BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE

N/A

Manufactured by Padagis Israel Pharmaceuticals Ltd

256 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE

BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Padagis Israel Pharmaceuticals Ltd. The most commonly reported adverse reactions for BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE include DRUG HYPERSENSITIVITY, DRUG INEFFECTIVE, PRURITUS, CONSTIPATION, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE.

Top Adverse Reactions

DRUG HYPERSENSITIVITY10 reports
DRUG INEFFECTIVE10 reports
PRURITUS7 reports
CONSTIPATION6 reports
OFF LABEL USE6 reports
RASH6 reports
DYSPNOEA5 reports
FATIGUE5 reports
MALAISE5 reports
NAUSEA5 reports
PAIN5 reports
URINARY TRACT INFECTION5 reports
CHILLS4 reports
DEATH4 reports
DIARRHOEA4 reports
DYSPHAGIA4 reports
FALL4 reports
WEIGHT DECREASED4 reports
ASTHENIA3 reports
CONDITION AGGRAVATED3 reports
COUGH3 reports
COVID 193 reports
DECREASED APPETITE3 reports
DRY SKIN3 reports
ERYTHEMA3 reports
FULL BLOOD COUNT DECREASED3 reports
HEADACHE3 reports
HYPOTENSION3 reports
INSOMNIA3 reports
PNEUMONIA3 reports
PRODUCT DOSE OMISSION ISSUE3 reports
SINUSITIS3 reports
SKIN LACERATION3 reports
SOMNOLENCE3 reports
ABDOMINAL PAIN UPPER2 reports
ABORTION SPONTANEOUS2 reports
ANAPHYLACTIC REACTION2 reports
ANXIETY2 reports
APHONIA2 reports
BACK PAIN2 reports
BRONCHITIS2 reports
CELLULITIS2 reports
DEHYDRATION2 reports
DEPRESSION2 reports
DISCOMFORT2 reports
DRUG DOSE OMISSION2 reports
DRUG EFFECT DECREASED2 reports
DRUG WITHDRAWAL SYNDROME2 reports
DYSGEUSIA2 reports
DYSURIA2 reports
ECTOPIC PREGNANCY2 reports
EXPOSURE DURING PREGNANCY2 reports
FOLLICULITIS2 reports
HEAD INJURY2 reports
HEART RATE DECREASED2 reports
HYPERHIDROSIS2 reports
HYPERTENSION2 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION2 reports
INFLUENZA2 reports
LETHARGY2 reports
LOSS OF CONSCIOUSNESS2 reports
MEMORY IMPAIRMENT2 reports
MIGRAINE2 reports
MULTIPLE SCLEROSIS2 reports
MUSCLE TIGHTNESS2 reports
MUSCULAR WEAKNESS2 reports
OEDEMA PERIPHERAL2 reports
OXYGEN SATURATION DECREASED2 reports
PERIPHERAL SWELLING2 reports
PRODUCT LABEL ISSUE2 reports
PRODUCT USE IN UNAPPROVED INDICATION2 reports
RESPIRATORY TRACT CONGESTION2 reports
RESPIRATORY TRACT INFECTION2 reports
RHEUMATOID ARTHRITIS2 reports
STAPHYLOCOCCAL INFECTION2 reports
TOXICITY TO VARIOUS AGENTS2 reports
UNEVALUABLE EVENT2 reports
ABDOMINAL DISCOMFORT1 reports
ABDOMINAL DISTENSION1 reports
ABDOMINAL PAIN1 reports
ABDOMINAL PAIN LOWER1 reports
ACCIDENT1 reports
ACCIDENTAL EXPOSURE TO PRODUCT1 reports
ACCIDENTAL OVERDOSE1 reports
ACUTE MYOCARDIAL INFARCTION1 reports
ADVERSE EVENT1 reports
AGEUSIA1 reports
AGITATION1 reports
ALANINE AMINOTRANSFERASE INCREASED1 reports
ALTERED STATE OF CONSCIOUSNESS1 reports
ANAPHYLACTOID SHOCK1 reports
ANOSMIA1 reports
APPLICATION SITE INFECTION1 reports
APPLICATION SITE INFLAMMATION1 reports
APPLICATION SITE SWELLING1 reports
ARTHRALGIA1 reports
ARTHROPOD BITE1 reports
ASPARTATE AMINOTRANSFERASE INCREASED1 reports
ASPHYXIA1 reports
ASTHMA1 reports

Report Outcomes

Out of 90 classified reports for BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE:

Serious 54.4%Non-Serious 45.6%

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

Female53 (61.6%)
Male33 (38.4%)

Reports by Age

Age 614 reports
Age 803 reports
Age 312 reports
Age 322 reports
Age 352 reports
Age 382 reports
Age 392 reports
Age 472 reports
Age 492 reports
Age 562 reports
Age 642 reports
Age 682 reports
Age 692 reports
Age 712 reports
Age 742 reports
Age 271 reports
Age 281 reports
Age 291 reports
Age 511 reports
Age 531 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, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE?

This profile reflects 256 FDA FAERS reports that mention BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE?

Frequently reported terms in FAERS include DRUG HYPERSENSITIVITY, DRUG INEFFECTIVE, PRURITUS, CONSTIPATION, OFF LABEL USE, RASH. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE?

Labeling and FAERS entries often list Padagis Israel Pharmaceuticals Ltd in connection with BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE 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.