Aprocitentan: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: February 27, 2026🚩 Report this page

Aprocitentan

Other Antihypertensives

Sold as Jeraygo

EU EMACA Health CanadaGB MHRA

Drug class: Other Antihypertensives
Availability: See label
Routes: Oral
Markets covered: 3
Products on record: 5

Overview

Aprocitentan is an active pharmaceutical ingredient in the Other Antihypertensives group (C02KN). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
EU European Union	EMA	1	February 27, 2026
CA Canada	Health Canada	2	February 27, 2026
GB United Kingdom	MHRA	2	February 20, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised February 27, 2026[1]

1). 3

How to take

EUOfficial regulatory label· revised February 27, 2026

CACanada· Health Canada

2 products

2 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [2].

Brands in Canada (1)

JERAYGOIDORSIA PHARMACEUTICALS LTD

GBUnited Kingdom· MHRA

2 products

2 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Brands in United Kingdom (1)

JERAYGO

Sources & citations

[1]European Medicines Agency · EMEA/H/C/006080 · revised February 27, 2026
[2]Health Canada (DPD) · 02563983 · revised February 27, 2026
[3]MHRA (UK) · PL487110009 · revised February 20, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised February 27, 2026[1]

4). 1). In this study, 724 patients received 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 frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data).
Table 1:
Adverse reactions System organ class Adverse reaction Frequency Infections and infestations Upper respiratory tract infectiona Common Blood and lymphatic system disorders Haemoglobin decreasedb Common Immune system disorders Hypersensitivityc Common Nervous system disorders Headache Common Vascular disorders Hypotension Uncommon Flushing Uncommon Respiratory, thoracic and mediastinal disorders Dyspnoead Common Hepatobiliary disorders Transaminase increased Uncommon General disorders and administration site conditions Oedema/fluid retentione Very common Investigations Glomerular filtration rate decreased during initial treatment Uncommon 8 Weight increased during initial treatment Uncommon a Upper respiratory tract infection includes pharyngitis, nasopharyngitis.
b Haemoglobin decreased includes anaemia. c Hypersensitivity includes rash, erythema, allergic oedema, dermatitis allergic. d Dyspnoea includes dyspnoea exertional. e Oedema/fluid retention includes mainly oedema peripheral, fluid retention, face oedema.
4% [25 mg] during the 4-week double-blind [DB] treatment. 8% of patients discontinued treatment of aprocitentan 25 mg due to oedema/fluid retention. 4. 2 kg in patients on placebo during the 4-week DB treatment (part 1). This increase disappeared during the 32-week single-blind (SB) treatment (part 2).
9% in placebo patients during the initial 4-week DB treatment (part 1). 5% of patients reported these events during the 32-week SB treatment (part 2) when all subjects received 25 mg. 0% on placebo. There were no reports of patients with ALT and/or AST > 3 × ULN and total bilirubin > 2 × ULN in the study.
, rash, erythema, allergic oedema, dermatitis allergic) occurred within the first 2 weeks of treatment and were mild to moderate. There were 2 patients who discontinued treatment, 1 of whom was hospitalised. 5 mg, 25 mg, and placebo, respectively.
4 g/dL in patients receiving placebo. 87 g/dL compared to baseline. Reversibility of the effect was observed within 4 weeks after discontinuation. 4% of patients during the 48-week exposure to aprocitentan 25 mg. 4 g/dL. 4. 5 mg, 25 mg, and placebo, respectively.
73 m2 in patients receiving placebo. 73 m2; it remained stable until the end of the study. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised February 27, 2026[1]

6). 6). Hepatotoxicity Elevations of aminotransferases and hepatotoxicity are known effects of other endothelin receptor antagonists (ERAs). 8). 3) and is not recommended in patients with elevated aminotransferases (> 3 × upper limit of normal [ULN]).
Liver enzyme tests should be obtained prior to initiation of JERAYGO. During treatment, monitoring of liver enzymes is recommended. If sustained, unexplained, clinically relevant aminotransferase elevations occur, or if elevations are accompanied by an increase in bilirubin > 2 × ULN, or by clinical symptoms of hepatotoxicity, JERAYGO should be discontinued.
8). After treatment initiation, patients should be monitored for signs of fluid retention such as oedema or weight gain. If clinically significant fluid retention develops, the patient should be evaluated to determine the cause and the need for additional supportive treatment, including additional diuretics or increase of dose of currently prescribed diuretic (as appropriate), before considering dose reduction or discontinuation of JERAYGO.
In patients treated with loop diuretics before starting therapy with JERAYGO, the loop diuretic should not be switched to a less effective diuretic at initiation. 73 m2) or pre-existing heart failure taking JERAYGO may be at a higher risk of developing fluid retention, as may elderly patients (> 65 years), patients with diabetes, or severely obese patients (body mass index [BMI] ≥ 40 kg/m2).
When switching to 25 mg, the risk of increasing fluid retention, potentially aggravating heart failure or cardiovascular (CV) events, has to be taken into consideration in these patients. Cardiovascular events Aprocitentan has not been studied in patients with unstable or severe cardiac disease, such as uncontrolled symptomatic arrhythmia (including atrial fibrillation), heart failure New York Heart Association stage III–IV or stage II with relevant valve disease, with NT-proBNP plasma concentration ≥ 500 pg/mL, or with recent (within 6 months) unstable angina, myocardial infarction, transient ischemic attack or stroke.
JERAYGO is not recommended in these patients. Due to the general risk of CV events in patients with resistant hypertension and since aprocitentan can cause fluid retention, patients at high risk of developing congestive heart failure or other CV events should be monitored for signs and symptoms of fluid retention.

This is not medical advice. Consult a qualified healthcare professional.