Nucalamepolizumab
According to the FDA label: NUCALA is an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa) indicated for: • Add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. ( 1.1 ) • Add-on maintenance treatment of adult patients aged 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP).
48,288 adverse event reports submitted to the FDA (2008–2026)
Top Reported Adverse Events
The most frequently reported events in association with Nucala in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Asthma 12,635 reports
A condition where the airways narrow and swell, causing wheezing and difficulty breathing.
Full definition in the glossary →Dyspnoea 10,418 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Wheezing 7,036 reports
A whistling sound when breathing, usually a sign the airways are narrowed.
Full definition in the glossary →Product Dose Omission Issue 6,427 reports
A report that a dose of the medication was missed or skipped.
Full definition in the glossary →Cough 5,038 reports
A reflex that clears the throat or airways.
Full definition in the glossary → See all drugs reporting this event →Therapeutic Product Effect Incomplete 5,004 reports
A report that the medication only partly worked. Similar to drug ineffective, it reflects that someone felt the treatment did not fully help.
Full definition in the glossary →Pneumonia 4,535 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Drug Ineffective 4,521 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Loss of Personal Independence in Daily Activities 4,206 reports
A report that a person became less able to carry out everyday tasks on their own.
Full definition in the glossary →Sleep Disorder Due to a General Medical Condition 3,090 reports
Difficulty sleeping that is linked to an underlying health condition.
Full definition in the glossary →Off Label Use 3,004 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Fatigue 2,998 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Malaise 2,710 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Condition Aggravated 2,670 reports
A report that the person's existing health condition got worse. This describes a worsening of something the person already had, not necessarily a new problem caused by the drug.
Full definition in the glossary →Headache 2,619 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 23,887 |
| Male | 11,343 |
| Unknown | 1 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 374 |
| 18-34 | 1,088 |
| 35-49 | 3,920 |
| 50-64 | 6,681 |
| 65-74 | 4,935 |
| 75+ | 3,019 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Nucala. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 23,419 |
| Non-Serious | 17,710 |
| Hospitalization | 15,560 |
| Death | 3,745 |
| Life-Threatening | 2,060 |
| Disability | 1,689 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Nucala. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2008 | 1 |
| 2009 | 2 |
| 2012 | 1 |
| 2013 | 5 |
| 2014 | 6 |
| 2015 | 18 |
| 2016 | 579 |
| 2017 | 1,547 |
| 2018 | 3,014 |
| 2019 | 4,611 |
| 2020 | 5,676 |
| 2021 | 6,084 |
| 2022 | 4,726 |
| 2023 | 5,643 |
| 2024 | 7,763 |
| 2025 | 7,619 |
| 2026 (partial) | 993 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Nucala
In FDA adverse event reports that mention Nucala, these medications appeared most often in the same report.
- Albuterol (9,958 reports)
- Prednisone (8,964 reports)
- Tiotropium (5,622 reports)
- Montelukast (4,936 reports)
- Budesonide And Formoterol (4,704 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026