Ranexaranolazine
According to the FDA label: Ranolazine extended-release tablet is indicated for the treatment of chronic angina. Ranolazine extended-release tablet 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 tablet is an antianginal indicated for the treatment of chronic angina. ( 1 )
10,189 adverse event reports submitted to the FDA (2005–2026)
Top Reported Adverse Events
The most frequently reported events in association with Ranexa in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Tap any term below for a plain-language definition.
Death 822 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Myocardial Infarction 644 reports
The medical term for a heart attack.
Full definition in the glossary →Chest Pain 612 reports
Pain or discomfort in the chest. Chest pain has many causes, but it is always worth taking seriously and discussing with a doctor.
Full definition in the glossary → See all drugs reporting this event →Angina Pectoris 595 reports
Chest pain caused by reduced blood flow to the heart, usually felt as pressure or tightness.
Full definition in the glossary →- Stent Placement 582 reports
Dyspnoea 432 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Dizziness 416 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Fall 373 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Cerebrovascular Accident 356 reports
The medical term for a stroke, which happens when blood flow to part of the brain is interrupted.
Full definition in the glossary →Cardiac Disorder 306 reports
A general report of a problem with the heart, used when no more specific condition is named.
Full definition in the glossary →Off Label Use 285 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Malaise 284 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Nausea 265 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Diabetes Mellitus 259 reports
A condition where the body cannot properly regulate blood sugar, commonly called diabetes.
Full definition in the glossary →Fatigue 255 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 5,807 |
| Female | 3,949 |
| Unknown | 7 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 43 |
| 18-34 | 56 |
| 35-49 | 307 |
| 50-64 | 2,075 |
| 65-74 | 2,533 |
| 75+ | 3,320 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Ranexa. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 7,268 |
| Hospitalization | 4,387 |
| Death | 1,321 |
| Non-Serious | 838 |
| Disability | 345 |
| Life-Threatening | 242 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Ranexa. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 7 |
| 2008 | 15 |
| 2009 | 23 |
| 2010 | 33 |
| 2011 | 61 |
| 2012 | 115 |
| 2013 | 133 |
| 2014 | 548 |
| 2015 | 1,488 |
| 2016 | 1,180 |
| 2017 | 1,382 |
| 2018 | 1,435 |
| 2019 | 983 |
| 2020 | 331 |
| 2021 | 313 |
| 2022 | 370 |
| 2023 | 425 |
| 2024 | 517 |
| 2025 | 670 |
| 2026 (partial) | 157 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Ranexa
In FDA adverse event reports that mention Ranexa, these medications appeared most often in the same report.
- Aspirin (1,453 reports)
- Clopidogrel (1,120 reports)
- Furosemide (929 reports)
- Clopidogrel Bisulfate (889 reports)
- Nitroglycerin (837 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026