BENRALIZUMAB

N/A

Manufactured by AstraZeneca Pharmaceuticals LP

31,657 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BENRALIZUMAB

BENRALIZUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AstraZeneca Pharmaceuticals LP. The most commonly reported adverse reactions for BENRALIZUMAB include ASTHMA, DYSPNOEA, DEATH, DRUG INEFFECTIVE, COUGH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BENRALIZUMAB.

Top Adverse Reactions

ASTHMA2,775 reports
DYSPNOEA1,802 reports
DEATH1,437 reports
DRUG INEFFECTIVE1,418 reports
COUGH944 reports
HEADACHE874 reports
PRODUCT DOSE OMISSION ISSUE825 reports
PNEUMONIA823 reports
WHEEZING692 reports
FATIGUE592 reports
MALAISE565 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION536 reports
ARTHRALGIA515 reports
PYREXIA510 reports
RASH486 reports
PAIN459 reports
COVID 19440 reports
PRURITUS428 reports
DIZZINESS417 reports
HYPERSENSITIVITY411 reports
CONDITION AGGRAVATED405 reports
DEVICE LEAKAGE391 reports
URTICARIA387 reports
OFF LABEL USE379 reports
INJECTION SITE PAIN369 reports
CHEST DISCOMFORT362 reports
FALL351 reports
ILLNESS324 reports
NAUSEA322 reports
FEELING ABNORMAL278 reports
HYPERTENSION265 reports
ASTHENIA243 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE242 reports
CHILLS238 reports
EOSINOPHIL COUNT INCREASED236 reports
PAIN IN EXTREMITY233 reports
LOWER RESPIRATORY TRACT INFECTION223 reports
MYALGIA223 reports
OROPHARYNGEAL PAIN222 reports
NASOPHARYNGITIS221 reports
WRONG TECHNIQUE IN DEVICE USAGE PROCESS221 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE216 reports
INCORRECT DOSE ADMINISTERED BY DEVICE216 reports
PRODUCT USE ISSUE216 reports
VOMITING211 reports
INFLUENZA209 reports
PRODUCTIVE COUGH208 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES198 reports
NASAL CONGESTION196 reports
CEREBROVASCULAR ACCIDENT195 reports
BACK PAIN191 reports
PERIPHERAL SWELLING191 reports
SINUSITIS190 reports
DIARRHOEA189 reports
WEIGHT INCREASED180 reports
LUNG DISORDER178 reports
WEIGHT DECREASED178 reports
CHEST PAIN175 reports
DYSPHONIA175 reports
GAIT DISTURBANCE172 reports
INFECTION161 reports
OXYGEN SATURATION DECREASED156 reports
ANAPHYLACTIC REACTION153 reports
MYOCARDIAL INFARCTION153 reports
DRUG HYPERSENSITIVITY149 reports
DRUG DOSE OMISSION BY DEVICE142 reports
EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS141 reports
ANXIETY138 reports
BRONCHITIS138 reports
OBSTRUCTIVE AIRWAYS DISORDER136 reports
BLOOD PRESSURE INCREASED135 reports
ERYTHEMA135 reports
INSOMNIA134 reports
FULL BLOOD COUNT ABNORMAL133 reports
HEART RATE INCREASED132 reports
NEOPLASM MALIGNANT127 reports
URINARY TRACT INFECTION122 reports
DEVICE MALFUNCTION121 reports
DEVICE DELIVERY SYSTEM ISSUE118 reports
CARDIAC DISORDER116 reports
DYSPNOEA EXERTIONAL116 reports
INFLUENZA LIKE ILLNESS116 reports
INSURANCE ISSUE116 reports
MIGRAINE116 reports
PRODUCT USE IN UNAPPROVED INDICATION116 reports
TREMOR113 reports
NEEDLE ISSUE111 reports
ALOPECIA106 reports
HERPES ZOSTER106 reports
MEMORY IMPAIRMENT106 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION106 reports
RHINORRHOEA105 reports
SINUS DISORDER104 reports
DEVICE ISSUE103 reports
MUSCLE SPASMS103 reports
RASH PRURITIC103 reports
ABDOMINAL PAIN102 reports
DEPRESSION101 reports
PARAESTHESIA100 reports
SWELLING100 reports

Report Outcomes

Out of 17,644 classified reports for BENRALIZUMAB:

Serious 62.5%Non-Serious 37.5%

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

Female11,037 (69.6%)
Male4,811 (30.4%)

Reports by Age

Age 60150 reports
Age 69141 reports
Age 65139 reports
Age 61133 reports
Age 63130 reports
Age 70125 reports
Age 62119 reports
Age 72115 reports
Age 59111 reports
Age 68111 reports
Age 66109 reports
Age 50108 reports
Age 53108 reports
Age 57106 reports
Age 81105 reports
Age 58104 reports
Age 71103 reports
Age 77102 reports
Age 56100 reports
Age 67100 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 BENRALIZUMAB?

This profile reflects 31,657 FDA FAERS reports that mention BENRALIZUMAB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BENRALIZUMAB?

Frequently reported terms in FAERS include ASTHMA, DYSPNOEA, DEATH, DRUG INEFFECTIVE, COUGH, HEADACHE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BENRALIZUMAB?

Labeling and FAERS entries often list AstraZeneca Pharmaceuticals LP in connection with BENRALIZUMAB. 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.