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Tofacitinib Side Effects

The most commonly reported side effects of tofacitinib include pain, arthralgia, and condition aggravated, based on 185,333 FDA adverse event reports from 2012 to 2025. 23.8% of reports found the drug to be ineffective.

Tofacitinib side effects

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

1
Drug Ineffective23.8%44,195
2
Pain14.0%26,036
3
Arthralgia10.7%19,795
4
Condition Aggravated10.6%19,674
5
Rheumatoid Arthritis10.4%19,218
6
Fatigue9.1%16,893
7
Off Label Use8.2%15,219
8
Joint Swelling7.9%14,601
9
Headache7.3%13,525
10
Rash6.6%12,183
11
Drug Intolerance6.5%12,027
12
Malaise5.7%10,581
13
Abdominal Discomfort5.6%10,421
14
Pain In Extremity5.6%10,343
15
Nausea5.4%10,025

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

Report severity

48.4%Serious89,783 reports
14.0%Hospitalizations25,878 reports
4.9%Fatal9,042 reports

Seriousness is determined by the reporter, not by OpenClaim.

Tofacitinib drug interactions

Other drugs that appear in adverse event reports alongside tofacitinib. 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
Methotrexate17.9%33,204
2
Etanercept17.2%31,843
3
Adalimumab14.1%26,222
4
Abatacept11.6%21,508
5
Leflunomide11.2%20,775
6
Hydroxychloroquine-sulfate10.9%20,166
7
Tocilizumab10.8%20,054
8
Infliximab9.4%17,440
9
Rituximab9.3%17,312
10
Sulfasalazine8.9%16,512
11
Prednisone7.4%13,714
12
Golimumab6.9%12,845
13
Certolizumab-pegol6.9%12,838
14
Diclofenac4.9%9,147
15
Folic-acid4.9%9,027

Taken alongside

1
Prednisone9.0%16,755
2
Methotrexate8.9%16,527
3
Folic-acid5.5%10,102
4
Hydroxychloroquine-sulfate5.4%10,040
5
Acetaminophen5.3%9,832
6
Ergocalciferol4.9%9,161
7
Sulfasalazine4.3%7,983
8
Leflunomide4.0%7,437
9
Ibuprofen3.6%6,649
10
Pantoprazole-sodium3.5%6,490
11
Levothyroxine-sodium3.1%5,653
12
Lisinopril2.5%4,634
13
Calcium2.2%4,157
14
Celecoxib2.1%3,982
15
Naproxen2.1%3,967

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 tofacitinib side effects

75.8% of tofacitinib adverse event reports involve female patients and 18.7% involve male patients. The largest age group is adult at 64%. These figures reflect who reports side effects, not underlying risk.

Sex

Female75.8%
Male18.7%
Unknown5.4%

Age group

< 20.1%
2–110.3%
12–170.6%
18–6464.1%
65+35.0%

What is tofacitinib used for

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

Abdominal DistensionAbdominal Pain UpperAbnormal FaecesAbscessActinic KeratosisAcute Febrile Neutrophilic DermatosisAcute Generalised Exanthematous PustulosisAcute Myeloid LeukaemiaAdrenal InsufficiencyAlopeciaAlopecia AreataAlopecia ScarringAlopecia TotalisAlopecia UniversalisAmyotrophic Lateral Sclerosis

Showing 15 of 1,106 indications

Tofacitinib brand names and reporting trend

Tofacitinib is sold under brand names including Tofacitinib, Tofacitinib.

Brand names

Tofacitinib12,743
Tofacitinib9,265

Quarterly reports (20122025)

20122016202020242025

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

Taking tofacitinib with another medication?

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