MELPHALAN HYDROCHLORIDE

N/A

Manufactured by Fresenius Kabi USA, LLC

43,335 FDA adverse event reports analyzed

Last updated: 2026-04-14

About MELPHALAN HYDROCHLORIDE

MELPHALAN HYDROCHLORIDE 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 MELPHALAN HYDROCHLORIDE include OFF LABEL USE, DRUG INEFFECTIVE, FEBRILE NEUTROPENIA, PLASMA CELL MYELOMA, NEUTROPENIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MELPHALAN HYDROCHLORIDE.

Top Adverse Reactions

OFF LABEL USE2,373 reports
DRUG INEFFECTIVE1,432 reports
FEBRILE NEUTROPENIA1,272 reports
PLASMA CELL MYELOMA1,236 reports
NEUTROPENIA1,213 reports
PYREXIA1,154 reports
MUCOSAL INFLAMMATION1,134 reports
PNEUMONIA1,134 reports
THROMBOCYTOPENIA1,117 reports
DIARRHOEA1,031 reports
PRODUCT USE IN UNAPPROVED INDICATION923 reports
SEPSIS880 reports
DISEASE PROGRESSION790 reports
ANAEMIA741 reports
NEUROPATHY PERIPHERAL736 reports
INFECTION735 reports
DEATH715 reports
MYELODYSPLASTIC SYNDROME697 reports
PANCYTOPENIA661 reports
TOXICITY TO VARIOUS AGENTS606 reports
NAUSEA581 reports
ACUTE KIDNEY INJURY556 reports
ACUTE GRAFT VERSUS HOST DISEASE554 reports
VENOOCCLUSIVE LIVER DISEASE537 reports
ACUTE MYELOID LEUKAEMIA500 reports
GRAFT VERSUS HOST DISEASE492 reports
RENAL FAILURE486 reports
CYTOMEGALOVIRUS INFECTION471 reports
VOMITING464 reports
THROMBOTIC MICROANGIOPATHY460 reports
FATIGUE454 reports
DYSPNOEA441 reports
SEPTIC SHOCK438 reports
RESPIRATORY FAILURE411 reports
RASH378 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME368 reports
CHRONIC GRAFT VERSUS HOST DISEASE358 reports
ADENOVIRUS INFECTION344 reports
HYPOTENSION339 reports
ACUTE GRAFT VERSUS HOST DISEASE IN SKIN331 reports
HYPERTENSION324 reports
STOMATITIS320 reports
PLATELET COUNT DECREASED310 reports
CARDIAC FAILURE295 reports
ASTHENIA293 reports
PLEURAL EFFUSION293 reports
ATRIAL FIBRILLATION289 reports
HERPES ZOSTER289 reports
INTENTIONAL PRODUCT USE ISSUE289 reports
PRODUCT USE ISSUE288 reports
LEUKOPENIA282 reports
PAIN279 reports
MALIGNANT NEOPLASM PROGRESSION278 reports
CYTOMEGALOVIRUS INFECTION REACTIVATION272 reports
RENAL IMPAIRMENT269 reports
DEEP VEIN THROMBOSIS262 reports
OSTEONECROSIS262 reports
THERAPY PARTIAL RESPONDER262 reports
SECOND PRIMARY MALIGNANCY260 reports
CYTOPENIA258 reports
VENOOCCLUSIVE DISEASE257 reports
POLYNEUROPATHY249 reports
MYELOSUPPRESSION240 reports
BACTERAEMIA239 reports
BONE MARROW FAILURE238 reports
MULTI ORGAN FAILURE237 reports
COUGH233 reports
DISEASE RECURRENCE230 reports
DECREASED APPETITE229 reports
GENERAL PHYSICAL HEALTH DETERIORATION229 reports
PULMONARY EMBOLISM227 reports
EPSTEIN BARR VIRUS INFECTION226 reports
POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER215 reports
CONSTIPATION212 reports
CONDITION AGGRAVATED210 reports
ABDOMINAL PAIN208 reports
OEDEMA PERIPHERAL206 reports
COLITIS202 reports
PLASMA CELL MYELOMA RECURRENT201 reports
GRAFT VERSUS HOST DISEASE IN SKIN200 reports
CONFUSIONAL STATE198 reports
GRAFT VERSUS HOST DISEASE IN GASTROINTESTINAL TRACT196 reports
HAEMATOTOXICITY196 reports
ACUTE GRAFT VERSUS HOST DISEASE IN INTESTINE194 reports
URINARY TRACT INFECTION192 reports
ACUTE RESPIRATORY DISTRESS SYNDROME188 reports
WHITE BLOOD CELL COUNT DECREASED186 reports
OSTEONECROSIS OF JAW181 reports
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY181 reports
COVID 19178 reports
DEHYDRATION177 reports
HYPOXIA176 reports
WEIGHT DECREASED176 reports
RENAL FAILURE ACUTE175 reports
GASTROINTESTINAL HAEMORRHAGE174 reports
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME174 reports
BACTERIAL INFECTION173 reports
BK VIRUS INFECTION173 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION171 reports
HAEMOGLOBIN DECREASED171 reports

Report Outcomes

Out of 24,239 classified reports for MELPHALAN HYDROCHLORIDE:

Serious 97.5%Non-Serious 2.5%

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

Male10,440 (55.3%)
Female8,039 (42.6%)
Unknown399 (2.1%)

Reports by Age

Age 68423 reports
Age 65422 reports
Age 61412 reports
Age 63412 reports
Age 67407 reports
Age 64391 reports
Age 66381 reports
Age 62379 reports
Age 69373 reports
Age 56362 reports
Age 70346 reports
Age 53339 reports
Age 54335 reports
Age 60329 reports
Age 58327 reports
Age 57307 reports
Age 72306 reports
Age 73303 reports
Age 55299 reports
Age 52286 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 MELPHALAN HYDROCHLORIDE?

This profile reflects 43,335 FDA FAERS reports that mention MELPHALAN HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for MELPHALAN HYDROCHLORIDE?

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

Who manufactures MELPHALAN HYDROCHLORIDE?

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