Ibrutinib: uses, dosing, side effects & brands
Ibrutinib is a medicine sold in the U.S. under one brand, for waldenstrom macroglobulinemia, b-cell chronic lymphocytic leukemia and b-cell lymphoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats (across its forms)
- Waldenstrom Macroglobulinemia, B-Cell Chronic Lymphocytic Leukemia and B-Cell Lymphoma
- Available as
- Capsule · Suspension · Tablet
- Sold as
- Imbruvica
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How ibrutinib is dosed
From the FDA label for Imbruvica (application NDA217003). Other ibrutinib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
CLL/SLL and WM : 420 mg taken orally once daily ( 2.1 ). cGVHD : ◦ Patients 12 years and older: 420 mg taken orally once daily ( 2.1 ). ◦ Patients 1 to less than 12 years of age: 240 mg/m 2 taken orally once daily (up to a dose of 420 mg) ( 2.1 ). Tablets or capsules should be taken orally with a glass of water. Do not open, break, or chew the capsules. Do not cut, crush, or chew the tablets. See full prescribing information for oral suspension administration instructions ( 2.1 ). 2.1 Recommended Dosage Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Waldenström’s Macroglobulinemia The recommended dosage of IMBRUVICA for CLL/SLL and WM is 420 mg orally once daily until disease progression or unacceptable toxicity. For CLL/SLL, IMBRUVICA can be administered as a single agent, in combination with rituximab or obinutuzumab, or in combination with bendamustine and rituximab (BR). For WM, IMBRUVICA can be administered as a single agent or in combination with rituximab. When administering IMBRUVICA in combination with rituximab or obinutuzumab, consider administering IMBRUVICA prior to rituximab or obinutuzumab when given on the same day. Chronic Graft versus Host Disease The recommended dosage of IMBRUVICA for patients age 12 years and older with cGVHD is 420 mg orally once daily, and for patients 1 to less than 12 years of age with cGVHD is 240 mg/m 2 orally once daily…
Ibrutinib side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Hemorrhage [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Cardiac Arrhythmias, Cardiac Failure, and Sudden Death [see Warnings and Precautions ( 5.3 )] Hypertension [see Warnings and Precautions ( 5.4 )] Cytopenias [see Warnings and Precautions ( 5.5 )] Second Primary Malignancies [see Warnings and Precautions ( 5.6 )] Hepatotoxicity, including DILI [see Warning s and Precautions ( 5.7 )] Tumor Lysis Syndrome [see Warnings and Precautions ( 5.8 )] The most common (≥30%) adverse reactions in patients with B-cell malignancies are thrombocytopenia, diarrhea, fatigue, musculoskeletal pain, neutropenia, rash, anemia, bruising, and nausea ( 6 ). The most common (≥20%) adverse reactions in adult or pediatric patients with cGVHD are fatigue, anemia, bruising, diarrhea, thrombocytopenia, musculoskeletal pain, pyrexia, muscle spasms, stomatitis, hemorrhage, nausea, abdominal pain, pneumonia, and headache ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely variable conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared with rates of clinical trials of…
Who shouldn’t take ibrutinib
None None ( 4 )
Ibrutinib drug interactions
CYP3A Inhibitors: Modify IMBRUVICA dose as described ( 2.3 , 7.1 ). CYP3A Inducers: Avoid coadministration with strong CYP3A inducers ( 7.2 ). 7.1 Effect of CYP3A Inhibitors on Ibrutinib The coadministration of IMBRUVICA with a strong or moderate CYP3A inhibitor may increase ibrutinib plasma concentrations [see Clinical Pharmacology ( 12.3 )] . Increased ibrutinib concentrations may increase the risk of drug-related toxicity. Dose modifications of IMBRUVICA are recommended when used concomitantly with posaconazole, voriconazole and moderate CYP3A inhibitors [see Dosage and Administration ( 2.3 )]. Avoid concomitant use of other strong CYP3A inhibitors. Interrupt IMBRUVICA if these inhibitors will be used short-term (such as anti-infectives for seven days or less) [see Dosage and Administration ( 2.3 ) ] . Avoid grapefruit and Seville oranges during IMBRUVICA treatment, as these contain strong or moderate inhibitors of CYP3A. 7.2 Effect of CYP3A Inducers on Ibrutinib The coadministration of IMBRUVICA with strong CYP3A inducers may decrease ibrutinib concentrations. Avoid coadministration with strong CYP3A inducers [see Clinical Pharmacology ( 12.3 ) ] .
Every ibrutinib product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Imbruvica.
What ibrutinib pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| ibr;70;mg | 70 mg | yellow | capsule | — |
| ibr;140;mg | 140 mg | white | capsule | — |
| ibr;140 | 140 mg | green | round | — |
| ibr;280 | 280 mg | purple | oval | — |
| ibr;420 | 420 mg | green | oval | — |
Can you crush or split ibrutinib?
At least one ibrutinibproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each ibrutinib label says about crushing, splitting and chewingIbrutinib and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for ibrutinib: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of ibrutinib during breastfeeding. Because ibrutinib is more than 97% bound to plasma proteins, the amount in milk is likely to be low. The manufacturer recommends that breastfeeding be discontinued during ibrutinib therapy and for 1 week after the last dose.
National Institute of Child Health and Human Development, record revised June 20, 2022. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about ibrutinib
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 12,370 reports naming ibrutinib, and the FDA flagged 96% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- atrial fibrillation966 reports
- neutropenia825 reports
- thrombocytopenia722 reports
- febrile neutropenia692 reports
- pneumonia683 reports
- anaemia668 reports
- infection583 reports
- diarrhoea568 reports
Read these as a signal, not a rate. A report does not mean ibrutinib caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is ibrutinib?
Imbruvica (Ibrutinib) is a medication used to treat Waldenstrom Macroglobulinemia, B-Cell Chronic Lymphocytic Leukemia, B-Cell Lymphoma, Mantle-Cell Lymphoma.
Can you take ibrutinib with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run ibrutinib against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does ibrutinib come in?
Across the brands we track, ibrutinib is currently marketed as capsule, suspension and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic ibrutinib?
We do not currently list a generic-labelled ibrutinib product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Ibrutinib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/ibrutinib
- MLA
- “Ibrutinib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/ibrutinib.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for ibrutinib on DailyMed (NIH) ↗.