Drug Safety Information for RANEXA (Ranolazine)

Safety-related Labeling Changes for RANEXA (RANOLAZINE) Rx Drug: FDA Link

Adverse Drug Reactions for RANEXA* (Ranolazine)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with RANEXA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dizziness372
2Nausea303
3Dyspnoea273
4Chest pain269
5Death258
6Myocardial infarction222
7Headache*195
8Constipation187
9Angina pectoris185
10Asthenia183
11Drug interaction175
12Fall164
13Fatigue154
14Malaise145
15Vomiting144
16Tremor133
17Diarrhoea121
18Stent placement110
19Cardiac failure congestive108
20Hypotension107

* This side effect also appears in "Top 10 Side Effects of RANEXA " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking RANEXA
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Angina pectoris*5356
2Product used for unknown indication3440
3Cardiac disorder504
4Coronary artery disease247
5Chest pain*212
6Myocardial ischaemia180
7Angina unstable75
8Dyspnoea53
9Chest discomfort37
10Atrial flutter29

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for RANEXA

Total Reports Filed with FDA: 15462


Number of FDA Adverse Event Reports by Patient Age for RANEXA

Total Reports Filed with FDA: 15462*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ranolazine (Ranexa, Ranolazine)

Charts are based on 15462 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and RANEXA Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.