Bimzelxbimekizumab
According to the FDA label: BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: Moderate to severe plaque psoriasis (PSO) in adults who are candidates for systemic therapy or phototherapy. ( 1.1 ) Adults with active psoriatic arthritis (PsA) . ( 1.2 ) Adults with active non-radiographic axial spondyloarthritis ( nr-axSpA ) with objective signs of inflammation. ( 1.3 ) Adults with active ankylosing spondylitis ( AS ). ( 1.4 ) Adults with moderate to severe hidradenitis suppurativa (HS) .
16,071 adverse event reports submitted to the FDA (2016–2026)
Top Reported Adverse Events
The most frequently reported events in association with Bimzelx 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 2,604 reports
A report that a dose of the medication was missed or skipped.
Full definition in the glossary →Psoriasis 2,019 reports
A condition where skin cells build up and form itchy, scaly patches. It often appears in reports because it is a condition being treated.
Full definition in the glossary →Drug Ineffective 1,487 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 →Psoriatic Arthropathy 1,391 reports
A form of joint disease linked to psoriasis, often called psoriatic arthritis, causing joint pain and swelling. It often appears in reports as a condition being treated.
Full definition in the glossary →Off Label Use 1,202 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 →- Hidradenitis 1,191 reports
Injection Site Pain 960 reports
Pain at the spot on the body where a medication was injected.
Full definition in the glossary →Condition Aggravated 911 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 →Inappropriate Schedule of Product Administration 766 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 →- Therapy Interrupted 735 reports
- Product Availability Issue 704 reports
Incorrect Dose Administered 571 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 →Pain 568 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →- Oral Candidiasis 559 reports
Fatigue 532 reports
Extreme tiredness or lack of energy that does not improve with rest.
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 | 2,587 |
| Male | 1,661 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 75 |
| 18-34 | 1,653 |
| 35-49 | 3,101 |
| 50-64 | 3,444 |
| 65-74 | 1,001 |
| 75+ | 326 |
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 Bimzelx. 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 |
|---|---|
| Non-Serious | 7,292 |
| Other Serious | 5,184 |
| Hospitalization | 1,578 |
| Death | 116 |
| Life-Threatening | 78 |
| Disability | 53 |
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 Bimzelx. 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 |
|---|---|
| 2016 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 5 |
| 2022 | 13 |
| 2023 | 125 |
| 2024 | 2,720 |
| 2025 | 10,922 |
| 2026 (partial) | 2,282 |
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 Bimzelx
In FDA adverse event reports that mention Bimzelx, these medications appeared most often in the same report.
- Methotrexate (302 reports)
- Ergocalciferol (278 reports)
- Secukinumab (268 reports)
- Metformin (235 reports)
- Levothyroxine (213 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