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Adalimumab Side Effects

The most commonly reported side effects of adalimumab include pain, arthralgia, and injection site pain, based on 712,119 FDA adverse event reports from 2004 to 2025. 12.1% of reports found the drug to be ineffective.

Adalimumab side effects

Percentages show how often each reaction appears relative to total reports for adalimumab.

1
Drug Ineffective12.1%86,299
2
Pain6.4%45,860
3
Arthralgia6.2%44,112
4
Injection Site Pain5.4%38,653
5
Fatigue5.1%36,296
6
Rheumatoid Arthritis4.8%34,114
7
Headache3.5%25,196
8
Nausea3.4%24,348
9
Diarrhoea3.3%23,534
10
Off Label Use3.2%22,886
11
Rash3.2%22,550
12
Pain In Extremity3.1%22,301
13
Psoriasis3.1%21,971
14
Joint Swelling3.1%21,873
15
Crohn^s Disease2.9%20,442

These are voluntary reports and do not establish that adalimumab caused these reactions.

Report severity

51.3%Serious365,322 reports
21.2%Hospitalizations150,691 reports
4.2%Fatal30,150 reports

Seriousness is determined by the reporter, not by OpenClaim.

Adalimumab drug interactions

Other drugs that appear in adverse event reports alongside adalimumab. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Methotrexate8.5%60,278
2
Etanercept7.9%56,133
3
Infliximab5.3%37,952
4
Leflunomide4.6%32,559
5
Abatacept4.5%32,278
6
Tocilizumab4.2%30,221
7
Hydroxychloroquine-sulfate4.2%29,605
8
Rituximab3.8%26,722
9
Sulfasalazine3.2%22,897
10
Prednisone3.1%22,091
11
Certolizumab-pegol2.9%20,584
12
Golimumab2.6%18,706
13
Tofacitinib2.4%16,907
14
Secukinumab2.0%14,042
15
Diclofenac2.0%13,920

Taken alongside

1
Methotrexate8.8%62,451
2
Prednisone6.7%47,814
3
Folic-acid5.8%41,292
4
Acetaminophen3.8%27,199
5
Ergocalciferol3.8%27,133
6
Levothyroxine-sodium3.2%22,813
7
Omeprazole3.1%21,997
8
Aspirin2.4%17,410
9
Hydroxychloroquine-sulfate2.3%16,561
10
Lisinopril2.3%16,368
11
Pantoprazole-sodium2.3%16,068
12
Calcium2.2%15,892
13
Ibuprofen2.2%15,683
14
Mesalamine2.1%14,636
15
Tofacitinib2.0%14,572

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports adalimumab side effects

63.8% of adalimumab adverse event reports involve female patients and 30.1% involve male patients. The largest age group is adult at 74%. These figures reflect who reports side effects, not underlying risk.

Sex

Female63.8%
Male30.1%
Unknown6.0%

Age group

< 20.3%
2–110.9%
12–172.4%
18–6474.0%
65+22.4%

What is adalimumab used for

Conditions and purposes for which patients were taking adalimumab when the adverse event was reported.

1p36 Deletion Syndrome22q11.2 Deletion SyndromeAbdominal AbscessAbdominal DiscomfortAbdominal PainAbdominal Pain UpperAbnormal FaecesAbortion SpontaneousAbscessAbscess IntestinalAbscess SterileAccidental ExposureAccidental Exposure To ProductAccidental Needle StickAcne

Showing 15 of 1,849 indications

Adalimumab brand names and reporting trend

Adalimumab is sold under several brand names including Humira, Yuflyma, Hyrimoz.

Brand names

Humira63,981
Yuflyma1,279
Hyrimoz85
Idacio45
Cyltezo27
Simlandi26
Yusimry20
Amjevita14
Hadlima9
Hulio6

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking adalimumab with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.