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Ibrutinib

Ibrutinib is a kinase inhibitor (a targeted cancer medicine) used for chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenström’s macroglobulinemia, and chronic graft versus host disease.

Brand name Imbruvica
Drug class Kinase Inhibitor
Rx Forms 3
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Ibrutinib at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Ibrutinib (Imbruvica) is a once-daily targeted medicine for chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), Waldenström's macroglobulinemia and chronic graft versus host disease; it blocks BTK, a protein B-cells (a type of white blood cell) need to grow and survive, and was the first drug of its kind, on the U.S. market since about 2013. Most people manage it well enough, noticing mainly diarrhea, tiredness, muscle aches and easy bruising. Watch most closely for serious bleeding (black or bloody stools, a severe headache), especially alongside blood thinners. It can also cause serious infections, irregular heartbeats, heart failure and high blood pressure, so expect regular heart and blood checks.

Clinical pearls

  • Skip grapefruit and Seville oranges, including their juices, because they can push ibrutinib levels up.
  • Have your pharmacist screen new prescriptions, since antifungals like voriconazole and antibiotics like erythromycin raise ibrutinib levels and rifampin lowers them.
  • Before surgery, tell the surgical team you take ibrutinib; it may be held for several days before and after.
  • Swallow tablets and capsules whole; a missed dose can be taken later that day, but never doubled the next.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet, Capsule, Oral suspension
Earliest FDA record2013
Companies listing it with the FDA1
FDA label last updatedOct 21, 2025
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Ibrutinib, written from its FDA label.

What Ibrutinib is used for

▾

Ibrutinib is used for several blood-related conditions.

  • Imbruvica: adults with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
  • Imbruvica: adults with CLL/SLL with 17p deletion
  • Imbruvica: adults with Waldenström’s macroglobulinemia (WM)
  • Imbruvica: adults and children age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy

How Ibrutinib works

▾

Ibrutinib blocks Bruton’s tyrosine kinase (BTK), a signaling protein in B-cells. It attaches firmly to BTK and switches it off.

BTK helps B-cells grow, move and stick to tissues. Blocking it slows the growth and survival of malignant B-cells.

Ibrutinib dosage

▾

Imbruvica is taken by mouth once daily at about the same time each day. It comes as tablets, capsules and an oral suspension.

  • Swallow tablets or capsules whole with a glass of water.
  • Do not open, break or chew capsules. Do not cut, crush or chew tablets.
  • Children’s doses for cGVHD are based on body size, and the oral suspension has separate Instructions for Use.
  • If you miss a dose, take it the same day as soon as you can. Do not double up the next day.

Follow your prescriber’s directions and the label.

Dosing details from the FDA-approved label

From the Ibrutinib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • CLL/SLL and WM
    • 420 mg orally once daily until disease progression or unacceptable toxicity
    • For CLL/SLL, may be given as a single agent, with rituximab or obinutuzumab, or with bendamustine and rituximab; for WM, as a single agent or with rituximab
  • cGVHD, patients 12 years and older
    • 420 mg orally once daily until cGVHD progression, recurrence of an underlying malignancy, or unacceptable toxicity
  • cGVHD, patients 1 to less than 12 years of age
    • 240 mg/m2 orally once daily until cGVHD progression, recurrence of an underlying malignancy, or unacceptable toxicity
    • Maximum: up to a dose of 420 mg
    • Dose by body surface area (Table 1) using capsules/tablets or oral suspension (70 mg/mL)
  • Adult patients with B-cell malignancies with mild hepatic impairment (Child-Pugh class A)
    • 140 mg daily
    • Hepatic impairment adjustment
  • Adult patients with B-cell malignancies with moderate hepatic impairment (Child-Pugh class B)
    • 70 mg daily
    • Avoid use in severe hepatic impairment (Child-Pugh class C)
  • cGVHD, patients 12 years and older with total bilirubin >1.5 to 3 x ULN
    • 140 mg daily
    • Unless of non-hepatic origin or due to Gilbert's syndrome; avoid if total bilirubin >3 x ULN
  • cGVHD, patients 1 to less than 12 years of age with total bilirubin >1.5 to 3 x ULN
    • 80 mg/m2 daily
    • Unless of non-hepatic origin or due to Gilbert's syndrome; avoid if total bilirubin >3 x ULN
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION 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 (up to a dose of 420 mg), until cGVHD progression, recurrence of an underlying malignancy, or unacceptable toxicity. When a patient no longer requires therapy for the treatment of cGVHD, IMBRUVICA should be discontinued considering the medical assessment of the individual patient.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Ibrutinib side effects

▾

The most common side effects in people with blood cancers include:

Common side effects

  • Low platelets (thrombocytopenia)
  • Diarrhea
  • Fatigue
  • Muscle and bone pain
  • Low neutrophils (neutropenia)
  • Rash
  • Anemia
  • Bruising
  • Nausea

When to get medical help

  • Call your doctor or get help right away for signs of serious bleeding, such as black or bloody stools, blood in urine, or a severe headache.
  • Tell your doctor promptly about fever or signs of infection.
  • Get medical help for a racing or irregular heartbeat, palpitations, lightheadedness, fainting, chest pain, or new shortness of breath.
  • Report new or worsening high blood pressure.
  • Tell your doctor about symptoms of liver problems, since liver injury can be severe.
  • Report any new skin changes or other new cancers to your doctor.

In cGVHD, fever, muscle spasms, mouth sores, belly pain, pneumonia and headache were also common. Call your doctor about bleeding, fever or infection, irregular heartbeat, shortness of breath, or signs of liver problems.

Ibrutinib warnings and precautions

▾
  • Bleeding: fatal bleeding has occurred, and the risk rises with blood thinners or antiplatelet drugs. Your doctor may hold ibrutinib before and after surgery.
  • Infections: serious and sometimes fatal infections occur, including PML (a rare brain infection) and a type of pneumonia called PJP.
  • Heart problems: irregular heartbeat, heart failure and sudden death have occurred, especially in people with heart risk factors.
  • High blood pressure: it can develop and rise over time.
  • Low blood counts: blood counts are checked monthly.
  • Other cancers: second cancers, mostly skin cancers, have occurred.
  • Liver injury: it can be severe, so liver tests are monitored.
  • Tumor lysis syndrome: it is infrequent, and your team will watch for it.
  • Pregnancy: it can harm an unborn baby.

Ibrutinib interactions

▾

Ibrutinib is broken down by the liver enzyme CYP3A, so drugs and foods that affect this enzyme matter.

  • Strong or moderate CYP3A inhibitors (such as ketoconazole, voriconazole, posaconazole and erythromycin) raise ibrutinib levels. Your dose may change or be paused.
  • Strong CYP3A inducers (such as rifampin) lower ibrutinib levels and should be avoided.
  • Blood thinners and antiplatelet drugs raise the risk of major bleeding.
  • Grapefruit and Seville oranges can raise ibrutinib levels, so avoid them.

Interactions listed in the FDA-approved label

From the Ibrutinib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Moderate CYP3A inhibitors: May increase ibrutinib plasma concentrations and may increase the risk of drug-related toxicity. Modify IMBRUVICA dose as recommended (280 mg once daily for B-cell malignancies; 420 mg once daily for cGVHD patients 12 years and older; 240 mg/m2 once daily for cGVHD patients 1 to less than 12 years).
  • Voriconazole: May increase ibrutinib plasma concentrations and may increase the risk of drug-related toxicity. With voriconazole 200 mg twice daily, use 140 mg once daily for B-cell malignancies or 280 mg once daily for cGVHD patients 12 years and older; for patients 1 to less than 12 years with voriconazole for suspension 9 mg/kg (maximum 350 mg) twice daily, use 160 mg/m2 once daily.
  • Posaconazole: May increase ibrutinib plasma concentrations and may increase the risk of drug-related toxicity. Dose modification is recommended per posaconazole formulation and dose: for B-cell malignancies 140 mg once daily (suspension 100 mg once or twice daily, or 200 mg twice daily) or 70 mg once daily (higher doses, IV, or delayed-release tablets); for cGVHD patients 1 to less than 12 years of age, 80 mg/m2 once daily.
  • Other strong CYP3A inhibitors: May increase ibrutinib plasma concentrations and may increase the risk of drug-related toxicity. Avoid concomitant use. If used short-term (such as anti-infectives for seven days or less), interrupt IMBRUVICA.
  • Grapefruit and Seville oranges: They contain strong or moderate inhibitors of CYP3A. Avoid during IMBRUVICA treatment.
  • Strong CYP3A inducers: May decrease ibrutinib concentrations. Avoid coadministration.
Read the label’s full interactions text

7 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 ) ] .

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿282 supplements and herbs with documented Ibrutinib interactions, ranked by severity Check Ibrutinib against a supplement or herb →

Before taking Ibrutinib

▾
  • Tell your doctor about heart disease, irregular heartbeat, high blood pressure or diabetes.
  • Liver problems: lower doses are used for mild or moderate impairment, and it should be avoided in severe impairment.
  • Pregnancy: it can cause fetal harm. Use effective contraception during treatment and for 1 month after the last dose. This applies to males with female partners too.
  • Do not breastfeed during treatment and for 1 week after the last dose.
  • Children: not established for CLL/SLL or WM, or for cGVHD under 1 year of age.
  • Older adults had more anemia, pneumonia, low platelets, high blood pressure and atrial fibrillation.

Ibrutinib overdose

▾

There is no specific experience managing ibrutinib overdose. One healthy person who took a very high dose had a reversible rise in liver enzymes. If someone takes more than prescribed, they should be closely monitored and given supportive care.

What Ibrutinib does in the body

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Ibrutinib occupies the BTK target in blood cells for at least 24 hours after dosing. At the recommended dose, occupancy was about 93% in adults with cGVHD and 95% to 99.6% in children. In lab tests it reduced collagen-induced platelet clumping, which may relate to bleeding risk. At a dose four times the maximum, it did not meaningfully affect the heart’s QT interval.

How your body processes Ibrutinib

▾

Ibrutinib is absorbed after swallowing and peaks in about 1 to 2 hours. A high-fat meal raises the amount absorbed. It is cleared mainly by the liver enzyme CYP3A, and the half-life is about 4 to 6 hours.

Most of it leaves the body in the stool as metabolites, with less than 10% in urine. Liver impairment sharply raises ibrutinib levels. Mild to moderate kidney impairment did not change exposure.

How to store Ibrutinib

▾

Store bottles at room temperature 20°C to 25°C (68°F to 77°F). Store tablets in original packaging at room temperature 20°C to 25°C (68°F to 77°F). Store the oral suspension bottle at 2°C to 25°C (36°F to 77°F).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

282

Supplements & herbs that interact with Ibrutinib

282 supplements and herbal products have documented interactions with Ibrutinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 236
  • Minor · 41
ACTIVATED CHARCOAL Major DANSHEN Major GRAPEFRUIT Major PIRACETAM Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ACONITE Moderate ADRAFINIL Moderate +274 more
Every supplement checked against Ibrutinib — ranked by severity The full interaction hub: 5 major · 236 moderate · 41 minor · every one linked to its full report. Check Ibrutinib against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Ibrutinib: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Ibrutinib — the kind of thing our pharmacy team would talk through with you at the counter.

What is ibrutinib for?

▾
It treats certain blood cancers in adults: CLL/SLL (including with 17p deletion) and Waldenström’s macroglobulinemia. Imbruvica is also used for chronic graft versus host disease in adults and children 1 year and older after other treatments haven’t worked.

How should I take it?

▾
Take Imbruvica by mouth once a day at about the same time. Swallow tablets or capsules whole with a glass of water, and don’t crush, chew, cut or open them. If you miss a dose, take it the same day, then go back to normal the next day. Don’t double up.

What side effects should I expect?

▾
Common ones are diarrhea, tiredness, muscle and bone pain, rash, nausea and easy bruising. Blood counts can also drop, so you’ll have regular blood tests. Call us about bleeding, fever, infection signs, or heart symptoms.

Can I take it with other medicines or foods?

▾
Check with me first. Some antifungals and antibiotics raise ibrutinib levels, and some drugs like rifampin lower them. Blood thinners raise the bleeding risk. Avoid grapefruit and Seville oranges.

What heart symptoms should I watch for?

▾
Tell your doctor right away about palpitations, lightheadedness, fainting, chest pain or new shortness of breath. Ibrutinib can cause irregular heartbeats, heart failure and high blood pressure, so your blood pressure and heart should be monitored.

Is it safe in pregnancy?

▾
It can harm an unborn baby. Your pregnancy status should be checked before you start. Use effective contraception during treatment and for 1 month after the last dose, which applies to men with female partners too. Don’t breastfeed during treatment and for 1 week after.

Is Ibrutinib available over the counter?

▾
No. Ibrutinib is a prescription medicine: every Ibrutinib product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Ibrutinib first available?

▾
The earliest FDA record we hold for Ibrutinib is from 2013: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Ibrutinib was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Ibrutinib on HelloPharmacist

📊Ibrutinib supplement interactions282 checked — ranked by severity 🌿Drug & Supplement CheckerIbrutinib vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Ibrutinib NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Ibrutinib Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Ibrutinib forms and strengths (how it comes)

Ibrutinib is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Ibrutinib inactive ingredients by manufacturer.

Tablet

By mouth
Brands Imbruvica
How this form is used
What it may be used for
  • Imbruvica is used for CLL/SLL, WM, and cGVHD after failure of one or more systemic therapies.
Important instructions
  • Imbruvica tablets should be swallowed whole with a glass of water.
  • Do not cut, crush or chew Imbruvica tablets.
  • Take Imbruvica at about the same time each day.
Available strengths 4 strengths
140 mg 280 mg 420 mg 560 mg
15 FDA-listed product records ⓘ

Capsule

By mouth
Brands Imbruvica
How this form is used
What it may be used for
  • Imbruvica is used for CLL/SLL, WM, and cGVHD after failure of one or more systemic therapies.
Important instructions
  • Imbruvica capsules should be swallowed whole with a glass of water.
  • Do not open, break or chew Imbruvica capsules.
  • Take Imbruvica at about the same time each day.
Available strengths 2 strengths
70 mg 140 mg
10 FDA-listed product records ⓘ

Oral suspension

By mouth
Brands Imbruvica
How this form is used
What it may be used for
  • Imbruvica oral suspension is included in the dosing for children 1 to less than 12 years old with cGVHD, based on body surface area.
Important instructions
  • Follow the Instructions for Use for Imbruvica oral suspension.
  • The volume of Imbruvica oral suspension is based on body surface area for children with cGVHD.
Available strengths 1 strength
70 mg/mL
3 FDA-listed product records ⓘ

Ibrutinib on the U.S. market: products, makers and brands

How Ibrutinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 6 Ibrutinib product records with the FDA, mostly as tablet, capsule, oral suspension; the earliest marketing or approval year on record is 2013. Brand names on the directory include Imbruvica; the rest are generics.

3
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
6
FDA-listed product records ⓘ
2013
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (17) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

How widely Ibrutinib is used (Medicaid data)

A general measure of how commonly Ibrutinib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Ibrutinib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

2,698
Medicaid prescriptions filled (Q1–Q4 2025)
$47.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ibrutinib prescribed? Of the 1,601 medications we measure, Ibrutinib ranks #1,146 by Medicaid prescriptions — more than 28% of them.

Where Ibrutinib ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,146 of 1,601
#1,141 Betaine 2,821 Rx #1,142 Dihydroergotamine Nasa... 2,813 Rx #1,143 Oxymetazoline Topical 2,766 Rx #1,144 Dasiglucagon Injection 2,752 Rx #1,145 Ketorolac / Phenylephr... 2,724 Rx #1,146 Ibrutinib 2,698 Rx #1,147 Canagliflozin / Metfor... 2,694 Rx #1,148 Phenol 2,689 Rx #1,149 Dabrafenib 2,673 Rx #1,150 Prasterone Vaginal 2,624 Rx #1,151 Mifepristone (Mifeprex... 2,590 Rx

Utilization by Ibrutinib product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 420 mg oral tablet is the most-dispensed Ibrutinib product — about 79% of these Medicaid prescriptions.

ibrutinib 420 MG Oral Tablet Most dispensed

2,132 Medicaid prescriptions (Q1–Q4 2025) 79% of Ibrutinib prescriptions shown $37.4M gross reimbursement (before rebates) ≈ $17,531 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2000025

ibrutinib 280 MG Oral Tablet

298 Medicaid prescriptions (Q1–Q4 2025) 11% of Ibrutinib prescriptions shown $6M gross reimbursement (before rebates) ≈ $20,062 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2000021

ibrutinib 140 MG Oral Capsule

243 Medicaid prescriptions (Q1–Q4 2025) 9% of Ibrutinib prescriptions shown $3.8M gross reimbursement (before rebates) ≈ $15,460 per prescription (gross)

Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1442986

ibrutinib 140 MG Oral Tablet

25 Medicaid prescriptions (Q1–Q4 2025) <1% of Ibrutinib prescriptions shown $491,339 gross reimbursement (before rebates) ≈ $19,654 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2000017

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ibrutinib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 5 of 9 listed Ibrutinib NDCs with Medicaid activity.

Compare Ibrutinib products

A representative set of FDA-listed product records for Ibrutinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Capsule
70 mg Oral Pharmacyclics LLC NDA View NDC →
140 mg Oral Pharmacyclics LLC NDA View NDC →
💊Oral suspension
70 mg/mL Oral Pharmacyclics LLC NDA View NDC →
💊Tablet
140 mg Oral Pharmacyclics LLC NDA View NDC →
280 mg Oral Pharmacyclics LLC NDA View NDC →
420 mg Oral Pharmacyclics LLC NDA View NDC →

Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Ibrutinib NDCs →

Ibrutinib recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Ibrutinib recalls since July 2021.

✅No Ibrutinib recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Ibrutinib RxCUI 1442981 3 dose forms · 7 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 1442985 In current FDA listings
    Clinical drug / strength (SCD) 70 MG RxCUI 1994360 140 MG RxCUI 1442986
  2. Dose form (SCDF) Oral Suspension RxCUI 2611535 In current FDA listings
    Clinical drug / strength (SCD) 70 MG/ML RxCUI 2611536
  3. Dose form (SCDF) Oral Tablet RxCUI 2000016 In current FDA listings
    Clinical drug / strength (SCD) 140 MG RxCUI 2000017 280 MG RxCUI 2000021 420 MG RxCUI 2000025 560 MG RxCUI 2000029

Look up RxCUI 1442981 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Ibrutinib brand names

Ibrutinib is sold under one brand name in the FDA directory — Imbruvica. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Imbruvica

Who makes Ibrutinib: manufacturers and labelers

One company lists Ibrutinib products with the FDA. By number of product records, the largest are Pharmacyclics LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Pharmacyclics LLC 6

Ibrutinib drug class (RxNorm)

Ibrutinib belongs to the Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) Bruton's tyrosine kinase (BTK) inhibitors
How it works Protein Kinase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Ibrutinib page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 21, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ibrutinib.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Ibrutinib after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
6
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Pharmacyclics LLC
Linked label effective
Oct 21, 2025
Composite sections available
22
Linked SPL Set ID
0dfd0279-ff17-4ea9-89be-9803c71bab44
Linked SPL Document ID
43280dcb-52ae-40e4-bd52-723f71f74ab7
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Pharmacyclics LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →