What the label lists and what reports show
Fezolinetant side effects
Fezolinetant's FDA label: “The most common adverse reactions with VEOZAH [at least 2% in VEOZAH 45 mg and greater than placebo] are: abdominal pain, diarrhea, insomnia, back pain, hot flush, and hepatic transaminase elevation.” FAERS holds 2,122 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is alanine aminotransferase increased (192 reports).
- 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 FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of VEOZAH?VEOZAH can cause serious side effects, including: • See “ What is the most important information I should know about VEOZAH? ” Common side effects of VEOZAH include: • stomach (abdominal) pain • diarrhea • difficulty sleeping (insomnia) • back pain • hot flashes or hot flushes Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of VEOZAH. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, 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 label list?
From the label: adverse reactionsThe most common adverse reactions with VEOZAH [at least 2% in VEOZAH 45 mg and greater than placebo] are: abdominal pain, diarrhea, insomnia, back pain, hot flush, and hepatic transaminase elevation.
Table 1: Adverse Reactions Reported in at Least 2% in VEOZAH 45 mg and Greater Than Placebo in a Placebo‑Controlled, Double-Blind 52-Week Trial (Trial 3)
| Adverse Reaction | VEOZAH 45 mg (n=609) Total Person-Years=504.2 n (%, EAIR EAIR = Number of individuals experiencing an adverse event divided by exposure… | Placebo (n=610) Total Person-Years=475.0 n (%, EAIR ) |
|---|---|---|
| Abdominal pain Abdominal pain (including Abdominal pain, Abdominal pain lower, Abdominal… | 26 (4.3%, 5.2) | 13 (2.1%, 2.7) |
| Diarrhea | 24 (3.9%, 4.8) | 16 (2.6%, 3.4) |
| Insomnia | 24 (3.9%, 4.8) | 11 (1.8%, 2.3) |
| Back pain | 18 (3.0%, 3.6) | 13 (2.1%, 2.7) |
| Hot flush | 15 (2.5%, 3.0) | 10 (1.6%, 2.1) |
| Hepatic transaminase elevation Hepatic transaminase elevations (including Alanine… | 14 (2.3%, 2.8) | 5 (0.8%, 1.1) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed elsewhere in the labeling: • Hepatic Transaminase Elevation and Hepatotoxicity [see Warnings and Precautions ( 5.1 )]. The most common adverse reactions with VEOZAH [at least 2% in VEOZAH 45 mg and greater than placebo] are: abdominal pain, diarrhea, insomnia, back pain, hot flush, and hepatic transaminase elevation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of VEOZAH was evaluated in three 52-week clinical trials [see Clinical Studies ( 14 )]. Across the three clinical trials, a total of 1100 women received VEOZAH. Trials 1 and 2 were placebo-controlled for the first 12 weeks, followed by re-randomization of women previously receiving placebo to VEOZAH (women on VEOZAH remained on VEOZAH) for an additional 40 weeks of uncontrolled treatment. Trial 3 was a randomized, placebo-controlled, double-blind safety study evaluating the safety of VEOZAH for 52 weeks. …
Source: FDA drug label, Astellas Pharma US, Inc., effective February 26, 2026 (SPL set cae9f798-24f9-4580-a4fc-e6c710cbda3c), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,122 reports list fezolinetant among the medicines taken, 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. Of the 21 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Fezolinetant: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions