Prescription medicine
Fezolinetant Brand names: Veozah
Fezolinetant (Veozah) is a prescription medicine with an FDA approval on record since 2023. No generic is listed; pharmacies paid $18.58 per Veozah 45 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the fezolinetant FDA label on DailyMed (effective February 26, 2026, Astellas Pharma US, Inc.); the NDA 216578 record on Drugs@FDA; every fezolinetant label on DailyMed.
Highlights of the record
FDA label of February 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RISKS OF HEPATOTOXICITY.
Hepatotoxicity has occurred with the use of VEOZAH in the postmarketing setting ( 5.1 ).
Perform hepatic laboratory tests prior to initiation of treatment to evaluate for hepatic function and injury. Do not start VEOZAH if either aminotransferase is ≥ 2 x the upper limit of normal (ULN) or if the total bilirubin is ≥ 2 x ULN for the evaluating laboratory.
Perform follow-up hepatic laboratory testing monthly for the first 3 months, at 6 months, and 9 months of treatment ( 2.1 , 5.1 ).
Advise patients to discontinue VEOZAH immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury (new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain) ( 2.1 , 5.1 ).
Discontinue VEOZAH if transaminase elevations are > 5 x ULN, or if transaminase elevations are > 3 x ULN and the total bilirubin level is > 2 x ULN.
If transaminase elevations > 3 x ULN occur, perform more frequent follow-up hepatic laboratory tests until resolution ( 5.1 ). WARNING: RISKS OF HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity has occurred with the use of VEOZAH in the postmarketing setting ( 5.1 ). […]
Used for
From the label: indications and usageVEOZAH ® is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
Forms and strengths
- 45 mg
Film-coated tablet.
On the market
- Earliest approval on file
- May 12, 2023 Veozah, Astellas; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 28, 2034 Veozah tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $18.58 per tablet Veozah 45 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,122 through July 30, 2026
What is fezolinetant used for?
From the label: indications and usageVEOZAH ® is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. VEOZAH is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
Conditions named in the indications of fezolinetant's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Neurokinin 3 Receptor Antagonist.
Source: FDA drug label (VEOZAH), Astellas Pharma US, Inc., effective February 26, 2026 (SPL set cae9f798-24f9-4580-a4fc-e6c710cbda3c), via openFDA; the full label on DailyMed
What does the patient leaflet for fezolinetant say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about VEOZAH?VEOZAH can cause serious side effects, including: • Liver Problems. Your healthcare provider will do a blood test to check your liver before you start taking VEOZAH. Your healthcare provider will also do this blood test monthly for the first 3 months, at month 6, and month 9 after you start taking VEOZAH or if you have signs or symptoms that suggest liver problems. If your liver blood test values are elevated, your healthcare provider may advise you to stop treatment or request additional liver blood tests. Stop VEOZAH right away and call your healthcare provider if you have the following signs or symptoms of liver problems: • feeling more tired than you do usually • decreased appetite • nausea • vomiting • itching • yellowing of the eyes or skin (jaundice) • pale feces • dark urine • pain in the stomach (abdomen) See “ What are the possible side effects of VEOZAH? ” for more information about side effects.
From the patient leaflet: How should I store VEOZAH?Store VEOZAH at room temperature between 68°F to 77°F (20°C to 25°C). • Dispose of the unused medicine through a take-back option, if available. See www.fda.gov/drugdisposal for more information. • Keep VEOZAH and all medicines out of the reach of children.
Source: FDA drug label (VEOZAH), Astellas Pharma US, Inc., effective February 26, 2026 (SPL set cae9f798-24f9-4580-a4fc-e6c710cbda3c), via openFDA; the full label on DailyMed
Is there a generic for fezolinetant (Veozah)?
No generic fezolinetant is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Veozah tablets: the compound patent runs to March 28, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fezolinetant (Veozah)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $18.58 per Veozah 45 mg tablet, up 3% from $18.08 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Veozah 45 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Veozah 45 mg tablet | Brand | $18.58 per tablet | $557.47 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for fezolinetant?
The FDA Adverse Event Reporting System holds 2,122 reports that list fezolinetant among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 84 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as fezolinetant?
6 other medicines are given the same way (oral) and in the same FDA class as fezolinetant or labeled mainly for the same use (menopause symptoms), the same class first. Menopause symptoms lists all 11 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Estradiol | Menopause symptoms | 21 labelers | $0.0635 per tablet 1 mg tablet | No current entry |
| Estradiol and norethindrone | Menopause symptoms | 7 labelers | $0.802 per tablet 0.5-0.1 mg tablet | No current entry |
| Estrogens conjugated | Menopause symptoms | 1 labeler | $5.47 per tablet 0.625 mg tablet | No current entry |
| Drospirenone and estradiol | Menopause symptoms | none listed | $6.37 per tablet 0.25 mg-0.5 mg tablet | No current entry |
| Elinzanetant | Menopause symptoms | none listed | $9.97 per capsule 60 mg capsule | No current entry |
| Ospemifene | Menopause symptoms | none listed | $8.17 per tablet 60 mg tablet | No current entry |
Every medicine labeled for the same conditions as fezolinetant
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to fezolinetant
- 6 medicines for the same use
- Fezolinetant side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other