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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-ATTO: 1,146 Adverse Event Reports & Safety Profile

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1,146
Total FAERS Reports
7 (0.6%)
Deaths Reported
68
Hospitalizations
1,146
As Primary/Secondary Suspect
4
Life-Threatening
5
Disabilities
Prescription
Status

FDA Application: 761024 ·

First Report: 20060615 · Latest Report: 20250911

What Are the Most Common ADALIMUMAB-ATTO Side Effects?

#1 Most Reported
Device difficult to use
328 reports (28.6%)
#2 Most Reported
Product storage error
279 reports (24.3%)
#3 Most Reported
Drug dose omission by device
219 reports (19.1%)

All ADALIMUMAB-ATTO Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Device difficult to use 328 28.6% 0 4
Product storage error 279 24.4% 0 0
Drug dose omission by device 219 19.1% 0 4
Circumstance or information capable of leading to medication error 194 16.9% 0 0
Accidental exposure to product 123 10.7% 0 0
Injection site pain 100 8.7% 0 0
Intercepted product administration error 75 6.5% 0 0
Wrong technique in product usage process 69 6.0% 0 0
Drug ineffective 48 4.2% 2 13
Off label use 47 4.1% 2 13
Product communication issue 46 4.0% 0 1
Pain 33 2.9% 2 15
Rheumatoid arthritis 33 2.9% 2 15
Device use error 29 2.5% 0 0
Arthralgia 25 2.2% 2 12
Condition aggravated 22 1.9% 2 10
Incorrect dose administered by device 22 1.9% 0 0
Rash 21 1.8% 2 12
Fatigue 20 1.8% 2 12
Injection site reaction 18 1.6% 2 4

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

Gender: 73.2% female, 26.8% male. Average age: 53.7 years. Most reports from: US. View detailed demographics →

Is ADALIMUMAB-ATTO Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 1 0 0
2012 3 0 3
2017 3 0 3
2018 6 0 4
2019 2 0 1
2020 5 0 3
2021 7 0 0
2022 1 0 0
2023 234 0 6
2024 189 0 5
2025 62 1 5

View full timeline →

What Is ADALIMUMAB-ATTO Used For?

IndicationReports
Product used for unknown indication 660
Rheumatoid arthritis 138
Inflammatory bowel disease 69
Crohn's disease 58
Psoriatic arthropathy 56
Psoriasis 43
Colitis ulcerative 26
Ankylosing spondylitis 19
Arthritis 16
Hidradenitis 14

ADALIMUMAB-ATTO vs Alternatives: Which Is Safer?

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

Official FDA Label for ADALIMUMAB-ATTO

Official prescribing information from the FDA-approved drug label.