VARDENAFIL HYDROCHLORIDE

N/A

Manufactured by Alembic Pharmaceuticals Inc.

218 FDA adverse event reports analyzed

Last updated: 2026-04-15

About VARDENAFIL HYDROCHLORIDE

VARDENAFIL HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alembic Pharmaceuticals Inc.. The most commonly reported adverse reactions for VARDENAFIL HYDROCHLORIDE include ENTEROCOLITIS INFECTIOUS, OVERDOSE, VISUAL IMPAIRMENT, BLOOD PRESSURE INCREASED, HYPOTENSION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VARDENAFIL HYDROCHLORIDE.

Top Adverse Reactions

ENTEROCOLITIS INFECTIOUS13 reports
OVERDOSE6 reports
VISUAL IMPAIRMENT6 reports
BLOOD PRESSURE INCREASED5 reports
HYPOTENSION5 reports
DIZZINESS4 reports
DYSCHROMATOPSIA4 reports
ERECTILE DYSFUNCTION4 reports
FLUSHING4 reports
INTENTIONAL PRODUCT USE ISSUE4 reports
MALAISE4 reports
PHOTOPHOBIA4 reports
RETINAL DEPOSITS4 reports
BRADYCARDIA3 reports
CHRONIC KIDNEY DISEASE3 reports
COUGH3 reports
DRUG INEFFECTIVE3 reports
DYSPHONIA3 reports
DYSPNOEA3 reports
EPILEPSY3 reports
FATIGUE3 reports
GASTROOESOPHAGEAL REFLUX DISEASE3 reports
HYPERSENSITIVITY3 reports
ILLNESS3 reports
INJECTION SITE EXTRAVASATION3 reports
INTENTIONAL OVERDOSE3 reports
INTENTIONAL PRODUCT MISUSE3 reports
NAUSEA3 reports
OFF LABEL USE3 reports
PULMONARY FUNCTION TEST ABNORMAL3 reports
VOMITING3 reports
WEIGHT DECREASED3 reports
ABDOMINAL PAIN2 reports
AGITATION2 reports
ANGIOEDEMA2 reports
ARRHYTHMIA2 reports
CELLULITIS2 reports
DIARRHOEA2 reports
DRUG INDUCED LIVER INJURY2 reports
FALL2 reports
GLOSSODYNIA2 reports
HYPERTENSION2 reports
INSOMNIA2 reports
LOSS OF CONSCIOUSNESS2 reports
MACULAR THICKENING2 reports
NOCTURIA2 reports
OBSTRUCTIVE AIRWAYS DISORDER2 reports
OROPHARYNGEAL PAIN2 reports
PAIN2 reports
PRURITUS2 reports
RENAL FAILURE2 reports
RETINAL DISORDER2 reports
SLEEP APNOEA SYNDROME2 reports
SLEEP DISORDER2 reports
SOMNOLENCE2 reports
SWOLLEN TONGUE2 reports
TONGUE DISCOMFORT2 reports
VISION BLURRED2 reports
ABDOMINAL DISCOMFORT1 reports
ACCESSORY SPLEEN1 reports
ADENOIDAL DISORDER1 reports
ADHESIVE TAPE USE1 reports
ADVERSE DRUG REACTION1 reports
ADVERSE EVENT1 reports
ALOPECIA1 reports
ANAEMIA1 reports
ANGINA PECTORIS1 reports
ANHEDONIA1 reports
ANXIETY1 reports
AORTIC ARTERIOSCLEROSIS1 reports
ARTHROPATHY1 reports
ATELECTASIS1 reports
BACK PAIN1 reports
BANKRUPTCY1 reports
BLINDNESS UNILATERAL1 reports
BLOOD PRESSURE DECREASED1 reports
BLOOD PRESSURE DIASTOLIC ABNORMAL1 reports
BLOOD TRIGLYCERIDES INCREASED1 reports
BONE LESION1 reports
BONE PAIN1 reports
BRONCHITIS1 reports
CANCER PAIN1 reports
CARDIOMYOPATHY1 reports
CENTRAL OBESITY1 reports
CEREBRAL HAEMORRHAGE1 reports
CEREBRAL VENOUS THROMBOSIS1 reports
CEREBROVASCULAR ACCIDENT1 reports
CHEST DISCOMFORT1 reports
CHILLS1 reports
CHOLELITHIASIS1 reports
CHOLESTASIS1 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE1 reports
CIRCULATORY COLLAPSE1 reports
CONDITION AGGRAVATED1 reports
CORONARY ARTERY DISEASE1 reports
DEATH1 reports
DELUSIONAL DISORDER, UNSPECIFIED TYPE1 reports
DEVICE ISSUE1 reports
DIABETES MELLITUS1 reports
DIASTOLIC DYSFUNCTION1 reports

Report Outcomes

Out of 81 classified reports for VARDENAFIL HYDROCHLORIDE:

Serious 74.1%Non-Serious 25.9%

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

Male69 (94.5%)
Female4 (5.5%)

Reports by Age

Age 508 reports
Age 493 reports
Age 723 reports
Age 422 reports
Age 622 reports
Age 642 reports
Age 662 reports
Age 702 reports
Age 752 reports
Age 331 reports
Age 381 reports
Age 401 reports
Age 411 reports
Age 441 reports
Age 461 reports
Age 511 reports
Age 521 reports
Age 531 reports
Age 581 reports
Age 591 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 VARDENAFIL HYDROCHLORIDE?

This profile reflects 218 FDA FAERS reports that mention VARDENAFIL HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for VARDENAFIL HYDROCHLORIDE?

Frequently reported terms in FAERS include ENTEROCOLITIS INFECTIOUS, OVERDOSE, VISUAL IMPAIRMENT, BLOOD PRESSURE INCREASED, HYPOTENSION, DIZZINESS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures VARDENAFIL HYDROCHLORIDE?

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