Endothelin Receptor Antagonist side effects compared: 3 drugs, 198,697 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Ambrisentan | 124,082 | 65% | 17,005 | boxed | Infusion site oedema; Pulmonary veno-occlusive disease | Infusion site pain; Right ventricular failure |
| Macitentan | 68,750 | 71% | 12,527 | boxed | Right ventricular failure; Infusion site infection; Pulmonary veno-occlusive disease | Catheter site erythema; Catheter site pain |
| Sparsentan (Filspari) | 5,865 | 17% | 32 | boxed | Dizziness; Hypotension; Blood pressure decreased | Peripheral swelling; Joint swelling |
Class-wide signals (flagged in at least 2 of 3 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Catheter site pruritus | 2/3 | 96.4 | 483 | 0/2 members' labels |
| Transplant evaluation | 2/3 | 92.6 | 282 | 0/2 members' labels |
| Catheter site rash | 2/3 | 91.9 | 233 | 0/2 members' labels |
| Catheter site irritation | 2/3 | 86.0 | 150 | 0/2 members' labels |
| Catheter site vesicles | 2/3 | 78.3 | 94 | 0/2 members' labels |
| Pulmonary arterial hypertension | 2/3 | 69.7 | 6,643 | 0/2 members' labels |
| Catheter site discharge | 2/3 | 55.9 | 418 | 0/2 members' labels |
| Infusion site infection | 2/3 | 55.5 | 886 | 1/2 members' labels |
| Catheter site erythema | 2/3 | 53.5 | 745 | 0/2 members' labels |
| Right ventricular failure | 2/3 | 52.0 | 2,532 | 1/2 members' labels |
| Infusion site discharge | 2/3 | 46.4 | 569 | 0/2 members' labels |
| Pulmonary veno-occlusive disease | 2/3 | 46.1 | 217 | 2/2 members' labels |
| Catheterisation cardiac abnormal | 2/3 | 43.5 | 82 | 0/2 members' labels |
| Ventilation perfusion mismatch | 2/3 | 41.8 | 85 | 0/2 members' labels |
| Vascular device occlusion | 2/3 | 41.8 | 98 | 0/2 members' labels |
| Infusion site irritation | 2/3 | 38.6 | 349 | 0/2 members' labels |
| Infusion site warmth | 2/3 | 38.4 | 335 | 0/2 members' labels |
Member-specific signals (flagged in exactly one drug)
No strong single-member signals (n ≥ 50) in this class.
Common questions
Which endothelin receptor antagonist has the most FDA adverse event reports?
Ambrisentan has the most FAERS co-reports in this class (124,082), followed by Macitentan (68,750). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.
Which side effects are shared across endothelin receptor antagonist drugs?
Reaction terms flagged in at least half of the 3 members include catheter site pruritus, transplant evaluation, catheter site rash, catheter site irritation, catheter site vesicles. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.
Does a FAERS signal mean the drug causes the reaction?
No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.