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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

BIMEKIZUMAB-BKZX: 5,360 Adverse Event Reports & Safety Profile

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5,360
Total FAERS Reports
43 (0.8%)
Deaths Reported
397
Hospitalizations
5,360
As Primary/Secondary Suspect
22
Life-Threatening
17
Disabilities
Prescription
Status

FDA Application: 761151 ·

First Report: 20050822 · Latest Report: 20250915

What Are the Most Common BIMEKIZUMAB-BKZX Side Effects?

#1 Most Reported
Product dose omission issue
694 reports (12.9%)
#2 Most Reported
Psoriasis
621 reports (11.6%)
#3 Most Reported
Drug ineffective
402 reports (7.5%)

All BIMEKIZUMAB-BKZX Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Product dose omission issue 694 13.0% 0 24
Psoriasis 621 11.6% 0 9
Drug ineffective 402 7.5% 0 11
Product availability issue 364 6.8% 0 17
Off label use 335 6.3% 3 39
Psoriatic arthropathy 301 5.6% 0 15
Injection site pain 263 4.9% 0 8
Therapy interrupted 252 4.7% 0 15
Hidradenitis 233 4.4% 0 14
Inappropriate schedule of product administration 214 4.0% 0 11
Incorrect dose administered 209 3.9% 0 5
Oral candidiasis 178 3.3% 0 9
Pain 159 3.0% 1 5
Fatigue 148 2.8% 0 6
Headache 146 2.7% 0 7
Pruritus 146 2.7% 0 7
Rash 135 2.5% 0 5
No adverse event 122 2.3% 0 0
Candida infection 116 2.2% 0 3
Condition aggravated 115 2.2% 0 9

Who Reports BIMEKIZUMAB-BKZX Side Effects? Age & Gender Data

Gender: 62.8% female, 37.2% male. Average age: 50.4 years. Most reports from: US. View detailed demographics →

Is BIMEKIZUMAB-BKZX Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 1 0 1
2020 5 0 5
2021 3 0 3
2022 11 2 7
2023 91 1 18
2024 1,346 9 112
2025 1,496 16 162

View full timeline →

What Is BIMEKIZUMAB-BKZX Used For?

IndicationReports
Psoriasis 3,059
Psoriatic arthropathy 1,033
Product used for unknown indication 716
Hidradenitis 598
Ankylosing spondylitis 199
Off label use 199
Axial spondyloarthritis 55
Rheumatoid arthritis 39
Dermatitis atopic 31
Illness 21

BIMEKIZUMAB-BKZX vs Alternatives: Which Is Safer?

BIMEKIZUMAB-BKZX vs BINIMETINIB BIMEKIZUMAB-BKZX vs BIOFLAVONOIDS BIMEKIZUMAB-BKZX vs BIOTIN BIMEKIZUMAB-BKZX vs BIPERIDEN BIMEKIZUMAB-BKZX vs BIRCH TRITERPENES BIMEKIZUMAB-BKZX vs BISACODYL BIMEKIZUMAB-BKZX vs BISACODYL OR DOCUSATE BIMEKIZUMAB-BKZX vs BISMUTH BIMEKIZUMAB-BKZX vs BISMUTH SUBCITRATE BIMEKIZUMAB-BKZX vs BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE

Official FDA Label for BIMEKIZUMAB-BKZX

Official prescribing information from the FDA-approved drug label.