Brilinta

N/A

Manufactured by Rising Pharma Holdings, Inc.

39,143 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Brilinta

Brilinta is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Rising Pharma Holdings, Inc.. The most commonly reported adverse reactions for Brilinta include DYSPNOEA, MYOCARDIAL INFARCTION, DEATH, FATIGUE, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for Brilinta.

Top Adverse Reactions

DYSPNOEA3,249 reports
MYOCARDIAL INFARCTION2,259 reports
DEATH1,462 reports
FATIGUE1,284 reports
OFF LABEL USE1,263 reports
CHEST PAIN1,075 reports
CONTUSION1,015 reports
DIZZINESS947 reports
MALAISE785 reports
ASTHENIA699 reports
HAEMORRHAGE669 reports
NAUSEA621 reports
HEADACHE596 reports
WEIGHT DECREASED565 reports
FEELING ABNORMAL561 reports
EPISTAXIS560 reports
COUGH554 reports
DRUG DOSE OMISSION534 reports
DIARRHOEA510 reports
PRODUCT USE ISSUE503 reports
CORONARY ARTERY OCCLUSION501 reports
PAIN498 reports
INTENTIONAL PRODUCT MISUSE487 reports
DRUG INEFFECTIVE484 reports
VASCULAR STENT THROMBOSIS476 reports
BLOOD PRESSURE INCREASED429 reports
CEREBROVASCULAR ACCIDENT429 reports
CHEST DISCOMFORT429 reports
PAIN IN EXTREMITY404 reports
GASTROINTESTINAL HAEMORRHAGE403 reports
FALL401 reports
INSOMNIA399 reports
HYPERTENSION368 reports
ANXIETY359 reports
RASH357 reports
ACUTE MYOCARDIAL INFARCTION350 reports
BACK PAIN330 reports
VOMITING321 reports
ANGINA PECTORIS316 reports
ARTHRALGIA314 reports
HYPOTENSION307 reports
THROMBOSIS IN DEVICE305 reports
MEMORY IMPAIRMENT294 reports
CARDIAC DISORDER292 reports
GAIT DISTURBANCE285 reports
THROMBOSIS269 reports
PNEUMONIA262 reports
PRURITUS249 reports
ABDOMINAL DISCOMFORT248 reports
HAEMOGLOBIN DECREASED246 reports
ABDOMINAL PAIN UPPER239 reports
DECREASED APPETITE234 reports
PRODUCT DOSE OMISSION ISSUE234 reports
NASOPHARYNGITIS218 reports
BLOOD PRESSURE DECREASED217 reports
WEIGHT INCREASED213 reports
ATRIAL FIBRILLATION212 reports
ANAEMIA211 reports
DRUG HYPERSENSITIVITY211 reports
MUSCLE SPASMS196 reports
DIABETES MELLITUS192 reports
CARDIAC ARREST191 reports
BLOOD GLUCOSE INCREASED188 reports
RENAL FAILURE188 reports
ARTERIAL OCCLUSIVE DISEASE185 reports
CONFUSIONAL STATE185 reports
PERIPHERAL SWELLING183 reports
SOMNOLENCE180 reports
HEART RATE INCREASED174 reports
LOSS OF CONSCIOUSNESS172 reports
CORONARY ARTERY DISEASE170 reports
MYALGIA170 reports
BLOOD CHOLESTEROL INCREASED169 reports
PALPITATIONS167 reports
ACUTE KIDNEY INJURY165 reports
CONSTIPATION165 reports
VISUAL IMPAIRMENT165 reports
HYPOAESTHESIA164 reports
CONDITION AGGRAVATED163 reports
SYNCOPE163 reports
DEPRESSION161 reports
DYSPNOEA EXERTIONAL155 reports
BRADYCARDIA154 reports
CEREBRAL HAEMORRHAGE153 reports
HYPERSENSITIVITY152 reports
CHRONIC KIDNEY DISEASE151 reports
PRODUCT USE IN UNAPPROVED INDICATION151 reports
STRESS151 reports
ABDOMINAL PAIN148 reports
DEVICE OCCLUSION148 reports
DYSPEPSIA146 reports
GASTROOESOPHAGEAL REFLUX DISEASE145 reports
HYPOACUSIS145 reports
SKIN DISCOLOURATION144 reports
ANGINA UNSTABLE143 reports
STENT PLACEMENT142 reports
VASCULAR STENT OCCLUSION141 reports
HEART RATE DECREASED139 reports
PULMONARY OEDEMA139 reports
CARDIAC FAILURE128 reports

Report Outcomes

Out of 21,930 classified reports for Brilinta:

  • Serious: 14,760 reports (67.3%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 7,170 reports (32.7%)
Serious 67.3%Non-Serious 32.7%

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

Male12,125 (59.8%)
Female8,014 (39.5%)
Unknown151 (0.7%)

Reports by Age

Age 70409 reports
Age 60336 reports
Age 65334 reports
Age 64327 reports
Age 69315 reports
Age 62310 reports
Age 68310 reports
Age 66302 reports
Age 67298 reports
Age 56294 reports
Age 59282 reports
Age 63267 reports
Age 72264 reports
Age 61246 reports
Age 71241 reports
Age 58238 reports
Age 74223 reports
Age 76222 reports
Age 77221 reports
Age 73213 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 Brilinta?

This profile reflects 39,143 FDA FAERS reports that mention Brilinta. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Brilinta?

Frequently reported terms in FAERS include DYSPNOEA, MYOCARDIAL INFARCTION, DEATH, FATIGUE, OFF LABEL USE, CHEST PAIN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Brilinta?

Labeling and FAERS entries often list Rising Pharma Holdings, Inc. in connection with Brilinta. 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.