BENDAMUSTINE HCL

N/A

Manufactured by Meitheal Pharmaceuticals Inc.

30,914 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BENDAMUSTINE HCL

BENDAMUSTINE HCL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Meitheal Pharmaceuticals Inc.. The most commonly reported adverse reactions for BENDAMUSTINE HCL include DISEASE PROGRESSION, OFF LABEL USE, NEUTROPENIA, PYREXIA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BENDAMUSTINE HCL.

Top Adverse Reactions

DISEASE PROGRESSION2,168 reports
OFF LABEL USE1,938 reports
NEUTROPENIA1,132 reports
PYREXIA1,018 reports
DRUG INEFFECTIVE918 reports
THROMBOCYTOPENIA916 reports
PNEUMONIA818 reports
FEBRILE NEUTROPENIA768 reports
ANAEMIA749 reports
COVID 19722 reports
DEATH673 reports
INFECTION545 reports
DIARRHOEA498 reports
SEPSIS462 reports
PANCYTOPENIA440 reports
FATIGUE418 reports
NAUSEA409 reports
RASH405 reports
DIFFUSE LARGE B CELL LYMPHOMA383 reports
BLOOD LACTATE DEHYDROGENASE INCREASED374 reports
MALIGNANT NEOPLASM PROGRESSION371 reports
DYSPNOEA364 reports
LYMPHOMA345 reports
PRODUCT USE IN UNAPPROVED INDICATION344 reports
CYTOKINE RELEASE SYNDROME325 reports
VOMITING324 reports
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY313 reports
ACUTE KIDNEY INJURY309 reports
PLASMA CELL MYELOMA292 reports
HYPOTENSION286 reports
LEUKOPENIA283 reports
PLATELET COUNT DECREASED283 reports
CYTOMEGALOVIRUS INFECTION281 reports
INTENTIONAL PRODUCT USE ISSUE275 reports
NEUROPATHY PERIPHERAL261 reports
DIFFUSE LARGE B CELL LYMPHOMA RECURRENT255 reports
GENERAL PHYSICAL HEALTH DETERIORATION255 reports
WHITE BLOOD CELL COUNT DECREASED253 reports
SEPTIC SHOCK248 reports
INFUSION RELATED REACTION247 reports
ASTHENIA234 reports
ATRIAL FIBRILLATION232 reports
LYMPHADENOPATHY227 reports
NEUTROPHIL COUNT DECREASED222 reports
CHILLS212 reports
THERAPY PARTIAL RESPONDER197 reports
WEIGHT DECREASED196 reports
NEOPLASM PROGRESSION195 reports
PRODUCT USE ISSUE195 reports
ABDOMINAL PAIN191 reports
THERAPY NON RESPONDER191 reports
CYTOPENIA189 reports
MYELOSUPPRESSION185 reports
MYELODYSPLASTIC SYNDROME180 reports
RENAL FAILURE179 reports
TUMOUR LYSIS SYNDROME173 reports
LYMPHOCYTE COUNT DECREASED172 reports
COUGH168 reports
DECREASED APPETITE166 reports
RESPIRATORY FAILURE166 reports
PRURITUS165 reports
HERPES ZOSTER163 reports
COVID 19 PNEUMONIA162 reports
HYPOGAMMAGLOBULINAEMIA162 reports
CARDIAC FAILURE160 reports
HYPERSENSITIVITY156 reports
LYMPHOPENIA155 reports
PLEURAL EFFUSION155 reports
HAEMOGLOBIN DECREASED153 reports
BLOOD CREATININE INCREASED148 reports
CONSTIPATION147 reports
ALANINE AMINOTRANSFERASE INCREASED145 reports
C REACTIVE PROTEIN INCREASED145 reports
CHRONIC LYMPHOCYTIC LEUKAEMIA145 reports
CYTOMEGALOVIRUS INFECTION REACTIVATION145 reports
HAEMATOTOXICITY142 reports
PAIN142 reports
HEADACHE141 reports
ASPARTATE AMINOTRANSFERASE INCREASED140 reports
DISEASE RECURRENCE137 reports
PNEUMONITIS136 reports
DEHYDRATION133 reports
CONDITION AGGRAVATED130 reports
MUCOSAL INFLAMMATION130 reports
URINARY TRACT INFECTION129 reports
BONE MARROW FAILURE128 reports
ERYTHEMA127 reports
TOXICITY TO VARIOUS AGENTS125 reports
PULMONARY EMBOLISM122 reports
ARTHRALGIA117 reports
HYPERTENSION114 reports
COLITIS112 reports
PNEUMOCYSTIS JIROVECII PNEUMONIA112 reports
HYPERCALCAEMIA111 reports
IMMUNE EFFECTOR CELL ASSOCIATED NEUROTOXICITY SYNDROME110 reports
FOLLICULAR LYMPHOMA109 reports
RASH MACULO PAPULAR108 reports
ILL DEFINED DISORDER106 reports
RENAL IMPAIRMENT105 reports
CONFUSIONAL STATE104 reports

Report Outcomes

Out of 14,856 classified reports for BENDAMUSTINE HCL:

Serious 95.5%Non-Serious 4.5%

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

Male7,127 (59.4%)
Female4,777 (39.8%)
Unknown88 (0.7%)

Reports by Age

Age 67357 reports
Age 69350 reports
Age 70344 reports
Age 68343 reports
Age 65338 reports
Age 73333 reports
Age 66325 reports
Age 72320 reports
Age 71318 reports
Age 74303 reports
Age 75298 reports
Age 76290 reports
Age 63282 reports
Age 64280 reports
Age 60277 reports
Age 62276 reports
Age 77244 reports
Age 61233 reports
Age 78233 reports
Age 59228 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 BENDAMUSTINE HCL?

This profile reflects 30,914 FDA FAERS reports that mention BENDAMUSTINE HCL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BENDAMUSTINE HCL?

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

Who manufactures BENDAMUSTINE HCL?

Labeling and FAERS entries often list Meitheal Pharmaceuticals Inc. in connection with BENDAMUSTINE HCL. 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.