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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.

ADALIMUMAB-BWWD: 723 Adverse Event Reports & Safety Profile

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723
Total FAERS Reports
10 (1.4%)
Deaths Reported
147
Hospitalizations
723
As Primary/Secondary Suspect
8
Life-Threatening
19
Disabilities
Prescription
Status

FDA Application: 761059 ·

First Report: 19740314 · Latest Report: 20250901

What Are the Most Common ADALIMUMAB-BWWD Side Effects?

#1 Most Reported
Injection site pain
95 reports (13.1%)
#2 Most Reported
Off label use
64 reports (8.9%)
#3 Most Reported
Drug ineffective
60 reports (8.3%)

All ADALIMUMAB-BWWD Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Injection site pain 95 13.1% 0 6
Off label use 64 8.9% 1 20
Drug ineffective 60 8.3% 0 15
Fatigue 48 6.6% 0 14
Arthralgia 46 6.4% 0 10
Device issue 42 5.8% 0 3
Rheumatoid arthritis 42 5.8% 0 5
Product substitution issue 40 5.5% 0 2
Accidental exposure to product 37 5.1% 0 2
Exposure via skin contact 34 4.7% 0 2
Pain 34 4.7% 2 9
Headache 32 4.4% 0 7
Rash 32 4.4% 0 5
Wrong technique in product usage process 32 4.4% 0 1
Injection site bruising 31 4.3% 0 2
Nausea 30 4.2% 0 10
Crohn's disease 29 4.0% 0 12
Pneumonia 29 4.0% 2 10
Diarrhoea 27 3.7% 0 8
Incorrect dose administered 27 3.7% 0 0

Who Reports ADALIMUMAB-BWWD Side Effects? Age & Gender Data

Gender: 65.3% female, 34.7% male. Average age: 54.0 years. Most reports from: CA. View detailed demographics →

Is ADALIMUMAB-BWWD Getting Safer? Reports by Year

YearReportsDeathsHosp.
2021 5 0 4
2022 27 0 9
2023 60 3 9
2024 199 1 36
2025 76 0 24

View full timeline →

What Is ADALIMUMAB-BWWD Used For?

IndicationReports
Rheumatoid arthritis 174
Crohn's disease 134
Product used for unknown indication 94
Psoriatic arthropathy 78
Ankylosing spondylitis 62
Hidradenitis 37
Uveitis 37
Psoriasis 33
Colitis ulcerative 32
Sarcoidosis 7

ADALIMUMAB-BWWD vs Alternatives: Which Is Safer?

ADALIMUMAB-BWWD vs ADALIMUMAB-FKJP ADALIMUMAB-BWWD vs ADALIMUMAB-RYVK ADALIMUMAB-BWWD vs ADALIMUMAB\ISOPROPYL ALCOHOL ADALIMUMAB-BWWD vs ADAPALENE ADALIMUMAB-BWWD vs ADAPALENE\BENZOYL PEROXIDE ADALIMUMAB-BWWD vs ADCETRIS ADALIMUMAB-BWWD vs ADDERALL ADALIMUMAB-BWWD vs ADEFOVIR ADALIMUMAB-BWWD vs ADEFOVIR DIPIVOXIL ADALIMUMAB-BWWD vs ADEMETIONINE

Official FDA Label for ADALIMUMAB-BWWD

Official prescribing information from the FDA-approved drug label.