ranolazine Side Effects
Also known as: Ranexa
Analysis of 10,014 adverse event reports submitted to the FDA from 2005 to 2025.
Total Reports
10,014
Death-Related
1,295
12.9% of reports
Hospitalizations
4,313
43.1% of reports
Top Indication
Angina Pectoris
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 1,295 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 810 |
| COMPLETED SUICIDE | 90 |
| CARDIAC ARREST | 61 |
| CARDIAC FAILURE | 49 |
| TOXICITY TO VARIOUS AGENTS | 48 |
| CARDIAC FAILURE CONGESTIVE | 42 |
| MYOCARDIAL INFARCTION | 40 |
| HYPOTENSION | 33 |
| FALL | 30 |
| PNEUMONIA | 30 |
| BRADYCARDIA | 28 |
| INTENTIONAL OVERDOSE | 27 |
| ELECTROCARDIOGRAM QT PROLONGED | 26 |
| DYSPNOEA | 25 |
| PULMONARY OEDEMA | 25 |
| SOMNOLENCE | 25 |
| HYPERHIDROSIS | 24 |
| PULSELESS ELECTRICAL ACTIVITY | 23 |
| CARDIAC DISORDER | 22 |
| HYPOXIA | 21 |
Reactions in Hospitalization Reports
Top reactions in 4,313 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| CHEST PAIN | 407 |
| MYOCARDIAL INFARCTION | 384 |
| STENT PLACEMENT | 329 |
| DYSPNOEA | 246 |
| FALL | 243 |
| ANGINA PECTORIS | 188 |
| DIZZINESS | 180 |
| CEREBROVASCULAR ACCIDENT | 174 |
| CARDIAC DISORDER | 164 |
| PNEUMONIA | 157 |
| DRUG INTERACTION | 156 |
| MALAISE | 143 |
| CARDIAC FAILURE CONGESTIVE | 130 |
| HYPOTENSION | 130 |
| NAUSEA | 117 |
| CARDIAC OPERATION | 116 |
| INTENTIONAL PRODUCT USE ISSUE | 107 |
| ASTHENIA | 104 |
| OFF LABEL USE | 100 |
| FATIGUE | 98 |
Nearby — Related Medications
What the FAERS Data Reveals About ranolazine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 10,014 voluntary reports linked to ranolazine and its brand equivalents (Ranexa), spanning 2005 through 2025. Of those, 1,295 (12.9%) listed death as an outcome and 4,313 (43.1%) involved hospitalization. The most common indication reported alongside adverse events was Angina Pectoris.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 40% were female and 60% male; age distribution skews toward 75+, with 3,280 reports in that bracket. The single most reported reaction is death with 816 submissions, followed by myocardial infarction and chest pain.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.