Elinzanetant
Elinzanetant (Lynkuet) is a non-hormonal oral capsule used to treat moderate to severe vasomotor symptoms (hot flashes and night sweats) due to menopause.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Elinzanetant: Patient Information Guide
A plain-language walkthrough of Elinzanetant — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Elinzanetant is used to treat vasomotor symptoms (hot flashes and night sweats) caused by menopause.
- Lynkuet capsules (oral): Approved for the treatment of moderate to severe vasomotor symptoms due to menopause
⚙️How it works▾
Elinzanetant works by blocking two receptors in the brain — neurokinin 1 (NK1) and neurokinin 3 (NK3). These receptors sit on a group of nerve cells that help regulate body temperature. During menopause, changing hormone levels can over-activate these nerve cells, setting off hot flashes. By blocking the NK1 and NK3 signals — carried by proteins called Substance P and Neurokinin B — elinzanetant helps quiet the misfiring temperature-control circuit and reduce the frequency and intensity of hot flashes.
💊How it's taken▾
Lynkuet comes as an oral capsule and is taken once a day at bedtime, at roughly the same time each night. It can be taken with or without food, but always swallow the capsules whole with water — do not cut, crush, or chew them.
- If you miss a bedtime dose, skip it and take your next dose the following night as scheduled
- Never take two doses in one day to make up for a missed one
- If you are also taking a moderate CYP3A4 inhibitor, your prescriber may lower your Lynkuet dose — follow their specific instructions
🤒Side effects — in detail▾
The most commonly reported side effects with Lynkuet include:
- Headache
- Fatigue or tiredness
- Dizziness (including balance problems and vertigo)
- Drowsiness (somnolence)
- Nausea
- Abdominal pain
- Diarrhea
- Rash
- Muscle spasms
More serious reactions include liver enzyme elevations and seizure — get medical help right away if you notice signs of liver injury (jaundice, dark urine, severe stomach pain) or if you have a seizure.
⚠️Warnings & precautions▾
- Drowsiness and impairment: About 12% of people taking Lynkuet in trials experienced nervous system effects like drowsiness, dizziness, or lightheadedness. Do not drive or use heavy machinery until you know how the medicine affects you.
- Liver injury risk: Liver enzyme elevations have been reported. Blood tests are required before you start Lynkuet and should be repeated 3 months into treatment. Stop immediately and seek care if you develop jaundice, dark urine, pale stools, unusual fatigue, or stomach pain.
- Seizure risk: Seizures have been reported. Use Lynkuet cautiously if you have a history of seizures or conditions that lower your seizure threshold.
- Pregnancy: Lynkuet must not be used during pregnancy — animal studies show it can cause pregnancy loss or stillbirth. Use effective contraception during treatment and for 2 weeks after stopping.
🔀What it interacts with▾
Elinzanetant is primarily broken down by a liver enzyme called CYP3A4, so drugs and foods that affect this enzyme can significantly change how much elinzanetant is in your body.
- Strong CYP3A4 inhibitors (e.g., certain antifungals, some antibiotics, some HIV medications): Avoid — these raise elinzanetant levels and increase the chance of side effects
- Grapefruit and grapefruit juice: Avoid — acts like a strong CYP3A4 inhibitor and can raise elinzanetant levels
- Moderate CYP3A4 inhibitors: Can be used with a lower Lynkuet dose — your prescriber will adjust your regimen
- Strong or moderate CYP3A4 inducers (e.g., certain anti-seizure or tuberculosis medications): Avoid — these lower elinzanetant levels and may make Lynkuet ineffective
- CYP3A4 substrate medications: Lynkuet mildly inhibits CYP3A4, so it can raise the blood levels of other drugs processed by this enzyme — your prescriber or pharmacist should review your full medication list
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Lynkuet is contraindicated (must not be used) during pregnancy due to risk of pregnancy loss or stillbirth — a negative pregnancy test is required before starting
- Reproductive-age women: Use effective contraception during treatment and for 2 weeks after stopping; stop and tell your doctor immediately if you become pregnant
- Breastfeeding: There are no human data on elinzanetant in breast milk; the drug is present in animal milk — discuss the risks with your doctor before breastfeeding
- Liver impairment: Not recommended for people with moderate to severe hepatic (liver) impairment; liver blood tests are required before starting
- End-stage kidney disease: Not recommended
- History of seizures: Use with extra caution; inform your doctor
- Children: Not approved for use in pediatric patients — safety and efficacy have not been established
- Adults over 65: Limited data available; discuss any concerns with your prescriber
🚑If you take too much▾
There is no specific antidote for a Lynkuet overdose. If too much is taken, the person should be closely monitored and treated based on any symptoms that develop. If you suspect an overdose, seek emergency medical attention right away.
📡Pharmacodynamics — effects in the body▾
In clinical studies, single doses of elinzanetant at up to five times the maximum recommended dose did not cause a clinically meaningful prolongation of the QTc interval — a heart-rhythm measurement tracked in drug safety studies. However, the effect on heart rhythm when elinzanetant is combined with strong CYP3A4 inhibitor medications has not been fully studied, which is one reason that combination is to be avoided.
🔬Pharmacokinetics — how your body processes it▾
After daily dosing, elinzanetant reaches steady-state blood levels (a stable plateau in the body) within 5 to 14 days. Drug levels in the blood increase at a rate greater than proportional to the dose — meaning doubling the dose raises blood levels by more than double — so staying at the prescribed dose is important. Elinzanetant is primarily broken down by the CYP3A4 enzyme system in the liver, which is why drugs and foods that affect CYP3A4 can significantly change how much elinzanetant is active in the body.
📦How to store it▾
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F) . Store the remaining capsule in the original blister card in the carton until the next dose.
📄 Written from Elinzanetant’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Elinzanetant — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does Lynkuet do for hot flashes? ▾
Can I take Lynkuet if I'm still having periods or could get pregnant? ▾
Will Lynkuet make me drowsy during the day? ▾
I've heard this medicine can affect the liver — should I be worried? ▾
Are there any medicines or foods I need to avoid while taking Lynkuet? ▾
Can I cut or crush the capsules if I have trouble swallowing them? ▾
Is Elinzanetant available over the counter? ▾
When was Elinzanetant first available? ▾
💬 Answers drafted from Elinzanetant’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Elinzanetant comes
Elinzanetant is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Lynkuet capsules are used to treat moderate to severe vasomotor symptoms (hot flashes and night sweats) due to menopause
- Lynkuet capsules are taken once daily at bedtime, at about the same time each night
- Lynkuet can be taken with or without food
- Swallow Lynkuet capsules whole with water — do not cut, crush, or chew them
- If you miss a bedtime dose of Lynkuet, skip it and resume your usual schedule the next night — never take two doses in one day
📊 Elinzanetant across the U.S. market
How Elinzanetant appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
🔍 Compare Elinzanetant products
A representative set of FDA-listed product records for Elinzanetant — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 60 mg | Oral | Bayer HealthCare Pharmaceuticals Inc. × 2 listings | NDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Elinzanetant NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Elinzanetant — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Elinzanetant in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Elinzanetant went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2725511 1 dose form · 1 strength
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Dose form (SCDF) Oral Capsule RxCUI 2725515In current FDA listingsClinical drug / strength (SCD) 60 MGRxCUI 2725516
Look up RxCUI 2725511 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Elinzanetant is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Elinzanetant belongs to the Other gynecologicals class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Bayer HealthCare Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.