BENZETHONIUM CHLORIDE

N/A

Manufactured by McKesson

326 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BENZETHONIUM CHLORIDE

BENZETHONIUM CHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by McKesson. The most commonly reported adverse reactions for BENZETHONIUM CHLORIDE include NAUSEA, HYPERSENSITIVITY, HEADACHE, THERAPEUTIC PRODUCT EFFECT DECREASED, CONTRAINDICATED PRODUCT ADMINISTERED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BENZETHONIUM CHLORIDE.

Top Adverse Reactions

NAUSEA24 reports
HYPERSENSITIVITY20 reports
HEADACHE19 reports
THERAPEUTIC PRODUCT EFFECT DECREASED17 reports
CONTRAINDICATED PRODUCT ADMINISTERED10 reports
APPLICATION SITE PAIN6 reports
DEATH6 reports
DIARRHOEA6 reports
DRUG INEFFECTIVE6 reports
OFF LABEL USE6 reports
PNEUMONIA6 reports
PYREXIA6 reports
DIZZINESS5 reports
HYPERTENSION5 reports
ABDOMINAL PAIN4 reports
PAIN4 reports
RHEUMATOID ARTHRITIS4 reports
WEIGHT DECREASED4 reports
ALANINE AMINOTRANSFERASE INCREASED3 reports
ANAEMIA3 reports
APPLICATION SITE ERYTHEMA3 reports
ASPARTATE AMINOTRANSFERASE INCREASED3 reports
COVID 193 reports
DECREASED APPETITE3 reports
DRUG HYPERSENSITIVITY3 reports
DYSPNOEA3 reports
FALL3 reports
FATIGUE3 reports
GALLBLADDER ADENOCARCINOMA3 reports
HEPATIC FUNCTION ABNORMAL3 reports
INTERSTITIAL LUNG DISEASE3 reports
LUNG NEOPLASM MALIGNANT3 reports
METASTASES TO LIVER3 reports
ORAL CANDIDIASIS3 reports
RENAL FAILURE3 reports
SHOCK HAEMORRHAGIC3 reports
SKIN DISCOLOURATION3 reports
STOMATITIS3 reports
TREATMENT FAILURE3 reports
ACUTE MYELOID LEUKAEMIA2 reports
ADENOCARCINOMA OF COLON2 reports
APPLICATION SITE IRRITATION2 reports
ARTHRALGIA2 reports
ASTHENIA2 reports
BACK PAIN2 reports
BLOOD LACTATE DEHYDROGENASE INCREASED2 reports
BRONCHOPULMONARY ASPERGILLOSIS2 reports
BURNING SENSATION2 reports
COLITIS ULCERATIVE2 reports
CONDITION AGGRAVATED2 reports
CONSTIPATION2 reports
COUGH2 reports
DRUG ERUPTION2 reports
DUODENAL ULCER PERFORATION2 reports
ERYTHEMA2 reports
FEBRILE NEUTROPENIA2 reports
GAIT DISTURBANCE2 reports
GASTRIC ULCER HAEMORRHAGE2 reports
GASTROENTERITIS2 reports
HYPOALBUMINAEMIA2 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION2 reports
INSOMNIA2 reports
MALIGNANT NEOPLASM PROGRESSION2 reports
OCULAR HYPERAEMIA2 reports
OSTEONECROSIS OF JAW2 reports
OVERDOSE2 reports
PLEURAL EFFUSION2 reports
PRODUCT USE IN UNAPPROVED INDICATION2 reports
PRURITUS2 reports
PULMONARY EMBOLISM2 reports
PULMONARY INFARCTION2 reports
RASH2 reports
RENAL IMPAIRMENT2 reports
SEPSIS2 reports
SINUSITIS2 reports
SWELLING2 reports
SYPHILIS2 reports
TREMOR2 reports
UPPER GASTROINTESTINAL HAEMORRHAGE2 reports
URINARY TRACT INFECTION2 reports
VOMITING2 reports
WHITE BLOOD CELL COUNT DECREASED2 reports
WOUND COMPLICATION2 reports
ABDOMINAL DISCOMFORT1 reports
ABDOMINAL PAIN UPPER1 reports
ABDOMINAL SYMPTOM1 reports
ABNORMAL BEHAVIOUR1 reports
ABSCESS1 reports
ACANTHAMOEBA KERATITIS1 reports
ACTIVATED PROTEIN C RESISTANCE1 reports
ALCOHOL POISONING1 reports
ALCOHOL WITHDRAWAL SYNDROME1 reports
ANAL ABSCESS1 reports
ANAPHYLACTIC REACTION1 reports
ANTICOAGULANT THERAPY1 reports
APPLICATION SITE DISCHARGE1 reports
APPLICATION SITE HYPERTROPHY1 reports
APPLICATION SITE INFECTION1 reports
APPLICATION SITE NODULE1 reports
APPLICATION SITE SCAR1 reports

Report Outcomes

Out of 124 classified reports for BENZETHONIUM CHLORIDE:

Serious 91.9%Non-Serious 8.1%

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

Female70 (60.9%)
Male45 (39.1%)

Reports by Age

Age 746 reports
Age 545 reports
Age 685 reports
Age 725 reports
Age 824 reports
Age 573 reports
Age 623 reports
Age 733 reports
Age 102 reports
Age 252 reports
Age 392 reports
Age 432 reports
Age 462 reports
Age 492 reports
Age 532 reports
Age 662 reports
Age 672 reports
Age 702 reports
Age 802 reports
Age 31 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 BENZETHONIUM CHLORIDE?

This profile reflects 326 FDA FAERS reports that mention BENZETHONIUM CHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BENZETHONIUM CHLORIDE?

Frequently reported terms in FAERS include NAUSEA, HYPERSENSITIVITY, HEADACHE, THERAPEUTIC PRODUCT EFFECT DECREASED, CONTRAINDICATED PRODUCT ADMINISTERED, APPLICATION SITE PAIN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BENZETHONIUM CHLORIDE?

Labeling and FAERS entries often list McKesson in connection with BENZETHONIUM CHLORIDE. 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.