PHENAZOPYRIDINE HYDROCHLORIDE

N/A

Manufactured by i-Health, Inc.

1,029 FDA adverse event reports analyzed

Last updated: 2026-04-15

About PHENAZOPYRIDINE HYDROCHLORIDE

PHENAZOPYRIDINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by i-Health, Inc.. The most commonly reported adverse reactions for PHENAZOPYRIDINE HYDROCHLORIDE include PAIN, DYSPNOEA, NAUSEA, HEADACHE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PHENAZOPYRIDINE HYDROCHLORIDE.

Top Adverse Reactions

PAIN35 reports
DYSPNOEA33 reports
NAUSEA32 reports
HEADACHE29 reports
FATIGUE27 reports
SULPHAEMOGLOBINAEMIA26 reports
URINARY TRACT INFECTION25 reports
DIARRHOEA23 reports
VOMITING22 reports
BACK PAIN20 reports
DIZZINESS18 reports
FEELING ABNORMAL17 reports
MYOCARDIAL INFARCTION17 reports
DYSURIA16 reports
HYPERTENSION16 reports
CHEST PAIN15 reports
ABDOMINAL PAIN14 reports
INJURY14 reports
ASTHENIA13 reports
DRUG INEFFECTIVE13 reports
SOMNOLENCE13 reports
WEIGHT INCREASED12 reports
ANAEMIA11 reports
CONDITION AGGRAVATED11 reports
FALL11 reports
METHAEMOGLOBINAEMIA11 reports
PAIN IN EXTREMITY11 reports
PYREXIA11 reports
ARTHRALGIA10 reports
CONSTIPATION10 reports
CYSTITIS10 reports
GASTROOESOPHAGEAL REFLUX DISEASE10 reports
OFF LABEL USE10 reports
URTICARIA10 reports
WEIGHT DECREASED10 reports
ABDOMINAL DISTENSION9 reports
ABDOMINAL PAIN UPPER9 reports
ACUTE KIDNEY INJURY9 reports
COUGH9 reports
COVID 199 reports
DECREASED APPETITE9 reports
DEPRESSION9 reports
DRUG HYPERSENSITIVITY9 reports
HYPERSENSITIVITY9 reports
PRURITUS9 reports
URINARY RETENTION9 reports
CARDIAC DISORDER8 reports
CEREBROVASCULAR ACCIDENT8 reports
CHROMATURIA8 reports
CORONARY ARTERY DISEASE8 reports
DEHYDRATION8 reports
HOT FLUSH8 reports
HYPOXIA8 reports
POLLAKIURIA8 reports
PULMONARY EMBOLISM8 reports
BLOOD PRESSURE INCREASED7 reports
CHRONIC KIDNEY DISEASE7 reports
COMA7 reports
CONTUSION7 reports
DEATH7 reports
EMOTIONAL DISTRESS7 reports
ERYTHEMA7 reports
HEART RATE INCREASED7 reports
HYPOAESTHESIA7 reports
MALAISE7 reports
NEPHROLITHIASIS7 reports
RESPIRATORY ALKALOSIS7 reports
SWOLLEN TONGUE7 reports
URINARY INCONTINENCE7 reports
ABDOMINAL DISCOMFORT6 reports
ANGINA PECTORIS6 reports
BLOOD CHOLESTEROL INCREASED6 reports
BURNING SENSATION6 reports
DRY SKIN6 reports
DYSPEPSIA6 reports
HYPERHIDROSIS6 reports
ILLNESS6 reports
INCORRECT DOSE ADMINISTERED6 reports
INFECTION6 reports
MEMORY IMPAIRMENT6 reports
PALPITATIONS6 reports
PNEUMONIA ASPIRATION6 reports
PRODUCT DOSE OMISSION ISSUE6 reports
SINUSITIS6 reports
STRESS6 reports
TREMOR6 reports
VERTIGO6 reports
VISION BLURRED6 reports
ANGINA UNSTABLE5 reports
ANORECTAL DISCOMFORT5 reports
ANXIETY5 reports
ASTHMA5 reports
ATRIAL FIBRILLATION5 reports
BLADDER DISORDER5 reports
BLISTER5 reports
BLOOD PRESSURE SYSTOLIC INCREASED5 reports
BLOOD URINE5 reports
CARDIAC FAILURE CONGESTIVE5 reports
CARDIOMYOPATHY5 reports
CARDIOVASCULAR DISORDER5 reports

Report Outcomes

Out of 307 classified reports for PHENAZOPYRIDINE HYDROCHLORIDE:

Serious 75.2%Non-Serious 24.8%

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

Female226 (77.9%)
Male64 (22.1%)

Reports by Age

Age 3722 reports
Age 7410 reports
Age 668 reports
Age 718 reports
Age 257 reports
Age 707 reports
Age 496 reports
Age 566 reports
Age 586 reports
Age 646 reports
Age 736 reports
Age 756 reports
Age 766 reports
Age 776 reports
Age 555 reports
Age 675 reports
Age 785 reports
Age 414 reports
Age 524 reports
Age 604 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 PHENAZOPYRIDINE HYDROCHLORIDE?

This profile reflects 1,029 FDA FAERS reports that mention PHENAZOPYRIDINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PHENAZOPYRIDINE HYDROCHLORIDE?

Frequently reported terms in FAERS include PAIN, DYSPNOEA, NAUSEA, HEADACHE, FATIGUE, SULPHAEMOGLOBINAEMIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PHENAZOPYRIDINE HYDROCHLORIDE?

Labeling and FAERS entries often list i-Health, Inc. in connection with PHENAZOPYRIDINE 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.