Ranolazine side effects: what 10,374 FDA adverse event reports show

Ranolazine · 998 reaction terms · 27,013 drug–reaction co-reports · data 2026-09-14

Drug class

Anti-anginal

FDA label (Established Pharmacologic Class)

Who reports

10,374 reports · 91% serious · 1,337 with death outcome · 41% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. Ranolazine extended-release tablets are antianginal indicated for the treatment of chronic angina.

FDA label, Indications and Usage

What it is

Ranolazine extended-release tablets are available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N (2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-.

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 (related wording) 1Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 37

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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. 958 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Stent placement	582	157.4 145.0–170.8ROR 166.7 · χ² 83,697 / p <1e-300	145.2 EB05 135.6 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	serious PRR 95.4 · 95% consumer	no trial data cached
Hypotensive crisis	10	154.5 81.2–293.9ROR 154.7 · χ² 1,277 / p 7e-280	113.1 EB05 65.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Implantable defibrillator insertion	67	108.5 84.9–138.6ROR 109.2 · χ² 6,666 / p <1e-300	100.1 EB05 81.5 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=67 · 94% consumer	no trial data cached
Microvascular coronary artery disease	10	101.2 53.6–190.9ROR 101.3 · χ² 851 / p 2e-187	81.8 EB05 47.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Cardiac assistance device user	14	77.7 45.6–132.5ROR 77.8 · χ² 948 / p 2e-208	68.2 EB05 43.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=14	no trial data cached
Arrhythmic storm	11	69.8 38.3–127.4ROR 69.9 · χ² 656 / p 5e-145	60.7 EB05 36.2 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Vascular graft	96	69.5 56.7–85.1ROR 70.1 · χ² 6,194 / p <1e-300	66.3 EB05 55.9 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=96 · 93% consumer	no trial data cached
Angioplasty	35	48.4 34.6–67.6ROR 48.5 · χ² 1,540 / p <1e-300	46.2 EB05 34.7 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=35 · ♀ 17% (drug 41%) · 94% consumer	no trial data cached
Cardiac operation	195	47.5 41.2–54.6ROR 48.4 · χ² 8,624 / p <1e-300	46.2 EB05 41.0 · IC025 +5.1 3/3 methods agree	Reporting / coding artifact	serious PRR 30.8 · 95% consumer	no trial data cached
Catheterisation cardiac	101	47.0 38.6–57.2ROR 47.5 · χ² 4,399 / p <1e-300	45.6 EB05 38.6 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=101 · 90% consumer	no trial data cached
Angina pectoris	595	42.5 39.3–46.0ROR 45.1 · χ² 23,628 / p <1e-300	41.6 EB05 38.9 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 27.1 · 80% consumer	no trial data cached
Myopathy toxic	12	41.5 23.4–73.4ROR 41.5 · χ² 425 / p 9e-95	38.4 EB05 23.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Cardiac pacemaker insertion	116	40.0 33.3–48.1ROR 40.5 · χ² 4,290 / p <1e-300	39.0 EB05 33.4 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=116 · 94% consumer	no trial data cached
Coronary arterial stent insertion	93	37.8 30.8–46.4ROR 38.1 · χ² 3,236 / p <1e-300	36.9 EB05 31.0 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=93 · 88% consumer	no trial data cached
Respiratory tract haemorrhage	10	34.4 18.4–64.2ROR 34.4 · χ² 287 / p 1e-64	31.9 EB05 18.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Coronary artery bypass	96	34.1 27.9–41.7ROR 34.4 · χ² 3,003 / p <1e-300	33.4 EB05 28.1 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=96 · 81% consumer	no trial data cached
Tonic clonic movements	20	31.7 20.4–49.3ROR 31.7 · χ² 555 / p 4e-123	30.4 EB05 20.8 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=20	no trial data cached
Heart valve replacement	17	23.7 14.7–38.2ROR 23.7 · χ² 343 / p 7e-77	22.9 EB05 15.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=17	no trial data cached
Aortic valve replacement	14	23.1 13.6–39.1ROR 23.1 · χ² 271 / p 3e-61	22.1 EB05 13.8 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=14	no trial data cached
Cardioversion	13	18.9 10.9–32.6ROR 18.9 · χ² 200 / p 8e-46	17.9 EB05 10.5 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Systemic infection	15	18.4 11.1–30.5ROR 18.4 · χ² 227 / p 1e-51	17.6 EB05 10.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=15	no trial data cached
Nodal rhythm	12	16.6 9.4–29.4ROR 16.7 · χ² 160 / p 6e-37	15.4 EB05 8.5 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Arterial occlusive disease	64	16.5 12.9–21.1ROR 16.6 · χ² 909 / p 5e-200	16.3 EB05 13.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 10.7 · 98% consumer	no trial data cached
Drug clearance decreased	10	16.2 8.7–30.1ROR 16.2 · χ² 126 / p 1e-29	14.5 EB05 7.2 · IC025 +2.1 3/3 methods agree	Lab value / disease marker	serious n=10	no trial data cached
Brash syndrome	10	15.0 8.1–27.9ROR 15.0 · χ² 116 / p 2e-27	13.2 EB05 6.6 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Coronary artery occlusion	98	14.5 11.9–17.6ROR 14.6 · χ² 1,207 / p 1e-264	14.3 EB05 12.0 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 9.1 · 90% consumer	no trial data cached
Pulseless electrical activity	28	13.6 9.4–19.8ROR 13.7 · χ² 313 / p 2e-70	13.1 EB05 9.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=28 · ♀ 76% (drug 41%) · 93% clinician	no trial data cached
Arterial disorder	12	12.8 7.2–22.5ROR 12.8 · χ² 118 / p 1e-27	11.1 EB05 6.0 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Catheter placement	11	12.0 6.6–21.7ROR 12.0 · χ² 100 / p 9e-24	10.1 EB05 5.3 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Ischaemic cardiomyopathy	17	11.1 6.9–17.9ROR 11.2 · χ² 146 / p 6e-34	9.9 EB05 6.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=17	no trial data cached
Vascular occlusion	11	10.6 5.9–19.1ROR 10.6 · χ² 86 / p 1e-20	8.6 EB05 4.7 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Coronary artery disease	141	9.4 8.0–11.1ROR 9.5 · χ² 1,043 / p 3e-229	9.2 EB05 8.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.0	no trial data cached
Hypoacusis	194	9.2 8.0–10.5ROR 9.3 · χ² 1,399 / p <1e-300	9.0 EB05 8.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 11.5 · 95% consumer	no trial data cached
Angina unstable	29	9.0 6.2–12.9ROR 9.0 · χ² 197 / p 6e-45	8.2 EB05 5.9 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=29	no trial data cached
Cardiac failure chronic	18	8.6 5.4–13.6ROR 8.6 · χ² 113 / p 1e-26	7.4 EB05 4.8 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious n=18	no trial data cached
Dementia	113	8.2 6.8–9.9ROR 8.3 · χ² 709 / p 2e-156	8.0 EB05 6.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.6 · 89% consumer	no trial data cached
Duodenitis	12	7.9 4.5–14.0ROR 7.9 · χ² 66 / p 3e-16	6.4 EB05 3.8 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Autonomic nervous system imbalance	11	7.7 4.3–14.0ROR 7.8 · χ² 58 / p 1e-14	6.2 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Hip surgery	20	7.6 4.9–11.8ROR 7.6 · χ² 108 / p 1e-25	6.7 EB05 4.5 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=20 · ♀ 75% (drug 41%) · 100% consumer	no trial data cached
Torsade de pointes	29	7.5 5.2–10.8ROR 7.5 · χ² 156 / p 5e-36	6.8 EB05 4.9 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.7 · ♀ 88% (drug 41%) · 100% clinician	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
Death	826	1.9 1.8–2.1ROR 2.0 · χ² 390 / p 3e-87	1.9 EB05 1.8 · IC025 +0.8	Outcome field, not a reaction	serious PRR 1.2 · 72% consumer	no trial data cached
Myocardial infarction (heart attack)	646	7.4 6.9–8.0ROR 7.9 · χ² 3,617 / p <1e-300	7.4 EB05 6.9 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 4.7 · 90% consumer	no trial data cached
Chest pain	614	6.7 6.2–7.2ROR 7.1 · χ² 2,991 / p <1e-300	6.7 EB05 6.2 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.3 · 73% consumer	no trial data cached
Angina pectoris	595	42.5 39.3–46.0ROR 45.1 · χ² 23,628 / p <1e-300	41.6 EB05 38.9 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 27.1 · 80% consumer	no trial data cached
Stent placement	582	157.4 145.0–170.8ROR 166.7 · χ² 83,697 / p <1e-300	145.2 EB05 135.6 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	serious PRR 95.4 · 95% consumer	no trial data cached
Dyspnoea (shortness of breath)	439	1.6 1.4–1.7ROR 1.6 · χ² 92 / p 3e-22	1.6 EB05 1.4 · IC025 +0.5	Labeled adverse reaction exact term	serious PRR 1.2	no trial data cached
Dizziness	427	1.7 1.6–1.9ROR 1.8 · χ² 135 / p 2e-31	1.7 EB05 1.6 · IC025 +0.6	Labeled adverse reaction exact term	serious PRR 1.6	no trial data cached
Fall	382	2.3 2.1–2.6ROR 2.4 · χ² 291 / p 2e-65	2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 1.6 · 74% consumer	no trial data cached
Cerebrovascular accident (stroke)	356	4.2 3.8–4.7ROR 4.4 · χ² 883 / p 3e-194	4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.7 · 89% consumer	no trial data cached
Cardiac disorder	307	6.6 5.9–7.4ROR 6.8 · χ² 1,462 / p <1e-300	6.5 EB05 6.0 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.7 · 91% consumer	no trial data cached
Off label use (used outside approved label)	296	0.7 0.6–0.8ROR 0.7 · χ² 43 / p 3e-11	0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 0.7	no trial data cached
Malaise (feeling unwell)	285	1.3 1.2–1.5ROR 1.3 · χ² 21 / p 2e-6	1.3 EB05 1.2 · IC025 +0.2	Not in label — unassessed	serious PRR 1.3	no trial data cached
Nausea	279	0.7 0.6–0.8ROR 0.7 · χ² 33 / p 5e-9	0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 0.7	no trial data cached
Drug interaction	279	3.6 3.2–4.0ROR 3.6 · χ² 514 / p 5e-114	3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 2.4	no trial data cached
Fatigue (tiredness)	260	0.7 0.6–0.8ROR 0.7 · χ² 41 / p 6e-11	0.7 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC	Labeled (related wording) related wording	serious PRR 0.6	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.

Stent placement — n=582, PRR 157.4
Implantable defibrillator insertion — n=67, PRR 108.5
Vascular graft — n=96, PRR 69.5
Angioplasty — n=35, PRR 48.4
Catheterisation cardiac — n=101, PRR 47.0
Angina pectoris — n=595, PRR 42.5
Cardiac pacemaker insertion — n=116, PRR 40.0
Coronary arterial stent insertion — n=93, PRR 37.8
Coronary artery bypass — n=96, PRR 34.1
Tonic clonic movements — n=20, PRR 31.7

✓ A hand-written Bradford Hill causality assessment exists for this drug: Ranolazine ↔ QT prolongation.

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 Ranolazine?

In FDA FAERS, the most frequently co-reported reaction terms for Ranolazine are myocardial infarction, chest pain, angina pectoris, stent placement, dyspnoea, 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 Ranolazine have an FDA boxed warning?

No. The FDA label retrieved for Ranolazine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Ranolazine 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 195c4b51-fec2-410d-8d90-487c536a8728, effective 20260506; matched on openfda.generic_name.exact:"RANOLAZINE")
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, field patient.drug.openfda.generic_name.exact, 998 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.