NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE

N/A

Manufactured by Amneal Pharmaceuticals NY LLC

690 FDA adverse event reports analyzed

Last updated: 2026-04-15

About NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE

NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals NY LLC. The most commonly reported adverse reactions for NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE include EAR DISCOMFORT, EYE IRRITATION, PAIN, INCORRECT ROUTE OF DRUG ADMINISTRATION, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE.

Top Adverse Reactions

EAR DISCOMFORT35 reports
EYE IRRITATION31 reports
PAIN21 reports
INCORRECT ROUTE OF DRUG ADMINISTRATION19 reports
DRUG INEFFECTIVE18 reports
ACCIDENTAL EXPOSURE TO PRODUCT17 reports
EAR PAIN17 reports
EYE PAIN17 reports
OFF LABEL USE17 reports
HYPOACUSIS16 reports
OCULAR HYPERAEMIA16 reports
DIZZINESS14 reports
DRUG DISPENSING ERROR14 reports
EXPIRED PRODUCT ADMINISTERED14 reports
PRODUCT DOSE OMISSION ISSUE12 reports
TINNITUS12 reports
WRONG PRODUCT ADMINISTERED11 reports
CONDITION AGGRAVATED10 reports
HEADACHE10 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION10 reports
NO ADVERSE EVENT10 reports
PRURITUS10 reports
VISION BLURRED10 reports
DEAFNESS9 reports
INSTILLATION SITE PAIN9 reports
OROPHARYNGEAL PAIN9 reports
PRODUCT USE IN UNAPPROVED INDICATION9 reports
ANXIETY8 reports
DIARRHOEA8 reports
EAR INFECTION8 reports
ERYTHEMA8 reports
ANHEDONIA7 reports
CHRONIC KIDNEY DISEASE7 reports
EMOTIONAL DISTRESS7 reports
NAUSEA7 reports
RASH7 reports
VOMITING7 reports
ACUTE KIDNEY INJURY6 reports
DYSPNOEA6 reports
PRODUCT DISPENSING ERROR6 reports
WRONG DRUG ADMINISTERED6 reports
ARTHRALGIA5 reports
BURNING SENSATION5 reports
COUGH5 reports
ECONOMIC PROBLEM5 reports
FATIGUE5 reports
INSOMNIA5 reports
OTORRHOEA5 reports
SKIN EXFOLIATION5 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS5 reports
ABDOMINAL DISCOMFORT4 reports
DEAFNESS UNILATERAL4 reports
DERMATITIS ATOPIC4 reports
DISCOMFORT4 reports
EAR DISORDER4 reports
EYE SWELLING4 reports
FALL4 reports
HYPERSENSITIVITY4 reports
PYREXIA4 reports
THROAT IRRITATION4 reports
VERTIGO4 reports
ALOPECIA3 reports
BALANCE DISORDER3 reports
CHEST DISCOMFORT3 reports
CONSTIPATION3 reports
COVID 193 reports
DEPRESSION3 reports
DRY MOUTH3 reports
EPISTAXIS3 reports
FEELING HOT3 reports
GAIT DISTURBANCE3 reports
HOSPITALISATION3 reports
IMPAIRED QUALITY OF LIFE3 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION3 reports
LIMB DISCOMFORT3 reports
MEDICATION ERROR3 reports
NASOPHARYNGITIS3 reports
PAIN IN EXTREMITY3 reports
PRODUCT CONTAINER ISSUE3 reports
RENAL FAILURE3 reports
RENAL INJURY3 reports
RESPIRATORY FAILURE3 reports
SINUSITIS3 reports
SKIN IRRITATION3 reports
STRESS3 reports
THERAPY NON RESPONDER3 reports
UPPER RESPIRATORY TRACT INFECTION3 reports
URTICARIA3 reports
WEIGHT INCREASED3 reports
ABNORMAL SENSATION IN EYE2 reports
ACNE2 reports
AMNESIA2 reports
ASTHENIA2 reports
BONE DENSITY DECREASED2 reports
BRONCHITIS2 reports
CHEST PAIN2 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE2 reports
CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR2 reports
CONFUSIONAL STATE2 reports
DRUG PRESCRIBING ERROR2 reports

Report Outcomes

Out of 253 classified reports for NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE:

Serious 26.1%Non-Serious 73.9%

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

Female159 (66.0%)
Male82 (34.0%)

Reports by Age

Age 656 reports
Age 525 reports
Age 605 reports
Age 695 reports
Age 745 reports
Age 815 reports
Age 514 reports
Age 554 reports
Age 333 reports
Age 353 reports
Age 413 reports
Age 443 reports
Age 493 reports
Age 563 reports
Age 583 reports
Age 623 reports
Age 663 reports
Age 703 reports
Age 763 reports
Age 773 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 NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE?

This profile reflects 690 FDA FAERS reports that mention NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE?

Frequently reported terms in FAERS include EAR DISCOMFORT, EYE IRRITATION, PAIN, INCORRECT ROUTE OF DRUG ADMINISTRATION, DRUG INEFFECTIVE, ACCIDENTAL EXPOSURE TO PRODUCT. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE?

Labeling and FAERS entries often list Amneal Pharmaceuticals NY LLC in connection with NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE. 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.