Aprocitentan
Aprocitentan (Tryvio) is a blood pressure-lowering medicine used to treat high blood pressure in adults whose blood pressure is not controlled on other medications.
🧬 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 →
Aprocitentan (Tryvio), on the U.S. market since 2024, is an add-on for blood pressure that stays high despite other medicines, which you keep taking; it blocks both receptors for endothelin-1, a natural chemical that tightens blood vessels. It is generally well tolerated; the side effect people notice most is swelling in the legs or feet from fluid retention. Its boxed warning is for serious birth defects, so anyone who could become pregnant needs a pregnancy test first and reliable contraception throughout and for one month after stopping. Expect liver tests and blood counts before starting and periodically after, since it can harm the liver and lower red cells.
Clinical pearls
- Swallow the tablet whole once daily, with or without food, and skip a missed dose rather than doubling up.
- Stop it and get care right away for yellow skin or eyes, dark urine, or pain under the right ribs.
- Report rapid weight gain or new breathlessness promptly; older adults and people with kidney disease are most prone to fluid buildup.
- It is not for use while breastfeeding, and in men it may lower sperm counts, worth raising before planning a family.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Tryvio must not be taken during pregnancy. Based on animal studies, it can cause serious birth defects or fetal death. If you can become pregnant, you must take a pregnancy test before starting Tryvio and use reliable contraception throughout treatment and for one month after your last dose. If you become pregnant while taking Tryvio, stop the medication as soon as possible and contact your doctor right away.
Patient information guide A plain-language walkthrough of Aprocitentan, written from its FDA label.
What Aprocitentan is used for
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Aprocitentan is an ingredient used to treat high blood pressure when other medications haven't done the job.
- Tryvio (oral tablet) is approved to treat high blood pressure (hypertension) in adults who are not adequately controlled on other antihypertensive drugs — it is always used in combination with other blood pressure-lowering medications, never alone.
- Lowering blood pressure with treatment like Tryvio reduces the overall risk of fatal and non-fatal cardiovascular events, primarily strokes and heart attacks, though Tryvio itself has not been studied in a controlled trial for those specific outcomes.
How Aprocitentan works
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Aprocitentan works by blocking endothelin receptors — specifically the ET-A and ET-B receptors. Endothelin-1 (ET-1) is a natural chemical in the body that causes blood vessels to constrict (tighten) and can promote inflammation, scarring, and vascular thickening. In people with high blood pressure, ET-1 contributes to stiff, narrowed blood vessels, which forces the heart to work harder. By blocking the receptors that ET-1 normally binds to, aprocitentan helps relax blood vessels and lower blood pressure.
Aprocitentan dosage
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Tryvio tablets are taken once a day by mouth, and can be taken with or without food. Swallow the tablet whole. If you miss a dose, skip it — take your next dose at the usual time and do not double up. Your prescriber will determine the right dose for you; do not adjust it on your own.
Dosing details from the FDA-approved label
From the Aprocitentan prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended Dosage (TRYVIO)
- 12.5 mg orally once daily, with or without food
- Swallow tablets whole
- If a dose is missed, skip the missed dose and take the next dose at the regular time
- Do not take two doses on the same day
- May be taken with or without food
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION The recommended dosage of TRYVIO is 12.5 mg orally once daily, with or without food. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of TRYVIO is 12.5 mg orally once daily. Swallow tablets whole. TRYVIO may be taken with or without food. If a dose is missed, skip the missed dose and take the next dose at the regular time. Do not take two doses on the same day. 2.2 Pregnancy Testing in Females of Reproductive Potential Exclude pregnancy before initiating treatment with TRYVIO in females of reproductive potential [see Boxed Warning , Contraindications (4.1) , Warnings and Precautions (5.1) , Use in Specific Populations (8.3) ] .
Read the full Dosage and Administration section on DailyMed →
Aprocitentan side effects
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The most common side effects reported with Tryvio include:
Common side effects
- Swelling or fluid retention (edema), especially in the legs or feet
- Anemia (low red blood cell levels, which may cause fatigue or weakness)
- Hypersensitivity reactions such as rash or skin redness
When to get medical help
- Call your doctor right away if you notice yellowing of the skin or eyes, dark urine, nausea, vomiting, right-sided stomach pain, or unusual fatigue — these can be signs of liver damage
- Contact your doctor if you experience significant weight gain, worsening swelling, or difficulty breathing — signs of fluid retention or worsening heart failure
- Tell your doctor if you feel unusually tired or short of breath — this could signal a significant drop in hemoglobin (red blood cell levels)
- Stop Tryvio and seek medical help immediately if you develop a severe allergic reaction (serious rash, swelling, or breathing difficulty)
- If you are pregnant or think you might be pregnant, stop taking Tryvio and contact your doctor immediately
Serious reactions to watch for include signs of liver damage (yellowing of skin or eyes, dark urine, stomach pain), significant fluid buildup, or a severe allergic reaction — contact your doctor or get medical help right away if these occur.
Aprocitentan warnings and precautions
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- Embryo-fetal toxicity: Tryvio is contraindicated in pregnancy. It can cause birth defects or fetal death. Anyone who can become pregnant must use effective contraception before, during, and for one month after stopping treatment, and must have a negative pregnancy test before starting.
- Liver damage (hepatotoxicity): This class of drug can cause elevated liver enzymes and liver damage. Liver tests are required before and during treatment. Stop Tryvio and seek care immediately if you develop symptoms like jaundice, dark urine, or abdominal pain.
- Fluid retention: Swelling and fluid buildup are known effects; older adults and those with kidney disease are at higher risk. Tryvio is not recommended in patients with severe or unstable heart failure.
- Hemoglobin decrease: Tryvio can lower red blood cell levels early in treatment. Not recommended for people who already have severe anemia.
- Decreased sperm counts: Tryvio may impair male fertility. Whether this is reversible is unknown.
Aprocitentan interactions
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The FDA label for Tryvio does not specify particular drug-drug interactions. Always tell your prescriber and pharmacist about all medications, supplements, and herbal products you take.
- No specific drug, food, or substance interactions are listed in the available prescribing information for Tryvio — consult your pharmacist or prescriber for personalized guidance.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Aprocitentan
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- Pregnancy: Tryvio is contraindicated — do not use it if you are pregnant. A pregnancy test is required before starting.
- People who can become pregnant: Must use effective contraception before, during, and for one month after stopping Tryvio.
- Breastfeeding: Do not breastfeed while taking Tryvio — the drug may pass into breast milk and harm a nursing infant.
- Liver disease: Do not start Tryvio if you have moderate to severe liver impairment or already elevated liver enzymes (more than 3 times the normal upper limit).
- Severe anemia: Tryvio is not recommended if you already have very low red blood cell levels.
- Severe or unstable heart failure: Tryvio has not been studied in patients with advanced heart failure or unstable cardiac function and is not recommended in these patients.
- Older adults: Fluid retention and swelling are more common in patients 65 and older — your doctor will monitor for this. No dose adjustment is required based on age alone.
- Kidney impairment: Tryvio can cause an initial small decline in kidney filtration (eGFR) that typically stabilizes. It is not recommended in patients with kidney failure. Older age and chronic kidney disease raise the risk of fluid retention.
- Children: Safety and effectiveness in patients under 18 have not been established.
- Men trying to father children: Tryvio may reduce sperm counts and could affect fertility.
Aprocitentan overdose
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In studies, healthy volunteers took much higher amounts of aprocitentan than the recommended dose; symptoms seen included headache, nasal congestion, nausea, and upper respiratory tract infection. If you suspect an overdose, call Poison Control at 1-800-222-1222 or go to an emergency room. Dialysis is unlikely to help because aprocitentan binds very tightly to proteins in the blood.
What Aprocitentan does in the body
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Aprocitentan blocks both ET-A and ET-B receptors, preventing endothelin-1 from triggering blood vessel constriction and other harmful effects. At doses much higher than the recommended amount, Tryvio did not cause clinically significant changes in the heart's electrical rhythm (QTc interval prolongation). The full relationship between blood levels of the drug and its blood pressure-lowering effect is not completely characterized.
How your body processes Aprocitentan
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After taking Tryvio by mouth, blood levels peak roughly 4 to 5 hours later. Food does not meaningfully affect how the drug is absorbed, so it can be taken with or without a meal. Aprocitentan has a long effective half-life of about 41 hours, meaning it stays active in the body well beyond a single day and reaches steady, stable levels in the blood by about Day 8 of once-daily dosing. The drug is broken down mainly by liver enzymes and excreted primarily through the urine, with a smaller amount passing through the stool. Its processing is not significantly affected by age, sex, race, body weight, mild-to-moderate liver impairment, or mild-to-severe kidney impairment.
How to store Aprocitentan
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Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) . Store in the original package. Protect from light and moisture.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Aprocitentan
189 supplements and herbal products have documented interactions with Aprocitentan in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 7
- Moderate · 161
- Minor · 21
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Aprocitentan has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Aprocitentan: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Aprocitentan — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Tryvio for — and will it replace my other blood pressure medications?
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How and when should I take Tryvio?
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What side effects should I watch out for?
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I'm a woman of childbearing age — what do I need to know before starting this medication?
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Will my doctor need to run any tests while I'm on this medication?
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I'm a man — could Tryvio affect my fertility?
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Is Aprocitentan available over the counter?
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When was Aprocitentan first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Aprocitentan on HelloPharmacist
Aprocitentan forms and strengths (how it comes)
Aprocitentan 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.
Tablet
How this form is used
- Tryvio tablets are used to treat high blood pressure (hypertension) in adults whose blood pressure is not adequately controlled on other antihypertensive medications
- Tryvio is always used in combination with at least one other blood pressure-lowering drug, not as a standalone treatment
- Tryvio tablets are taken by mouth once daily, with or without food
- Swallow Tryvio tablets whole — do not crush or chew
- If you miss a dose of Tryvio, skip it and take the next dose at your regular time; never double up on doses
- A pregnancy test is required before starting Tryvio for anyone who can become pregnant
Aprocitentan on the U.S. market: products, makers and brands
How Aprocitentan 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.
1 company lists 1 Aprocitentan product record with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2024. Brand names on the directory include Tryvio; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Compare Aprocitentan products
A representative set of FDA-listed product records for Aprocitentan — 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 |
|---|---|---|---|---|
| 💊Tablet | ||||
| 12.5 mg | Oral | Idorsia Pharmaceuticals Ltd | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Aprocitentan NDCs →
Aprocitentan side effects reported to the 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 Aprocitentan — 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 Aprocitentan 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.
Aprocitentan FDA approval history
How Aprocitentan went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Aprocitentan 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.
The FDA’s enforcement reports list no Aprocitentan recalls since July 2021.
✅No Aprocitentan recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
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 2679059 1 dose form · 1 strength
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Dose form (SCDF) Oral Tablet RxCUI 2679063In current FDA listingsClinical drug / strength (SCD) 12.5 MGRxCUI 2679064
Look up RxCUI 2679059 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.
Aprocitentan supply and shortage status
Whether Aprocitentan 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.
Aprocitentan brand names
Aprocitentan is sold under one brand name in the FDA directory — Tryvio. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Aprocitentan: manufacturers and labelers
One company lists Aprocitentan products with the FDA. By number of product records, the largest are Idorsia Pharmaceuticals Ltd. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Aprocitentan drug class (RxNorm)
Aprocitentan belongs to the Endothelin Receptor Antagonist 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.
Sources for this Aprocitentan page
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 this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Idorsia Pharmaceuticals Ltd is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →