BLEOMYCIN SULFATE

N/A

Manufactured by Fresenius Kabi USA, LLC

16,267 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BLEOMYCIN SULFATE

BLEOMYCIN SULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. The most commonly reported adverse reactions for BLEOMYCIN SULFATE include FEBRILE NEUTROPENIA, OFF LABEL USE, NEUTROPENIA, DRUG INEFFECTIVE, PYREXIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BLEOMYCIN SULFATE.

Top Adverse Reactions

FEBRILE NEUTROPENIA796 reports
OFF LABEL USE767 reports
NEUTROPENIA584 reports
DRUG INEFFECTIVE494 reports
PYREXIA454 reports
PULMONARY TOXICITY404 reports
ANAEMIA354 reports
VOMITING350 reports
NAUSEA347 reports
THROMBOCYTOPENIA347 reports
ACUTE MYELOID LEUKAEMIA304 reports
RESPIRATORY FAILURE301 reports
SEPSIS294 reports
PRODUCT USE IN UNAPPROVED INDICATION287 reports
DISEASE PROGRESSION281 reports
DYSPNOEA280 reports
TOXICITY TO VARIOUS AGENTS260 reports
PNEUMONIA247 reports
SECOND PRIMARY MALIGNANCY239 reports
DEATH219 reports
FATIGUE219 reports
INTERSTITIAL LUNG DISEASE218 reports
PANCYTOPENIA212 reports
MUCOSAL INFLAMMATION204 reports
PNEUMONITIS196 reports
NEUROPATHY PERIPHERAL193 reports
INFECTION188 reports
MYELODYSPLASTIC SYNDROME180 reports
PULMONARY FIBROSIS178 reports
MALIGNANT NEOPLASM PROGRESSION171 reports
HODGKIN^S DISEASE167 reports
PULMONARY EMBOLISM167 reports
COUGH161 reports
LEUKOPENIA160 reports
SEPTIC SHOCK154 reports
ACUTE RESPIRATORY DISTRESS SYNDROME150 reports
DIARRHOEA147 reports
HEADACHE139 reports
BONE MARROW FAILURE128 reports
LUNG DISORDER125 reports
ACUTE HEPATIC FAILURE122 reports
BACK PAIN120 reports
PLEURAL EFFUSION117 reports
FOETAL EXPOSURE DURING PREGNANCY114 reports
DEEP VEIN THROMBOSIS113 reports
HYPOTENSION112 reports
CHILLS111 reports
DISEASE RECURRENCE110 reports
CANDIDA INFECTION107 reports
HAEMATOTOXICITY107 reports
HEPATITIS B REACTIVATION107 reports
CONDITION AGGRAVATED105 reports
GENERAL PHYSICAL HEALTH DETERIORATION102 reports
TACHYCARDIA102 reports
ASTHENIA99 reports
DRUG INTERACTION97 reports
RENAL FAILURE97 reports
CARDIOTOXICITY94 reports
ARTHRALGIA93 reports
CARDIAC FAILURE92 reports
WHITE BLOOD CELL COUNT DECREASED91 reports
PAIN90 reports
ACUTE KIDNEY INJURY89 reports
LYMPHADENOPATHY89 reports
DECREASED APPETITE88 reports
DYSPHAGIA88 reports
ABDOMINAL PAIN87 reports
DEAFNESS87 reports
BONE PAIN86 reports
HYPOTHYROIDISM86 reports
HYPOXIA85 reports
DIZZINESS84 reports
NEOPLASM PROGRESSION81 reports
BRAIN OEDEMA80 reports
MALAISE80 reports
OSTEONECROSIS80 reports
PREMATURE BABY80 reports
MATERNAL EXPOSURE DURING PREGNANCY78 reports
MYOCARDIAL INFARCTION76 reports
EXPOSURE DURING PREGNANCY75 reports
ACUTE MYOCARDIAL INFARCTION74 reports
PLATELET COUNT DECREASED74 reports
PNEUMOCYSTIS JIROVECII PNEUMONIA74 reports
ALOPECIA73 reports
NEUTROPHIL COUNT DECREASED73 reports
PERIPHERAL SENSORY NEUROPATHY73 reports
STOMATITIS73 reports
HYPOAESTHESIA71 reports
BLOOD PRESSURE DECREASED70 reports
MYALGIA70 reports
NEUTROPENIC SEPSIS70 reports
PNEUMOTHORAX70 reports
CHEST PAIN69 reports
NEUROTOXICITY69 reports
NEUTROPENIC INFECTION67 reports
CONSTIPATION66 reports
FALL66 reports
PRODUCT USE ISSUE66 reports
RENAL IMPAIRMENT66 reports
TREATMENT FAILURE66 reports

Report Outcomes

Out of 10,015 classified reports for BLEOMYCIN SULFATE:

Serious 97.2%Non-Serious 2.8%

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

Male4,612 (58.6%)
Female3,063 (38.9%)
Unknown191 (2.4%)

Reports by Age

Age 33205 reports
Age 35164 reports
Age 30163 reports
Age 34162 reports
Age 32158 reports
Age 40156 reports
Age 28153 reports
Age 37146 reports
Age 26142 reports
Age 24141 reports
Age 31141 reports
Age 27140 reports
Age 25138 reports
Age 17136 reports
Age 36134 reports
Age 49133 reports
Age 18128 reports
Age 29126 reports
Age 57121 reports
Age 45119 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 BLEOMYCIN SULFATE?

This profile reflects 16,267 FDA FAERS reports that mention BLEOMYCIN SULFATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BLEOMYCIN SULFATE?

Frequently reported terms in FAERS include FEBRILE NEUTROPENIA, OFF LABEL USE, NEUTROPENIA, DRUG INEFFECTIVE, PYREXIA, PULMONARY TOXICITY. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BLEOMYCIN SULFATE?

Labeling and FAERS entries often list Fresenius Kabi USA, LLC in connection with BLEOMYCIN 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.