RANOLAZINE

N/A

Manufactured by A2A Integrated Pharmaceuticals

15,363 FDA adverse event reports analyzed

Last updated: 2026-04-14

About RANOLAZINE

RANOLAZINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by A2A Integrated Pharmaceuticals. The most commonly reported adverse reactions for RANOLAZINE include DEATH, MYOCARDIAL INFARCTION, CHEST PAIN, ANGINA PECTORIS, STENT PLACEMENT. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RANOLAZINE.

Top Adverse Reactions

DEATH817 reports
MYOCARDIAL INFARCTION640 reports
CHEST PAIN605 reports
ANGINA PECTORIS594 reports
STENT PLACEMENT582 reports
DYSPNOEA419 reports
DIZZINESS409 reports
FALL368 reports
CEREBROVASCULAR ACCIDENT355 reports
CARDIAC DISORDER298 reports
MALAISE278 reports
OFF LABEL USE275 reports
DIABETES MELLITUS259 reports
NAUSEA253 reports
DRUG INTERACTION248 reports
FATIGUE246 reports
INTENTIONAL PRODUCT USE ISSUE239 reports
CARDIAC FAILURE CONGESTIVE217 reports
PNEUMONIA212 reports
HYPOTENSION205 reports
DRUG INEFFECTIVE198 reports
CARDIAC OPERATION195 reports
HYPOACUSIS194 reports
PRODUCT USE ISSUE190 reports
ASTHENIA184 reports
VOMITING168 reports
DIARRHOEA167 reports
HEADACHE163 reports
HYPERTENSION159 reports
ATRIAL FIBRILLATION147 reports
CARDIAC FAILURE140 reports
CORONARY ARTERY DISEASE138 reports
MEMORY IMPAIRMENT134 reports
SYNCOPE131 reports
CONSTIPATION128 reports
CONFUSIONAL STATE122 reports
CARDIAC ARREST121 reports
ACUTE KIDNEY INJURY117 reports
CARDIAC PACEMAKER INSERTION115 reports
PAIN114 reports
DEMENTIA113 reports
DRUG DOSE OMISSION110 reports
UNEVALUABLE EVENT107 reports
COUGH103 reports
CATHETERISATION CARDIAC101 reports
LOSS OF CONSCIOUSNESS101 reports
NEOPLASM MALIGNANT100 reports
ARTHRALGIA98 reports
CORONARY ARTERY OCCLUSION98 reports
CORONARY ARTERY BYPASS96 reports
VASCULAR GRAFT96 reports
WEIGHT DECREASED96 reports
ELECTROCARDIOGRAM QT PROLONGED95 reports
ANAEMIA94 reports
CORONARY ARTERIAL STENT INSERTION93 reports
GENERAL PHYSICAL HEALTH DETERIORATION93 reports
FEELING ABNORMAL92 reports
PAIN IN EXTREMITY91 reports
COMPLETED SUICIDE90 reports
CHEST DISCOMFORT89 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE89 reports
RENAL FAILURE89 reports
TOXICITY TO VARIOUS AGENTS89 reports
DECREASED APPETITE86 reports
DEHYDRATION85 reports
URINARY TRACT INFECTION85 reports
BRADYCARDIA84 reports
GAIT DISTURBANCE84 reports
HYPERHIDROSIS83 reports
SEIZURE83 reports
TREMOR82 reports
BACK PAIN81 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS79 reports
GASTROINTESTINAL HAEMORRHAGE78 reports
SURGERY77 reports
INTENTIONAL DOSE OMISSION75 reports
CONDITION AGGRAVATED74 reports
RHABDOMYOLYSIS74 reports
ABDOMINAL PAIN73 reports
ANXIETY73 reports
DEAFNESS73 reports
ABDOMINAL PAIN UPPER69 reports
PRODUCT DOSE OMISSION ISSUE68 reports
RENAL IMPAIRMENT68 reports
IMPLANTABLE DEFIBRILLATOR INSERTION67 reports
VISUAL IMPAIRMENT67 reports
AMNESIA66 reports
ARTERIAL OCCLUSIVE DISEASE64 reports
SOMNOLENCE63 reports
WEIGHT INCREASED62 reports
MUSCULAR WEAKNESS61 reports
PERIPHERAL SWELLING61 reports
PRODUCT USE IN UNAPPROVED INDICATION58 reports
THROMBOSIS58 reports
CHRONIC KIDNEY DISEASE57 reports
EPISTAXIS57 reports
PRURITUS57 reports
ACUTE MYOCARDIAL INFARCTION55 reports
MYALGIA55 reports
INTENTIONAL OVERDOSE54 reports

Report Outcomes

Out of 10,011 classified reports for RANOLAZINE:

Serious 92.1%Non-Serious 7.9%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male5,726 (59.6%)
Female3,881 (40.4%)
Unknown7 (0.1%)

Reports by Age

Age 75309 reports
Age 76290 reports
Age 74284 reports
Age 71270 reports
Age 72265 reports
Age 70261 reports
Age 77255 reports
Age 69251 reports
Age 73251 reports
Age 78250 reports
Age 81247 reports
Age 80246 reports
Age 68240 reports
Age 79237 reports
Age 64235 reports
Age 66230 reports
Age 65221 reports
Age 63216 reports
Age 67215 reports
Age 82203 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with RANOLAZINE?

This profile reflects 15,363 FDA FAERS reports that mention RANOLAZINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for RANOLAZINE?

Frequently reported terms in FAERS include DEATH, MYOCARDIAL INFARCTION, CHEST PAIN, ANGINA PECTORIS, STENT PLACEMENT, DYSPNOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures RANOLAZINE?

Labeling and FAERS entries often list A2A Integrated Pharmaceuticals in connection with RANOLAZINE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.