NADOLOL

N/A

Manufactured by Alembic Pharmaceuticals Inc.

20,171 FDA adverse event reports analyzed

Last updated: 2026-04-14

About NADOLOL

NADOLOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alembic Pharmaceuticals Inc.. The most commonly reported adverse reactions for NADOLOL include DRUG INEFFECTIVE, MACULAR DEGENERATION, NAUSEA, HEADACHE, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NADOLOL.

Top Adverse Reactions

DRUG INEFFECTIVE1,281 reports
MACULAR DEGENERATION814 reports
NAUSEA662 reports
HEADACHE587 reports
OFF LABEL USE580 reports
FATIGUE521 reports
PAIN502 reports
WEIGHT DECREASED454 reports
DIARRHOEA433 reports
MALAISE412 reports
PYREXIA397 reports
ANAEMIA342 reports
DIZZINESS332 reports
DYSPNOEA319 reports
ABDOMINAL PAIN318 reports
CONSTIPATION305 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE279 reports
DYSPEPSIA276 reports
INFUSION RELATED REACTION264 reports
CHRONIC SINUSITIS260 reports
ERYTHEMA259 reports
ASTHENIA254 reports
RECTAL HAEMORRHAGE253 reports
PARAESTHESIA ORAL241 reports
HAEMATOCHEZIA232 reports
PROCEDURAL PAIN225 reports
FALL224 reports
VOMITING222 reports
ARTHRALGIA208 reports
PAIN IN EXTREMITY207 reports
FREQUENT BOWEL MOVEMENTS204 reports
DEATH200 reports
COLITIS ULCERATIVE197 reports
COLITIS194 reports
FEMALE GENITAL TRACT FISTULA193 reports
ORAL CANDIDIASIS192 reports
RADICULOPATHY192 reports
VAGINAL DISCHARGE185 reports
VAGINAL FLATULENCE183 reports
PROCTITIS182 reports
CONFUSIONAL STATE168 reports
INSOMNIA166 reports
COUGH161 reports
PNEUMONIA160 reports
HYPOTENSION158 reports
PRURITUS158 reports
RASH157 reports
BLOOD PRESSURE INCREASED154 reports
BACK PAIN152 reports
WEIGHT INCREASED151 reports
ANXIETY148 reports
DECREASED APPETITE141 reports
CONDITION AGGRAVATED139 reports
URINARY TRACT INFECTION132 reports
HEPATIC CIRRHOSIS129 reports
CHEST PAIN128 reports
HYPERTENSION127 reports
HAEMOGLOBIN DECREASED125 reports
MUSCLE SPASMS122 reports
FEELING ABNORMAL119 reports
MIGRAINE119 reports
GASTROINTESTINAL HAEMORRHAGE115 reports
RENAL FAILURE115 reports
SOMNOLENCE114 reports
DEPRESSION110 reports
ACUTE KIDNEY INJURY108 reports
OEDEMA PERIPHERAL108 reports
ALOPECIA105 reports
PALPITATIONS105 reports
PERIPHERAL SWELLING103 reports
GAIT DISTURBANCE102 reports
PLATELET COUNT DECREASED100 reports
NASOPHARYNGITIS98 reports
ASCITES97 reports
DEHYDRATION97 reports
ABDOMINAL PAIN UPPER96 reports
DRUG INTERACTION96 reports
SINUSITIS94 reports
PRODUCT DOSE OMISSION ISSUE90 reports
BLOOD GLUCOSE INCREASED89 reports
MYALGIA89 reports
ABDOMINAL DISTENSION86 reports
HEPATIC ENCEPHALOPATHY86 reports
CHRONIC KIDNEY DISEASE85 reports
PRODUCT USE IN UNAPPROVED INDICATION85 reports
BRADYCARDIA84 reports
HYPOAESTHESIA84 reports
ATRIAL FIBRILLATION83 reports
CHEST DISCOMFORT83 reports
HYPERHIDROSIS83 reports
PRODUCT USE ISSUE82 reports
DRUG DOSE OMISSION80 reports
MEMORY IMPAIRMENT80 reports
HEART RATE INCREASED79 reports
LOSS OF CONSCIOUSNESS79 reports
CARDIAC ARREST77 reports
INFECTION77 reports
COMPLETED SUICIDE76 reports
HEPATIC FAILURE76 reports
TOXICITY TO VARIOUS AGENTS76 reports

Report Outcomes

Out of 7,392 classified reports for NADOLOL:

Serious 69.8%Non-Serious 30.2%

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

Female4,534 (65.8%)
Male2,345 (34.0%)
Unknown9 (0.1%)

Reports by Age

Age 71252 reports
Age 65180 reports
Age 60146 reports
Age 62133 reports
Age 59132 reports
Age 69129 reports
Age 68125 reports
Age 61124 reports
Age 66122 reports
Age 54119 reports
Age 57114 reports
Age 63107 reports
Age 70105 reports
Age 72105 reports
Age 64103 reports
Age 56100 reports
Age 5392 reports
Age 5592 reports
Age 5891 reports
Age 6791 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 NADOLOL?

This profile reflects 20,171 FDA FAERS reports that mention NADOLOL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for NADOLOL?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, MACULAR DEGENERATION, NAUSEA, HEADACHE, OFF LABEL USE, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures NADOLOL?

Labeling and FAERS entries often list Alembic Pharmaceuticals Inc. in connection with NADOLOL. 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.