POLYMYXIN B SULFATE

N/A

Manufactured by FOSUN PHARMA USA INC

5,004 FDA adverse event reports analyzed

Last updated: 2026-04-15

About POLYMYXIN B SULFATE

POLYMYXIN B SULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by FOSUN PHARMA USA INC. The most commonly reported adverse reactions for POLYMYXIN B SULFATE include DRUG INEFFECTIVE, PAIN, DRUG HYPERSENSITIVITY, MACULAR DEGENERATION, MALAISE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for POLYMYXIN B SULFATE.

Top Adverse Reactions

DRUG INEFFECTIVE322 reports
PAIN204 reports
DRUG HYPERSENSITIVITY194 reports
MACULAR DEGENERATION177 reports
MALAISE176 reports
PNEUMONIA174 reports
VOMITING144 reports
OFF LABEL USE135 reports
OEDEMA130 reports
ASTHMA129 reports
DYSPNOEA126 reports
CHEST PAIN124 reports
NASAL OEDEMA117 reports
RESPIRATORY TRACT INFECTION114 reports
COUGH107 reports
WHEEZING107 reports
PYREXIA105 reports
NAUSEA86 reports
ACUTE KIDNEY INJURY79 reports
DIARRHOEA58 reports
ANAEMIA57 reports
SEPSIS52 reports
WEIGHT DECREASED52 reports
HEADACHE51 reports
INFUSION RELATED REACTION48 reports
PARAESTHESIA ORAL47 reports
ABDOMINAL PAIN46 reports
DYSPEPSIA43 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE43 reports
CHRONIC SINUSITIS42 reports
ERYTHEMA42 reports
CONSTIPATION41 reports
FEBRILE NEUTROPENIA41 reports
PROCEDURAL PAIN41 reports
DRUG RESISTANCE40 reports
PLATELET COUNT DECREASED39 reports
RESPIRATORY FAILURE38 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION37 reports
HAEMATOCHEZIA37 reports
ORAL CANDIDIASIS37 reports
TREATMENT FAILURE37 reports
COLITIS36 reports
HEPATIC FUNCTION ABNORMAL36 reports
COLITIS ULCERATIVE35 reports
CONDITION AGGRAVATED35 reports
FEMALE GENITAL TRACT FISTULA35 reports
FREQUENT BOWEL MOVEMENTS35 reports
RECTAL HAEMORRHAGE35 reports
RENAL IMPAIRMENT35 reports
PROCTITIS34 reports
RADICULOPATHY34 reports
VAGINAL DISCHARGE34 reports
VAGINAL FLATULENCE34 reports
DEATH31 reports
RASH30 reports
PATHOGEN RESISTANCE29 reports
WHITE BLOOD CELL COUNT DECREASED29 reports
DISSEMINATED INTRAVASCULAR COAGULATION28 reports
RHEUMATOID ARTHRITIS28 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME27 reports
RENAL FAILURE26 reports
SEPTIC SHOCK26 reports
FATIGUE23 reports
THROMBOCYTOPENIA23 reports
CHRONIC KIDNEY DISEASE22 reports
JOINT SWELLING22 reports
THERAPEUTIC PRODUCT EFFECT DECREASED22 reports
CYTOMEGALOVIRUS TEST POSITIVE21 reports
HYPERTENSION21 reports
PRODUCT USE IN UNAPPROVED INDICATION21 reports
STOMATITIS21 reports
PRURITUS20 reports
ALANINE AMINOTRANSFERASE INCREASED19 reports
BLOOD CREATININE INCREASED18 reports
NEUTROPENIA18 reports
CYTOMEGALOVIRUS INFECTION17 reports
NEUTROPHIL COUNT DECREASED17 reports
COVID 1916 reports
HYPOTENSION16 reports
C REACTIVE PROTEIN INCREASED15 reports
CHRONIC GRAFT VERSUS HOST DISEASE15 reports
HYPOKALAEMIA15 reports
INFECTION15 reports
PRODUCT DOSE OMISSION ISSUE15 reports
ASPARTATE AMINOTRANSFERASE INCREASED14 reports
BLOOD BILIRUBIN INCREASED14 reports
ACUTE GRAFT VERSUS HOST DISEASE IN SKIN13 reports
ACUTE RESPIRATORY DISTRESS SYNDROME13 reports
BACK PAIN13 reports
INTERSTITIAL LUNG DISEASE13 reports
LEUKOPENIA13 reports
NEUROTOXICITY13 reports
SKIN HYPERPIGMENTATION13 reports
BONE MARROW FAILURE12 reports
DIZZINESS12 reports
ENCEPHALOPATHY12 reports
HAEMOGLOBIN DECREASED12 reports
KLEBSIELLA INFECTION12 reports
ABDOMINAL PAIN UPPER11 reports
ACUTE GRAFT VERSUS HOST DISEASE11 reports

Report Outcomes

Out of 1,477 classified reports for POLYMYXIN B SULFATE:

Serious 85.8%Non-Serious 14.2%

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

Female773 (56.7%)
Male569 (41.7%)
Unknown21 (1.5%)

Reports by Age

Age 65121 reports
Age 7154 reports
Age 4828 reports
Age 6826 reports
Age 7526 reports
Age 5724 reports
Age 6624 reports
Age 6423 reports
Age 6321 reports
Age 6921 reports
Age 5820 reports
Age 3419 reports
Age 6719 reports
Age 1218 reports
Age 5918 reports
Age 5517 reports
Age 7216 reports
Age 3515 reports
Age 6215 reports
Age 5014 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 POLYMYXIN B SULFATE?

This profile reflects 5,004 FDA FAERS reports that mention 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 POLYMYXIN B SULFATE?

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

Who manufactures POLYMYXIN B SULFATE?

Labeling and FAERS entries often list FOSUN PHARMA USA INC in connection with 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.