BACITRACIN ZINC AND POLYMYXIN B SULFATE

N/A

Manufactured by Kenvue Brands LLC

622 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BACITRACIN ZINC AND POLYMYXIN B SULFATE

BACITRACIN ZINC AND POLYMYXIN B SULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Kenvue Brands LLC. The most commonly reported adverse reactions for BACITRACIN ZINC AND POLYMYXIN B SULFATE include OFF LABEL USE, HEADACHE, PRURITUS, PAIN, WEIGHT INCREASED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BACITRACIN ZINC AND POLYMYXIN B SULFATE.

Top Adverse Reactions

OFF LABEL USE14 reports
HEADACHE12 reports
PRURITUS12 reports
PAIN11 reports
WEIGHT INCREASED11 reports
DYSPEPSIA10 reports
DYSPNOEA10 reports
HYPERSENSITIVITY10 reports
NAUSEA10 reports
RASH10 reports
CHEST PAIN9 reports
CONDITION AGGRAVATED9 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES9 reports
PYREXIA9 reports
SPINAL FUSION SURGERY9 reports
WEIGHT DECREASED9 reports
WHEEZING9 reports
WOUND INFECTION9 reports
DIARRHOEA8 reports
DIZZINESS8 reports
HIP ARTHROPLASTY8 reports
INFUSION RELATED REACTION8 reports
SWELLING8 reports
WOUND8 reports
AMNESIA7 reports
ANXIETY7 reports
BLISTER7 reports
FATIGUE7 reports
WALKING AID USER7 reports
ALOPECIA6 reports
ARTHRALGIA6 reports
ASTHMA6 reports
BLOOD CHOLESTEROL INCREASED6 reports
CONTUSION6 reports
DECREASED APPETITE6 reports
DEPRESSION6 reports
DISCOMFORT6 reports
DRUG INEFFECTIVE6 reports
ERYTHEMA6 reports
FOOT DEFORMITY6 reports
HYPERTENSION6 reports
MEMORY IMPAIRMENT6 reports
PRODUCT USE IN UNAPPROVED INDICATION6 reports
URTICARIA6 reports
VISUAL IMPAIRMENT6 reports
VOMITING6 reports
ABDOMINAL DISCOMFORT5 reports
ABDOMINAL PAIN5 reports
ADJUSTMENT DISORDER WITH DEPRESSED MOOD5 reports
ANAEMIA5 reports
ANTI CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE5 reports
ARTHRITIS5 reports
ARTHROPATHY5 reports
AUTOIMMUNE DISORDER5 reports
BONE EROSION5 reports
BREAST CANCER STAGE III5 reports
C REACTIVE PROTEIN INCREASED5 reports
CONFUSIONAL STATE5 reports
CONSTIPATION5 reports
CROHN^S DISEASE5 reports
DEEP VEIN THROMBOSIS POSTOPERATIVE5 reports
DELIRIUM5 reports
DISLOCATION OF VERTEBRA5 reports
DRUG HYPERSENSITIVITY5 reports
DRUG INDUCED LIVER INJURY5 reports
DUODENAL ULCER PERFORATION5 reports
EXOSTOSIS5 reports
FIBROMYALGIA5 reports
GAIT DISTURBANCE5 reports
GAIT INABILITY5 reports
GENERAL PHYSICAL HEALTH DETERIORATION5 reports
GLOSSODYNIA5 reports
GRIP STRENGTH DECREASED5 reports
HAND DEFORMITY5 reports
HYPOAESTHESIA5 reports
IMPAIRED HEALING5 reports
JOINT SWELLING5 reports
MUSCULAR WEAKNESS5 reports
OCULAR HYPERAEMIA5 reports
OEDEMA PERIPHERAL5 reports
PULMONARY FIBROSIS5 reports
STOMATITIS5 reports
SYNOVITIS5 reports
TACHYCARDIA5 reports
UPPER RESPIRATORY TRACT INFECTION5 reports
ANTI CYCLIC CITRULLINATED PEPTIDE ANTIBODY4 reports
BRONCHITIS4 reports
CHRONIC SINUSITIS4 reports
COLITIS4 reports
COLITIS ULCERATIVE4 reports
EAR INFECTION4 reports
FEMALE GENITAL TRACT FISTULA4 reports
FOLLICULITIS4 reports
FREQUENT BOWEL MOVEMENTS4 reports
HEPATIC CIRRHOSIS4 reports
HEPATIC ENZYME INCREASED4 reports
HYPERCHOLESTEROLAEMIA4 reports
INFECTION4 reports
INJURY4 reports
INSOMNIA4 reports

Report Outcomes

Out of 102 classified reports for BACITRACIN ZINC AND POLYMYXIN B SULFATE:

Serious 61.8%Non-Serious 38.2%

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

Female69 (73.4%)
Male25 (26.6%)

Reports by Age

Age 715 reports
Age 835 reports
Age 583 reports
Age 683 reports
Age 352 reports
Age 382 reports
Age 522 reports
Age 692 reports
Age 702 reports
Age 742 reports
Age 91 reports
Age 141 reports
Age 151 reports
Age 201 reports
Age 271 reports
Age 281 reports
Age 291 reports
Age 301 reports
Age 321 reports
Age 361 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 BACITRACIN ZINC AND POLYMYXIN B SULFATE?

This profile reflects 622 FDA FAERS reports that mention BACITRACIN ZINC AND POLYMYXIN B SULFATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BACITRACIN ZINC AND POLYMYXIN B SULFATE?

Frequently reported terms in FAERS include OFF LABEL USE, HEADACHE, PRURITUS, PAIN, WEIGHT INCREASED, DYSPEPSIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BACITRACIN ZINC AND POLYMYXIN B SULFATE?

Labeling and FAERS entries often list Kenvue Brands LLC in connection with BACITRACIN ZINC AND POLYMYXIN B SULFATE. 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.