Humiraadalimumab
According to the FDA label: HUMIRA is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) ( 1.1 ) : reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. Juvenile Idiopathic Arthritis (JIA) ( 1.2 ) : reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
699,272 adverse event reports submitted to the FDA (1993–2026)
Top Reported Adverse Events
The most frequently reported events in association with Humira in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Drug Ineffective 91,120 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Pain 49,354 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Arthralgia 48,311 reports
Injection Site Pain 47,302 reports
Pain at the spot on the body where a medication was injected.
Full definition in the glossary →Fatigue 39,343 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Rheumatoid Arthritis 35,784 reports
An autoimmune condition where the immune system attacks the joints, causing pain and swelling. It often appears in reports because it is a condition being treated, not always a reaction.
Full definition in the glossary →Headache 28,558 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Nausea 27,277 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 25,615 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Rash 25,504 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Psoriasis 24,819 reports
A condition where skin cells build up and form itchy, scaly patches. It often appears in reports because it is a condition being treated.
Full definition in the glossary →Pain in Extremity 24,453 reports
Pain in an arm or leg.
Full definition in the glossary →Joint Swelling 23,449 reports
Swelling in or around a joint.
Full definition in the glossary →Incorrect Dose Administered 22,347 reports
A report that the wrong dose was given or taken. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →Malaise 21,523 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 448,467 |
| Male | 210,757 |
| Unknown | 1,947 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 13,122 |
| 18-34 | 54,631 |
| 35-49 | 86,493 |
| 50-64 | 129,124 |
| 65-74 | 56,992 |
| 75+ | 24,379 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Humira. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 344,123 |
| Other Serious | 245,718 |
| Hospitalization | 147,772 |
| Death | 29,475 |
| Disability | 16,363 |
| Life-Threatening | 11,863 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Humira. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 1993 | 1 |
| 2004 | 6,016 |
| 2005 | 5,446 |
| 2006 | 1,501 |
| 2007 | 3,876 |
| 2008 | 12,339 |
| 2009 | 18,064 |
| 2010 | 9,215 |
| 2011 | 19,374 |
| 2012 | 27,621 |
| 2013 | 24,115 |
| 2014 | 48,971 |
| 2015 | 53,593 |
| 2016 | 85,176 |
| 2017 | 37,237 |
| 2018 | 42,046 |
| 2019 | 45,996 |
| 2020 | 48,439 |
| 2021 | 39,140 |
| 2022 | 78,517 |
| 2023 | 41,341 |
| 2024 | 26,913 |
| 2025 | 21,051 |
| 2026 (partial) | 3,284 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Humira
In FDA adverse event reports that mention Humira, these medications appeared most often in the same report.
- Methotrexate (117,517 reports)
- Prednisone (61,748 reports)
- Etanercept (60,284 reports)
- Folic Acid (52,614 reports)
- Leflunomide (43,811 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026