Prescription medication · Anti-IL-5R Monoclonal Antibody
benralizumab
Also sold as Fasenra. Fasenra is used to treat severe asthma in adults and children 6 years and older when used with other asthma medicines.
Data updated 2026-05-15
- 17,680
- FDA reportsModerately reported
- Rx
- Availability
benralizumab (Fasenra) is a prescription Anti-IL-5R Monoclonal Antibody. Fasenra is used to treat severe asthma in adults and children 6 years and older when used with other asthma medicines.
Fasenra is a medicine that can help treat severe asthma and EGPA. It works by lowering the number of eosinophils in your blood, which can reduce swelling in your lungs and blood vessels.
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What it does
Fasenra is used to treat severe asthma in adults and children 6 years and older when used with other asthma medicines.
Common side effects
Headache, Sore throat, Fever
Key warnings
Serious allergic reactions can happen after you get a Fasenra shot.
The sections below are summarized in plain English from benralizumab's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Fasenra is a special type of antibody that targets a protein called interleukin-5 receptor alpha (IL-5Rα). This protein is found on the surface of eosinophils. By attaching to this protein, Fasenra helps to lower the number of eosinophils in your blood.
Side Effects (from patient reports)
Based on 17,680 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for benralizumab, by number of reports
- Asthma
Asthma
2,775 reports
- Dyspnoea
Dyspnoea
1,802 reports
- Death
Death
1,437 reports
- Cough 944
Cough
944 reports
- Headache 874
Headache
874 reports
- Pneumonia 823
Pneumonia
823 reports
- Wheezing 692
Wheezing
692 reports
- Fatigue 592
Fatigue
592 reports
- Malaise 565
Malaise
565 reports
- Inappropriate Schedule Of Product Administration 536
Inappropriate Schedule Of Product Administration
536 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for benralizumab each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where benralizumab sits
benralizumab has more FDA adverse-event reports than 52% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is benralizumab; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 17,680 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2012–2025.
Total Reports
17,680
Reports Mentioning Death
1,749
9.9% of reports — not proof of cause
Hospitalization Reports
4,130
Top Indication
Asthma
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | ASTHMA | 2,775 |
| 2 | DYSPNOEA | 1,802 |
| 3 | DEATH | 1,437 |
| 5 | COUGH | 944 |
| 6 | HEADACHE | 874 |
| 8 | PNEUMONIA | 823 |
| 9 | WHEEZING | 692 |
| 10 | FATIGUE | 592 |
| 11 | MALAISE | 565 |
| 12 | INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION | 536 |
| 13 | ARTHRALGIA | 515 |
| 14 | PYREXIA | 510 |
| 15 | RASH | 486 |
| 16 | PAIN | 459 |
| 17 | COVID-19 | 440 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Serious allergic reactions can happen after you get a Fasenra shot. Tell your doctor right away if you have any signs of an allergic reaction, such as hives, swelling, or trouble breathing. Do not stop taking your steroid medicines suddenly when you start Fasenra. Your doctor will lower your steroid dose slowly, if needed. If you have a parasitic infection, it should be treated before you start Fasenra.
Common Questions
What should I tell my doctor before taking Fasenra?
Can Fasenra be used for sudden asthma attacks?
How will I know if Fasenra is working?
Can I stop taking my other asthma medicines while using Fasenra?
How is Fasenra given?
What if I have side effects from Fasenra?
How long will I need to take Fasenra?
Can children take Fasenra?
What does Fasenra look like?
Can I travel with Fasenra?
What are the common side effects of benralizumab?
What drug class is benralizumab?
What pregnancy or breastfeeding source fields are listed for benralizumab?
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for benralizumab: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 17,680.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 9.89%.
- letrozole Δ 0.00 pts · 59,013 reports · Aromatase Inhibitor 9.89%death share
- famciclovir Δ 0.00 pts · 2,678 reports · Antiviral (Nucleoside Analog) 9.90%death share
- doxycycline hyclate Δ 0.01 pts · 63,762 reports · Tetracycline Antibiotic (Antimalarial) 9.90%death share
- dolutegravir Δ 0.01 pts · 8,756 reports · Integrase Strand Transfer Inhibitor 9.88%death share
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What the FDA Data Shows for benralizumab
The FDA label for benralizumab (sold under brand names such as Fasenra) classifies it as a prescription-only medication in the Anti-IL-5R Monoclonal Antibody class. Fasenra is used to treat severe asthma in adults and children 6 years and older when used with other asthma medicines. Official labeling lists 3 commonly reported side effects, including Headache, Sore throat, Fever.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 17,680 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: September 17, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages