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Nilotinib

Nilotinib is a kinase inhibitor (a targeted cancer medicine) used to treat Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML), in newly diagnosed patients and in those whose earlier treatment stopped working or caused problems.

Brand names TasignaDanzitenCavhanza
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 11 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 6, 2026 🚨Recall on record
Nilotinib 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

Nilotinib is a targeted medicine for Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML), a blood cancer, that blocks BCR-ABL, the abnormal protein driving the cancer cells’ growth. It is one of the standard first choices and a common switch after imatinib, on the market since about 2007 and available generically. Most people tolerate it reasonably well, with rash, itching, headache and tiredness the side effects most often noticed. Its boxed warning covers QT prolongation (a heart rhythm change) and sudden deaths, so expect regular ECGs and potassium and magnesium checks, and get help right away for fainting or a racing, irregular heartbeat.

Clinical pearls

  • Capsules (including Tasigna) need an empty stomach, no food 2 hours before or 1 hour after; Danziten and Cavhanza do not.
  • The brands are not interchangeable milligram for milligram, so check that every refill is the exact product you were prescribed.
  • Proton pump inhibitors such as omeprazole lower nilotinib levels; an H2 blocker or antacid timed away from the dose is preferred.
  • Ketoconazole-type antifungals, heart rhythm drugs, some statins and grapefruit juice can clash with it, so clear new medicines and supplements first.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Nilotinib can cause a dangerous heart rhythm problem (QT prolongation) and sudden deaths have been reported. The boxed warning in the nilotinib capsule label says:

  • You need an ECG before starting, about 7 days after starting, periodically afterward, and after any dose change.
  • Potassium and magnesium levels must be checked and corrected.
  • It must not be given to people with low potassium, low magnesium, or long QT syndrome.
  • Avoid medicines that prolong the QT interval and strong CYP3A4 inhibitors.
  • For nilotinib capsules, avoid food for 2 hours before and 1 hour after the dose.

Fainting, a fast or irregular heartbeat, or seizures need urgent medical attention.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asCapsule, Tablet, Orally disintegrating tablet
Earliest FDA record2007
Companies listing it with the FDA10
FDA label last updatedAug 7, 2026
FDA’s strongest warning (boxed)Yes, read the warning

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

What Nilotinib is used for

▾

Nilotinib treats Ph+ CML, with uses that vary by product.

  • Newly diagnosed Ph+ CML in chronic phase: adults (Tasigna, nilotinib capsules, Danziten, Cavhanza) and children 1 year and older (Tasigna, nilotinib capsules).
  • Chronic or accelerated phase Ph+ CML in adults resistant or intolerant to prior therapy that included imatinib (Tasigna, nilotinib capsules, Danziten, Cavhanza).
  • Children 1 year and older resistant or intolerant to prior TKI therapy (Tasigna and nilotinib capsules).

How Nilotinib works

▾

Nilotinib blocks the BCR-ABL protein, an abnormal enzyme that fuels leukemia cell growth in Ph+ CML. It binds to the protein and holds it in its inactive shape. In lab tests it also overcame most imatinib-resistance changes tested (32 of 33).

Nilotinib dosage

▾

Nilotinib is taken by mouth twice daily, about 12 hours apart. Follow the dose your prescriber chose for your specific product.

  • Tasigna and nilotinib capsules: empty stomach, no food 2 hours before and 1 hour after. Swallow whole with water. Tasigna contents can go in applesauce if needed.
  • Danziten tablets and Cavhanza orally disintegrating tablets: with or without food.
  • Danziten tablets: swallow whole, do not cut, crush, or chew.
  • Nilotinib capsules missed dose: skip it and take the next dose on time. Never double up.

Dosing details from the FDA-approved label

From the Nilotinib 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 Ph+ CML-CP (Tasigna capsules)
    • 300 mg orally twice daily at approximately 12-hour intervals on an empty stomach
    • No food for at least 2 hours before the dose and at least 1 hour after the dose; reduce starting dose in patients with baseline hepatic impairment
  • Adult patients with resistant or intolerant Ph+ CML-CP and CML-AP (Tasigna capsules)
    • 400 mg orally twice daily at approximately 12-hour intervals on an empty stomach
    • No food for at least 2 hours before the dose and at least 1 hour after the dose; reduce starting dose in patients with baseline hepatic impairment
  • Pediatric patients with newly diagnosed Ph+ CML-CP or resistant or intolerant Ph+ CML-CP and CML-AP (Tasigna capsules)
    • 230 mg/m2 orally twice daily, rounded to the nearest 50 mg dose
    • Maximum: 400 mg single dose
    • Dose by body surface area per Table 1, e.g. up to 0.32 m2: 50 mg; 1.64 m2 or more: 400 mg; empty stomach
  • Adult patients with newly diagnosed Ph+ CML-CP (Danziten tablets)
    • 142 mg orally twice daily at approximately 12-hour intervals with or without food
    • Not substitutable milligram per milligram with other nilotinib products; reduce starting dose in baseline hepatic impairment
  • Adult patients with resistant or intolerant Ph+ CML-CP and CML-AP (Danziten tablets)
    • 190 mg orally twice daily at approximately 12-hour intervals with or without food
    • Not substitutable milligram per milligram with other nilotinib products; reduce starting dose in baseline hepatic impairment
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Recommended Adult Dose: Newly diagnosed Ph+ CML-CP: 300 mg orally twice daily. Resistant or intolerant Ph+ CML-CP and CML-AP: 400 mg orally twice daily. ( 2.1 ) Recommended Pediatric Dose: Newly Diagnosed Ph+ CML-CP or Ph+CML-CP resistant or intolerant to prior TKI therapy: 230 mg/m2 orally twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg). ( 2.1 ) See Dosage and Administration for full dosing instructions and dose- reduction instructions for toxicity. ( 2.1 ) Reduce starting dose in patients with baseline hepatic impairment. ( 2.7 ) Eligible newly diagnosed adult patients with Ph+ CML-CP who have received nilotinib for a minimum of 3 years and have achieved a sustained molecular response (MR4.5) and patients with Ph+ CML-CP resistant or intolerant to imatinib who have received nilotinib for at least 3 years and have achieved a sustained molecular response (MR4.5) may be considered for treatment discontinuation. ( 2.2 , 2.3 , 5.16 ) 2.1 Recommended Dosage Dose nilotinib capsules twice daily at approximately 12-hour intervals on an empty stomach. No food should be consumed for at least 2 hours before the dose is taken and for at least 1 hour after the dose is taken. Advise patients to swallow the capsules whole with water [see Boxed Warning, Clinical Pharmacology ( 12.3) ]. For patients who are unable to swallow capsules, the contents of each capsule may be dispersed in 1 teaspoon of applesauce (puréed apple). The mixture should be taken immediately (within 15 minutes) and should not be stored for future use [see Clinical Pharmacology ( 12.3 )]. Nilotinib capsules may be given in combination with hematopoietic growth factors, such as erythropoietin or G-CSF if clinically indicated. Nilotinib capsules may be given with hydroxyurea or anagrelide if clinically indicated. Dosage in Adult Patients with Newly Diagnosed Ph+ CML-CP The recommended dosage of nilotinib capsules is 300 mg orally twice daily. Dosage in Adult Patients with Resistant or Intolerant Ph+ CML-CP and CML-AP The recommended dosage of nilotinib capsules is 400 mg orally twice daily.

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

Nilotinib side effects

▾

Common side effects include:

Common side effects

  • Rash
  • Itching
  • Headache
  • Nausea
  • Tiredness
  • Constipation or diarrhea
  • Vomiting
  • Low blood counts (platelets, white cells, red cells)
  • Joint or muscle pain

When to get medical help

  • Fainting, seizure, a racing or irregular heartbeat, or dizziness: these can signal a dangerous heart rhythm problem (QT prolongation). Get help right away.
  • Chest pain, or signs of a stroke or poor blood flow to the legs: seek immediate medical attention.
  • Unusual bleeding or bruising, or black or bloody stools.
  • Severe stomach pain, which can signal pancreatitis (inflamed pancreas).
  • Rapid weight gain, swelling, or shortness of breath, which can signal fluid retention.
  • Fever, infection, or unusual tiredness, which may reflect low blood counts.
  • Yellowing of the skin or eyes, which can signal liver problems.

Nilotinib warnings and precautions

▾

Heart rhythm risk (QT prolongation) and sudden deaths are the biggest concerns. ECGs and electrolyte checks are required.

  • Low blood counts: checked often, especially early in treatment.
  • Heart and artery blockages, including stroke and poor leg circulation.
  • Pancreatitis and raised lipase.
  • Liver problems.
  • Electrolyte changes.
  • Tumor lysis syndrome (rapid cancer cell breakdown): stay hydrated.
  • Bleeding and fluid retention.
  • Slowed growth in children.
  • Harm to a fetus.

Nilotinib interactions

▾

Several drugs change nilotinib levels or add to heart rhythm risk.

  • Strong CYP3A4 inhibitors: raise levels and heart risk. Avoid, or lower the dose.
  • Strong CYP3A inducers: lower levels so it may work less well. Avoid.
  • QT-prolonging drugs such as anti-arrhythmics: add to heart rhythm risk. Avoid.
  • Proton pump inhibitors: lower levels. H2 blockers or antacids timed away from the dose are an alternative, per the nilotinib capsules label.
  • Grapefruit juice: modestly raised levels in a study.

Interactions listed in the FDA-approved label

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

  • Strong CYP3A inhibitors: Increased nilotinib concentrations compared to nilotinib alone, which may increase the risk of nilotinib toxicities. Avoid concomitant use with nilotinib capsules; if coadministration cannot be avoided, reduce the nilotinib capsules dose.
  • Strong CYP3A inducers: Decreased nilotinib concentrations compared to nilotinib alone, which may reduce nilotinib capsules efficacy. Avoid concomitant use with nilotinib capsules.
  • Proton pump inhibitors (PPIs): Decreased nilotinib concentrations compared to nilotinib alone, which may reduce nilotinib capsules efficacy. Avoid concomitant use; as an alternative use H2 blockers approximately 10 hours before or approximately 2 hours after the nilotinib capsules dose, or antacids approximately 2 hours before or approximately 2 hours after the dose.
  • Drugs that prolong the QT interval (e.g., anti-arrhythmic drugs): Agents that may prolong the QT interval, such as anti-arrhythmic drugs, are a concern with nilotinib capsules. Avoid coadministration with nilotinib capsules.
Read the label’s full interactions text

5.8 Tumor Lysis Syndrome Tumor lysis syndrome (TLS) cases have been reported in nilotinib treated patients with resistant or intolerant CML. Malignant disease progression, high white blood cell (WBC) counts and/or dehydration were present in the majority of these cases. Due to potential for TLS, maintain adequate hydration and correct uric acid levels prior to initiating therapy with nilotinib capsules.

7 DRUG INTERACTIONS Strong CYP3A Inhibitors: Avoid concomitant use with nilotinib capsules, or reduce nilotinib capsules dose if coadministration cannot be avoided. ( 7.1 ) Strong CYP3A Inducers: Avoid concomitant use with nilotinib capsules. ( 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 Nilotinib Capsules Strong CYP3A Inhibitors Concomitant use with a strong CYP3A inhibitor increased nilotinib concentrations compared to nilotinib alone [see Clinical Pharmacology (12.3)] , which may increase the risk of nilotinib toxicities. Avoid concomitant use of strong CYP3A inhibitors with nilotinib capsules. If patients must be coadministered a strong CYP3A4 inhibitor, reduce nilotinib capsules dose [see Dosage and Administration ( 2.8 )] . Strong CYP3A Inducers Concomitant use with a strong CYP3A inducer decreased nilotinib concentrations compared to nilotinib alone [see Clinical Pharmacology ( 12.3 )] , which may reduce nilotinib capsules efficacy. Avoid concomitant use of strong CYP3A inducers with nilotinib capsules. Proton Pump Inhibitors Concomitant use with a proton pump inhibitor (PPI) decreased nilotinib concentrations compared to nilotinib alone [see Clinical Pharmacology ( 12.3 )] , which may reduce nilotinib capsules efficacy. Avoid concomitant use of PPI with nilotinib capsules.

Excerpted — the section continues on the label. 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.

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

Before taking Nilotinib

▾
  • Not for people with low potassium, low magnesium, or long QT syndrome.
  • Use caution with heart disease.
  • Liver impairment: lower starting dose and closer ECG monitoring.
  • Previous pancreatitis or total gastrectomy: tell your doctor.
  • Pregnancy: can cause fetal harm. Use contraception during treatment and for 14 days after.
  • Do not breastfeed during treatment and for 14 days after the last dose.
  • Children: growth monitoring. Pediatric use is labeled only for Tasigna and nilotinib capsules.
  • Older adults: no major safety differences were seen.

Nilotinib overdose

▾

Overdose has been reported with nilotinib capsules taken together with alcohol and other drugs. Effects included low white cells (neutropenia), vomiting, and drowsiness. The label advises observation and supportive treatment, so get medical help right away.

What Nilotinib does in the body

▾

Nilotinib causes a concentration-dependent lengthening of the QT interval on an ECG. Higher drug exposure was linked both to a better chance of response and to more safety events, including bilirubin elevations.

How your body processes Nilotinib

▾

Peak levels occur about 3 hours after a dose, and steady state is reached by about day 8. Food raised exposure by 82% after a high-fat meal, which is why nilotinib capsules are taken on an empty stomach. The half-life is about 17 hours. It is broken down mainly by the liver enzyme CYP3A4 and leaves mostly in stool.

How to store Nilotinib

▾

stored at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) .

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

221

Supplements & herbs that interact with Nilotinib

221 supplements and herbal products have documented interactions with Nilotinib 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 · 11
  • Moderate · 176
  • Minor · 34
ACTIVATED CHARCOAL Major AMERICAN HELLEBORE Major ARSENIC Major BEER Major CESIUM Major EPHEDRA Major GRAPEFRUIT Major SIBERIAN COCKLEBUR Major +213 more
Every supplement checked against Nilotinib — ranked by severity The full interaction hub: 11 major · 176 moderate · 34 minor · every one linked to its full report. Check Nilotinib 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.

Nilotinib: pharmacist answers to common questions

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

What is nilotinib for?

▾
It treats Ph+ CML, a type of chronic myeloid leukemia. It is used in newly diagnosed patients and in those whose earlier treatment, such as imatinib, stopped working or caused problems. Some products are also labeled for children.

How should I take it?

▾
Take it by mouth twice a day, about 12 hours apart. Tasigna and nilotinib capsules must be taken with no food 2 hours before and 1 hour after. Danziten and Cavhanza can be taken with or without food. Follow your prescriber and label for your product.

Can I switch between nilotinib brands?

▾
Not on your own. Danziten and Cavhanza do not convert milligram for milligram with other nilotinib products, and a mix-up could mean too much or too little drug. Always check with your pharmacist that you received the product your prescriber intended.

What side effects should I expect?

▾
Rash, itching, headache, nausea, tiredness, and constipation or diarrhea are common. Regular blood tests will track your blood counts and liver and other labs. Call right away for fainting, a racing heartbeat, chest pain, bleeding, or severe stomach pain.

Are there medicines I should avoid?

▾
Yes. Tell me about everything you take. Strong CYP3A4 inhibitors, strong inducers, and QT-prolonging drugs should be avoided. Acid reducers called proton pump inhibitors can also lower nilotinib levels, so check with us first.

Is it safe in pregnancy?

▾
Nilotinib can harm a developing baby. If you could become pregnant, you will need a pregnancy test first and effective contraception during treatment and for 14 days after your last dose. Do not breastfeed during that time either.

Is Nilotinib available over the counter?

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

▾
The earliest FDA record we hold for Nilotinib is from 2007: 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 Nilotinib was first used.

Who makes Nilotinib?

▾
10 companies currently list Nilotinib products in the FDA's NDC Directory, including Apotex Corp., Cipla USA Inc., Dr. Reddy's Laboratories Inc. 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 Nilotinib on HelloPharmacist

📊Nilotinib supplement interactions221 checked — ranked by severity 🌿Drug & Supplement CheckerNilotinib vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Nilotinib NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Nilotinib 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.

Nilotinib forms and strengths (how it comes)

Nilotinib 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 Nilotinib inactive ingredients by manufacturer.

Capsule

By mouth
Brands Tasigna
How this form is used
What it may be used for
  • Tasigna is labeled for adults and children 1 year and older with newly diagnosed Ph+ CML in chronic phase.
  • Tasigna is also labeled for adults with chronic or accelerated phase Ph+ CML resistant or intolerant to imatinib-containing therapy, and for children 1 year and older resistant or intolerant to prior TKI therapy.
  • Nilotinib capsules are labeled for adults and children 1 year and older with newly diagnosed Ph+ CML in chronic phase.
Important instructions
  • Tasigna is taken twice daily about 12 hours apart on an empty stomach, with no food for 2 hours before and 1 hour after.
  • Tasigna capsules are swallowed whole with water. If swallowing is hard, the capsule contents can be mixed into 1 teaspoon of applesauce and taken within 15 minutes.
  • Nilotinib capsules are swallowed whole with water and should not be opened.
  • Nilotinib capsules: if a dose is missed, take the next dose at the regular time and do not take two doses together.
Available strengths 3 strengths
50 mg 150 mg 200 mg
32 FDA-listed product records ⓘ

Tablet

By mouth
Brands Danziten
How this form is used
What it may be used for
  • Danziten is labeled for adults with newly diagnosed Ph+ CML in chronic phase.
  • Danziten is labeled for adults with chronic or accelerated phase Ph+ CML resistant or intolerant to imatinib-containing therapy.
Important instructions
  • Danziten is taken twice daily about 12 hours apart, with or without food.
  • Danziten tablets are swallowed whole with water and not cut, crushed, or chewed.
  • Danziten may not be substitutable with other nilotinib products milligram for milligram. Use the dose prescribed for Danziten.
Available strengths 2 strengths
71 mg 95 mg
6 FDA-listed product records ⓘ

Orally disintegrating tablet

By mouth
Brands Cavhanza
How this form is used
What it may be used for
  • Cavhanza is labeled for adults with newly diagnosed Ph+ CML in chronic phase.
  • Cavhanza is labeled for adults with chronic or accelerated phase Ph+ CML resistant or intolerant to imatinib-containing therapy.
Important instructions
  • Cavhanza is taken twice daily about 12 hours apart, with or without food.
  • Cavhanza may not be substitutable with other nilotinib products milligram for milligram. Use the dose prescribed for Cavhanza.
Available strengths 2 strengths
60 mg 80 mg
4 FDA-listed product records ⓘ

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

How Nilotinib 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.

10 companies list 25 Nilotinib product records with the FDA, mostly as capsule, tablet, orally disintegrating tablet; the earliest marketing or approval year on record is 2007. Brand names on the directory include Tasigna, Danziten, Cavhanza; the rest are generics.

3
Dose forms ⓘ
10
Labelers (makers, repackagers, distributors)
4
Brand names
25
FDA-listed product records ⓘ
2007
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 (20) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Apotex Corp.12%
Cipla USA Inc.12%
Dr. Reddy's Laboratories Inc12%
Novadoz Pharmaceuticals LLC12%
Novartis Pharmaceuticals Corporation12%
AvKARE8%
Other makers32%

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

How widely Nilotinib is used (Medicaid data)

A general measure of how commonly Nilotinib 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 Nilotinib 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.

3,130
Medicaid prescriptions filled (Q1–Q4 2025)
$57.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Nilotinib prescribed? Of the 1,601 medications we measure, Nilotinib ranks #1,119 by Medicaid prescriptions — more than 30% of them.

Where Nilotinib ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,119 of 1,601
#1,114 Luspatercept-aamt Inje... 3,270 Rx #1,115 Asciminib 3,208 Rx #1,116 Povidone-Iodine 3,207 Rx #1,117 Anakinra 3,205 Rx #1,118 Efgartigimod alfa-fcab... 3,198 Rx #1,119 Nilotinib 3,130 Rx #1,120 Metformin / Pioglitazo... 3,108 Rx #1,121 Flurbiprofen 3,098 Rx #1,122 Clindamycin / Tretinoi... 3,090 Rx #1,123 Ziprasidone Injection 3,085 Rx #1,124 Pindolol 3,081 Rx

Utilization by Nilotinib 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 150 mg oral capsule is the most-dispensed Nilotinib product — about 77% of these Medicaid prescriptions.

nilotinib 150 MG Oral Capsule Most dispensed

2,399 Medicaid prescriptions (Q1–Q4 2025) 77% of Nilotinib prescriptions shown $44.1M gross reimbursement (before rebates) ≈ $18,401 per prescription (gross)

Summed across the 3 of 21 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 997653

nilotinib 200 MG Oral Capsule

716 Medicaid prescriptions (Q1–Q4 2025) 23% of Nilotinib prescriptions shown $12.9M gross reimbursement (before rebates) ≈ $18,005 per prescription (gross)

Summed across the 2 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 746606

nilotinib 71 MG Oral Tablet

15 Medicaid prescriptions (Q1–Q4 2025) <1% of Nilotinib prescriptions shown $270,535 gross reimbursement (before rebates) ≈ $18,036 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2698564

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 Nilotinib, 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 6 of 46 listed Nilotinib NDCs with Medicaid activity.

Compare Nilotinib products

A representative set of FDA-listed product records for Nilotinib — 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.)

Showing 25 of 25 products — FDA National Drug Code Directory. See every product, package size and price: browse all 25 Nilotinib NDCs →

Nilotinib side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Nilotinib — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Nilotinib are death, fatigue, rash; about 74% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

29,318
Reports mentioning it
74%
Reported as serious
12
Distinct effects shown
Most reported effects
Death
3,226
Fatigue
2,112
Rash
1,653
Nausea
1,545
Headache
1,490
Dyspnoea
1,391
Pain
1,344
Diarrhoea
1,215
Malaise
1,139
Pruritus
1,132
Age groups
Adult · 1,048Elderly · 722Neonate · 22Child · 16Adolescent · 11

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Nilotinib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Nilotinib FDA approval history

How Nilotinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Nilotinib was first approved by the FDA in 2007 (Brand: TASIGNA · Novartis); the first generic version was approved in 2024. It remains available in U.S. pharmacies today.

2007
Brand approved
Brand: TASIGNA · Novartis
2024
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Nilotinib 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 one Nilotinib recall since July 2021, covering 2 product listings. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class III Feb 18, 2026 · Cipla USA, Inc.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
  • Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individu… Lots: Lot #: 5GJ0223, Exp 04/30/2027 FDA record D-0382-2026 →
  • Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren,… Lots: Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027 FDA record D-0381-2026 →

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) Nilotinib RxCUI 662281 3 dose forms · 10 strengths
  1. Dose form (SCDF) Disintegrating Oral Tablet RxCUI 2747508 In current FDA listings
    Clinical drug / strength (SCD) 60 MG RxCUI 2747509 80 MG RxCUI 2747518
  3. Dose form (SCDF) Oral Tablet RxCUI 2698563 In current FDA listings
    Clinical drug / strength (SCD) 71 MG RxCUI 2698564 95 MG RxCUI 2698572

Look up RxCUI 662281 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.

Nilotinib brand names

Nilotinib is sold under 3 brand names in the FDA directory — Tasigna, Danziten, Cavhanza. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Tasigna Danziten Cavhanza

Who makes Nilotinib: manufacturers and labelers

10 companies list Nilotinib products with the FDA. By number of product records, the largest are Apotex Corp., Cipla USA Inc., Dr. Reddy's Laboratories Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Apotex Corp. 3 Cipla USA Inc. 3 Dr. Reddy's Laboratories Inc 3 Novadoz Pharmaceuticals LLC 3 Novartis Pharmaceuticals Corporation 3 AvKARE 2 Azurity Pharmaceuticals, Inc. 2 Camber Pharmaceuticals, Inc. 2 Cycle Pharmaceuticals Ltd 2 Torrent Pharmaceuticals Limited 2

Nilotinib drug class (RxNorm)

Nilotinib 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, Cytochrome P450 2D6 Inhibitors, P-Glycoprotein Inhibitors, Cytochrome P450 2C8 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 Nilotinib 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 Aug 7, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Nilotinib.
📈
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 Nilotinib after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
11
Finished products in the current FDA directory
25
Companies listing them (makers, repackagers, distributors)
10
FDA labeler codes behind them ⓘ
10
Linked representative label ⓘ
Cycle Pharmaceuticals Ltd
Linked label effective
Aug 7, 2026
Composite sections available
23
Linked SPL Set ID
98b197ea-bca4-427e-8737-97f70a3262bc
Linked SPL Document ID
8991c94b-a4c1-46f8-aafe-a106aba4f8cf
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. Cycle Pharmaceuticals Ltd 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 →