BENDAMUSTINE HYDROCHLORIDE

N/A

Manufactured by Cephalon, LLC

20,231 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BENDAMUSTINE HYDROCHLORIDE

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

Top Adverse Reactions

OFF LABEL USE1,120 reports
PYREXIA849 reports
DISEASE PROGRESSION572 reports
RASH554 reports
FEBRILE NEUTROPENIA532 reports
NEUTROPENIA500 reports
PNEUMONIA454 reports
DRUG INEFFECTIVE442 reports
PLATELET COUNT DECREASED431 reports
DEATH421 reports
PRODUCT USE IN UNAPPROVED INDICATION413 reports
COVID 19406 reports
NEUTROPHIL COUNT DECREASED406 reports
PANCYTOPENIA381 reports
MALIGNANT NEOPLASM PROGRESSION375 reports
ANAEMIA373 reports
NAUSEA367 reports
THROMBOCYTOPENIA354 reports
WHITE BLOOD CELL COUNT DECREASED340 reports
DIARRHOEA332 reports
FATIGUE307 reports
PRESCRIBED UNDERDOSE278 reports
CYTOMEGALOVIRUS INFECTION269 reports
MYELOSUPPRESSION262 reports
INFUSION RELATED REACTION259 reports
SEPSIS252 reports
LYMPHOCYTE COUNT DECREASED245 reports
DYSPNOEA237 reports
VOMITING221 reports
INFECTION217 reports
ASTHENIA216 reports
HYPOTENSION201 reports
CHILLS197 reports
NEUROPATHY PERIPHERAL192 reports
DECREASED APPETITE189 reports
BLOOD LACTATE DEHYDROGENASE INCREASED182 reports
PRODUCT USE ISSUE181 reports
ACUTE KIDNEY INJURY177 reports
CYTOPENIA166 reports
DIFFUSE LARGE B CELL LYMPHOMA166 reports
ATRIAL FIBRILLATION157 reports
HYPERSENSITIVITY153 reports
ERYTHEMA149 reports
PRURITUS149 reports
TUMOUR LYSIS SYNDROME145 reports
COVID 19 PNEUMONIA141 reports
SEPTIC SHOCK134 reports
MALAISE128 reports
PLEURAL EFFUSION128 reports
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY127 reports
COUGH125 reports
HYPOGAMMAGLOBULINAEMIA124 reports
DEHYDRATION123 reports
HERPES ZOSTER123 reports
ABDOMINAL PAIN122 reports
LYMPHADENOPATHY119 reports
GENERAL PHYSICAL HEALTH DETERIORATION116 reports
WEIGHT DECREASED116 reports
BONE MARROW FAILURE113 reports
HAEMOGLOBIN DECREASED113 reports
CONSTIPATION112 reports
MYELODYSPLASTIC SYNDROME111 reports
HEADACHE110 reports
CHRONIC LYMPHOCYTIC LEUKAEMIA108 reports
BLOOD PRESSURE DECREASED107 reports
PAIN106 reports
RESPIRATORY FAILURE103 reports
RASH MACULO PAPULAR102 reports
LEUKOPENIA99 reports
PLASMA CELL MYELOMA98 reports
RENAL FAILURE98 reports
THERAPY PARTIAL RESPONDER98 reports
INTERSTITIAL LUNG DISEASE94 reports
LYMPHOMA93 reports
EXTRAVASATION92 reports
ALANINE AMINOTRANSFERASE INCREASED90 reports
DIZZINESS90 reports
ASPARTATE AMINOTRANSFERASE INCREASED89 reports
ACUTE MYELOID LEUKAEMIA88 reports
END STAGE RENAL DISEASE88 reports
CYTOMEGALOVIRUS CHORIORETINITIS87 reports
LYMPHOPENIA86 reports
RENAL IMPAIRMENT86 reports
ALOPECIA85 reports
NEOPLASM PROGRESSION85 reports
INTENTIONAL PRODUCT USE ISSUE84 reports
BACK PAIN81 reports
HEPATIC FUNCTION ABNORMAL81 reports
PULMONARY EMBOLISM81 reports
STOMATITIS81 reports
CD4 LYMPHOCYTES DECREASED80 reports
CYTOKINE RELEASE SYNDROME80 reports
STEVENS JOHNSON SYNDROME80 reports
INFUSION SITE PAIN79 reports
CONDITION AGGRAVATED78 reports
DIFFUSE LARGE B CELL LYMPHOMA RECURRENT78 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION77 reports
FALL76 reports
CONFUSIONAL STATE75 reports
RASH PRURITIC74 reports

Report Outcomes

Out of 11,747 classified reports for BENDAMUSTINE HYDROCHLORIDE:

Serious 84.6%Non-Serious 15.4%

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

Male5,831 (58.7%)
Female3,980 (40.1%)
Unknown122 (1.2%)

Reports by Age

Age 67343 reports
Age 70297 reports
Age 71291 reports
Age 74281 reports
Age 65280 reports
Age 73274 reports
Age 72260 reports
Age 60237 reports
Age 68233 reports
Age 64229 reports
Age 75228 reports
Age 77223 reports
Age 66221 reports
Age 69221 reports
Age 62194 reports
Age 76193 reports
Age 78181 reports
Age 80171 reports
Age 63163 reports
Age 56156 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 HYDROCHLORIDE?

This profile reflects 20,231 FDA FAERS reports that mention BENDAMUSTINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BENDAMUSTINE HYDROCHLORIDE?

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

Who manufactures BENDAMUSTINE HYDROCHLORIDE?

Labeling and FAERS entries often list Cephalon, LLC in connection with BENDAMUSTINE HYDROCHLORIDE. 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.