NEBIVOLOL

N/A

Manufactured by ANI Pharmaceuticals, Inc.

25,085 FDA adverse event reports analyzed

Last updated: 2026-04-14

About NEBIVOLOL

NEBIVOLOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. The most commonly reported adverse reactions for NEBIVOLOL include ACUTE KIDNEY INJURY, DYSPNOEA, DIARRHOEA, DRUG INTERACTION, HYPOTENSION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NEBIVOLOL.

Top Adverse Reactions

ACUTE KIDNEY INJURY922 reports
DYSPNOEA774 reports
DIARRHOEA724 reports
DRUG INTERACTION615 reports
HYPOTENSION611 reports
ANAEMIA598 reports
NAUSEA573 reports
DRUG INEFFECTIVE553 reports
OFF LABEL USE543 reports
FATIGUE521 reports
FALL513 reports
DIZZINESS477 reports
ASTHENIA471 reports
HEADACHE450 reports
VOMITING419 reports
HYPERTENSION410 reports
GENERAL PHYSICAL HEALTH DETERIORATION385 reports
MALAISE373 reports
BRADYCARDIA363 reports
PYREXIA353 reports
HYPONATRAEMIA331 reports
PNEUMONIA310 reports
COUGH308 reports
HYPERKALAEMIA307 reports
SYNCOPE307 reports
THROMBOCYTOPENIA301 reports
CONDITION AGGRAVATED294 reports
DECREASED APPETITE284 reports
RENAL FAILURE280 reports
CARDIAC FAILURE277 reports
WEIGHT DECREASED266 reports
BLOOD PRESSURE INCREASED257 reports
HYPOKALAEMIA256 reports
OEDEMA PERIPHERAL255 reports
CONFUSIONAL STATE247 reports
PRURITUS240 reports
ARTHRALGIA239 reports
MYALGIA239 reports
ATRIAL FIBRILLATION236 reports
ABDOMINAL PAIN232 reports
RASH225 reports
CHEST PAIN223 reports
NEUTROPENIA215 reports
SOMNOLENCE214 reports
RENAL IMPAIRMENT212 reports
PAIN211 reports
LACTIC ACIDOSIS196 reports
DEATH184 reports
TOXICITY TO VARIOUS AGENTS184 reports
INSOMNIA176 reports
PAIN IN EXTREMITY173 reports
ANXIETY171 reports
GAIT DISTURBANCE167 reports
HYPOGLYCAEMIA167 reports
ABDOMINAL PAIN UPPER166 reports
ERYTHEMA162 reports
HYPOMAGNESAEMIA162 reports
PRODUCT USE IN UNAPPROVED INDICATION162 reports
LOSS OF CONSCIOUSNESS160 reports
ANGINA PECTORIS159 reports
PALPITATIONS159 reports
TREMOR158 reports
INTERSTITIAL LUNG DISEASE156 reports
HAEMOGLOBIN DECREASED155 reports
CONSTIPATION153 reports
COVID 19153 reports
SEPSIS152 reports
DEHYDRATION150 reports
BLOOD CREATININE INCREASED149 reports
BACK PAIN145 reports
VERTIGO143 reports
PULMONARY EMBOLISM142 reports
MUSCULAR WEAKNESS140 reports
EPISTAXIS139 reports
RHABDOMYOLYSIS139 reports
HYPERHIDROSIS138 reports
URINARY TRACT INFECTION135 reports
WEIGHT INCREASED135 reports
TACHYCARDIA133 reports
MUSCLE SPASMS131 reports
RESPIRATORY FAILURE130 reports
CEREBROVASCULAR ACCIDENT129 reports
HYPOCALCAEMIA129 reports
CHOLESTASIS125 reports
COMPLETED SUICIDE125 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS124 reports
GASTROINTESTINAL HAEMORRHAGE123 reports
DEPRESSION122 reports
DRUG INTOLERANCE121 reports
LEUKOPENIA119 reports
METABOLIC ACIDOSIS118 reports
PARAESTHESIA117 reports
CHEST DISCOMFORT116 reports
PERIPHERAL SWELLING115 reports
CHRONIC KIDNEY DISEASE113 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE113 reports
MYOCARDIAL INFARCTION113 reports
DRY MOUTH110 reports
OVERDOSE108 reports
DYSPNOEA EXERTIONAL107 reports

Report Outcomes

Out of 14,990 classified reports for NEBIVOLOL:

Serious 93.2%Non-Serious 6.8%

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

Male6,999 (50.4%)
Female6,869 (49.5%)
Unknown20 (0.1%)

Reports by Age

Age 70476 reports
Age 76425 reports
Age 72410 reports
Age 73404 reports
Age 78380 reports
Age 75373 reports
Age 74362 reports
Age 69353 reports
Age 71350 reports
Age 62347 reports
Age 66338 reports
Age 67338 reports
Age 65336 reports
Age 77329 reports
Age 68310 reports
Age 80307 reports
Age 83305 reports
Age 82292 reports
Age 63279 reports
Age 81276 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 NEBIVOLOL?

This profile reflects 25,085 FDA FAERS reports that mention NEBIVOLOL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for NEBIVOLOL?

Frequently reported terms in FAERS include ACUTE KIDNEY INJURY, DYSPNOEA, DIARRHOEA, DRUG INTERACTION, HYPOTENSION, ANAEMIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures NEBIVOLOL?

Labeling and FAERS entries often list ANI Pharmaceuticals, Inc. in connection with NEBIVOLOL. 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.