ALFUZOSIN HYDROCHLORIDE

N/A

Manufactured by Cipla USA Inc.

3,364 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ALFUZOSIN HYDROCHLORIDE

ALFUZOSIN HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Cipla USA Inc.. The most commonly reported adverse reactions for ALFUZOSIN HYDROCHLORIDE include DRUG INEFFECTIVE, OFF LABEL USE, DYSPNOEA, DRUG INTERACTION, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ALFUZOSIN HYDROCHLORIDE.

Top Adverse Reactions

DRUG INEFFECTIVE112 reports
OFF LABEL USE96 reports
DYSPNOEA89 reports
DRUG INTERACTION87 reports
FATIGUE87 reports
ACUTE KIDNEY INJURY79 reports
DIZZINESS74 reports
HYPOTENSION74 reports
DIARRHOEA71 reports
ASTHENIA68 reports
FALL62 reports
CONFUSIONAL STATE54 reports
DEATH53 reports
MALAISE48 reports
NAUSEA48 reports
HEADACHE47 reports
PNEUMONIA47 reports
COUGH43 reports
HYPONATRAEMIA43 reports
ANAEMIA41 reports
HEPATIC CYTOLYSIS40 reports
URINARY TRACT INFECTION40 reports
ATRIAL FIBRILLATION38 reports
THROMBOCYTOPENIA38 reports
PYREXIA37 reports
COMA36 reports
HOT FLUSH36 reports
PRODUCT DOSE OMISSION ISSUE36 reports
SOMNOLENCE36 reports
NEUTROPENIA35 reports
PAIN35 reports
HALLUCINATION34 reports
HYPERKALAEMIA34 reports
ARTHRALGIA33 reports
CONSTIPATION33 reports
MYALGIA33 reports
PRURITUS33 reports
CHOLESTASIS32 reports
RASH32 reports
VERTIGO32 reports
VOMITING31 reports
OEDEMA PERIPHERAL30 reports
INSOMNIA29 reports
PANCREATITIS ACUTE29 reports
PRODUCT ADMINISTRATION ERROR29 reports
SYNCOPE29 reports
OVERDOSE28 reports
PITUITARY TUMOUR BENIGN27 reports
THERAPY NON RESPONDER27 reports
AGITATION26 reports
ERYTHEMA26 reports
GROWTH HORMONE DEFICIENCY26 reports
LOWER RESPIRATORY TRACT INFECTION26 reports
PAIN IN EXTREMITY26 reports
WEIGHT DECREASED26 reports
MUSCLE SPASMS25 reports
RENAL FAILURE25 reports
URINARY RETENTION25 reports
WRONG PATIENT RECEIVED PRODUCT25 reports
WRONG PRODUCT ADMINISTERED25 reports
CONDITION AGGRAVATED24 reports
PRODUCT STORAGE ERROR24 reports
BRADYCARDIA23 reports
DECREASED APPETITE23 reports
DRUG DISPENSED TO WRONG PATIENT23 reports
GASTROINTESTINAL HAEMORRHAGE23 reports
HYPERHIDROSIS23 reports
PRODUCT DISPENSING ERROR23 reports
PRODUCT USE IN UNAPPROVED INDICATION23 reports
CHILLS21 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION21 reports
EXPIRED PRODUCT ADMINISTERED21 reports
GAIT DISTURBANCE21 reports
ABDOMINAL PAIN UPPER20 reports
ASTHMA20 reports
DYSPNOEA EXERTIONAL20 reports
FEELING ABNORMAL20 reports
INCORRECT DOSE ADMINISTERED20 reports
INTENTIONAL PRODUCT MISUSE20 reports
PURPURA20 reports
WEIGHT INCREASED20 reports
ANTIMICROBIAL SUSCEPTIBILITY TEST RESISTANT19 reports
ANXIETY19 reports
COVID 1919 reports
DEHYDRATION19 reports
DEPRESSION19 reports
DISORIENTATION19 reports
HAEMATURIA19 reports
HYPERTENSION19 reports
THERAPEUTIC RESPONSE DELAYED19 reports
AGRANULOCYTOSIS18 reports
BACK PAIN18 reports
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION18 reports
TREMOR18 reports
ABDOMINAL DISCOMFORT17 reports
DRUG HYPERSENSITIVITY17 reports
ELECTROCARDIOGRAM QT PROLONGED17 reports
ERECTILE DYSFUNCTION17 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION17 reports
LACTIC ACIDOSIS17 reports

Report Outcomes

Out of 2,217 classified reports for ALFUZOSIN HYDROCHLORIDE:

Serious 81.9%Non-Serious 18.1%

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

Male1,919 (96.7%)
Female66 (3.3%)

Reports by Age

Age 7679 reports
Age 7478 reports
Age 6877 reports
Age 7376 reports
Age 6968 reports
Age 7766 reports
Age 8065 reports
Age 7961 reports
Age 7257 reports
Age 7054 reports
Age 7553 reports
Age 8253 reports
Age 6650 reports
Age 7147 reports
Age 8546 reports
Age 8145 reports
Age 6744 reports
Age 6539 reports
Age 7836 reports
Age 8436 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 ALFUZOSIN HYDROCHLORIDE?

This profile reflects 3,364 FDA FAERS reports that mention ALFUZOSIN HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ALFUZOSIN HYDROCHLORIDE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, OFF LABEL USE, DYSPNOEA, DRUG INTERACTION, FATIGUE, ACUTE KIDNEY INJURY. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ALFUZOSIN HYDROCHLORIDE?

Labeling and FAERS entries often list Cipla USA Inc. in connection with ALFUZOSIN HYDROCHLORIDE. 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.