Aprocitentan: uses, dosing, side effects & brands
Aprocitentan is a medicine sold in the U.S. under one brand, for hypertension. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Hypertension
- Available as
- Tablet
- Sold as
- Tryvio
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
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How aprocitentan is dosed
From the FDA label for Tryvio (application NDA217686). Other aprocitentan products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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) ] .
Aprocitentan side effects
Clinically significant adverse reactions that appear in other sections of the labeling include: Embryo-fetal toxicity [see Warnings and Precautions (5.1) ] Hepatotoxicity [see Warnings and Precautions (5.2) ] Fluid retention [see Warnings and Precautions (5.3) ] Hemoglobin decrease [see Warnings and Precautions (5.4) ] Decreased sperm counts [see Warnings and Precautions (5.5) ] Most common adverse reactions (more frequent than placebo and ≥ 2% in TRYVIO-treated patients) are edema/fluid retention and anemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Idorsia Pharmaceuticals Ltd at 1-833-400-9611 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 practice. The safety of TRYVIO was evaluated in a placebo-controlled phase 3 clinical study (PRECISION, NCT03541174) in adults with uncontrolled BP (systolic blood pressure [SBP] ≥140 mmHg) despite the use of at least three antihypertensive medications. In this study, 724 patients received any dose of aprocitentan, with 633 patients treated for at least 26 weeks, 192 patients for at least 47 weeks, and 99 patients for at least 48 weeks. The…
Who shouldn’t take aprocitentan
Pregnancy ( 4.1 ) Hypersensitivity ( 4.2 ) 4.1 Pregnancy Use of TRYVIO is contraindicated in patients who are pregnant [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . 4.2 Hypersensitivity TRYVIO is contraindicated in patients who are hypersensitive to aprocitentan or any of its excipients [see Adverse Reactions (6.1) ] .
Every aprocitentan product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Tryvio.
What aprocitentan pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| AN | 12.5 mg | yellow | round | — |
What people report to the FDA about aprocitentan
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1 reports naming aprocitentan. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- catheter site pain1 reports
Read these as a signal, not a rate. A report does not mean aprocitentan caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is aprocitentan?
Tryvio (Aprocitentan) is a medication used to treat Hypertension.
Can you take aprocitentan with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run aprocitentan against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does aprocitentan come in?
Across the brands we track, aprocitentan is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic aprocitentan?
We do not currently list a generic-labelled aprocitentan product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Aprocitentan: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/aprocitentan
- MLA
- “Aprocitentan: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/aprocitentan.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for aprocitentan on DailyMed (NIH) ↗ — including its boxed warning in full.