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Infliximab Side Effects

The most commonly reported side effects of infliximab include off label use, condition aggravated, and arthralgia, based on 249,286 FDA adverse event reports from 2004 to 2025. 16.8% of reports found the drug to be ineffective.

Infliximab side effects

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

1
Off Label Use21.3%53,106
2
Drug Ineffective16.8%41,785
3
Condition Aggravated11.5%28,731
4
Arthralgia8.2%20,482
5
Pain7.8%19,559
6
Intentional Product Use Issue7.8%19,472
7
Fatigue7.5%18,698
8
Rheumatoid Arthritis7.3%18,102
9
Infusion Related Reaction6.4%15,896
10
Product Use Issue6.0%14,916
11
Inappropriate Schedule Of Product Administration5.4%13,414
12
Rash5.3%13,279
13
Nausea5.3%13,119
14
Drug Intolerance5.0%12,454
15
Headache4.9%12,208

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

Report severity

87.8%Serious218,904 reports
29.0%Hospitalizations72,407 reports
5.7%Fatal14,249 reports

Seriousness is determined by the reporter, not by OpenClaim.

Infliximab drug interactions

Other drugs that appear in adverse event reports alongside infliximab. 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
Methotrexate15.4%38,479
2
Adalimumab15.1%37,600
3
Etanercept12.8%32,006
4
Abatacept9.8%24,327
5
Tocilizumab9.3%23,095
6
Leflunomide9.2%22,810
7
Rituximab8.8%21,892
8
Hydroxychloroquine-sulfate8.7%21,724
9
Prednisone7.6%18,992
10
Sulfasalazine7.2%17,840
11
Certolizumab-pegol6.6%16,342
12
Golimumab6.5%16,171
13
Tofacitinib4.9%12,259
14
Folic-acid4.5%11,319
15
Alendronate-sodium4.4%11,067

Taken alongside

1
Prednisone12.4%30,915
2
Methotrexate10.7%26,719
3
Acetaminophen7.4%18,467
4
Azathioprine5.7%14,278
5
Folic-acid5.7%14,157
6
Mesalamine4.4%10,865
7
Ergocalciferol4.1%10,309
8
Pantoprazole-sodium3.9%9,688
9
Hydrocortisone3.8%9,597
10
Tofacitinib3.6%8,860
11
Sulfasalazine3.5%8,747
12
Diphenhydramine3.2%8,015
13
Calcium2.7%6,785
14
Adalimumab2.7%6,636
15
Hydroxychloroquine-sulfate2.5%6,262

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 infliximab side effects

49.3% of infliximab adverse event reports involve female patients and 29.0% involve male patients. The largest age group is adult at 70%. These figures reflect who reports side effects, not underlying risk.

Sex

Female49.3%
Male29.0%
Unknown21.7%

Age group

< 20.7%
2–113.5%
12–177.9%
18–6470.4%
65+17.4%

What is infliximab used for

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

Abdominal DistensionAbdominal PainAbdominal Pain UpperAbscessAbscess IntestinalAbscess SterileAccidental ExposureAccidental Exposure To ProductAcneAcne ConglobataAcne CysticAcne FulminansAcrodermatitisAcute Febrile Neutrophilic DermatosisAcute Generalised Exanthematous Pustulosis

Showing 15 of 1,551 indications

Infliximab brand names and reporting trend

Infliximab is sold under several brand names including Remicade, Zymfentra, Renflexis.

Brand names

Remicade137,427
Zymfentra2,786
Renflexis61
Ixifi6
Avsola3

Quarterly reports (20042025)

20052010201520202025

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

Taking infliximab with another medication?

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