Nemluvionemolizumab

Name: NEMLUVIO (nemolizumab) — FDA Adverse Event Reports
Creator: PillSignal
License: https://open.fda.gov/license/

According to the FDA label: NEMLUVIO is an interleukin-31 receptor antagonist indicated for: Prurigo Nodularis The treatment of adults with prurigo nodularis. ( 1.1 ) Atopic Dermatitis The treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.

9,893 adverse event reports submitted to the FDA (2020–2026)

This data reflects voluntary reports submitted to the FDA's Adverse Event Monitoring System (AEMS), formerly the FDA Adverse Event Reporting System (FAERS). A report does not mean the medication caused the event. Data may be incomplete or contain errors. Learn more about AEMS. New to this data? Read our guide on how to interpret FDA adverse event reports →

New to FDA adverse event data? Here's how to read these reports →

Top Reported Adverse Events

The most frequently reported events in association with Nemluvio 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.

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Product Dose Omission Issue 3,056 reports
A report that a dose of the medication was missed or skipped.
Full definition in the glossary →
Device Malfunction 1,634 reports
A report that a medical device did not work as intended.
Full definition in the glossary →
Inappropriate Schedule of Product Administration 1,431 reports
A report that the medication was taken on the wrong schedule, such as too often, not often enough, or at the wrong time. This is a usage category, not a sign of a problem with the drug.
Full definition in the glossary →
Incorrect Dose Administered 1,036 reports
A report that the wrong dose was given or taken. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →
Pruritus 994 reports
Itching of the skin.
Full definition in the glossary → See all drugs reporting this event →
Rash 651 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →
Drug Ineffective 536 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 →
Headache 345 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →
Dermatitis Atopic 334 reports
Device Leakage 291 reports
Eczema 262 reports
Device Use Issue 250 reports
Dry Skin 223 reports
Skin that lacks moisture, which can feel rough, tight, or flaky.
Full definition in the glossary → See all drugs reporting this event →
Neurodermatitis 222 reports
Arthralgia 216 reports
Joint pain.
Full definition in the glossary → See all drugs reporting this event →

Browse the full glossary →

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

Nemluvio adverse event reports by reporter sex
Sex	Reports
Female	339
Male	161

By Age Group

View age group data as a table

Nemluvio adverse event reports by reporter age group
Age group	Reports
0-17	17
18-34	38
35-49	47
50-64	104
65-74	72
75+	68

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 Nemluvio. 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

Nemluvio adverse event reports by reported outcome
Outcome	Reports
Non-Serious	9,313
Other Serious	430
Hospitalization	252
Death	80
Disability	5
Life-Threatening	1

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 Nemluvio. 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

Nemluvio adverse event reports by year
Year	Reports
2020	2
2022	4
2023	4
2024	159
2025	7,249
2026 (partial)	2,475

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.

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