Skip to the answer

Bosutinib

Bosutinib is a targeted cancer medicine used to treat Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) in adults and, for Bosulif, in children as young as 1 year old.

Brand name Bosulif
Drug classes Kinase Inhibitor
Rx Forms 2
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 5 clinical label sets 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
Bosutinib 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

Bosutinib (Bosulif) is a targeted oral medicine for Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), a blood cancer, that blocks BCR-ABL, the faulty protein behind it, and related Src-family kinases; on the market since about 2012 and available generically, it is one of several options used from diagnosis or after another drug fails. Most people manage it, though diarrhea is very common early on and usually eases; nausea and rash also show up. Your liver needs the closest watch in the first 3 months, so report yellow skin or eyes or dark urine and keep every scheduled check, which also covers blood counts, kidneys and heart.

Clinical pearls

  • Take every dose with food, since food significantly boosts how much bosutinib your body absorbs.
  • Avoid proton pump inhibitors like omeprazole; use an antacid or H2 blocker (such as famotidine) instead, more than 2 hours apart.
  • Before starting an antifungal, HIV medicine, rifampin or seizure medicine, have it checked, since several raise or lower bosutinib levels.
  • Bosutinib can seriously harm an unborn baby, so use reliable contraception and avoid breastfeeding until 2 weeks after the last dose.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet, Capsule
Earliest FDA record2012
Companies listing it with the FDA5
FDA label last updatedMar 10, 2026
FDA’s strongest warning (boxed)None on the label

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

What Bosutinib is used for

▾

Bosutinib is a targeted cancer treatment approved for Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) — a blood cancer driven by a specific genetic abnormality. The specific approvals vary by product:

  • Bosulif (tablet or capsule): approved for adults and children 1 year and older with chronic phase Ph+ CML, whether newly diagnosed or resistant/intolerant to prior therapy
  • Bosulif (tablet or capsule): approved for adults with accelerated phase or blast phase Ph+ CML that is resistant or intolerant to prior therapy
  • Bosutinib tablets (generic): approved for adults only with chronic phase Ph+ CML, newly diagnosed or resistant/intolerant to prior therapy
  • Bosutinib tablets (generic): approved for adults only with accelerated phase or blast phase Ph+ CML resistant or intolerant to prior therapy

How Bosutinib works

▾

Bosutinib is a tyrosine kinase inhibitor (TKI) — a type of targeted therapy that blocks specific proteins involved in cancer cell growth. In CML, a chromosomal abnormality creates a faulty protein called BCR-ABL kinase, which continuously signals blood cells to divide uncontrollably. Bosutinib binds to and blocks this protein, as well as related proteins in the Src kinase family (including Src, Lyn, and Hck), cutting off those growth signals.

Bosutinib can block 16 of 18 known imatinib-resistant forms of BCR-ABL, which is helpful for patients whose cancer has become resistant to earlier CML treatments. However, it does not block two specific mutations — T315I and V299L — so it may not work in patients whose cancer carries those changes.

Bosutinib dosage

▾

Bosutinib is taken by mouth once a day, with food. Taking it with food is important because food substantially increases how much medicine your body absorbs. Both the tablet and capsule forms of Bosulif are taken the same way under fed conditions. Bosulif capsules may be opened and mixed with applesauce or yogurt immediately before taking, if swallowing is difficult.

  • Always take at roughly the same time each day
  • Follow your prescriber's instructions exactly — do not adjust your own dose
  • If you need antacids, use short-acting antacids or H2 blockers rather than proton pump inhibitors (PPIs), and separate their use by more than 2 hours from your bosutinib dose

Dosing details from the FDA-approved label

From the Bosutinib 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.

  • Adult patients with newly-diagnosed chronic phase Ph+ CML
    • 400 mg orally once daily with food
    • Consider dose escalation by increments of 100 mg once daily to a maximum of 600 mg daily in adult patients who do not reach complete hematologic, cytogenetic, or molecular response and do not have Grade 3 or greater adverse reactions
  • Adult patients with chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy
    • 500 mg orally once daily with food
    • Consider dose escalation by increments of 100 mg once daily to a maximum of 600 mg daily in adult patients who do not reach complete hematologic, cytogenetic, or molecular response and do not have Grade 3 or greater adverse reactions
  • Pediatric patients with newly-diagnosed chronic phase Ph+ CML
    • 300 mg/m2 orally once daily with food
  • Pediatric patients with chronic phase Ph+ CML with resistance or intolerance to prior therapy
    • 400 mg/m2 orally once daily with food
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • Adult patients with newly-diagnosed chronic phase Ph+ CML: 400 mg orally once daily with food. ( 2.1 ) • Adult patients with chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy: 500 mg orally once daily with food. ( 2.1 ) • Pediatric patients with newly-diagnosed chronic phase Ph+ CML: 300 mg/m 2 orally once daily with food. ( 2.1 ) • Pediatric patients with chronic phase Ph+ CML with resistance or intolerance to prior therapy: 400 mg/m 2 orally once daily with food. ( 2.1 ) • Consider dose escalation by increments of 100 mg once daily to a maximum of 600 mg daily in adult patients who do not reach complete hematologic, cytogenetic, or molecular response and do not have Grade 3 or greater adverse reactions. ( 2.2 ) • Consider dose escalation by increments of 50 mg for those with a BSA <1.1 m 2 and 100 mg for those with a BSA ≥1.1 m 2 to a maximum of 600 mg daily in pediatric patients who do not reach sufficient response after 3 months. ( 2.2 ) • Adjust dosage for toxicity and organ impairment ( 2 ) 2.1 Recommended Dosage The recommended dosage is taken orally once daily with food. Swallow tablets whole. Do not cut, crush, break or chew tablets. Continue treatment with BOSULIF until disease progression or intolerance to therapy. Capsules may be swallowed whole. For patients who are unable to swallow a whole capsule(s), each capsule can be opened and the contents mixed with applesauce or yogurt. Mixing the capsule contents with applesauce or yogurt cannot be considered a substitute of a proper meal. If a dose is missed beyond 12 hours, the patient should skip the dose and take the usual prescribed dose on the following day. Dosage in Adult Patients with Newly-Diagnosed CP Ph+ CML The recommended dosage of BOSULIF is 400 mg orally once daily with food. Dosage in Adult Patients with CP, AP, or BP Ph+ CML with Resistance or Intolerance to Prior Therapy The recommended dosage of BOSULIF is 500 mg orally once daily with food.

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

Bosutinib side effects

▾

The most common side effects of bosutinib affect many patients and are important to know about going in:

Common side effects

  • Diarrhea (very common)
  • Nausea and vomiting
  • Abdominal (stomach) pain
  • Skin rash
  • Fatigue (tiredness)
  • Headache
  • Fever (pyrexia)
  • Decreased appetite
  • Constipation
  • Respiratory tract infections

When to get medical help

  • Signs of liver problems: yellowing of the skin or eyes, dark urine, severe nausea, or unusual fatigue — call your doctor right away
  • Signs of heart problems: chest pain, shortness of breath, swelling in the legs, or rapid or irregular heartbeat
  • Signs of fluid buildup: sudden or worsening swelling, difficulty breathing, or chest pain
  • Signs of low blood counts: unusual bruising or bleeding, signs of infection such as fever or chills
  • Signs of kidney problems: decreased urination, swelling, or unusual fatigue
  • Severe or persistent diarrhea — contact your care team if you cannot manage it with supportive measures

More serious reactions — including liver enzyme elevations, significant drops in blood counts, heart problems, fluid buildup, and kidney function decline — can occur and require prompt medical attention. Contact your doctor right away if you develop yellowing skin or eyes, chest pain, difficulty breathing, unusual bleeding or bruising, or signs of infection.

Bosutinib warnings and precautions

▾
  • Liver toxicity: Elevations in liver enzymes are common, especially in the first 3 months. Liver tests are done monthly for at least the first 3 months. Rare cases of serious drug-induced liver injury have been reported.
  • Low blood counts (myelosuppression): Bosutinib can lower platelets, red blood cells, and white blood cells, increasing risks of bleeding and infection. Blood counts are checked weekly during the first month, then monthly.
  • Heart problems: Cardiac failure and cardiac ischemia (reduced blood flow to the heart) have occurred, more often in patients with pre-existing heart conditions or risk factors such as diabetes, obesity, or high blood pressure.
  • Fluid retention: Fluid can build up around the lungs (pleural effusion), around the heart (pericardial effusion), or in the limbs (edema). Tell your doctor about any new or worsening swelling or breathing difficulty.
  • Kidney function decline: An on-treatment drop in kidney function (eGFR) has been observed; kidney function is monitored throughout treatment.
  • Embryo-fetal harm: Bosutinib can seriously harm an unborn baby. Reliable contraception must be used during treatment and for 2 weeks after the last dose. Do not breastfeed during this period either.

Bosutinib interactions

▾

Bosutinib's blood levels are significantly affected by other medicines — making some combinations potentially dangerous or ineffective:

  • Strong or moderate CYP3A inhibitors (e.g., ketoconazole, certain antifungals, some HIV medications): raise bosutinib levels sharply, increasing the risk of serious side effects — avoid combining
  • Strong CYP3A inducers (e.g., rifampin, certain seizure medications): lower bosutinib levels, potentially making it less effective — avoid combining
  • Proton pump inhibitors (PPIs) (e.g., omeprazole, esomeprazole for acid reflux): reduce how much bosutinib is absorbed; use short-acting antacids or H2 blockers as alternatives, taken more than 2 hours apart from bosutinib

Interactions listed in the FDA-approved label

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

  • Strong and Moderate CYP3A Inhibitors: Bosutinib is a CYP3A substrate; concomitant use increases bosutinib Cmax and AUC, which may increase the risk of toxicities. Avoid concomitant use with bosutinib tablets.
  • Strong CYP3A Inducers: Bosutinib is a CYP3A substrate; concomitant use decreases bosutinib Cmax and AUC, which may reduce bosutinib tablets efficacy. Avoid concomitant use with bosutinib tablets.
  • Proton Pump Inhibitors (PPI): Bosutinib displays pH dependent aqueous solubility; concomitant use with a PPI decreases bosutinib Cmax and AUC, which may reduce bosutinib tablets efficacy. As an alternative to PPIs, use short-acting antacids or H2 blockers and separate dosing by more than 2 hours from bosutinib tablets dosing.
Read the label’s full interactions text

7 DRUG INTERACTIONS • Strong and Moderate CYP3A Inhibitors: Avoid concomitant use with bosutinib tablets. ( 7.1 ) • Strong CYP3A Inducers: Avoid concomitant use with bosutinib tablets. ( 7.1 ) • Proton Pump Inhibitors: Use short-acting antacids or H2 blockers as an alternative to proton pump inhibitors. ( 7.1 ) 7.1 Effect of Other Drugs on Bosutinib Tablets Strong or Moderate CYP3A Inhibitors Avoid the concomitant use of strong or moderate CYP3A inhibitors with bosutinib tablets. Bosutinib is a CYP3A substrate. Concomitant use with a strong or moderate CYP3A inhibitor increases bosutinib C max and AUC [see Clinical Pharmacology (12.3)] which may increase the risk of toxicities. Strong CYP3A Inducers Avoid the concomitant use of strong CYP3A inducers with bosutinib tablets. Bosutinib is a CYP3A substrate. Concomitant use with a strong CYP3A inducer decreases bosutinib C max and AUC [see Clinical Pharmacology (12.3)] which may reduce bosutinib tablets efficacy. Proton Pump Inhibitors (PPI) As an alternative to PPIs, use short-acting antacids or H2 blockers and separate dosing by more than 2 hours from bosutinib tablets dosing. Bosutinib displays pH dependent aqueous solubility, Concomitant use with a PPI decreases bosutinib C max and AUC [see Clinical Pharmacology (12.3)] which may reduce bosutinib tablets efficacy.

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.

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

Before taking Bosutinib

▾
  • Allergy to bosutinib: Do not take bosutinib if you have ever had a serious allergic reaction (including anaphylaxis) to it — this is a contraindication
  • Liver disease: Bosutinib exposure is higher in people with liver impairment; dose adjustments may be needed and liver function must be monitored closely
  • Kidney disease: Bosutinib levels are higher with moderate or severe kidney impairment; dose adjustments and careful monitoring are required
  • Heart disease: Tell your doctor about any history of heart failure, coronary artery disease, diabetes, high blood pressure, or obesity — these increase the risk of cardiac side effects
  • Pregnancy: Bosutinib can cause fetal harm. A pregnancy test is recommended before starting. Use effective contraception during treatment and for 2 weeks after your last dose.
  • Breastfeeding: Do not breastfeed while taking bosutinib or for 2 weeks after your last dose — bosutinib passes into animal milk and may harm a nursing child
  • Children: Bosulif (brand) is approved for children 1 year and older for chronic phase Ph+ CML; generic bosutinib tablets are approved for adults only
  • Fertility: Based on animal studies, bosutinib may affect fertility in both men and women; discuss this with your doctor if it is a concern

Bosutinib overdose

▾

Experience with bosutinib overdose in clinical studies has been very limited, and no serious adverse events were reported in those cases. If you or someone else takes too much, seek medical attention right away. Treatment is supportive — your care team will monitor you and manage any symptoms that arise.

What Bosutinib does in the body

▾

In clinical studies, higher bosutinib blood levels were associated with a greater likelihood of responding to treatment — but also with a greater likelihood of experiencing side effects. The full time course of bosutinib's effects in the body has not been completely mapped out. At studied doses, bosutinib does not cause a clinically meaningful prolongation of the QT interval (an electrical measurement of the heart's rhythm), which is reassuring from a cardiac standpoint.

How your body processes Bosutinib

▾

After an oral dose taken with food, bosutinib is absorbed gradually, reaching peak blood levels around 6 hours in adults. Food meaningfully increases absorption — a high-fat meal raises peak levels roughly 1.6 to 1.8 times compared to fasting, which is why it must always be taken with food. The drug has a half-life of about 22.5 hours, meaning it takes roughly a day to clear half the dose from your body, which supports once-daily dosing. Bosutinib is broken down primarily by a liver enzyme called CYP3A4 and is excreted mainly in the feces (about 91%), with very little leaving through the urine.

How to store Bosutinib

▾

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) and Store and Dispense in Original Container.

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

172

Supplements & herbs that interact with Bosutinib

172 supplements and herbal products have documented interactions with Bosutinib 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 · 7
  • Moderate · 126
  • Minor · 39
ACTIVATED CHARCOAL Major ASARABACCA Major BEER Major GRAPEFRUIT Major SIBERIAN COCKLEBUR Major ST. JOHN'S WORT Major WINE Major ACACIA RIGIDULA Moderate +164 more
Every supplement checked against Bosutinib — ranked by severity The full interaction hub: 7 major · 126 moderate · 39 minor · every one linked to its full report. Check Bosutinib 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.

Bosutinib: pharmacist answers to common questions

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

What exactly is bosutinib treating in my body?

▾
You have a type of leukemia called Ph+ CML, which is driven by a faulty protein in your blood cells called BCR-ABL. Think of it like a stuck 'on' switch that keeps telling those cells to multiply. Bosutinib blocks that switch, along with some related proteins, to slow or stop the cancer from growing. It's a targeted therapy, meaning it goes after a specific molecular problem rather than attacking all rapidly dividing cells the way traditional chemotherapy does.

Do I have to take it with food every single time?

▾
Yes — this is actually pretty important. Food significantly increases how much of the medicine your body absorbs, so taking it on an empty stomach means you'd be getting much less than your prescribed dose. Make it a habit to take it with a meal at roughly the same time each day. If you're taking the Bosulif capsule and have trouble swallowing it, you can open it and mix it with applesauce or yogurt right before taking it — just make sure you do that as part of a meal.

Diarrhea seems really common — how bad is it, and what should I do?

▾
Diarrhea is genuinely the most common side effect, affecting the large majority of people who take bosutinib, and it tends to start within the first few days. The good news is that individual episodes are usually short — often just a couple of days. Your care team can recommend antidiarrheal medicines, fluids, and other supportive measures to manage it. If it becomes severe or you can't keep yourself hydrated, call your doctor, because your dose may need to be adjusted or briefly paused.

What warning signs should make me call my doctor right away?

▾
There are a few things you should never wait on. Call your doctor immediately if you notice yellowing of your skin or the whites of your eyes, very dark urine, or severe stomach pain — those can signal liver problems. Also seek prompt attention for chest pain or pressure, sudden shortness of breath, rapid swelling of your legs or feet, unusual bruising or bleeding, or signs of infection like fever with chills. These could point to serious heart, blood count, or fluid-retention issues that need quick attention.

Can I take my regular heartburn or antacid medicine while on bosutinib?

▾
It depends on which one. Proton pump inhibitors — PPIs like omeprazole or pantoprazole — are not a good combination with bosutinib because they reduce how much of the drug your body absorbs, which could make it less effective. Instead, ask your doctor or pharmacist about using a short-acting antacid or an H2 blocker (like famotidine), and take it more than 2 hours away from your bosutinib dose. Always run any new medicine — prescription or over-the-counter — by your care team first, because several drug classes can significantly raise or lower bosutinib levels.

Is it safe to get pregnant or try to conceive while taking this?

▾
Unfortunately, bosutinib is known to cause serious harm to a developing baby based on animal studies, so pregnancy must be avoided during treatment. If you could become pregnant, you'll need to use reliable contraception the entire time you're on bosutinib and for 2 weeks after your very last dose. Breastfeeding is also not recommended during treatment and for 2 weeks after. There's also some evidence from animal studies that the drug may affect fertility in both men and women, so if having children is something you're planning for, definitely have that conversation with your doctor before starting treatment.

Is Bosutinib available over the counter?

▾
No. Bosutinib is a prescription medicine: every Bosutinib 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 Bosutinib first available?

▾
The earliest FDA record we hold for Bosutinib is from 2012: 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 Bosutinib was first used.

Who makes Bosutinib?

▾
5 companies currently list Bosutinib products in the FDA's NDC Directory, including Pfizer Laboratories Div Pfizer Inc, Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

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

More about Bosutinib on HelloPharmacist

📊Bosutinib supplement interactions172 checked — ranked by severity 🌿Drug & Supplement CheckerBosutinib vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Bosutinib NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Bosutinib 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.

Bosutinib forms and strengths (how it comes)

Bosutinib is available in 2 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 Bosutinib inactive ingredients by manufacturer.

Tablet

By mouth
Brands Bosulif
How this form is used
What it may be used for
  • Bosulif tablets are used for adults and children 1 year and older with chronic phase Ph+ CML, newly diagnosed or resistant/intolerant to prior therapy
  • Bosulif tablets are used for adults with accelerated phase or blast phase Ph+ CML resistant or intolerant to prior therapy
  • Bosutinib tablets are approved for adult patients with chronic phase Ph+ CML, newly diagnosed or resistant/intolerant to prior therapy
  • Bosutinib tablets are approved for adult patients with accelerated phase or blast phase Ph+ CML resistant or intolerant to prior therapy
Important instructions
  • Bosulif tablets are taken by mouth once daily with food
  • Bosutinib tablets are taken by mouth once daily with food
  • Bosulif tablets: food significantly increases the amount of medicine absorbed — do not take on an empty stomach
  • Bosutinib tablets: avoid taking proton pump inhibitors (PPIs) at the same time; use short-acting antacids or H2 blockers separated by more than 2 hours if needed
Available strengths 3 strengths
100 mg 400 mg 500 mg
16 FDA-listed product records ⓘ

Capsule

By mouth
Brands Bosulif
How this form is used
What it may be used for
  • Bosulif capsules are used for adults and children 1 year and older with chronic phase Ph+ CML, newly diagnosed or resistant/intolerant to prior therapy
  • Bosulif capsules are used for adults with accelerated phase or blast phase Ph+ CML resistant or intolerant to prior therapy
Important instructions
  • Bosulif capsules are taken by mouth once daily with food
  • Bosulif capsules: food increases absorption — always take with a meal
  • Bosulif capsules may be opened and the contents mixed with applesauce or yogurt immediately before use if needed
Available strengths 2 strengths
50 mg 100 mg
4 FDA-listed product records ⓘ

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

How Bosutinib 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.

5 companies list 11 Bosutinib product records with the FDA, mostly as tablet, capsule; the earliest marketing or approval year on record is 2012. Brand names on the directory include Bosulif; the rest are generics.

2
Dose forms ⓘ
5
Labelers (makers, repackagers, distributors)
2
Brand names
11
FDA-listed product records ⓘ
2012
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 (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Pfizer Laboratories Div Pfizer Inc45%
Alembic Pharmaceuticals Inc.18%
Alembic Pharmaceuticals Limited18%
Dr. Reddy's Laboratories Inc.9%
U.S. Pharmaceuticals9%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Bosutinib is used (Medicaid data)

A general measure of how commonly Bosutinib 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 Bosutinib 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.

1,739
Medicaid prescriptions filled (Q1–Q4 2025)
$32.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Bosutinib prescribed? Of the 1,601 medications we measure, Bosutinib ranks #1,207 by Medicaid prescriptions — more than 25% of them.

Where Bosutinib ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,207 of 1,601
#1,202 Rotigotine Transdermal... 1,775 Rx #1,203 Ceftazidime and Avibac... 1,753 Rx #1,204 Hydrocodone 1,748 Rx #1,205 Palivizumab Injection 1,742 Rx #1,206 Obinutuzumab Injection 1,741 Rx #1,207 Bosutinib 1,739 Rx #1,208 Trifluridine and Tipir... 1,725 Rx #1,209 Pyrazinamide 1,725 Rx #1,210 Dextrose / Heparin 1,720 Rx #1,211 Eculizumab Injection 1,719 Rx #1,212 Oxacillin Injection 1,714 Rx

Utilization by Bosutinib 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 400 mg oral tablet is the most-dispensed Bosutinib product — about 56% of these Medicaid prescriptions.

bosutinib 400 MG Oral Tablet Most dispensed

978 Medicaid prescriptions (Q1–Q4 2025) 56% of Bosutinib prescriptions shown $20.2M gross reimbursement (before rebates) ≈ $20,624 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1987732

bosutinib 100 MG Oral Tablet

605 Medicaid prescriptions (Q1–Q4 2025) 35% of Bosutinib prescriptions shown $8.6M gross reimbursement (before rebates) ≈ $14,230 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1307624

bosutinib 500 MG Oral Tablet

156 Medicaid prescriptions (Q1–Q4 2025) 9% of Bosutinib prescriptions shown $3.3M gross reimbursement (before rebates) ≈ $21,167 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1307633

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 Bosutinib, 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 3 of 9 listed Bosutinib NDCs with Medicaid activity.

Compare Bosutinib products

A representative set of FDA-listed product records for Bosutinib — 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
50 mg Oral Pfizer Laboratories Div Pfizer Inc NDA View NDC →
100 mg Oral Pfizer Laboratories Div Pfizer Inc NDA View NDC →
💊Tablet
100 mg Oral Alembic Pharmaceuticals Inc. ANDA View NDC →
500 mg Oral Alembic Pharmaceuticals Inc. ANDA View NDC →
100 mg Oral Alembic Pharmaceuticals Limited ANDA View NDC →
500 mg Oral Alembic Pharmaceuticals Limited ANDA View NDC →
400 mg Oral Dr. Reddy's Laboratories Inc. ANDA View NDC →
100 mg Oral Pfizer Laboratories Div Pfizer Inc NDA View NDC →
400 mg Oral Pfizer Laboratories Div Pfizer Inc NDA View NDC →
500 mg Oral Pfizer Laboratories Div Pfizer Inc NDA View NDC →
400 mg Oral U.S. Pharmaceuticals NDA View NDC →

Showing 11 of 11 products — FDA National Drug Code Directory.

Bosutinib 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 Bosutinib recalls since July 2021.

✅No Bosutinib 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) Bosutinib RxCUI 1307619 2 dose forms · 5 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 2669662 In current FDA listings
    Clinical drug / strength (SCD) 50 MG RxCUI 2669665 100 MG RxCUI 2669663
  2. Dose form (SCDF) Oral Tablet RxCUI 1307623 In current FDA listings
    Clinical drug / strength (SCD) 100 MG RxCUI 1307624 400 MG RxCUI 1987732 500 MG RxCUI 1307633

Look up RxCUI 1307619 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.

Bosutinib brand names

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

Bosulif

Who makes Bosutinib: manufacturers and labelers

5 companies list Bosutinib products with the FDA. By number of product records, the largest are Pfizer Laboratories Div Pfizer Inc, Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Pfizer Laboratories Div Pfizer Inc 5 Alembic Pharmaceuticals Inc. 2 Alembic Pharmaceuticals Limited 2 Dr. Reddy's Laboratories Inc. 1 U.S. Pharmaceuticals 1

Bosutinib drug class (RxNorm)

Bosutinib belongs to the Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) BCR-ABL tyrosine kinase inhibitors
How it works Bcr-Abl Tyrosine 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 Bosutinib 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 Mar 10, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Bosutinib.
📈
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 Bosutinib after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
5
Finished products in the current FDA directory
11
Companies listing them (makers, repackagers, distributors)
5
FDA labeler codes behind them ⓘ
5
Linked representative label ⓘ
Pfizer Laboratories Div Pfizer Inc
Linked label effective
Mar 10, 2026
Composite sections available
24
Linked SPL Set ID
adc84ad5-a04d-4fee-9ba8-91f7abd928e3
Linked SPL Document ID
ca8600d9-46e6-402d-89f9-bc6a156bf751
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. Pfizer Laboratories Div Pfizer Inc 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 →