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Ibrutinib Side Effects

The most commonly reported side effects of ibrutinib include death, off label use, and fatigue, based on 78,917 FDA adverse event reports from 2012 to 2025.

Ibrutinib side effects

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

1
Death10.6%8,372
2
Off Label Use7.5%5,883
3
Fatigue5.9%4,671
4
Diarrhoea5.2%4,110
5
Atrial Fibrillation4.8%3,807
6
Pneumonia4.0%3,190
7
Contusion3.5%2,779
8
Incorrect Dose Administered3.5%2,779
9
Fall3.1%2,477
10
Asthenia2.9%2,319
11
Nausea2.9%2,275
12
Arthralgia2.8%2,181
13
Rash2.7%2,121
14
Disease Progression2.5%1,965
15
Haemorrhage2.5%1,960

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

Report severity

77.3%Serious60,986 reports
33.2%Hospitalizations26,231 reports
17.0%Fatal13,401 reports

Seriousness is determined by the reporter, not by OpenClaim.

Ibrutinib drug interactions

Other drugs that appear in adverse event reports alongside ibrutinib. 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
Rituximab6.2%4,905
2
Venetoclax5.3%4,162
3
Cyclophosphamide2.6%2,043
4
Prednisone2.2%1,731
5
Obinutuzumab2.1%1,663
6
Vincristine-sulfate1.9%1,536
7
Doxorubicin-hydrochloride1.9%1,486
8
Bendamustine-hydrochloride1.8%1,444
9
Dexamethasone1.6%1,249
10
Lenalidomide1.2%986
11
Etoposide1.2%953
12
Cytarabine1.1%902
13
Methotrexate1.1%902
14
Fludarabine-phosphate1.1%869
15
Ifosfamide0.8%595

Taken alongside

1
Allopurinol6.1%4,814
2
Aspirin5.7%4,459
3
Acetaminophen4.9%3,894
4
Ergocalciferol4.7%3,724
5
Acyclovir4.6%3,631
6
Levothyroxine-sodium4.5%3,541
7
Metoprolol4.4%3,444
8
Atorvastatin-calcium4.2%3,331
9
Omeprazole4.1%3,240
10
Amlodipine4.0%3,125
11
Furosemide3.7%2,923
12
Lisinopril3.1%2,437
13
Pantoprazole-sodium2.9%2,282
14
Prednisone2.8%2,199
15
Metformin2.8%2,195

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 ibrutinib side effects

35.4% of ibrutinib adverse event reports involve female patients and 56.7% involve male patients. The largest age group is elderly at 74%. These figures reflect who reports side effects, not underlying risk.

Sex

Female35.4%
Male56.7%
Unknown7.9%

Age group

< 2<0.1%
2–110.2%
12–170.2%
18–6426.0%
65+73.6%

What is ibrutinib used for

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

Abdominal LymphadenopathyAbdominal NeoplasmAccidental Exposure To ProductAcute Graft Versus Host DiseaseAcute Graft Versus Host Disease In SkinAcute LeukaemiaAcute Leukaemia In RemissionAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia (in Remission)Acute Lymphocytic Leukaemia RecurrentAcute Myeloid LeukaemiaAcute Myeloid Leukaemia (in Remission)Adenocarcinoma GastricAdenocarcinoma Of ColonAdenocarcinoma Pancreas

Showing 15 of 696 indications

Ibrutinib brand names and reporting trend

Ibrutinib is sold under the brand name Ibrutinib.

Brand names

Ibrutinib17,047

Quarterly reports (20122025)

20122016202020242025

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

Taking ibrutinib with another medication?

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