Veozah for hot flashes: side effects, the liver warning, and who shouldn't take it

Is Veozah for hot flashes safe? The side effects of Veozah most women actually get

For most women, yes, with one condition covered in the next section: liver blood tests. Everyday side effects are uncommon and mostly mild.

First, a word on placebo. A placebo is a dummy pill with no medicine in it. People on a dummy pill report aches and bad nights too, so the gap between the two groups is what the drug itself adds.

The current FDA label for Veozah was revised in February 2026. Its side-effect table comes from one study: Trial 3, a year-long, placebo-controlled safety trial also called SKYLIGHT 4.

Each effect below was reported by at least 2% of women on Veozah 45 mg in that trial, and was more common than on placebo.

• Stomach pain. 4.3% on Veozah, 2.1% on placebo.
• Diarrhea. 3.9% on Veozah, 2.6% on placebo.
• Trouble sleeping, or insomnia. 3.9% on Veozah, 1.8% on placebo.
• Back pain. 3.0% on Veozah, 2.1% on placebo.
• Hot flushes. 2.5% on Veozah, 1.6% on placebo. It sounds odd for a hot flash drug, but the label lists it.
• Raised liver enzymes. 2.3% on Veozah, 0.8% on placebo. This is a blood test result, and it usually causes no symptoms.

The biggest gap on that list is about 2 extra women in every 100, for stomach pain and for insomnia.

Side effects of any kind were just as common on the dummy pill. In SKYLIGHT 4, 63.9% of women on Veozah reported at least one, against 64.1% on placebo.

Having a side effect is not the same as quitting over one. In that trial, 4.6% of women on Veozah stopped treatment because of an adverse event, meaning any unwanted medical event. On placebo, 4.3% stopped.

The boxed liver warning: how rare it is and what it asks of you

A boxed warning is the FDA's strongest label alert, printed in a black box at the top of the prescribing information. Veozah received one on December 16, 2024.

It rests on one reported case. A woman with normal liver tests developed fatigue, nausea, itching, and yellow eyes and skin within 40 days of starting Veozah.

After she stopped the drug, her symptoms gradually went away. Her blood tests slowly returned to normal.

The FDA first flagged the risk in September 2024 and calls it rare but serious. In December it moved the warning into the box and asked for more frequent testing.

In the trials, the signal was smaller. ALT and AST are liver enzymes that leak into the blood when liver cells are under strain.

Across three trials, ALT or AST rose above three times the normal limit in 2.3% of women on Veozah and 0.9% on placebo.

The label says those women generally had no symptoms. Their levels went back to where they started, whether they kept taking Veozah, paused it or stopped. A pooled safety analysis found no trial case of severe drug-induced liver injury.

The blood test schedule

• Before your first pill. A liver blood panel checks ALT, AST, alkaline phosphatase and bilirubin.
• Months 1, 2 and 3. One test each month.
• Months 6 and 9. One test at each.

That routine schedule ends at month 9. Symptoms at any point still mean stopping and getting checked, as listed below.

The numbers your prescriber watches

Labs report each result against an upper limit of normal. Bilirubin is a yellow pigment the liver clears, and it builds up when the liver struggles.

• Do not start. ALT or AST is already at twice the upper limit of normal or higher, or bilirubin is. This rule comes from the boxed warning.
• Test more often. ALT or AST climbs above three times the upper limit. Tests then come more often until levels settle.
• Stop. ALT or AST climbs above five times the upper limit of normal.
• Stop. ALT or AST climbs above three times the upper limit, and bilirubin climbs above twice the upper limit.

Symptoms that mean stop and call

The FDA says to stop Veozah right away and call the prescriber if you notice any of these:

• Feeling more tired than usual
• Nausea or vomiting
• Unusual itching
• Light-colored stools
• Yellow eyes or skin, called jaundice
• Dark urine
• Swelling in the belly, or pain in the upper right side of it

For how the monitoring plays out in practice, and where the lawsuits stand, see is Veozah legit?.

Who shouldn't take Veozah

Section 4 of the label lists three contraindications. A contraindication is a firm reason never to use a drug.

• Cirrhosis. Any known cirrhosis, which is scarring of the liver. Even mild liver impairment raised the amount of drug in the blood.
• Severe kidney disease or kidney failure. This includes end-stage kidney disease. Mild or moderate kidney problems need no change.
• Drugs that block CYP1A2. CYP1A2 is the liver enzyme that breaks Veozah down. Blocking it lets the drug build up. With fluvoxamine, a strong blocker, total exposure was about nine times higher.

The label's drug studies tested three blockers. Fluvoxamine is an antidepressant, mexiletine is a heart rhythm drug, and cimetidine is an acid reducer.

Even cimetidine, the weakest of the three, doubled the amount of Veozah in the blood. The label says weak, moderate and strong blockers all raise Veozah levels, so your full medication list matters.

Groups the trials barely studied

• Women over 65. The main trials enrolled women aged 40 to 65. The label says too few older women took part to know whether they respond differently.
• Breast cancer survivors. The label says nothing about breast cancer. Astellas began a trial in 2024 in women taking hormone-blocking therapy after breast cancer, and its results are not in the label.
• Pregnancy and breastfeeding. The label has no human data on either.

Does Veozah make you sleepy, or keep you awake?

Veozah is more likely to keep you up than make you drowsy. Insomnia is on the label's table, at 3.9% versus 1.8% on placebo.

Sleepiness, which doctors call somnolence, does not appear anywhere in the Veozah prescribing information. It is also missing from the trials' list of frequent side effects.

Lynkuet is different. It is elinzanetant from Bayer, a second non-hormonal hot flash pill, approved by the FDA on October 24, 2025.

Its label carries a warning about sleepiness and slowed reactions, and it is taken at bedtime. In its year-long trial, somnolence affected 5.1% of women on Lynkuet and 1.3% on placebo.

The Lynkuet label also says to avoid driving until those effects pass. Our Veozah alternatives page puts the two pills side by side.

Does Veozah cause headaches?

Probably not more than you would get anyway. Headache is not on the label's side-effect table.

Headaches were common in every group. In the pooled analysis of three trials, they were about as common on Veozah as on placebo: 8.2% versus 7.7%.

So a headache on Veozah may well be unrelated to the pill. What women report day to day is collected in our Veozah reviews guide.

Does Veozah cause hair loss?

Hair loss does not appear on the Veozah label. That includes Section 6.2, where the label records problems reported after the drug went on sale. That section describes only liver injury.

Hair loss was also absent from the list of frequent side effects in the pooled trial data.

Hair often thins in midlife as hormones shift, whatever you take for hot flashes. Our guide to perimenopause hair loss walks through the usual causes and what helps.

Veozah and alcohol

The Veozah label does not mention alcohol. It sets no limit and lists no interaction.

Since the one serious risk involves the liver, tell your prescriber how much you usually drink. It helps them read your liver tests.

For coffee, food and drinks while on the pill, see our Veozah diet guide.

Weight, mood, blood pressure, uterine lining and bones

None of these is on the label's side-effect table. Here is what the trials reported.

The pooled figures combine three trials. Placebo groups there were followed for less time on average, which tends to make placebo rates look lower, not higher.

• Weight. The label does not list weight gain. In the pooled data, weight gain was reported by 0.7% of women on Veozah and 1.1% on placebo.
• Mood. Depression was reported by 1.9% of women on Veozah and 2.0% on placebo.
• Blood pressure. High blood pressure was reported by 2.4% of women on Veozah and 2.3% on placebo.
• Uterine lining. The endometrium is the lining of the uterus. A biopsy takes a small tissue sample from it to look at under a microscope. After 12 months, biopsies found one overgrown lining and one cancer among 350 women on Veozah 45 mg, and none among 186 on placebo.
• Bones. In SKYLIGHT 4, changes in bone density were similar on Veozah and placebo. Veozah is not approved to protect bones.

Together, those two lining findings came to 0.6% of the women biopsied on Veozah. FDA guidance asks that this rate stay at 1% or less, and the label says Veozah met that bar.

Can I stop taking Veozah?

Yes. Veozah comes in one strength, taken once a day, and the label gives no tapering steps.

The pill quiets the brain signal behind hot flashes only while you take it. It does not change the hormone shift underneath, so hot flashes can come back after you stop.

The label does not describe what happens after stopping.

Missed a dose? The label says to take it as soon as possible, unless the next dose is less than 12 hours away. Then go back to your usual schedule the next day.

The brain side of all this is explained in how Veozah works.

How Veozah's side effects compare with HRT and other hot flash medication

Veozah is one of several real options. The Menopause Society's 2023 position statement recommends non-hormonal drugs including fezolinetant, SSRI and SNRI antidepressants, gabapentin and oxybutynin.

On benefit, pooled data from SKYLIGHT 1 and 2 show 58.7% of women on Veozah cut their hot flashes at least in half by week 12, against 36.0% on placebo.

• Hormone therapy, or HRT. Estrogen remains the most effective hot flash treatment, and it also helps bones and vaginal dryness. On February 12, 2026, the FDA approved new labels for six HRT products that drop heart disease, breast cancer and probable dementia from the boxed warning. The endometrial cancer warning stays boxed on estrogen-alone products. HRT is not used to protect the heart.
• Lynkuet. No boxed warning. Its label flags sleepiness, dizziness and fatigue, asks for liver tests before starting and at three months, and rules out use in pregnancy.
• Low-dose paroxetine. An SSRI antidepressant approved for hot flashes as Brisdelle. Like all SSRIs, it carries a boxed warning about suicidal thoughts. Its label warns it may weaken tamoxifen, a breast cancer drug.
• Gabapentin. A seizure and nerve pain drug used off-label for hot flashes, meaning without FDA approval for that use. Drowsiness and dizziness are its best-known side effects.

Every option has a trade-off. Veozah's is liver monitoring, while others bring drowsiness, hormone cautions or drug interactions.

For the head-to-head with estrogen, read Veozah vs HRT. The full menu is in menopause treatment options.

So is Veozah worth the side-effect risk?

For many women who can't or won't use estrogen, the trade is reasonable. Everyday side effects run close to placebo, and the liver risk comes with a clear testing plan.

• You can't take estrogen and your liver tests are normal. This is the woman Veozah was built for, as long as the blood test schedule fits your life.
• You take fluvoxamine, or have cirrhosis or severe kidney disease. Veozah is off the table, and the other options above are where to look.
• You already sleep badly. Veozah's sleep-related side effect is insomnia, while Lynkuet leans toward drowsiness. That difference can guide the choice.
• You can take estrogen and want the strongest relief. HRT usually does more for hot flashes, and it treats other menopause symptoms too.

If hot flashes are still new to you, start with perimenopause hot flashes. For how it went for other women, read Veozah reviews. For timing, see Veozah results, and for the full picture, our Veozah review.