NIACIN

N/A

Manufactured by Avondale Pharmaceuticals, LLC

22,654 FDA adverse event reports analyzed

Last updated: 2026-04-14

About NIACIN

NIACIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Avondale Pharmaceuticals, LLC. The most commonly reported adverse reactions for NIACIN include FATIGUE, DRUG INEFFECTIVE, NAUSEA, DIARRHOEA, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NIACIN.

Top Adverse Reactions

FATIGUE750 reports
DRUG INEFFECTIVE735 reports
NAUSEA671 reports
DIARRHOEA630 reports
DIZZINESS547 reports
DYSPNOEA531 reports
DRUG HYPERSENSITIVITY495 reports
PAIN489 reports
HEADACHE473 reports
ASTHENIA443 reports
FALL380 reports
PAIN IN EXTREMITY375 reports
ARTHRALGIA373 reports
RASH348 reports
VOMITING346 reports
PRURITUS341 reports
WEIGHT DECREASED337 reports
MYALGIA324 reports
OFF LABEL USE309 reports
BACK PAIN306 reports
FLUSHING295 reports
INSOMNIA293 reports
MYOCARDIAL INFARCTION282 reports
CONSTIPATION278 reports
RENAL FAILURE275 reports
PNEUMONIA273 reports
ANXIETY266 reports
DEATH264 reports
MALAISE251 reports
COUGH250 reports
CHEST PAIN240 reports
CHRONIC KIDNEY DISEASE237 reports
DEPRESSION225 reports
MUSCLE SPASMS225 reports
ACUTE KIDNEY INJURY220 reports
BLOOD GLUCOSE INCREASED216 reports
FEELING ABNORMAL216 reports
HYPERTENSION214 reports
ERYTHEMA213 reports
HYPOTENSION209 reports
DECREASED APPETITE207 reports
GAIT DISTURBANCE206 reports
ABDOMINAL PAIN UPPER192 reports
OEDEMA PERIPHERAL187 reports
ANAEMIA184 reports
MUSCULAR WEAKNESS182 reports
PYREXIA182 reports
GASTROINTESTINAL HAEMORRHAGE181 reports
CEREBROVASCULAR ACCIDENT178 reports
CONDITION AGGRAVATED177 reports
PARAESTHESIA175 reports
ABDOMINAL PAIN174 reports
URINARY TRACT INFECTION173 reports
WEIGHT INCREASED171 reports
DRUG INTERACTION170 reports
HYPOAESTHESIA169 reports
ATRIAL FIBRILLATION167 reports
BLOOD PRESSURE INCREASED166 reports
URTICARIA166 reports
TREMOR163 reports
DEHYDRATION162 reports
CARDIAC FAILURE CONGESTIVE159 reports
SINUSITIS153 reports
CONTUSION152 reports
SOMNOLENCE152 reports
CONFUSIONAL STATE143 reports
DRUG DOSE OMISSION140 reports
ABDOMINAL DISCOMFORT138 reports
HYPERSENSITIVITY137 reports
DYSPEPSIA136 reports
NASOPHARYNGITIS136 reports
HYPERHIDROSIS135 reports
INJECTION SITE PAIN134 reports
VISION BLURRED133 reports
ALOPECIA131 reports
GASTROOESOPHAGEAL REFLUX DISEASE128 reports
CHILLS127 reports
CORONARY ARTERY DISEASE127 reports
PRODUCT DOSE OMISSION ISSUE127 reports
MEMORY IMPAIRMENT126 reports
BLOOD CHOLESTEROL INCREASED125 reports
PALPITATIONS124 reports
CHEST DISCOMFORT123 reports
RENAL FAILURE ACUTE121 reports
PERIPHERAL SWELLING117 reports
RHABDOMYOLYSIS112 reports
HEART RATE INCREASED110 reports
BRONCHITIS109 reports
NEUROPATHY PERIPHERAL109 reports
INFLUENZA107 reports
SYNCOPE107 reports
BALANCE DISORDER103 reports
HOT FLUSH102 reports
PRODUCT QUALITY ISSUE102 reports
STRESS101 reports
HAEMOGLOBIN DECREASED100 reports
CARDIAC DISORDER98 reports
EPISTAXIS98 reports
OROPHARYNGEAL PAIN98 reports
ABDOMINAL DISTENSION97 reports

Report Outcomes

Out of 11,375 classified reports for NIACIN:

Serious 56.5%Non-Serious 43.5%

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

Male6,137 (57.2%)
Female4,579 (42.7%)
Unknown17 (0.2%)

Reports by Age

Age 66261 reports
Age 64242 reports
Age 72237 reports
Age 63234 reports
Age 70232 reports
Age 67227 reports
Age 68223 reports
Age 69220 reports
Age 76214 reports
Age 74209 reports
Age 60206 reports
Age 75206 reports
Age 65198 reports
Age 59195 reports
Age 62195 reports
Age 71195 reports
Age 73195 reports
Age 61193 reports
Age 58164 reports
Age 77160 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 NIACIN?

This profile reflects 22,654 FDA FAERS reports that mention NIACIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for NIACIN?

Frequently reported terms in FAERS include FATIGUE, DRUG INEFFECTIVE, NAUSEA, DIARRHOEA, DIZZINESS, DYSPNOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures NIACIN?

Labeling and FAERS entries often list Avondale Pharmaceuticals, LLC in connection with NIACIN. 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.