BIMEKIZUMAB

N/A

Manufactured by UCB, Inc.

25,281 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BIMEKIZUMAB

BIMEKIZUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by UCB, Inc.. The most commonly reported adverse reactions for BIMEKIZUMAB include PRODUCT DOSE OMISSION ISSUE, PSORIASIS, DRUG INEFFECTIVE, PSORIATIC ARTHROPATHY, HIDRADENITIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BIMEKIZUMAB.

Top Adverse Reactions

PRODUCT DOSE OMISSION ISSUE2,035 reports
PSORIASIS1,713 reports
DRUG INEFFECTIVE1,259 reports
PSORIATIC ARTHROPATHY1,174 reports
HIDRADENITIS976 reports
OFF LABEL USE956 reports
INJECTION SITE PAIN810 reports
CONDITION AGGRAVATED697 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION653 reports
PRODUCT AVAILABILITY ISSUE645 reports
THERAPY INTERRUPTED574 reports
ORAL CANDIDIASIS509 reports
INCORRECT DOSE ADMINISTERED490 reports
FATIGUE462 reports
PAIN456 reports
HEADACHE415 reports
PRURITUS393 reports
RASH342 reports
CANDIDA INFECTION297 reports
DIARRHOEA291 reports
INSURANCE ISSUE284 reports
ARTHRALGIA279 reports
ADVERSE DRUG REACTION264 reports
NO ADVERSE EVENT259 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE258 reports
ANKYLOSING SPONDYLITIS246 reports
DEPRESSION246 reports
DEVICE ISSUE236 reports
INTENTIONAL DOSE OMISSION216 reports
PNEUMONIA214 reports
NASOPHARYNGITIS213 reports
NAUSEA212 reports
ILLNESS207 reports
THERAPEUTIC RESPONSE SHORTENED206 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES194 reports
FUNGAL INFECTION187 reports
INFECTION180 reports
ACNE174 reports
URINARY TRACT INFECTION171 reports
HYPERSENSITIVITY160 reports
SURGERY155 reports
COUGH144 reports
ERYTHEMA143 reports
PRODUCT DISTRIBUTION ISSUE143 reports
DEVICE MALFUNCTION140 reports
ANXIETY135 reports
SINUSITIS133 reports
OESOPHAGEAL CANDIDIASIS131 reports
PYREXIA128 reports
INJECTION SITE ERYTHEMA127 reports
INJECTION SITE REACTION127 reports
OROPHARYNGEAL PAIN125 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS121 reports
INJECTION SITE SWELLING120 reports
STRESS114 reports
FALL112 reports
SUICIDAL IDEATION112 reports
INFLUENZA110 reports
INJECTION SITE PRURITUS110 reports
MALAISE108 reports
COVID 19105 reports
ABDOMINAL PAIN UPPER104 reports
DIZZINESS104 reports
PRODUCT USE ISSUE104 reports
INJECTION SITE BRUISING101 reports
URTICARIA101 reports
VOMITING100 reports
EAR INFECTION94 reports
DRY SKIN92 reports
ALOPECIA91 reports
CELLULITIS90 reports
ECZEMA87 reports
PAIN IN EXTREMITY87 reports
LOWER RESPIRATORY TRACT INFECTION86 reports
DRUG HYPERSENSITIVITY82 reports
WEIGHT DECREASED82 reports
ADVERSE EVENT81 reports
PERIPHERAL SWELLING81 reports
PRODUCT USE IN UNAPPROVED INDICATION80 reports
DYSPNOEA77 reports
RHEUMATOID ARTHRITIS77 reports
UPPER RESPIRATORY TRACT INFECTION77 reports
SKIN DISORDER76 reports
GASTROINTESTINAL DISORDER74 reports
HOSPITALISATION74 reports
BACK PAIN72 reports
ABDOMINAL DISCOMFORT70 reports
INSOMNIA70 reports
NEEDLE ISSUE70 reports
FEELING ABNORMAL69 reports
SEPSIS67 reports
ASTHENIA66 reports
ACCIDENTAL EXPOSURE TO PRODUCT65 reports
BLISTER65 reports
ORAL HERPES65 reports
DECREASED APPETITE64 reports
BRONCHITIS61 reports
PRODUCT STORAGE ERROR60 reports
WEIGHT INCREASED60 reports
ARTHRITIS59 reports

Report Outcomes

Out of 10,775 classified reports for BIMEKIZUMAB:

Serious 47.4%Non-Serious 52.6%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female2,629 (60.8%)
Male1,696 (39.2%)

Reports by Age

Age 53240 reports
Age 54240 reports
Age 59203 reports
Age 49201 reports
Age 55198 reports
Age 51196 reports
Age 43193 reports
Age 45192 reports
Age 40191 reports
Age 61191 reports
Age 44190 reports
Age 47190 reports
Age 56189 reports
Age 60189 reports
Age 48188 reports
Age 63184 reports
Age 50182 reports
Age 57180 reports
Age 52179 reports
Age 62179 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with BIMEKIZUMAB?

This profile reflects 25,281 FDA FAERS reports that mention BIMEKIZUMAB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BIMEKIZUMAB?

Frequently reported terms in FAERS include PRODUCT DOSE OMISSION ISSUE, PSORIASIS, DRUG INEFFECTIVE, PSORIATIC ARTHROPATHY, HIDRADENITIS, OFF LABEL USE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BIMEKIZUMAB?

Labeling and FAERS entries often list UCB, Inc. in connection with BIMEKIZUMAB. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.