptoms, or other estrogen-dependent processes.
What Should You Know Before Taking Veoza?
Contraindications
There are specific situations in which Veoza must not be used. Understanding these contraindications is essential before starting treatment.
- Hypersensitivity: Do not take Veoza if you are allergic to fezolinetant or any of the other ingredients in the tablet (mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate, hypromellose, talc, macrogol, titanium dioxide, or red iron oxide).
- CYP1A2 inhibitors: Do not take Veoza together with medications known to be moderate or strong CYP1A2 inhibitors. These include fluvoxamine (used for depression and anxiety), enoxacin (an antibiotic), mexiletine (used for muscle stiffness), and contraceptives containing ethinylestradiol. These drugs slow the breakdown of fezolinetant in the body, leading to increased blood levels and a higher risk of side effects.
- Pregnancy: Do not take Veoza if you are pregnant or think you may be pregnant. Veoza is intended only for menopausal women. If you become pregnant while taking this medication, stop immediately and contact your doctor.
Warnings and Precautions
Before starting Veoza, your doctor must perform a blood test to check your liver function. This test must be repeated monthly during the first three months of treatment and periodically thereafter as your doctor determines. Contact your doctor immediately if you experience any signs of liver problems: unusual fatigue, itchy skin, yellowing of the skin or eyes, dark-colored urine, light-colored stools, nausea or vomiting, decreased appetite, or abdominal pain.
Talk to your doctor or pharmacist before taking Veoza if any of the following apply to you:
- Liver disease or liver problems: Your doctor may request a complete medical history and assess whether Veoza is appropriate for you. Patients with significant liver impairment may not be suitable candidates for this medication.
- Kidney problems: If you have kidney impairment, your doctor may decide not to prescribe Veoza or may need to monitor you more closely.
- Current or past breast cancer or estrogen-related cancer: Although Veoza is non-hormonal, your doctor needs to evaluate whether it is appropriate in the context of your cancer history. Your doctor may decide not to prescribe this medication.
- Estrogen hormone replacement therapy: If you are currently taking HRT with estrogen, your doctor may decide not to prescribe Veoza, as the combination has not been adequately studied.
- History of seizures: If you have previously experienced seizures or epilepsy, your doctor may decide not to prescribe Veoza.
Your doctor may also ask about your complete medical history and your family’s medical history before prescribing Veoza. This helps ensure the medication is appropriate and safe for your individual circumstances.
Pregnancy and Breastfeeding
Veoza is intended exclusively for menopausal women and must not be taken during pregnancy or breastfeeding. If you are a woman of childbearing potential who has not yet reached menopause and there is any possibility you could become pregnant, you should use an effective non-hormonal method of contraception while taking Veoza. Note that hormonal contraceptives containing ethinylestradiol are contraindicated with Veoza due to drug interactions.
If you become pregnant while taking Veoza, discontinue the medication immediately and contact your healthcare provider. The effects of fezolinetant on the developing fetus have not been fully established, and a precautionary approach is warranted.
It is not known whether fezolinetant is excreted into human breast milk. Because Veoza is designed for menopausal women, breastfeeding is generally not applicable. However, if breastfeeding is relevant to your situation, discuss this with your doctor before starting treatment.
Driving and Operating Machinery
Veoza has no known effect on the ability to drive or operate machinery. Clinical trials did not identify driving impairment as a concern with fezolinetant 45 mg. However, if you experience any unexpected side effects such as dizziness or drowsiness, exercise appropriate caution until you know how the medication affects you personally.
Children and Adolescents
Veoza must not be given to children or adolescents under 18 years of age. This medication is intended solely for women experiencing menopausal vasomotor symptoms and has no approved pediatric indication.
How Does Veoza Interact with Other Drugs?
Fezolinetant is primarily metabolized in the liver by the cytochrome P450 1A2 (CYP1A2) enzyme. Medications that inhibit this enzyme can substantially increase fezolinetant blood levels, raising the risk of side effects. Conversely, medications that induce CYP1A2 may reduce fezolinetant's effectiveness. It is crucial to inform your doctor about all medications, supplements, and herbal products you are taking before starting Veoza.
Major Interactions (Contraindicated)
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Fluvoxamine | Strong CYP1A2 inhibitor; markedly increases fezolinetant blood levels | Contraindicated – do not combine |
| Enoxacin | Strong CYP1A2 inhibitor; significantly reduces fezolinetant clearance | Contraindicated – do not combine |
| Mexiletine | Moderate CYP1A2 inhibitor; increases fezolinetant exposure | Contraindicated – do not combine |
| Ethinylestradiol-containing contraceptives | CYP1A2 inhibition by ethinylestradiol; increased fezolinetant levels | Contraindicated – use non-hormonal contraception instead |
Other Potential Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Smoking (tobacco) | Tobacco smoke induces CYP1A2; may decrease fezolinetant levels | May reduce efficacy; inform your doctor if you smoke |
| Caffeine | Both caffeine and fezolinetant are CYP1A2 substrates | No significant clinical interaction expected at normal intake |
| Other mild CYP1A2 inhibitors | Possible modest increase in fezolinetant levels | Use with caution; discuss with your doctor |
| CYP1A2 inducers (e.g., rifampicin, carbamazepine) | May decrease fezolinetant plasma concentrations | May reduce effectiveness; discuss alternative treatments |
The interaction profile of fezolinetant is primarily driven by its dependence on CYP1A2 for metabolism. Unlike many other drugs, fezolinetant does not appear to significantly inhibit or induce other CYP enzymes at therapeutic doses, which limits its potential to affect the levels of other medications you may be taking. However, the CYP1A2-dependent metabolism means that anything affecting this enzyme pathway can have a meaningful impact on fezolinetant levels.
It is also worth noting that some foods and beverages can influence CYP1A2 activity. For example, charcoal-grilled foods can induce CYP1A2, while grapefruit juice may have mild inhibitory effects on certain CYP enzymes. While these dietary interactions are generally less clinically significant than drug-drug interactions, it is prudent to maintain consistent dietary habits and discuss any concerns with your doctor.
What Is the Correct Dosage of Veoza?
Always take Veoza exactly as your doctor or pharmacist has instructed. If you are unsure about any aspect of your dosing regimen, consult your healthcare provider before making any changes. Veoza is available in a single strength of 45 mg, and the dosing is straightforward.
Adults
Standard Adult Dose
Indication: Moderate to severe vasomotor symptoms (hot flashes and night sweats) associated with menopause
Dose: 45 mg (one tablet) taken orally once daily
Administration: Take at approximately the same time each day, with or without food. Swallow the tablet whole with liquid. Do not split, crush, or chew the tablet.
Duration: As determined by your doctor based on ongoing symptom evaluation. Treatment can be continued as long as symptoms persist and the medication is tolerated.
Consistency in timing is important for maintaining stable blood levels of fezolinetant. Choose a time of day that fits your routine and try to take the tablet at that same time every day. The medication can be taken with a meal or on an empty stomach, as food does not significantly affect its absorption.
Children
Veoza is not approved for use in children or adolescents under 18 years of age. This medication is exclusively indicated for menopausal women and has no pediatric applications.
Elderly Patients
No dose adjustment is required for elderly patients based on age alone. Veoza is indicated for menopausal women, and the clinical trials included women across a wide age range. However, as with all medications, kidney and liver function should be assessed, as these may decline with age and could influence drug metabolism.
Hepatic and Renal Impairment
Patients with significant liver impairment should be evaluated carefully before starting Veoza, as fezolinetant is metabolized primarily in the liver. Your doctor may decide that Veoza is not appropriate if you have clinically significant liver disease. Similarly, patients with severe kidney impairment require careful assessment, and your doctor may choose not to prescribe the medication.
Missed Dose
If you miss a dose, take it as soon as you remember on the same day, provided there are at least 12 hours until your next scheduled dose. If fewer than 12 hours remain before your next dose, skip the missed dose entirely and take your next dose at the regular time. Do not take a double dose to make up for a missed one. If you miss several doses in a row, contact your doctor for guidance on how to resume treatment.
Overdose
If you take more tablets than prescribed, or if someone else accidentally takes your medication, contact your doctor or pharmacist immediately, or go to the nearest emergency department. Symptoms of overdose may include headache, nausea, and paraesthesia (tingling or prickling sensations). There is no specific antidote for fezolinetant overdose; treatment would be supportive and based on the symptoms observed.
Stopping Treatment
Do not stop taking Veoza unless your doctor tells you to. If you decide to discontinue treatment before your prescribed course is complete, speak with your doctor first. Stopping Veoza will not cause withdrawal symptoms, but your menopausal vasomotor symptoms may return once the medication is discontinued.
What Are the Side Effects of Veoza?
Like all medicines, Veoza can cause side effects, although not everyone will experience them. Most side effects are mild to moderate and manageable. However, some side effects can be serious, particularly those involving the liver, and require immediate medical attention.
Contact your doctor immediately if you experience any of the following symptoms, which may indicate liver damage: unusual tiredness or fatigue, itchy skin, yellowing of the skin or whites of the eyes (jaundice), dark-colored urine, light-colored (pale) stools, feeling sick (nausea or vomiting), decreased appetite, and/or abdominal (stomach) pain. The frequency of liver damage is not fully established from available data.
Common Side Effects
- Diarrhea (loose stools)
- Insomnia (difficulty sleeping)
- Elevated liver enzymes (ALT or AST), detected through blood tests
- Abdominal pain (stomach pain)
Frequency Not Known
- Liver damage (hepatotoxicity) – see warning signs above
The side effect profile of Veoza is generally favorable compared with many alternative treatments for menopausal symptoms. In the SKYLIGHT clinical trials, the overall incidence of adverse events was similar between the fezolinetant 45 mg group and the placebo group, indicating that the medication is well tolerated by most patients. The most notable safety concern is hepatotoxicity (liver damage), which is why liver function monitoring is mandatory.
Elevated liver enzymes (ALT and AST) were observed in some patients during clinical trials. In most cases, these elevations were mild, transient, and resolved either spontaneously or after discontinuation of the medication. However, because more serious liver injury has been reported in post-marketing surveillance, regular monitoring is essential. Your doctor will perform liver function tests before you start Veoza and at regular intervals during treatment.
Insomnia reported with Veoza is worth noting in the context of menopause, where sleep disturbances are already common. In clinical trials, it was sometimes difficult to distinguish medication-related insomnia from the sleep disruption caused by night sweats themselves. If you experience new or worsening sleep difficulties, discuss this with your doctor, who can help determine the cause and suggest appropriate management strategies.
Gastrointestinal side effects, primarily diarrhea and abdominal pain, were generally mild and typically did not require discontinuation of treatment. These symptoms often improved as the body adjusted to the medication over the first few weeks of use.
It is important to report any suspected side effects after a medication has been approved. This allows ongoing monitoring of the medication's benefit-risk balance. Healthcare professionals and patients are encouraged to report suspected adverse reactions to their national medicines regulatory authority (such as the FDA in the United States, the EMA in Europe, or the MHRA in the United Kingdom).
How Should You Store Veoza?
Proper storage of medications is important to ensure they remain safe and effective throughout their shelf life. Veoza does not require any special storage conditions, which makes it convenient for everyday use at home.
- Temperature: No special temperature requirements. Store at normal room temperature.
- Children: Keep Veoza out of the sight and reach of children at all times.
- Expiration: Do not use the tablets after the expiration date (EXP) printed on the carton and blister pack. The expiration date refers to the last day of the stated month.
- Packaging: Veoza is supplied in PA/aluminium/PVC/aluminium unit-dose blister packs. Keep tablets in the original blister packaging until you are ready to take them.
- Disposal: Do not throw unused medicines in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.
Available pack sizes include 10, 28, 30, and 100 film-coated tablets. Not all pack sizes may be marketed in your country.
What Does Veoza Contain?
Understanding the full composition of your medication can be important, particularly if you have known allergies or sensitivities to certain excipients (inactive ingredients). Below is the complete composition of Veoza 45 mg film-coated tablets:
Active Ingredient
Each film-coated tablet contains 45 mg of fezolinetant.
Inactive Ingredients (Excipients)
Tablet core: Mannitol (E421), hydroxypropylcellulose (E463), low-substituted hydroxypropylcellulose (E463a), microcrystalline cellulose (E460), and magnesium stearate (E470b).
Film coating: Hypromellose (E464), talc (E553b), macrogol (E1521), titanium dioxide (E171), and red iron oxide (E172).
Appearance
Veoza 45 mg tablets are round, light red, film-coated tablets with the manufacturer’s logo and “645” imprinted on the same side. The tablets are designed to be swallowed whole and should not be split, crushed, or chewed.
Marketing Authorization
Veoza is manufactured by Delpharm Meppel B.V., Hogemaat 2, 7942 JG Meppel, Netherlands. The marketing authorization holder is Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, Netherlands. Veoza has been approved by major regulatory authorities including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
Frequently Asked Questions About Veoza
No, Veoza is not a hormone replacement therapy (HRT). It is a completely non-hormonal medication. Unlike HRT, which works by supplementing estrogen and sometimes progesterone, Veoza works by blocking neurokinin 3 (NK3) receptors in the brain's temperature regulation center. It does not contain any hormones and does not affect estrogen levels in the body. This makes it a suitable alternative for women who cannot or prefer not to use hormonal treatments.
In clinical trials, patients taking Veoza 45 mg daily began experiencing reductions in the frequency and severity of hot flashes within the first week of treatment. The medication reaches steady-state blood concentrations within approximately 3 days of daily dosing. Most women notice meaningful clinical improvement within 4 weeks, with benefits continuing to accrue over the first 12 weeks of treatment. However, individual responses may vary.
This requires individual medical evaluation. While Veoza is non-hormonal and does not directly affect estrogen pathways, patients with a current or past history of breast cancer or other estrogen-related cancers should discuss the use of Veoza with their oncologist and gynecologist. Your healthcare team will weigh the potential benefits against any theoretical risks in the context of your specific cancer history and current treatment plan.
Liver function tests are required because fezolinetant is metabolized in the liver, and elevated liver enzymes (ALT, AST) have been observed in some patients during clinical trials. Although most elevations were mild and reversible, cases of more significant liver injury have been reported. Regular monitoring allows your doctor to detect any changes early, before they become clinically significant. If abnormalities are found, your doctor may adjust or discontinue your treatment to prevent further liver damage.
The prescribing information for Veoza does not specifically prohibit alcohol consumption. However, since Veoza is metabolized in the liver and requires liver function monitoring, it is advisable to discuss your alcohol intake with your doctor. Excessive alcohol consumption can stress the liver independently and may compound any hepatotoxic potential. Moderate alcohol use should be discussed with your healthcare provider on an individual basis.
Stopping Veoza does not cause withdrawal symptoms or rebound effects. However, your menopausal vasomotor symptoms (hot flashes and night sweats) are likely to return once the medication is discontinued, as the underlying cause (hormonal changes of menopause) remains. If you wish to stop taking Veoza, discuss this with your doctor first. There is no need to taper the dose gradually; you can stop taking it as directed by your doctor.
No, Veoza is specifically designed and approved only for the treatment of vasomotor symptoms (hot flashes and night sweats). It does not address other menopausal symptoms such as vaginal dryness, urinary symptoms, bone loss, or mood changes, as these are primarily related to estrogen deficiency and require different treatment approaches. If you are experiencing multiple menopausal symptoms, discuss a comprehensive management plan with your healthcare provider.
References
- European Medicines Agency (EMA). Veoza (fezolinetant) – Summary of Product Characteristics. 2024. Available at: EMA – Veoza EPAR.
- U.S. Food and Drug Administration (FDA). VEOZA (fezolinetant) tablets – Prescribing Information. 2023. FDA Approved Labeling.
- Lederman S, Ottery FD, Cano A, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled trial. The Lancet. 2023;401(10382):1091–1102.
- Johnson KA, Martin N, Nappi RE, et al. Efficacy and safety of fezolinetant in moderate-to-severe vasomotor symptoms associated with menopause: SKYLIGHT 2 phase 3 trial. J Clin Endocrinol Metab. 2023;108(7):1695–1706.
- Neal-Perry G, Cano A, Engeli RT, et al. Safety of fezolinetant for vasomotor symptoms of menopause over 52 weeks: SKYLIGHT 4 phase 3 trial. J Clin Endocrinol Metab. 2024;109(1):e198–e208.
- The North American Menopause Society (NAMS). The 2022 Hormone Therapy Position Statement. Menopause. 2022;29(7):767–794.
- International Menopause Society (IMS). Updated 2023 IMS Recommendations on Menopausal Hormone Therapy and Preventive Strategies for Midlife Health. Climacteric. 2023;26(4):255–274.
- Rance NE, Dacks PA, Mittelman-Smith MA, et al. Modulation of body temperature and LH secretion by hypothalamic KNDy (kisspeptin, neurokinin B and dynorphin) neurons: a novel hypothesis on the mechanism of hot flushes. Front Neuroendocrinol. 2013;34(3):211–227.
- World Health Organization (WHO). Menopause: Overview. 2022. Available at: who.int.
- British National Formulary (BNF). Fezolinetant. National Institute for Health and Care Excellence (NICE). 2024.
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January 2, 2026 – Content verified against current EMA SmPC, FDA label, and international clinical guidelines
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