EMICIZUMAB

N/A

Manufactured by Genentech, Inc.

15,224 FDA adverse event reports analyzed

Last updated: 2026-04-14

About EMICIZUMAB

EMICIZUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genentech, Inc.. The most commonly reported adverse reactions for EMICIZUMAB include HAEMORRHAGE, NO ADVERSE EVENT, HAEMARTHROSIS, OFF LABEL USE, FALL. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for EMICIZUMAB.

Top Adverse Reactions

HAEMORRHAGE4,059 reports
NO ADVERSE EVENT754 reports
HAEMARTHROSIS739 reports
OFF LABEL USE725 reports
FALL587 reports
ARTHRALGIA462 reports
CONTUSION369 reports
EPISTAXIS358 reports
HEAD INJURY313 reports
PAIN301 reports
MUSCLE HAEMORRHAGE282 reports
WEIGHT INCREASED217 reports
JOINT INJURY208 reports
LIMB INJURY202 reports
DRUG INEFFECTIVE201 reports
MOUTH HAEMORRHAGE201 reports
INJURY194 reports
HEADACHE165 reports
JOINT SWELLING160 reports
HAEMATOMA158 reports
INJECTION SITE PAIN144 reports
WEIGHT DECREASED130 reports
DEATH125 reports
PYREXIA124 reports
GINGIVAL BLEEDING117 reports
PAIN IN EXTREMITY113 reports
SWELLING113 reports
LIGAMENT SPRAIN112 reports
SKIN LACERATION111 reports
TRAUMATIC HAEMORRHAGE106 reports
GASTROINTESTINAL HAEMORRHAGE102 reports
PERIPHERAL SWELLING92 reports
PRODUCT DOSE OMISSION ISSUE88 reports
ARTHROPATHY86 reports
SPONTANEOUS HAEMORRHAGE81 reports
POST PROCEDURAL HAEMORRHAGE76 reports
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED74 reports
COVID 1973 reports
HAEMATURIA71 reports
ROAD TRAFFIC ACCIDENT67 reports
VOMITING67 reports
BACK PAIN65 reports
BLOOD URINE PRESENT65 reports
UNDERDOSE65 reports
SEIZURE60 reports
INJECTION SITE REACTION59 reports
DRUG SPECIFIC ANTIBODY PRESENT58 reports
INTENTIONAL PRODUCT USE ISSUE57 reports
CEREBRAL HAEMORRHAGE56 reports
PRODUCT STORAGE ERROR56 reports
RASH56 reports
HAEMORRHAGE INTRACRANIAL52 reports
DYSPNOEA51 reports
TONGUE HAEMORRHAGE51 reports
ARTHRITIS50 reports
INFLUENZA50 reports
PNEUMONIA50 reports
NAUSEA48 reports
NASOPHARYNGITIS47 reports
FATIGUE46 reports
GAIT DISTURBANCE46 reports
INCORRECT DOSE ADMINISTERED46 reports
THROMBOSIS45 reports
ILL DEFINED DISORDER43 reports
DIARRHOEA42 reports
MUSCLE STRAIN42 reports
TREATMENT NONCOMPLIANCE42 reports
CEREBROVASCULAR ACCIDENT40 reports
INTERNAL HAEMORRHAGE40 reports
CHEST PAIN39 reports
INFECTION39 reports
MASS39 reports
ABDOMINAL PAIN UPPER37 reports
COUGH37 reports
DIZZINESS37 reports
INJECTION SITE SWELLING37 reports
MYALGIA37 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS37 reports
ABDOMINAL PAIN36 reports
EYE HAEMORRHAGE36 reports
LIP HAEMORRHAGE36 reports
MALAISE36 reports
MYOCARDIAL INFARCTION35 reports
PRURITUS35 reports
SEPSIS35 reports
GASTRIC HAEMORRHAGE34 reports
HAEMATOCHEZIA34 reports
NEPHROLITHIASIS34 reports
THERAPEUTIC RESPONSE DECREASED34 reports
ANTI FACTOR VIII ANTIBODY POSITIVE33 reports
INTERMENSTRUAL BLEEDING33 reports
BURNING SENSATION32 reports
HAEMOGLOBIN DECREASED32 reports
PROCEDURAL HAEMORRHAGE32 reports
FACE INJURY31 reports
INTENTIONAL PRODUCT MISUSE31 reports
INTERCEPTED PRODUCT STORAGE ERROR31 reports
EAR INFECTION30 reports
ERYTHEMA30 reports
INJECTION SITE ERYTHEMA30 reports

Report Outcomes

Out of 11,024 classified reports for EMICIZUMAB:

Serious 36.6%Non-Serious 63.4%

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

Male9,466 (96.1%)
Female381 (3.9%)

Reports by Age

Age 6206 reports
Age 2205 reports
Age 7204 reports
Age 8195 reports
Age 5191 reports
Age 4186 reports
Age 9159 reports
Age 3158 reports
Age 14154 reports
Age 17146 reports
Age 15142 reports
Age 18136 reports
Age 10134 reports
Age 16133 reports
Age 12118 reports
Age 13118 reports
Age 1116 reports
Age 11112 reports
Age 19106 reports
Age 3995 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 EMICIZUMAB?

This profile reflects 15,224 FDA FAERS reports that mention EMICIZUMAB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for EMICIZUMAB?

Frequently reported terms in FAERS include HAEMORRHAGE, NO ADVERSE EVENT, HAEMARTHROSIS, OFF LABEL USE, FALL, ARTHRALGIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures EMICIZUMAB?

Labeling and FAERS entries often list Genentech, Inc. in connection with EMICIZUMAB. 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.