Drug · FAERS side-effect profile with label screen
Ambrisentan side effects: what 124,082 FDA adverse event reports show
Drug class
Endothelin Receptor Antagonist
FDA label (Established Pharmacologic Class) · compare the class
Who reports
124,082 reports · 65% serious · 17,005 with death outcome · 76% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability .
FDA label, Indications and Usage
What it is
Ambrisentan is an endothelin receptor antagonist.
FDA label, Description section
Boxed warning
EMBRYO-FETAL TOXICITY Ambrisentan tablets are contraindicated for use during pregnancy because it may cause major birth defects if used by pregnant patients, based on studies in animals [see Contraindications ( 4.1 ), Warnings and Precautions ( 5.1 ), and Use in Specific Populations ( 8.1 )] .
FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled — boxed warning 1Labeled (related wording) 1Likely indication confounding 2Reporting / coding artifact 4Lab value / disease marker 3Not in label — unassessed 29
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,189 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Bendopnoea | 64 | 75.2 56.0–101.1ROR 75.2 · calibrated p 1e-6 ✓ | 51.3 EB05 41.6 · IC025 +4.8 3/3 methods agree vs other Endothelin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=57 · 77% consumer | not reported in cached trials |
| Transplant evaluation | 133 | 59.4 48.7–72.4ROR 59.5 · calibrated p 5e-6 ✓ | 43.7 EB05 37.8 · IC025 +5.0 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 6.8 (5.4–8.6) | Not in label — unassessed | serious n=130 | not reported in cached trials |
| Oxygen consumption | 41 | 56.6 39.7–80.7ROR 56.6 · calibrated p 1e-5 ✓ | 41.7 EB05 32.0 · IC025 +4.3 3/3 methods agree vs other Endothelin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=24 · ♀ 100% (drug 76%) · 71% consumer | not reported in cached trials |
| Infusion site pustule | 30 | 52.3 34.7–78.9ROR 52.3 · calibrated p 2e-5 ✓ | 39.1 EB05 28.7 · IC025 +4.0 3/3 methods agree vs other Endothelin Receptor Antagonists: only this drug | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Catheter site pruritus | 207 | 52.2 44.7–61.0ROR 52.3 · calibrated p 1e-5 ✓ | 39.8 EB05 35.5 · IC025 +5.0 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 5.8 (4.8–6.9) | Not in label — unassessed | serious n=160 | not reported in cached trials |
| Catheter site vesicles | 45 | 51.8 37.1–72.4ROR 51.8 · calibrated p 2e-5 ✓ | 39.1 EB05 30.4 · IC025 +4.3 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 7.0 (4.7–10.6) | Not in label — unassessed | serious n=37 · ♀ 100% (drug 76%) | not reported in cached trials |
| Pulmonary arterial hypertension | 3,352 | 50.4 48.5–52.4ROR 51.8 · calibrated p 1e-5 ✓ | 38.9 EB05 37.8 · IC025 +5.2 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 7.8 (7.5–8.2) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 38.6 · serious PRR 34.1 | NCT01178073: 1/152 (0.7%) on Ambrisentan (serious AE) |
| Infusion site infection | 490 | 46.5 42.1–51.4ROR 46.7 · calibrated p 2e-5 ✓ | 36.5 EB05 33.8 · IC025 +5.0 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 9.5 (8.3–10.8) | Not in label — unassessed | serious n=260 · 72% consumer | NCT01178073: 1/152 (0.7%) on Ambrisentan (serious AE) |
| Device wireless communication issue | 53 | 45.3 33.4–61.3ROR 45.3 · calibrated p 4e-5 ✓ | 35.4 EB05 28.1 · IC025 +4.3 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 4.8 (3.4–6.8) | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Pulmonary hypertensive crisis | 56 | 44.8 33.4–60.2ROR 44.8 · calibrated p 4e-5 ✓ | 35.1 EB05 28.0 · IC025 +4.3 3/3 methods agree vs other Endothelin Receptor Antagonists: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=56 · 100% clinician | not reported in cached trials |
| Oxygen consumption increased | 474 | 42.3 38.3–46.8ROR 42.5 · calibrated p 4e-5 ✓ | 33.9 EB05 31.4 · IC025 +4.9 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 7.7 (6.8–8.8) | Lab value / disease marker | serious n=332 | not reported in cached trials |
| Catheter site rash | 90 | 42.0 33.3–52.9ROR 42.0 · calibrated p 5e-5 ✓ | 33.5 EB05 28.1 · IC025 +4.5 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 4.8 (3.7–6.3) | Not in label — unassessed | serious n=75 | not reported in cached trials |
| Oxygen supplementation | 146 | 40.8 34.0–48.9ROR 40.8 · calibrated p 5e-5 ✓ | 32.8 EB05 28.6 · IC025 +4.6 3/3 methods agree vs other Endothelin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=67 · 80% consumer | not reported in cached trials |
| Walking distance test abnormal | 72 | 38.6 29.9–49.9ROR 38.6 · calibrated p 8e-5 ✓ | 31.3 EB05 25.7 · IC025 +4.3 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 6.7 (4.9–9.1) | Reporting / coding artifact | serious n=37 | not reported in cached trials |
| Catheter site discharge | 204 | 38.3 32.9–44.6ROR 38.4 · calibrated p 7e-5 ✓ | 31.2 EB05 27.8 · IC025 +4.6 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 7.3 (6.0–8.9) | Not in label — unassessed | serious n=151 | not reported in cached trials |
| Device maintenance issue | 103 | 37.6 30.4–46.6ROR 37.6 · calibrated p 9e-5 ✓ | 30.7 EB05 26.0 · IC025 +4.4 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 4.9 (3.8–6.3) | Reporting / coding artifact | serious n=31 · 100% consumer | not reported in cached trials |
| Catheterisation cardiac | 802 | 37.1 34.4–40.0ROR 37.3 · calibrated p 8e-5 ✓ | 30.5 EB05 28.7 · IC025 +4.8 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 15.0 (13.3–16.9) | Not in label — unassessed | serious n=684 | not reported in cached trials |
| Pulmonary arterial pressure increased | 290 | 36.3 32.0–41.2ROR 36.4 · calibrated p 1e-4 ✓ | 29.9 EB05 27.1 · IC025 +4.6 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 6.7 (5.7–7.9) | Lab value / disease marker | serious n=220 | not reported in cached trials |
| Right ventricular failure | 1,240 | 35.8 33.7–38.1ROR 36.2 · calibrated p 9e-5 ✓ | 29.6 EB05 28.3 · IC025 +4.8 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 7.4 (6.8–7.9) | Not in label — unassessed | serious PRR 26.2 | NCT01178073: 8/152 (5.3%) on Ambrisentan (serious AE) |
| Infusion site discharge | 298 | 35.5 31.3–40.3ROR 35.6 · calibrated p 1e-4 ✓ | 29.4 EB05 26.7 · IC025 +4.6 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 8.4 (7.2–9.9) | Not in label — unassessed | serious n=107 · 75% consumer | not reported in cached trials |
| Lung transplant | 618 | 35.3 32.4–38.5ROR 35.5 · calibrated p 1e-4 ✓ | 29.3 EB05 27.4 · IC025 +4.7 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 10.5 (9.3–11.8) | Not in label — unassessed | serious n=605 | not reported in cached trials |
| Ventilation perfusion mismatch | 46 | 33.6 24.5–46.1ROR 33.6 · calibrated p 2e-4 ✓ | 27.8 EB05 21.7 · IC025 +4.0 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 9.0 (5.9–13.9) | Not in label — unassessed | serious n=36 | not reported in cached trials |
| Infusion site vesicles | 84 | 32.2 25.5–40.7ROR 32.2 · calibrated p 2e-4 ✓ | 27.0 EB05 22.5 · IC025 +4.2 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 11.1 (8.0–15.5) | Not in label — unassessed | serious n=30 | not reported in cached trials |
| Catheter management | 145 | 32.2 27.0–38.5ROR 32.2 · calibrated p 2e-4 ✓ | 27.0 EB05 23.5 · IC025 +4.4 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 3.3 (2.7–4.0) | Reporting / coding artifact | serious n=137 | not reported in cached trials |
| Infusion site cellulitis | 80 | 31.6 24.9–40.2ROR 31.7 · calibrated p 2e-4 ✓ | 26.6 EB05 22.0 · IC025 +4.2 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 11.4 (8.0–16.0) | Not in label — unassessed | serious n=64 | NCT01178073: 5/152 (3.3%) on Ambrisentan (serious AE) |
| Continuous positive airway pressure | 37 | 31.6 22.2–44.9ROR 31.6 · calibrated p 3e-4 ✓ | 26.4 EB05 20.0 · IC025 +3.8 3/3 methods agree vs other Endothelin Receptor Antagonists: only this drug | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Catheter site erythema | 328 | 31.3 27.8–35.2ROR 31.3 · calibrated p 2e-4 ✓ | 26.4 EB05 24.1 · IC025 +4.5 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 6.0 (5.2–7.0) | Not in label — unassessed | serious n=246 | not reported in cached trials |
| Scleroderma | 561 | 30.6 28.0–33.5ROR 30.7 · calibrated p 2e-4 ✓ | 26.0 EB05 24.2 · IC025 +4.5 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 14.1 (12.3–16.2) | Not in label — unassessed | serious n=528 | not reported in cached trials |
| Catheter site irritation | 49 | 30.5 22.5–41.4ROR 30.5 · calibrated p 3e-4 ✓ | 25.7 EB05 20.2 · IC025 +3.9 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 3.7 (2.6–5.2) | Not in label — unassessed | serious n=39 | not reported in cached trials |
| Pulmonary arterial pressure abnormal | 43 | 29.6 21.4–40.9ROR 29.6 · calibrated p 4e-4 ✓ | 25.0 EB05 19.3 · IC025 +3.8 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 5.6 (3.8–8.3) | Lab value / disease marker | serious n=37 · ♀ 55% (drug 76%) · 100% clinician | not reported in cached trials |
| Catheterisation cardiac abnormal | 38 | 27.6 19.6–38.9ROR 27.6 · calibrated p 6e-4 ✓ | 23.6 EB05 17.9 · IC025 +3.7 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 6.6 (4.3–10.2) | Not in label — unassessed | serious n=30 | not reported in cached trials |
| Infusion site irritation | 174 | 27.4 23.3–32.1ROR 27.4 · calibrated p 5e-4 ✓ | 23.6 EB05 20.8 · IC025 +4.2 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 7.6 (6.2–9.4) | Not in label — unassessed | serious n=66 · 83% consumer | not reported in cached trials |
| Crest syndrome | 33 | 27.1 18.7–39.1ROR 27.1 · calibrated p 7e-4 ✓ | 23.1 EB05 17.2 · IC025 +3.6 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 8.4 (5.1–13.8) | Not in label — unassessed | serious n=32 · ♀ 100% (drug 76%) | not reported in cached trials |
| Sickle cell anaemia | 90 | 27.0 21.6–33.7ROR 27.0 · calibrated p 5e-4 ✓ | 23.2 EB05 19.5 · IC025 +4.0 3/3 methods agree vs other Endothelin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=90 | not reported in cached trials |
| Infusion site warmth | 165 | 26.8 22.7–31.5ROR 26.8 · calibrated p 5e-4 ✓ | 23.1 EB05 20.3 · IC025 +4.2 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 7.4 (6.0–9.2) | Not in label — unassessed | serious n=57 · 74% consumer | not reported in cached trials |
| Infusion site pain | 1,703 | 25.9 24.6–27.2ROR 26.2 · calibrated p 5e-4 ✓ | 22.5 EB05 21.6 · IC025 +4.4 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 8.3 (7.7–8.8) | Not in label — unassessed | age-adj. PRR 21.6 · serious n=660 · 73% consumer | NCT01178073: 1/302 (0.3%) on Ambrisentan (serious AE) |
| Central venous catheterisation | 402 | 25.8 23.2–28.7ROR 25.9 · calibrated p 6e-4 ✓ | 22.4 EB05 20.7 · IC025 +4.3 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 21.4 (17.7–25.9) | Not in label — unassessed | serious n=385 | not reported in cached trials |
| Pulmonary veno-occlusive disease | 92 | 25.6 20.6–31.9ROR 25.6 · calibrated p 7e-4 ✓ | 22.2 EB05 18.7 · IC025 +4.0 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 5.6 (4.3–7.4) | Labeled — boxed warning exact term | serious n=89 | not reported in cached trials |
| Infusion site oedema | 109 | 25.5 20.8–31.2ROR 25.5 · calibrated p 7e-4 ✓ | 22.1 EB05 18.9 · IC025 +4.0 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 16.4 (11.8–22.8) | Labeled (related wording) related wording | serious n=35 · 79% consumer | NCT01178073: 2/152 (1.3%) on Ambrisentan (serious AE) |
| Vascular device occlusion | 44 | 25.3 18.4–34.8ROR 25.3 · calibrated p 8e-4 ✓ | 21.9 EB05 17.0 · IC025 +3.7 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 6.2 (4.2–9.3) | Not in label — unassessed | serious n=42 · ♀ 100% (drug 76%) | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Heart failure | 3,877 | 3.73.6–3.8 | signal |
| Serious infection | 10,624 | 2.32.3–2.4 | signal |
| Anaemia | 2,913 | 1.61.6–1.7 | raised |
| Fall / fracture | 3,042 | 1.41.3–1.4 | raised |
| Gi bleeding | 1,456 | 1.31.3–1.4 | raised |
| Arrhythmia / qt | 1,439 | 1.31.2–1.3 | raised |
| Interstitial lung disease | 649 | 1.11.1–1.2 | raised |
| Venous thromboembolism | 1,075 | 0.80.8–0.9 | lower than other drugs |
| Kidney injury | 1,960 | 0.70.7–0.8 | lower than other drugs |
| Myocardial infarction | 703 | 0.60.5–0.6 | lower than other drugs |
| Stroke | 849 | 0.60.5–0.6 | lower than other drugs |
| Opportunistic infection | 398 | 0.50.4–0.5 | lower than other drugs |
| Hyponatraemia | 212 | 0.40.4–0.5 | lower than other drugs |
| Hypoglycaemia | 247 | 0.40.4–0.5 | lower than other drugs |
| Malignancy | 936 | 0.40.4–0.4 | lower than other drugs |
| Thrombocytopenia | 532 | 0.40.4–0.4 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Ambrisentan as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (6 of 40 signal terms matched).
- NCT01178073 — A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypert (N=610, PHASE3; 313 AE terms posted; arms: Combination Therapy: Ambrisentan + Tadal; Ambrisentan Monotherapy; Tadalafil Monotherapy)
- NCT00768300 — (ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF (N=494, PHASE3; 148 AE terms posted; arms: Ambrisentan; Placebo)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 19,143 | 5.9 5.8–6.0ROR 6.8 · calibrated p 0.108 | 5.7 EB05 5.6 · IC025 +2.5 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 12.3 (12.1–12.5) | Not in label — unassessed | age-adj. PRR 5.2 · serious PRR 4.7 | NCT01178073: 2/152 (1.3%) on Ambrisentan (serious AE) |
| Death | 11,353 | 2.2 2.2–2.3ROR 2.4 · calibrated p 0.871 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 11.8 (11.5–12.1) | Outcome field, not a reaction | age-adj. PRR 2.4 · serious PRR 2.0 | NCT01178073: 1/302 (0.3%) on Ambrisentan (serious AE) |
| Headache | 10,770 | 2.9 2.9–3.0ROR 3.1 · calibrated p 0.587 | 2.9 EB05 2.9 · IC025 +1.5 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 9.5 (9.3–9.8) | Labeled adverse reaction exact term | age-adj. PRR 2.8 · serious PRR 2.6 | NCT01178073: 1/302 (0.3%) on Ambrisentan (serious AE) |
| Pneumonia (lung infection) | 7,267 | 3.9 3.8–4.0ROR 4.0 · calibrated p 0.370 | 3.8 EB05 3.7 · IC025 +1.9 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 12.2 (11.8–12.7) | Not in label — unassessed | age-adj. PRR 3.1 · serious PRR 3.4 | NCT01178073: 1/302 (0.3%) on Ambrisentan (serious AE) |
| Diarrhoea (diarrhea) | 7,105 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.905 | 1.9 EB05 1.8 · IC025 +0.9 vs other Endothelin Receptor Antagonists: PRR 8.3 (8.0–8.5) | Not in label — unassessed | age-adj. PRR 1.6 · serious PRR 1.7 | NCT01178073: 35/152 (23.0%) on Ambrisentan |
| Fatigue (tiredness) | 6,598 | 1.4 1.4–1.5ROR 1.5 · calibrated p 0.617 | 1.4 EB05 1.4 · IC025 +0.5 vs other Endothelin Receptor Antagonists: PRR 8.7 (8.4–9.0) | Not in label — unassessed | age-adj. PRR 1.3 · serious PRR 1.3 | NCT01178073: 22/152 (14.5%) on Ambrisentan |
| Dizziness | 6,553 | 2.2 2.2–2.3ROR 2.3 · calibrated p 0.899 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 9.4 (9.0–9.7) | Not in label — unassessed | age-adj. PRR 2.0 · serious PRR 1.9 | NCT01178073: 1/151 (0.7%) on Ambrisentan (serious AE) |
| Nausea | 6,542 | 1.4 1.4–1.4ROR 1.4 · calibrated p 0.593 | 1.4 EB05 1.4 · IC025 +0.4 vs other Endothelin Receptor Antagonists: PRR 7.9 (7.6–8.1) | Not in label — unassessed | age-adj. PRR 1.3 · serious PRR 1.3 | NCT01178073: 23/152 (15.1%) on Ambrisentan |
| Fluid retention | 5,470 | 20.3 19.7–20.8ROR 21.2 · calibrated p 0.002 ✓ | 18.2 EB05 17.8 · IC025 +4.1 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 10.7 (10.3–11.1) | Labeled — boxed warning exact term | age-adj. PRR 19.6 · serious PRR 16.5 | NCT01178073: 3/302 (1.0%) on Ambrisentan (serious AE) |
| Malaise (feeling unwell) | 5,334 | 2.1 2.0–2.1ROR 2.1 · calibrated p 0.997 | 2.0 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 11.4 (10.9–11.8) | Not in label — unassessed | age-adj. PRR 2.1 · serious PRR 1.8 | not reported in cached trials |
| Cough | 4,613 | 2.8 2.7–2.9ROR 2.9 · calibrated p 0.665 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 8.7 (8.3–9.0) | Labeled adverse reaction exact term | age-adj. PRR 2.4 · serious PRR 2.1 | NCT01178073: 20/152 (13.2%) on Ambrisentan |
| Oedema peripheral (swelling of legs/feet) | 4,197 | 6.0 5.8–6.2ROR 6.1 · calibrated p 0.141 | 5.8 EB05 5.6 · IC025 +2.5 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 11.8 (11.3–12.4) | Labeled — boxed warning synonym match | age-adj. PRR 5.2 · serious PRR 3.8 | NCT01178073: 1/152 (0.7%) on Ambrisentan (serious AE) |
| Peripheral swelling | 4,051 | 4.6 4.4–4.7ROR 4.7 · calibrated p 0.273 | 4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 10.5 (10.1–11.0) | Not in label — unassessed | age-adj. PRR 4.3 · serious PRR 3.6 | not reported in cached trials |
| Chest pain | 3,839 | 3.5 3.4–3.7ROR 3.6 · calibrated p 0.454 | 3.5 EB05 3.4 · IC025 +1.8 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 11.8 (11.3–12.4) | Not in label — unassessed | age-adj. PRR 3.1 · serious PRR 3.0 | NCT01178073: 7/302 (2.3%) on Ambrisentan (serious AE) |
| Nasal congestion (stuffy nose) | 3,811 | 11.7 11.3–12.1ROR 12.0 · calibrated p 0.017 ✓ | 11.0 EB05 10.7 · IC025 +3.4 3/3 methods agree vs other Endothelin Receptor Antagonists: PRR 14.4 (13.6–15.1) | Labeled adverse reaction exact term | age-adj. PRR 10.7 · serious PRR 7.5 | NCT01178073: 25/152 (16.4%) on Ambrisentan |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Bendopnoea — n=64, PRR 75.2
- Transplant evaluation — n=133, PRR 59.4
- Oxygen consumption — n=41, PRR 56.6
- Infusion site pustule — n=30, PRR 52.3
- Catheter site pruritus — n=207, PRR 52.2
- Catheter site vesicles — n=45, PRR 51.8
- Infusion site infection — n=490, PRR 46.5 (also seen in trial arm)
- Catheter site rash — n=90, PRR 42.0
- Oxygen supplementation — n=146, PRR 40.8
- Catheter site discharge — n=204, PRR 38.3
✓ A hand-written Bradford Hill causality assessment exists for this drug: Ambrisentan ↔ Fluid retention.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Ambrisentan?
In FDA FAERS, the most frequently co-reported reaction terms for Ambrisentan are dyspnoea, headache, pneumonia, diarrhoea, fatigue, dizziness. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Ambrisentan have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: EMBRYO-FETAL TOXICITY Ambrisentan tablets are contraindicated for use during pregnancy because it may cause major birth defects if used by pregnant patients, based on studies in animals [see Contraindications ( 4.1 ), Warnings and Precautions ( 5.1 ), and Use in Specific Populations ( 8.1 )] .
Do FAERS signals prove that Ambrisentan causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 32549c43-f8ff-422c-b42d-ca0877e661cf, effective 20250530; matched on
openfda.generic_name.exact:"AMBRISENTAN" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,229 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
AMBRISENTAN, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.