Drug · Label read August 15, 2026
Veozah: what it costs, and the 5 blood draws the label actually asks for
Veozah (fezolinetant) is one 45 mg tablet taken once a day for moderate to severe menopausal hot flashes, and it lists at $566 a month. It carries a boxed warning for liver injury added on December 16, 2024, and the label requires a hepatic panel before your first dose plus 5 follow-up draws inside the first nine months: months one, two, three, six and nine. The schedule most pages still print, bloodwork at three, six and nine months, is what the label approved in 2023 required, and it is no longer what the label says. In its two registration trials, women on 45 mg had 2.6 and 2.5 fewer moderate to severe hot flashes a day than women on placebo at week 12. It is the route for women who cannot take estrogen, or who have decided against it. For women who can, the 2023 Menopause Society statement still calls hormone therapy the most effective treatment for these symptoms.
By Iacob Pastina. Every clinical figure below is read from a primary source: the FDA approval record on Drugs@FDA, the prescribing information on DailyMed, and the published trials on PubMed. Pricing is read from the page Astellas publishes it on.
This is general information, not medical advice. Veozah is a prescription medicine with a boxed warning and required bloodwork. Whether it is right for you is a decision for you and a licensed clinician.
What is Veozah?
Veozah is a prescription non-hormonal tablet for hot flashes: a neurokinin 3 (nk3) receptor antagonist approved by the FDA on May 12, 2023 under application 216578, with one labelled indication, the treatment of moderate to severe vasomotor symptoms due to menopause. It blocks the neurokinin 3 receptor in the brain's temperature-control signalling rather than replacing the estrogen that fell, which is why it is prescribed to women who cannot take hormones. Veozah is the brand name and fezolinetant is the molecule inside it, and neither is a hormone, a bioidentical, or a compounded preparation.
Non-hormonal does not mean low-maintenance. Veozah carries a boxed warning for hepatotoxicity and its label requires a liver panel before the first dose and 5 more inside nine months. Hormone therapy labels carry no equivalent required monitoring schedule. The full non-hormonal class, compared.
The boxed warning, and what the monitoring schedule costs you
Veozah was approved on May 12, 2023. The boxed warning came later, on December 16, 2024, through labeling supplement SUPPL-4 on application 216578. Its heading reads: WARNING: RISKS OF HEPATOTOXICITY. Hepatotoxicity has occurred with the use of VEOZAH in the postmarketing setting.
The schedule the label requires now
Before the first dose: ALT, AST, alkaline phosphatase, total bilirubin and direct bilirubin, before the first dose.
Then, in the label's own words: follow-up hepatic laboratory testing monthly for the first 3 months, at 6 months, and 9 months of treatment.
- Draw 1Month 1
- Draw 2Month 2
- Draw 3Month 3
- Draw 4Month 6
- Draw 5Month 9
Do not start if ALT or AST is at or above 2 times the upper limit of normal, or total bilirubin is at or above 2 times ULN. Discontinue if transaminases exceed 5 times ULN, or exceed 3 times ULN with total bilirubin above 2 times ULN.
The correction most pages have not made
Follow-up bloodwork at 3 months, 6 months and 9 months after starting. That is what the label approved in May 2023 required, in its own words, and it is no longer what the label requires. Most consumer pages about this drug still print it. Count them against each other and the difference is two extra blood draws in the first year, at months one and two. That is the window the current label points at when it says serious drug-induced hepatotoxicity occurred within 40 days of starting the drug.
Check it against the label as approved in May 2023 and the label as it reads now. DailyMed carries the current version only, so the old schedule is only checkable on the as-approved PDF.
Read that schedule as a year of your life rather than as a bullet point. It is 6 lab appointments inside nine months, each one a copay or a cash lab fee and a result somebody has to chase. Every missed draw is a month on a drug whose boxed warning exists precisely because the injury showed up after approval. It also means no honest telehealth provider can put this drug in a cart behind a questionnaire. Somebody has to order labs and read them before the first tablet.
Who cannot take Veozah
The label lists 3 contraindications.
- Known cirrhosis
- Severe renal impairment or end-stage renal disease
- Concomitant use of a CYP1A2 inhibitor
The CYP1A2 line is the one that catches people out, because it is a drug-interaction rule rather than a diagnosis, and the inhibitors include medicines a woman may already be taking without thinking of them as liver drugs. Bring the full list to the appointment, including anything over the counter.
On top of the contraindications, the label sets a starting gate on the bloodwork itself. Do not start if ALT or AST is at or above 2 times the upper limit of normal, or total bilirubin is at or above 2 times ULN.
What the trials showed, with the placebo column
Two 12-week registration trials sit in the label's Clinical Studies section. Both measured moderate to severe vasomotor symptoms per 24 hours. Both are reported here with the placebo arm beside the drug arm, because the placebo response in hot flash trials is large and a drug number quoted alone will mislead you about what the drug did.
| Trial | Veozah 45 mg | Placebo |
|---|---|---|
| Trial 1SKYLIGHT 1, NCT04003155Difference -2.6 a day (95% CI -3.4 to -1.7), p<0.001 | n=174. Baseline 10.4 a day, change -6.4.62% fewer, calculated | n=175. Baseline 10.5 a day, change -3.9.37% fewer, calculated |
| Trial 2SKYLIGHT 2, NCT04003142Difference -2.5 a day (95% CI -3.6 to -1.5), p<0.001 | n=167. Baseline 11.8 a day, change -7.5.64% fewer, calculated | n=167. Baseline 11.6 a day, change -5.43% fewer, calculated |
Changes are least-squares means from baseline at week 12. Percentages: Calculated from the label's own baseline count and least-squares mean change. Neither the label nor the published trial reports a percentage. Trials published as SKYLIGHT 1 (PMID 36924778) and SKYLIGHT 2 (PMID 36734148).
The honest reading. In Trial 1 the drug arm was down 62% and the placebo arm was down 37%. In Trial 2 it was 64% against 43%. What is attributable to Veozah is the gap between those columns, 2.6 and 2.5 fewer episodes a day. Real, and considerably smaller than the drug column alone reads.
SKYLIGHT 4, 52 weeks, 1,830 randomised and dosed
Liver enzyme elevations above 3 times the upper limit of normal, over 52 weeks. No Hy's law cases were reported.
- Placebo6 of 583
- Fezolinetant 30 mg8 of 590
- Fezolinetant 45 mg12 of 589
PMID 36897180. The 45 mg arm rate was about double the placebo arm rate on this measure, and the absolute counts are small in both. The boxed warning came from postmarketing reports rather than from this trial.
What Veozah costs
Astellas publishes the number, which is more than most drug makers in this category do. List price is $566.00 for a 30-day supply. Published by Astellas, sourced on that page to AnalySource data exported 1/13/25.
Average out of pocket, by coverage
- Commercial insurance$42 per month
- Medicare Part D$55 per month
- Medicaid$2 per month
Astellas footnotes all three to Symphony Health PatientSource, covering May 26, 2023 to January 3, 2025, and defines out-of-pocket cost as what the patient finally pays after any secondary insurance and savings card. There is no fourth row here on purpose. Astellas publishes no average out-of-pocket figure for uninsured patients. It shows the list price as what a patient without prescription insurance might pay, and directs that group to the Astellas Patient Assistance Program, which it says may bring the cost to $0 for patients who meet the eligibility requirements.
Savings program: you may pay $0 for the first month, as little as $30 per monthly refill. Commercial insurance only. Astellas states it is not valid for patients whose claims are reimbursed by any state or federal government program, naming Medicare and Medicaid. Read those two facts together and the Medicare Part D group, which carries the highest of the three published averages, is the one the card cannot help.
Cost page, Astellas and savings program terms, both read August 15, 2026.
Against what hormone therapy costs
The cheapest all-in monthly price on the 13women's-wing platforms we verify is Alloy at $40/mo, Transparency Grade A, and that number includes the medication. Veozah's list price is about 14 times that.
Two caveats keep that comparison honest. A woman with commercial insurance is not paying list for Veozah, she is paying nearer $42, while cash-pay HRT subscriptions are the same price insured or not. And the cheaper number buys a different thing: hormone therapy replaces the estrogen, Veozah works on the symptom signal without it. Price is the reason to check your formulary before you decide. The class of drug is a clinical decision.
The full price table is on our cheapest HRT comparison, sorted strictly by verified price.
If you can take estrogen, read this before you fill the prescription
The Menopause Society 2023 nonhormone therapy position statement puts it in one sentence: Hormone therapy remains the most effective treatment for vasomotor symptoms and should be considered in menopausal women within 10 years of their final menstrual periods. The same statement recommends fezolinetant at Level I, so this is a comparison between two recommended options rather than a warning against one of them.
For a woman with no contraindication to estrogen, hormone therapy is the more effective route by the guideline's own reading, it costs a fraction of the list price above, and it carries no required liver panel. Start with our scored provider rankings, then estradiol by delivery form and price, then the price-sorted table.
For a woman who cannot take estrogen, or who has decided against it, this drug class is the FDA-approved route and it has two members. Lynkuet (elinzanetant) is the newer one, with one follow-up liver draw instead of 5. The two side by side is the comparison to read next, and Veozah alternatives covers what else is in the pipeline and what is not.
FAQ
Veozah, answered
Is Veozah better than HRT?
No trial has compared them head to head, and the guideline position is the opposite. The Menopause Society's 2023 nonhormone therapy position statement says hormone therapy remains the most effective treatment for vasomotor symptoms and should be considered in menopausal women within 10 years of their final menstrual periods. The same statement recommends fezolinetant at Level I, so Veozah is a genuine option, and it is positioned as the option for women who cannot or will not take estrogen. Veozah also carries a boxed warning for liver injury and a monitoring schedule of a baseline hepatic panel plus 5 follow-up draws in the first nine months. Hormone therapy labels carry no equivalent required monitoring schedule.
How much does Veozah cost without insurance?
$566 for a 30-day supply. That is the list price Astellas publishes, and it describes it as what a patient without prescription insurance might pay. It publishes an average out-of-pocket figure for three coverage types only: $42 on commercial insurance, $55 on Medicare Part D, $2 on Medicaid. Astellas publishes no average out-of-pocket figure for uninsured patients. It shows the list price as what a patient without prescription insurance might pay, and directs that group to the Astellas Patient Assistance Program, which it says may bring the cost to $0 for patients who meet the eligibility requirements. The savings card is a separate program: you may pay $0 for the first month and as little as $30 per monthly refill. Commercial insurance only. Astellas states it is not valid for patients whose claims are reimbursed by any state or federal government program, naming Medicare and Medicaid. The highest of the three published averages, Medicare Part D at $55, belongs to a group the card will not cover.
Who cannot take Veozah?
The label lists three contraindications: known cirrhosis, severe renal impairment or end-stage renal disease, and concomitant use of a CYP1A2 inhibitor. Beyond those, the label says do not start treatment if ALT or AST is at or above 2 times the upper limit of normal, or if total bilirubin is at or above 2 times ULN, which is why the baseline blood panel comes before the first dose rather than after it. Treatment is discontinued if transaminases exceed 5 times ULN, or exceed 3 times ULN with total bilirubin above 2 times ULN. A provider who prescribes this drug off a questionnaire without ordering labs is skipping a step the label requires.
Does Veozah help lose weight?
The label gives one indication, quoted in full: "VEOZAH is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause." There is no weight-loss indication and no weight efficacy claim in the Clinical Studies section. Weight is not what this drug was studied to change and it is not what it was approved to change. Any weight claim you see attached to Veozah is coming from somewhere other than the prescribing information.
How often do you need blood tests on Veozah?
A hepatic panel before the first dose covering ALT, AST, alkaline phosphatase, total bilirubin and direct bilirubin, then 5 follow-up draws: monthly for the first three months, at six months, and at nine months. The older schedule, bloodwork at three, six and nine months, is what the label approved in May 2023 required, and it was replaced when the boxed warning was added in December 2024. Pages still printing the old schedule are understating the requirement by two draws.
Sources
- Veozah, Drugs@FDA application record (NDA 216578)
- Veozah prescribing information, DailyMed
- Veozah label as approved May 2023, Drugs@FDA (the superseded monitoring schedule)
- SKYLIGHT 1, fezolinetant phase 3 (PMID 36924778)
- SKYLIGHT 2, fezolinetant phase 3 (PMID 36734148)
- SKYLIGHT 4, 52-week safety (PMID 36897180)
- Veozah cost, published by Astellas
- Veozah savings program terms
- The Menopause Society 2023 nonhormone therapy position statement, Menopause 30(6):573-590
The FDA announcements that approved this drug and added its boxed warning are the source of record for both dates. They are named here rather than linked, because www.fda.gov returns a 404 to automated clients and a dead citation is worse than a named one. The approval and the labeling supplement are both visible on the Drugs@FDA application record linked above.
This is general information, not medical advice. Veozah is a prescription medicine with a boxed warning for liver injury and a monitoring schedule the label requires. Talk to a licensed clinician before starting, stopping or changing any treatment. Reviewed by Iacob Pastina.