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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-ADAZ: 6,935 Adverse Event Reports & Safety Profile

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6,935
Total FAERS Reports
930 (13.4%)
Deaths Reported
2,120
Hospitalizations
6,935
As Primary/Secondary Suspect
680
Life-Threatening
700
Disabilities
Prescription
Status

FDA Application: 761071 ·

First Report: 20050409 · Latest Report: 20250919

What Are the Most Common ADALIMUMAB-ADAZ Side Effects?

#1 Most Reported
Drug ineffective
928 reports (13.4%)
#2 Most Reported
Off label use
925 reports (13.3%)
#3 Most Reported
Fatigue
798 reports (11.5%)

All ADALIMUMAB-ADAZ Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 928 13.4% 194 384
Off label use 925 13.3% 293 454
Fatigue 798 11.5% 196 349
Arthralgia 787 11.4% 180 318
Pain 735 10.6% 206 355
Diarrhoea 721 10.4% 175 299
General physical health deterioration 597 8.6% 222 302
Malaise 566 8.2% 168 318
Product dose omission issue 562 8.1% 13 137
Rheumatoid arthritis 506 7.3% 223 303
Abdominal pain 482 7.0% 73 163
Crohn's disease 470 6.8% 73 155
Nausea 469 6.8% 164 303
Headache 458 6.6% 162 233
Condition aggravated 427 6.2% 184 262
Rash 420 6.1% 234 279
Pain in extremity 419 6.0% 147 230
Psoriatic arthropathy 391 5.6% 224 264
Dizziness 367 5.3% 131 213
Death 365 5.3% 365 40

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

Gender: 65.0% female, 35.0% male. Average age: 50.0 years. Most reports from: CA. View detailed demographics →

Is ADALIMUMAB-ADAZ Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 1 0 1
2008 1 0 0
2009 3 0 2
2013 2 0 1
2014 7 0 6
2015 8 4 7
2016 5 0 3
2017 5 1 2
2018 33 0 7
2019 135 6 53
2020 166 11 80
2021 310 16 133
2022 561 38 201
2023 444 23 145
2024 611 37 143
2025 405 10 54

View full timeline →

What Is ADALIMUMAB-ADAZ Used For?

IndicationReports
Rheumatoid arthritis 1,779
Crohn's disease 1,499
Product used for unknown indication 1,140
Psoriatic arthropathy 586
Ankylosing spondylitis 580
Colitis ulcerative 413
Psoriasis 400
Hidradenitis 185
Uveitis 72
Juvenile idiopathic arthritis 60

ADALIMUMAB-ADAZ vs Alternatives: Which Is Safer?

ADALIMUMAB-ADAZ vs ADALIMUMAB-ADBM ADALIMUMAB-ADAZ vs ADALIMUMAB-AFZB ADALIMUMAB-ADAZ vs ADALIMUMAB-ATTO ADALIMUMAB-ADAZ vs ADALIMUMAB-BWWD ADALIMUMAB-ADAZ vs ADALIMUMAB-FKJP ADALIMUMAB-ADAZ vs ADALIMUMAB-RYVK ADALIMUMAB-ADAZ vs ADALIMUMAB\ISOPROPYL ALCOHOL ADALIMUMAB-ADAZ vs ADAPALENE ADALIMUMAB-ADAZ vs ADAPALENE\BENZOYL PEROXIDE ADALIMUMAB-ADAZ vs ADCETRIS

Official FDA Label for ADALIMUMAB-ADAZ

Official prescribing information from the FDA-approved drug label.