NEOMYCIN SULFATE

N/A

Manufactured by Total Resources International

12,389 FDA adverse event reports analyzed

Last updated: 2026-04-15

About NEOMYCIN SULFATE

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

Top Adverse Reactions

DRUG INEFFECTIVE500 reports
DRUG HYPERSENSITIVITY497 reports
PAIN353 reports
NAUSEA319 reports
DYSPNOEA303 reports
MALAISE282 reports
OFF LABEL USE282 reports
INFUSION RELATED REACTION231 reports
RASH230 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE210 reports
MACULAR DEGENERATION201 reports
PYREXIA198 reports
HEADACHE197 reports
VOMITING192 reports
PNEUMONIA183 reports
WEIGHT DECREASED164 reports
RHEUMATOID ARTHRITIS160 reports
SWELLING158 reports
TYPE 2 DIABETES MELLITUS155 reports
COUGH150 reports
CONFUSIONAL STATE146 reports
THERAPEUTIC PRODUCT EFFECT DECREASED144 reports
DIARRHOEA143 reports
CHEST PAIN140 reports
FATIGUE140 reports
WHEEZING140 reports
DIZZINESS139 reports
ASTHMA138 reports
PRODUCT USE IN UNAPPROVED INDICATION138 reports
SYSTEMIC LUPUS ERYTHEMATOSUS138 reports
PSORIATIC ARTHROPATHY137 reports
DYSPEPSIA136 reports
TREATMENT FAILURE135 reports
C REACTIVE PROTEIN INCREASED133 reports
ERYTHEMA133 reports
ILL DEFINED DISORDER133 reports
PRODUCT USE ISSUE133 reports
SLEEP DISORDER130 reports
SYNOVITIS125 reports
WOUND125 reports
C REACTIVE PROTEIN ABNORMAL122 reports
PEMPHIGUS120 reports
PERICARDITIS120 reports
RHEUMATIC FEVER118 reports
CONTRAINDICATED PRODUCT ADMINISTERED114 reports
ONYCHOMYCOSIS113 reports
ABDOMINAL PAIN109 reports
INJECTION SITE REACTION106 reports
ONYCHOMADESIS104 reports
OEDEMA98 reports
CONDITION AGGRAVATED96 reports
ANAEMIA92 reports
ARTHRALGIA88 reports
CONSTIPATION87 reports
DECREASED APPETITE87 reports
HYPERTENSION87 reports
PARAESTHESIA ORAL87 reports
RECTAL HAEMORRHAGE86 reports
INTENTIONAL PRODUCT USE ISSUE85 reports
CHRONIC SINUSITIS83 reports
INSOMNIA81 reports
PROCEDURAL PAIN81 reports
DRUG INTOLERANCE80 reports
JOINT SWELLING79 reports
HAEMATOCHEZIA78 reports
OVERDOSE78 reports
FALL77 reports
NASOPHARYNGITIS77 reports
COLITIS ULCERATIVE76 reports
GENERAL PHYSICAL HEALTH DETERIORATION76 reports
ORAL CANDIDIASIS75 reports
FREQUENT BOWEL MOVEMENTS74 reports
RESPIRATORY TRACT INFECTION74 reports
ABDOMINAL DISCOMFORT73 reports
FEMALE GENITAL TRACT FISTULA73 reports
NASAL OEDEMA73 reports
PRURITUS72 reports
RADICULOPATHY70 reports
ALOPECIA68 reports
HYPOAESTHESIA68 reports
ABDOMINAL PAIN UPPER67 reports
COLITIS67 reports
HYPERSENSITIVITY65 reports
VAGINAL DISCHARGE65 reports
ASTHENIA64 reports
FIBROMYALGIA64 reports
PROCTITIS64 reports
VAGINAL FLATULENCE64 reports
DEPRESSION63 reports
INFECTION63 reports
SINUSITIS62 reports
UNDERDOSE61 reports
URTICARIA59 reports
HEPATIC ENZYME INCREASED55 reports
WEIGHT INCREASED53 reports
DRY MOUTH52 reports
GLOSSODYNIA52 reports
HAND DEFORMITY52 reports
HELICOBACTER INFECTION51 reports
DUODENAL ULCER PERFORATION50 reports

Report Outcomes

Out of 2,669 classified reports for NEOMYCIN SULFATE:

Serious 59.6%Non-Serious 40.4%

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

Female1,692 (71.8%)
Male628 (26.7%)
Unknown35 (1.5%)

Reports by Age

Age 40125 reports
Age 71104 reports
Age 6593 reports
Age 6146 reports
Age 4437 reports
Age 6433 reports
Age 7231 reports
Age 6329 reports
Age 5528 reports
Age 5927 reports
Age 6227 reports
Age 6026 reports
Age 7026 reports
Age 4924 reports
Age 5724 reports
Age 6624 reports
Age 7924 reports
Age 5823 reports
Age 5422 reports
Age 7422 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?

This profile reflects 12,389 FDA FAERS reports that mention NEOMYCIN SULFATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for NEOMYCIN SULFATE?

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

Who manufactures NEOMYCIN SULFATE?

Labeling and FAERS entries often list Total Resources International in connection with NEOMYCIN 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.