Humira (adalimumab) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Humira
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Adalimumab

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 639,882 adverse event reports that name Humira. In these reports the drug is a suspect or interacting product.

In the same period, 26,384 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 8,749 reports in the 12 months to June 2026 and 16,102 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 8,749 (0.7%) name Humira. Reports from consumers or other non-health professionals were 69.3% of the reports that name Humira and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Humira is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 1,802 reports that name Humira.
In January to March 2026, FDA received 1,734.
In April to June 2025, FDA received 3,530.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 5,455 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for all 639,882 reports.

The site keeps a term for a year only if two or more reports of that year record it.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 5,455 terms.

Reaction terms in the reports that name Humira, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 639,882 reports
Drug ineffectivethe medicine did not work as expected	79,047	12.4%
Injection site painpain where the injection was given	46,109	7.2%
Painpain, site not specified	43,976	6.9%
Arthralgiajoint pain	42,872	6.7%
Fatiguetiredness	34,747	5.4%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	31,806	5%
Headachehead pain	25,106	3.9%
Nauseafeeling sick	23,924	3.7%
Rashskin rash	22,558	3.5%
Diarrhoealoose or frequent stools	22,076	3.5%
Pain in extremitypain in an arm or leg	21,940	3.4%
Incorrect dose administeredthe wrong dose was given	21,896	3.4%
Psoriasispsoriasis, a skin condition	21,624	3.4%
Joint swellinga swollen joint	20,472	3.2%
Nasopharyngitisa cold	18,688	2.9%
Malaisegeneral feeling of being unwell	18,515	2.9%
Device issuea problem with the device	17,946	2.8%
Crohn's disease	16,879	2.6%
Pyrexiafever	16,864	2.6%
Injection site haemorrhagebleeding where the injection was given	15,973	2.5%
Off label useused for a purpose or in a way not on the label	14,880	2.3%
Drug intolerancethe medicine was not tolerated	14,711	2.3%
Injection site erythemaredness where the injection was given	14,648	2.3%
Alopeciahair loss	14,632	2.3%
Vomitingbeing sick	14,357	2.2%
Abdominal painstomach or belly pain	14,024	2.2%
Peripheral swellingswelling of the arms or legs	13,598	2.1%
Dyspnoeashortness of breath	13,571	2.1%
Pneumonialung infection	13,511	2.1%
Condition aggravatedthe condition being treated got worse	13,405	2.1%
Falla fall	13,196	2.1%
Sinusitissinus infection	12,745	2%
Dizzinesslight-headedness or unsteadiness	12,673	2%
Pruritusitching	12,614	2%
Infectionan infection, type not specified	12,557	2%
Back pain	12,021	1.9%
Abdominal discomfortstomach discomfort	11,899	1.9%
Arthropathy	11,820	1.8%
Wrong technique in product usage processthe product was used in the wrong way	11,809	1.8%
Astheniaweakness or lack of energy	11,804	1.8%
Systemic lupus erythematosuslupus, an autoimmune disease	11,542	1.8%
Musculoskeletal stiffnessstiffness in muscles or joints	11,535	1.8%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	11,517	1.8%
Hypersensitivityan allergic-type reaction	11,508	1.8%
Weight decreasedweight loss	11,298	1.8%
Swelling	11,238	1.8%
Deaththe patient died; cause not stated by this term	11,161	1.7%
Cough	11,010	1.7%
Contraindicated product administered	10,783	1.7%
Therapeutic product effect decreased	10,648	1.7%

Download all 5,455 terms of Humira (CSV)

The counts add to more than 639,882 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Adalimumab with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Adalimumab	Generic name	39,338
Humira (this page)	Brand name	639,882

Sum of the separately reported names: 679,220. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Humira, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	6,402	1,272	276	56	976	59	3	183	5,130
2005	5,076	1,416	249	70	973	74	0	391	3,660
2006	1,325	1,174	172	61	751	37	2	429	151
2007	4,408	2,125	248	102	1,437	76	14	835	2,283
2008	11,715	3,188	315	152	1,951	87	9	1,543	8,527
2009	20,901	4,524	367	176	2,724	119	17	2,427	16,377
2010	16,414	5,233	447	171	3,009	165	23	3,006	11,181
2011	24,463	7,463	644	229	4,194	206	49	4,370	17,000
2012	7,565	7,443	737	241	3,954	190	39	4,376	122
2013	22,388	11,180	992	272	6,060	219	32	6,510	11,208
2014	46,425	13,388	1,143	260	6,639	393	75	8,061	33,037
2015	50,837	16,428	1,167	271	8,421	501	49	9,650	34,409
2016	82,264	21,775	1,442	352	10,487	467	85	13,320	60,489
2017	32,627	25,183	1,779	338	10,867	730	85	17,324	7,444
2018	37,820	28,579	2,015	338	12,447	648	61	19,507	9,241
2019	41,533	31,758	1,848	375	12,261	912	84	22,427	9,775
2020	44,340	33,258	1,810	436	11,105	1,040	54	24,362	11,082
2021	37,708	26,484	1,697	300	9,000	1,346	73	19,300	11,224
2022	69,399	22,203	1,563	411	7,153	1,351	57	16,330	47,196
2023	37,371	16,884	1,349	472	5,889	810	116	12,496	20,487
2024	20,273	13,756	2,106	1,447	5,599	1,681	542	10,512	6,517
2025	13,972	9,864	2,120	1,403	4,102	1,646	775	7,409	4,108
2026	4,656	3,334	1,019	778	1,632	853	502	2,543	1,322

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Humira, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Humira, by the year in which FDA received them
Year	Reports
2004	5,566
2005	5,343
2006	1,388
2007	3,752
2008	11,919
2009	17,741
2010	8,691
2011	18,501
2012	26,216
2013	22,583
2014	47,982
2015	51,981
2016	83,156
2017	34,790
2018	38,402
2019	41,855
2020	43,763
2021	34,877
2022	72,717
2023	33,678
2024	18,805
2025	12,640
2026	3,536

Reports that name Humira, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Humira
Age	Reports	Share
Under 2	446	0.1%
2 to 11	2,348	0.4%
12 to 17	7,441	1.2%
18 to 44	96,975	15.2%
45 to 64	145,070	22.7%
65 to 74	51,504	8%
75 and over	22,273	3.5%
Age not given	313,825	49%

Sex of the patient in the reports that name Humira
Sex	Reports	Share
Female	415,610	65%
Male	194,117	30.3%
Unknown or not given	30,155	4.7%

Type of reporter in the reports that name Humira
Reporter	Reports	Share
Physician	77,983	12.2%
Pharmacist	11,532	1.8%
Other health professional	77,241	12.1%
Lawyer	163	under 0.1%
Consumer or non-health professional	443,557	69.3%
Not given	29,406	4.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 74% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Humira record
Indication as recorded (MedDRA)	Reports	Share
Rheumatoid arthritis	196,049	30.6%
Crohn's disease	97,462	15.2%
Psoriasis	64,617	10.1%
Psoriatic arthropathy	48,466	7.6%
Colitis ulcerative	32,038	5%
Ankylosing spondylitis	26,958	4.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 639,882 reports.

Drugs in the same reports

Other drugs that the reports of Humira name, in any role, in order of name
Drug	Reports that name the two
Actemra	25,088
Arava	22,158
Enbrel	43,801
Folic acid	46,641
Methotrexate	90,794
Orencia	28,165
Prednisone	51,734
Remicade	25,183
Sulfasalazine	26,894
Xeljanz	21,722

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for HumiraThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

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Reported Reactions. Humira: adverse event reports that FDA received. https://reportedreactions.com/drug/humira/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Humira as a suspect or interacting product. The 26,384 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Humira was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Humira?

No. It is a count of what people reported to FDA: 639,882 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (69.3%), physician (12.2%) and other health professional (12.1%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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