CHLORHEXIDINE GLUCONATE 4%

N/A

Manufactured by Xttrium Laboratories, Inc.

120 FDA adverse event reports analyzed

Last updated: 2026-04-15

About CHLORHEXIDINE GLUCONATE 4%

CHLORHEXIDINE GLUCONATE 4% is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Xttrium Laboratories, Inc.. The most commonly reported adverse reactions for CHLORHEXIDINE GLUCONATE 4% include RASH, HYPERSENSITIVITY, ACCIDENTAL EXPOSURE TO PRODUCT, EYE IRRITATION, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CHLORHEXIDINE GLUCONATE 4%.

Top Adverse Reactions

RASH5 reports
HYPERSENSITIVITY4 reports
ACCIDENTAL EXPOSURE TO PRODUCT3 reports
EYE IRRITATION3 reports
PAIN3 reports
ALOPECIA2 reports
APPLICATION SITE PRURITUS2 reports
BURKHOLDERIA INFECTION2 reports
COMPLICATION OF DEVICE INSERTION2 reports
DIARRHOEA2 reports
ERYTHEMA2 reports
HYPOAESTHESIA2 reports
PARAESTHESIA2 reports
PROCEDURAL PAIN2 reports
PRURITUS2 reports
SEPSIS2 reports
SPUTUM CULTURE POSITIVE2 reports
ABDOMINAL PAIN LOWER1 reports
ACCIDENTAL DEVICE INGESTION1 reports
ADVERSE DRUG REACTION1 reports
ADVERSE EVENT1 reports
AGEUSIA1 reports
ANOSMIA1 reports
APPLICATION SITE DISCOMFORT1 reports
APPLICATION SITE PARAESTHESIA1 reports
APPLICATION SITE RASH1 reports
ATELECTASIS1 reports
BALANCE DISORDER1 reports
BLOOD PRESSURE DECREASED1 reports
CHEST X RAY ABNORMAL1 reports
CONDITION AGGRAVATED1 reports
CYSTITIS1 reports
DERMATITIS1 reports
DERMATITIS CONTACT1 reports
DEVICE DIFFICULT TO USE1 reports
DEVICE EXPULSION1 reports
DEVICE USE ISSUE1 reports
DISCOMFORT1 reports
DRUG DISPENSING ERROR1 reports
DRUG INEFFECTIVE1 reports
DYSPEPSIA1 reports
DYSPHAGIA1 reports
DYSPNOEA1 reports
ESCHERICHIA INFECTION1 reports
EYE MOVEMENT DISORDER1 reports
EYE PAIN1 reports
EYE SWELLING1 reports
FEELING ABNORMAL1 reports
GAIT DISTURBANCE1 reports
HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS1 reports
HEART RATE INCREASED1 reports
HOSPITALISATION1 reports
HYPERTENSION1 reports
IMPAIRED HEALING1 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION1 reports
INFECTION1 reports
KERATITIS1 reports
LUNG CONSOLIDATION1 reports
LUNG OPACITY1 reports
MASTICATION DISORDER1 reports
MEDICAL DEVICE DISCOMFORT1 reports
MENORRHAGIA1 reports
METRORRHAGIA1 reports
MOUTH ULCERATION1 reports
NASAL INFLAMMATION1 reports
OESOPHAGITIS1 reports
ORAL DISCOMFORT1 reports
ORAL PAIN1 reports
OVULATION PAIN1 reports
PALLOR1 reports
PATHOGEN RESISTANCE1 reports
PNEUMONIA1 reports
POST PROCEDURAL HAEMORRHAGE1 reports
PRESYNCOPE1 reports
PROCEDURAL NAUSEA1 reports
PRODUCT DISPENSING ISSUE1 reports
PRODUCT FORMULATION ISSUE1 reports
PRODUCT PACKAGING CONFUSION1 reports
PULMONARY OEDEMA1 reports
RESPIRATORY RATE INCREASED1 reports
SERRATIA INFECTION1 reports
SKIN BURNING SENSATION1 reports
SKIN EXFOLIATION1 reports
SNEEZING1 reports
SWELLING FACE1 reports
THROAT IRRITATION1 reports
THROAT TIGHTNESS1 reports
TONGUE ULCERATION1 reports
TREMOR1 reports
URINARY INCONTINENCE1 reports
URTICARIA1 reports
VAGINAL DISCHARGE1 reports
VISUAL IMPAIRMENT1 reports
VOMITING1 reports
WRONG DRUG ADMINISTERED1 reports

Report Outcomes

Out of 38 classified reports for CHLORHEXIDINE GLUCONATE 4%:

Serious 63.2%Non-Serious 36.8%

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

Female19 (70.4%)
Male8 (29.6%)

Reports by Age

Age 632 reports
Age 111 reports
Age 191 reports
Age 231 reports
Age 261 reports
Age 291 reports
Age 341 reports
Age 371 reports
Age 381 reports
Age 411 reports
Age 461 reports
Age 511 reports
Age 531 reports
Age 551 reports
Age 571 reports
Age 661 reports
Age 681 reports
Age 821 reports
Age 831 reports
Age 841 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 CHLORHEXIDINE GLUCONATE 4%?

This profile reflects 120 FDA FAERS reports that mention CHLORHEXIDINE GLUCONATE 4%. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CHLORHEXIDINE GLUCONATE 4%?

Frequently reported terms in FAERS include RASH, HYPERSENSITIVITY, ACCIDENTAL EXPOSURE TO PRODUCT, EYE IRRITATION, PAIN, ALOPECIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CHLORHEXIDINE GLUCONATE 4%?

Labeling and FAERS entries often list Xttrium Laboratories, Inc. in connection with CHLORHEXIDINE GLUCONATE 4%. 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.