BACITRACIN ZINC

N/A

Manufactured by Topco Associates LLC

7,550 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BACITRACIN ZINC

BACITRACIN ZINC is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Topco Associates LLC. The most commonly reported adverse reactions for BACITRACIN ZINC include DRUG HYPERSENSITIVITY, DRUG INEFFECTIVE, PAIN, NAUSEA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BACITRACIN ZINC.

Top Adverse Reactions

DRUG HYPERSENSITIVITY374 reports
DRUG INEFFECTIVE227 reports
PAIN202 reports
NAUSEA195 reports
DIARRHOEA188 reports
DYSPNOEA181 reports
RASH174 reports
FATIGUE167 reports
PYREXIA137 reports
DIZZINESS134 reports
VOMITING134 reports
OFF LABEL USE133 reports
PNEUMONIA132 reports
ANXIETY131 reports
HEADACHE131 reports
RENAL FAILURE121 reports
COUGH114 reports
FALL111 reports
ASTHENIA110 reports
ERYTHEMA110 reports
DEATH103 reports
CHRONIC KIDNEY DISEASE92 reports
MALAISE92 reports
PRURITUS88 reports
URINARY TRACT INFECTION87 reports
ACUTE KIDNEY INJURY85 reports
HYPERTENSION85 reports
WEIGHT DECREASED83 reports
ARTHRALGIA82 reports
CONSTIPATION80 reports
HYPOTENSION79 reports
HYPERSENSITIVITY77 reports
SEPSIS76 reports
ANAEMIA75 reports
ABDOMINAL PAIN73 reports
DEPRESSION72 reports
INSOMNIA72 reports
CONDITION AGGRAVATED66 reports
BACK PAIN65 reports
EMOTIONAL DISTRESS65 reports
OCULAR HYPERAEMIA64 reports
DECREASED APPETITE63 reports
INFECTION61 reports
FEELING ABNORMAL57 reports
SINUSITIS57 reports
TREMOR57 reports
DEHYDRATION56 reports
GASTROOESOPHAGEAL REFLUX DISEASE56 reports
PAIN IN EXTREMITY56 reports
VISION BLURRED56 reports
BRONCHITIS55 reports
NEUROPATHY PERIPHERAL55 reports
BLOOD GLUCOSE INCREASED54 reports
GAIT DISTURBANCE54 reports
CONFUSIONAL STATE53 reports
INJURY53 reports
EYE PAIN52 reports
RESPIRATORY FAILURE52 reports
SOMNOLENCE51 reports
NASOPHARYNGITIS50 reports
PRODUCT QUALITY ISSUE50 reports
ABDOMINAL PAIN UPPER49 reports
EYE IRRITATION48 reports
EYE SWELLING48 reports
MUSCLE SPASMS48 reports
DRY SKIN47 reports
OEDEMA PERIPHERAL47 reports
UNEVALUABLE EVENT47 reports
CHEST PAIN46 reports
PARAESTHESIA45 reports
ALOPECIA44 reports
HYPOXIA44 reports
PLATELET COUNT DECREASED44 reports
CELLULITIS43 reports
WEIGHT INCREASED43 reports
LOSS OF CONSCIOUSNESS42 reports
MENTAL STATUS CHANGES42 reports
ANHEDONIA41 reports
DYSPHAGIA41 reports
FEBRILE NEUTROPENIA41 reports
MUSCULAR WEAKNESS41 reports
HYPOAESTHESIA40 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION40 reports
CHILLS39 reports
RENAL INJURY39 reports
ACNE38 reports
CARDIAC FAILURE CONGESTIVE38 reports
JOINT SWELLING38 reports
MEMORY IMPAIRMENT37 reports
ABDOMINAL DISTENSION36 reports
HAEMOGLOBIN DECREASED36 reports
MYALGIA36 reports
THROMBOCYTOPENIA36 reports
EYE PRURITUS35 reports
STOMATITIS35 reports
URTICARIA35 reports
ANAPHYLACTIC REACTION34 reports
BLOOD PRESSURE INCREASED34 reports
DRUG INTERACTION34 reports
HEART RATE INCREASED34 reports

Report Outcomes

Out of 3,841 classified reports for BACITRACIN ZINC:

Serious 58.4%Non-Serious 41.6%

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

Female2,143 (60.9%)
Male1,354 (38.5%)
Unknown19 (0.5%)

Reports by Age

Age 7265 reports
Age 6359 reports
Age 6459 reports
Age 6959 reports
Age 7155 reports
Age 6654 reports
Age 6053 reports
Age 5851 reports
Age 6751 reports
Age 7051 reports
Age 5550 reports
Age 5746 reports
Age 6544 reports
Age 6844 reports
Age 7944 reports
Age 6243 reports
Age 5242 reports
Age 5942 reports
Age 7741 reports
Age 7639 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?

This profile reflects 7,550 FDA FAERS reports that mention BACITRACIN ZINC. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BACITRACIN ZINC?

Frequently reported terms in FAERS include DRUG HYPERSENSITIVITY, DRUG INEFFECTIVE, PAIN, NAUSEA, DIARRHOEA, DYSPNOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BACITRACIN ZINC?

Labeling and FAERS entries often list Topco Associates LLC in connection with BACITRACIN ZINC. 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.