ALEMTUZUMAB

N/A

Manufactured by Genzyme Corporation

52,058 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ALEMTUZUMAB

ALEMTUZUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genzyme Corporation. The most commonly reported adverse reactions for ALEMTUZUMAB include HEADACHE, FATIGUE, PYREXIA, OFF LABEL USE, RASH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ALEMTUZUMAB.

Top Adverse Reactions

HEADACHE1,882 reports
FATIGUE1,860 reports
PYREXIA1,764 reports
OFF LABEL USE1,560 reports
RASH1,188 reports
NAUSEA1,180 reports
DRUG INEFFECTIVE1,002 reports
DYSPNOEA982 reports
ASTHENIA938 reports
MULTIPLE SCLEROSIS RELAPSE898 reports
LYMPHOCYTE COUNT DECREASED869 reports
CYTOMEGALOVIRUS INFECTION830 reports
URINARY TRACT INFECTION815 reports
PAIN748 reports
CONDITION AGGRAVATED714 reports
PLATELET COUNT DECREASED708 reports
COUGH677 reports
WHITE BLOOD CELL COUNT DECREASED656 reports
DIZZINESS655 reports
VOMITING654 reports
DIARRHOEA651 reports
MALAISE651 reports
GAIT DISTURBANCE650 reports
NEUTROPENIA637 reports
PNEUMONIA630 reports
MUSCULAR WEAKNESS608 reports
PRURITUS598 reports
THROMBOCYTOPENIA589 reports
INSOMNIA587 reports
PRODUCT USE IN UNAPPROVED INDICATION563 reports
CHEST DISCOMFORT553 reports
HYPOAESTHESIA551 reports
URTICARIA535 reports
FEELING ABNORMAL514 reports
PAIN IN EXTREMITY511 reports
SEPSIS503 reports
LYMPHOPENIA498 reports
CHILLS495 reports
FALL480 reports
HERPES ZOSTER473 reports
HYPERTENSION473 reports
BACK PAIN466 reports
FLUSHING453 reports
TACHYCARDIA453 reports
ERYTHEMA451 reports
HAEMOGLOBIN DECREASED437 reports
ARTHRALGIA435 reports
ABDOMINAL PAIN429 reports
CONTUSION428 reports
BRADYCARDIA420 reports
LEUKOPENIA416 reports
IMMUNE THROMBOCYTOPENIC PURPURA407 reports
URINE ABNORMALITY402 reports
HYPOTENSION398 reports
DEATH396 reports
INFECTION396 reports
CHEST PAIN382 reports
TREMOR380 reports
PANCYTOPENIA375 reports
PARAESTHESIA369 reports
ADENOVIRUS INFECTION364 reports
NASOPHARYNGITIS364 reports
BLOOD URINE PRESENT356 reports
ANAEMIA354 reports
OROPHARYNGEAL PAIN351 reports
HEART RATE INCREASED348 reports
WEIGHT DECREASED346 reports
MUCOSAL INFLAMMATION338 reports
ANXIETY337 reports
MEMORY IMPAIRMENT327 reports
BLOOD PRESSURE INCREASED323 reports
MULTIPLE SCLEROSIS322 reports
FEBRILE NEUTROPENIA319 reports
ABDOMINAL PAIN UPPER316 reports
HAEMATOCRIT DECREASED309 reports
RESPIRATORY FAILURE308 reports
IMMUNE THROMBOCYTOPENIA304 reports
INFLUENZA304 reports
POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER296 reports
GRAFT VERSUS HOST DISEASE293 reports
MUSCLE SPASMS290 reports
WHITE BLOOD CELLS URINE POSITIVE290 reports
BALANCE DISORDER287 reports
FEELING HOT286 reports
WEIGHT INCREASED279 reports
HYPERTHYROIDISM271 reports
DECREASED APPETITE266 reports
CYTOMEGALOVIRUS INFECTION REACTIVATION262 reports
EPSTEIN BARR VIRUS INFECTION262 reports
SOMNOLENCE260 reports
RENAL FAILURE256 reports
HYPERHIDROSIS255 reports
COVID 19254 reports
HYPOTHYROIDISM254 reports
PALPITATIONS254 reports
LYMPHOCYTE PERCENTAGE DECREASED249 reports
MOBILITY DECREASED248 reports
URINE ANALYSIS ABNORMAL246 reports
MYALGIA245 reports
DEPRESSION242 reports

Report Outcomes

Out of 18,937 classified reports for ALEMTUZUMAB:

Serious 86.0%Non-Serious 14.0%

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

Female8,999 (58.4%)
Male6,283 (40.7%)
Unknown137 (0.9%)

Reports by Age

Age 36316 reports
Age 39291 reports
Age 41289 reports
Age 34287 reports
Age 38287 reports
Age 35285 reports
Age 33281 reports
Age 60278 reports
Age 51272 reports
Age 40271 reports
Age 43267 reports
Age 37262 reports
Age 52260 reports
Age 47259 reports
Age 42258 reports
Age 44257 reports
Age 49252 reports
Age 48245 reports
Age 30244 reports
Age 45243 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 ALEMTUZUMAB?

This profile reflects 52,058 FDA FAERS reports that mention ALEMTUZUMAB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ALEMTUZUMAB?

Frequently reported terms in FAERS include HEADACHE, FATIGUE, PYREXIA, OFF LABEL USE, RASH, NAUSEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ALEMTUZUMAB?

Labeling and FAERS entries often list Genzyme Corporation in connection with ALEMTUZUMAB. 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.