Drug · FAERS side-effect profile with label screen
Ivabradine side effects: what 6,817 FDA adverse event reports show
Drug class
Hyperpolarization-activated cyclic nucleotide-gated channel blocker
FDA label, Indications wording
Who reports
6,817 reports · 72% serious · 523 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction.
FDA label, Indications and Usage
What it is
Ivabradine tablets contains ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous.
FDA label, Description section
Boxed warning
None in the current 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 adverse reaction 5Labeled (related wording) 5Likely indication confounding 3Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 23
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 310 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 |
|---|---|---|---|---|---|---|
| Ejection fraction decreased | 108 | 21.5 17.8–25.9ROR 21.8 · χ² 2,075 / p <1e-300 | 21.3 EB05 18.1 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 18.3 · ♀ 36% (drug 58%) | no trial data cached |
| Sinus bradycardia | 59 | 18.8 14.6–24.3ROR 19.0 · χ² 974 / p 5e-214 | 18.6 EB05 15.0 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.5 · 95% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 256 | 14.9 13.2–16.8ROR 15.4 · χ² 3,295 / p <1e-300 | 14.8 EB05 13.3 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.6 · 94% clinician | no trial data cached |
| Mitral valve incompetence | 53 | 14.5 11.1–18.9ROR 14.6 · χ² 648 / p 3e-143 | 14.2 EB05 11.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 · 94% clinician | no trial data cached |
| Cardiac failure (heart failure) | 338 | 13.0 11.7–14.4ROR 13.6 · χ² 3,727 / p <1e-300 | 12.9 EB05 11.8 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.4 · ♀ 31% (drug 58%) | no trial data cached |
| Ventricular extrasystoles | 42 | 12.5 9.2–16.9ROR 12.5 · χ² 430 / p 8e-96 | 12.1 EB05 9.2 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 10.8 · ♀ 26% (drug 58%) | no trial data cached |
| Sinus tachycardia | 55 | 12.0 9.2–15.6ROR 12.1 · χ² 541 / p 6e-120 | 11.7 EB05 9.2 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 · ♀ 83% (drug 58%) | no trial data cached |
| Ventricular fibrillation | 41 | 11.4 8.4–15.4ROR 11.4 · χ² 376 / p 5e-84 | 10.9 EB05 8.2 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 · 95% clinician | no trial data cached |
| Ventricular tachycardia | 61 | 11.4 8.8–14.6ROR 11.5 · χ² 564 / p 5e-125 | 11.1 EB05 8.8 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.2 · 93% clinician | no trial data cached |
| Presyncope (near-fainting) | 86 | 11.0 8.9–13.5ROR 11.1 · χ² 767 / p 4e-169 | 10.7 EB05 8.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 · ♀ 25% (drug 58%) | no trial data cached |
| Angina pectoris | 101 | 10.8 8.9–13.1ROR 11.0 · χ² 887 / p 4e-195 | 10.6 EB05 8.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · ♀ 23% (drug 58%) | no trial data cached |
| Cardiomyopathy | 46 | 9.6 7.2–12.8ROR 9.6 · χ² 345 / p 3e-77 | 9.1 EB05 7.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Glomerular filtration rate decreased | 34 | 8.7 6.2–12.1ROR 8.7 · χ² 222 / p 2e-50 | 8.0 EB05 5.9 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 8.6 · ♀ 24% (drug 58%) · 100% clinician | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 46 | 8.1 6.1–10.8ROR 8.2 · χ² 280 / p 4e-63 | 7.7 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · 91% clinician | no trial data cached |
| Pulmonary oedema | 117 | 8.0 6.7–9.6ROR 8.2 · χ² 715 / p 1e-157 | 7.8 EB05 6.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · ♀ 15% (drug 58%) | no trial data cached |
| Electrocardiogram qt prolonged | 93 | 8.0 6.5–9.8ROR 8.1 · χ² 559 / p 7e-124 | 7.7 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.5 · 95% clinician | no trial data cached |
| Supraventricular tachycardia | 24 | 7.7 5.2–11.5ROR 7.8 · χ² 134 / p 3e-31 | 6.9 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Heart rate decreased | 88 | 7.7 6.2–9.5ROR 7.8 · χ² 505 / p 4e-112 | 7.4 EB05 6.2 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.8 | no trial data cached |
| Malignant melanoma | 32 | 7.4 5.2–10.4ROR 7.4 · χ² 169 / p 6e-39 | 6.8 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 90% (drug 58%) | no trial data cached |
| Myoclonus | 28 | 7.2 5.0–10.5ROR 7.3 · χ² 144 / p 2e-33 | 6.6 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 100% clinician | no trial data cached |
| Ischaemic stroke | 39 | 6.7 4.9–9.2ROR 6.8 · χ² 184 / p 3e-42 | 6.3 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · ♀ 95% (drug 58%) · 92% clinician | no trial data cached |
| Hypotension (low blood pressure) | 437 | 6.7 6.1–7.4ROR 7.1 · χ² 2,139 / p <1e-300 | 6.7 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 | no trial data cached |
| Iron deficiency anaemia | 20 | 6.7 4.3–10.4ROR 6.7 · χ² 91 / p 6e-22 | 5.9 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Status epilepticus | 24 | 6.5 4.4–9.7ROR 6.6 · χ² 107 / p 2e-25 | 5.9 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · ♀ 0% (drug 58%) | no trial data cached |
| Electrolyte imbalance | 24 | 6.4 4.3–9.6ROR 6.4 · χ² 104 / p 8e-25 | 5.8 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Dyspnoea exertional | 78 | 6.4 5.1–8.0ROR 6.5 · χ² 350 / p 2e-78 | 6.2 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Contraindicated product administered | 62 | 6.3 4.9–8.1ROR 6.4 · χ² 273 / p 1e-61 | 6.1 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 | no trial data cached |
| Drug interaction | 324 | 6.3 5.7–7.0ROR 6.6 · χ² 1,445 / p <1e-300 | 6.2 EB05 5.7 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 | no trial data cached |
| Blood potassium increased | 33 | 6.3 4.5–8.8ROR 6.3 · χ² 141 / p 1e-32 | 5.8 EB05 4.3 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 6.1 · ♀ 18% (drug 58%) | no trial data cached |
| Cardiogenic shock | 29 | 6.3 4.4–9.0ROR 6.3 · χ² 123 / p 8e-29 | 5.7 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · 97% clinician | no trial data cached |
| Circulatory collapse | 34 | 6.1 4.4–8.6ROR 6.2 · χ² 141 / p 1e-32 | 5.7 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 97% clinician | no trial data cached |
| Serotonin syndrome | 38 | 6.1 4.5–8.4ROR 6.1 · χ² 158 / p 2e-36 | 5.7 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · ♀ 83% (drug 58%) | no trial data cached |
| Drug effective for unapproved indication | 58 | 6.1 4.7–7.9ROR 6.2 · χ² 243 / p 4e-55 | 5.8 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious n=15 · ♀ 81% (drug 58%) | no trial data cached |
| Acute myocardial infarction | 58 | 6.0 4.7–7.8ROR 6.1 · χ² 239 / p 4e-54 | 5.8 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · ♀ 31% (drug 58%) | no trial data cached |
| Hyperkalaemia (high potassium) | 65 | 5.7 4.5–7.3ROR 5.8 · χ² 249 / p 2e-56 | 5.5 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · ♀ 26% (drug 58%) · 97% clinician | no trial data cached |
| Tachypnoea | 24 | 5.5 3.7–8.1ROR 5.5 · χ² 83 / p 4e-20 | 5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 100% clinician | no trial data cached |
| Dizziness postural | 17 | 5.5 3.4–8.8ROR 5.5 · χ² 57 / p 2e-14 | 4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Hypomagnesaemia | 24 | 5.3 3.6–7.9ROR 5.3 · χ² 80 / p 2e-19 | 4.9 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 35% (drug 58%) · 92% clinician | no trial data cached |
| Hypertensive crisis | 19 | 5.2 3.3–8.2ROR 5.3 · χ² 61 / p 3e-15 | 4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Syncope (fainting) | 163 | 5.0 4.3–5.8ROR 5.1 · χ² 522 / p 1e-115 | 4.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 1,341 | 4.8 4.5–5.0ROR 5.7 · χ² 4,143 / p <1e-300 | 4.7 EB05 4.5 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.0 | no trial data cached |
| Dyspnoea (shortness of breath) | 471 | 2.6 2.3–2.8ROR 2.7 · χ² 459 / p 3e-102 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Hypotension (low blood pressure) | 437 | 6.7 6.1–7.4ROR 7.1 · χ² 2,139 / p <1e-300 | 6.7 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 | no trial data cached |
| Dizziness | 362 | 2.2 2.0–2.5ROR 2.3 · χ² 252 / p 4e-57 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Cardiac failure (heart failure) | 338 | 13.0 11.7–14.4ROR 13.6 · χ² 3,727 / p <1e-300 | 12.9 EB05 11.8 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.4 · ♀ 31% (drug 58%) | no trial data cached |
| Drug interaction | 324 | 6.3 5.7–7.0ROR 6.6 · χ² 1,445 / p <1e-300 | 6.2 EB05 5.7 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 | no trial data cached |
| Bradycardia (slow heart rate) | 256 | 14.9 13.2–16.8ROR 15.4 · χ² 3,295 / p <1e-300 | 14.8 EB05 13.3 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.6 · 94% clinician | no trial data cached |
| Chest pain | 202 | 3.4 2.9–3.8ROR 3.4 · χ² 333 / p 9e-75 | 3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Palpitations (pounding heartbeat) | 181 | 4.8 4.1–5.5ROR 4.9 · χ² 537 / p 5e-119 | 4.7 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Syncope (fainting) | 163 | 5.0 4.3–5.8ROR 5.1 · χ² 522 / p 1e-115 | 4.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 162 | 4.1 3.5–4.7ROR 4.2 · χ² 375 / p 8e-84 | 4.0 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 · ♀ 25% (drug 58%) | no trial data cached |
| Heart rate increased | 147 | 4.6 3.9–5.4ROR 4.7 · χ² 408 / p 5e-91 | 4.5 EB05 3.9 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.4 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 143 | 2.9 2.5–3.4ROR 2.9 · χ² 176 / p 2e-40 | 2.9 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 · 91% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 143 | 5.0 4.2–5.8ROR 5.0 · χ² 449 / p 6e-100 | 4.9 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Feeling abnormal | 130 | 1.7 1.4–2.0ROR 1.7 · χ² 34 / p 3e-9 | 1.7 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
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.
- Mitral valve incompetence — n=53, PRR 14.5
- Presyncope — n=86, PRR 11.0
- Angina pectoris — n=101, PRR 10.8
- Cardiomyopathy — n=46, PRR 9.6
- Orthostatic hypotension — n=46, PRR 8.1
- Pulmonary oedema — n=117, PRR 8.0
- Supraventricular tachycardia — n=24, PRR 7.7
- Malignant melanoma — n=32, PRR 7.4
- Myoclonus — n=28, PRR 7.2
- Ischaemic stroke — n=39, PRR 6.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Ivabradine ↔ Bradycardia.
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 Ivabradine?
In FDA FAERS, the most frequently co-reported reaction terms for Ivabradine are dyspnoea, hypotension, dizziness, cardiac failure, bradycardia, chest pain. 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 Ivabradine have an FDA boxed warning?
No. The FDA label retrieved for Ivabradine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ivabradine 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 236cc914-7eef-600c-e063-6394a90a4bd1, effective 20250415; matched on
openfda.generic_name.exact:"IVABRADINE") - 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, 350 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
Page generated 2026-10-08. 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.