Nilotinib: uses, dosing, side effects & brands

Nilotinib is a kinase inhibitor sold in the U.S. under 3 brand and generic names, for accelerated phase myeloid leukemia, chronic-phase myeloid leukemia and gastrointestinal stromal tumors. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class: Kinase Inhibitor
Treats (across its forms): Accelerated Phase Myeloid Leukemia, Chronic-Phase Myeloid Leukemia and Gastrointestinal Stromal Tumors
Available as: Tablet · Capsule · Tablet, orally disintegrating
Sold as: 3 products — Danziten, Tasigna and Cavhanza
Prescription?: Prescription only
Generic available?: Not in our catalog
Boxed warning: Boxed warning

How Danziten is dosed

From the FDA label for Danziten (application NDA219293). Other nilotinib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

To avoid medication errors and overdosage or under dosage, note that DANZITEN may have different strengths and dosages than other nilotinib products and may not be substitutable with other nilotinib products on a milligram per milligram basis. ( 2.1 ) • Recommended Adult Dose: • Newly diagnosed Ph+ CML-CP: 142 mg orally twice daily. • Resistant or intolerant Ph+ CML-CP and CML-AP: 190 mg orally twice daily. ( 2.2 ) • See Dosage and Administration for full dosing instructions and dose- reduction instructions for toxicity. ( 2.4 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9 ) • Reduce starting dose in patients with baseline hepatic impairment. ( 2.8 ) • Eligible newly diagnosed adult patients with Ph+ CML-CP who have received DANZITEN 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 DANZITEN for at least 3 years and have achieved a sustained molecular response (MR4.5) may be considered for treatment discontinuation. ( 2.3 , 2.4 , 5.16 ) 2.1 Important Use and Administration Instructions • Nilotinib is available in different formulations, dosage forms, and strengths that are approved with different indications and recommended dosages. • DANZITEN may not be substitutable with other nilotinib products on a milligram per milligram basis; to avoid medication errors, including overdosage…

Everything below is the FDA label for Danziten (tablet). Nilotinib is also sold as capsule and tablet, orally disintegrating, and those are different medicines to take — follow the label for the one you were prescribed.

Danziten side effects

The following clinically significant adverse reactions can occur with DANZITEN and are discussed in greater detail in other sections of labeling: • Myelosuppression [ see Warnings and Precautions ( 5.2 ) ] • QT Prolongation [ see Boxed Warning, Warnings and Precautions ( 5.3 ) ] • Sudden Deaths [ see Boxed Warning, Warnings and Precautions ( 5.4 ) ] • Cardiac and Arterial Vascular Occlusive Events [ see Warnings and Precautions ( 5.5 ) ] • Pancreatitis and Elevated Serum Lipase [ see Warnings and Precautions ( 5.6 ) ] • Hepatotoxicity [ see Warnings and Precautions ( 5.7 ) ] • Electrolyte Abnormalities [ see Boxed Warning, Warnings and Precautions ( 5.8 ) ] • Hemorrhage [ see Warnings and Precautions ( 5.10 ) ] • Fluid Retention [ see Warnings and Precautions ( 5.13 ) ] The most commonly reported non-hematologic adverse reactions (≥ 20%) in adult patients are nausea, rash, headache, fatigue, pruritus, vomiting, diarrhea, cough, constipation, arthralgia, nasopharyngitis, pyrexia, and night sweats. Hematologic adverse drug reactions include myelosuppression: thrombocytopenia, neutropenia, and anemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc., at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates…

Who shouldn’t take Danziten

DANZITEN is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Boxed Warning and Warnings and Precautions ( 5.3 )]. DANZITEN is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome. ( 4 )

Danziten drug interactions

Strong CYP3A Inhibitors : Avoid concomitant use with DANZITEN or reduce DANZITEN dose if concomitant use cannot be avoided. ( 7.1 ) • Strong CYP3A Inducers : Avoid concomitant use with DANZITEN. ( 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 DANZITEN Strong CYP3A Inhibitors Avoid concomitant use of strong CYP3A inhibitors with DANZITEN. If concomitant use cannot be avoided, reduce DANZITEN dose [see Dosage and Administration ( 2.9 )] . Nilotinib is a CYP3A substrate [see Clinical Pharmacology ( 12.3 )]. Concomitant use with a strong CYP3A inhibitor increases nilotinib exposure [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of DANZITEN adverse reactions. Strong CYP3A Inducers Avoid concomitant use of strong CYP3A inducers with DANZITEN. Nilotinib is a CYP3A substrate [see Clinical Pharmacology ( 12.3 )] . Concomitant use with a strong CYP3A inducer decreases nilotinib exposure [see Clinical Pharmacology ( 12.3 )] , which may reduce DANZITEN efficacy. Proton Pump Inhibitors Avoid concomitant use of PPI with DANZITEN. As an alternative to PPIs, use H 2 blockers approximately 10 hours before or approximately 2 hours after the dose of DANZITEN, or use antacids approximately 2 hours before or approximately 2 hours after the dose of DANZITEN. Nilotinib displays pH-dependent aqueous solubility [see Description ( 11 )] . Concomitant use with a proton pump inhibitor (PPI) decreases nilotinib concentrations [see Clinical Pharmacology ( 12.3 )] , which may reduce DANZITEN efficacy. 7.2 Drugs that Prolong the QT Interval Avoid coadministration of DANZITEN with agents that may prolong the QT interval, such as anti-arrhythmic drugs [see Boxed Warning, Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.3 ), Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.2 )]. Nilotinib is associated with a clinically significant concentration-dependent QT prolongation [see Clinical Pharmacology ( 12.2 )].

Every nilotinib product we track (3)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Nilotinib products
#	Drug	Rating	Type	Form	Generic?	Pharmacy pays
1	Danziten Boxed warning	70/100	Prescription	Tablet	No data	—	View →
2	Tasigna Boxed warning	70/100	Prescription	Capsule	No data	—	View →
3	Cavhanza	Not yet rated	Prescription	Tablet	No data	—	View →

Nilotinib recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

Can you crush or split nilotinib?

At least one nilotinibproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.

What each nilotinib label says about crushing, splitting and chewing

How long nilotinib keeps

No nilotinib label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.

Does nilotinib expire? The in-use limits and storage rules from its labels

Nilotinib and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Although the amount of nilotinib in milk appears to be small and one breastfed infant apparently experienced no adverse effects during maternal use of nilotinib, no long-term data are available. Because nilotinib is 98% bound to plasma proteins, the amounts in milk are likely to be low. However, there is little published experience with nilotinib during breastfeeding, and an alternate drug may be preferred, especially while nursing a newborn or preterm infant. National Comprehensive Cancer Network guidelines recommend avoiding breastfeeding during nilotinib therapy and the manufacturer recommends withholding breastfeeding until 2 weeks following the last dose.

Full LactMed record for nilotinib: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised April 15, 2024. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about nilotinib

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 3,932 reports naming nilotinib, and the FDA flagged 93% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

drug intolerance408 reports
dyspnoea357 reports
diarrhoea352 reports
fatigue340 reports
drug resistance336 reports
nausea322 reports
headache298 reports
abdominal pain293 reports

Read these as a signal, not a rate. A report does not mean nilotinib caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 30, 2026.

Related calculators

How long it stays in your system →

Frequently asked questions

What is Danziten?

Danziten (Nilotinib Tartrate) is a kinase inhibitor used to treat Accelerated Phase Myeloid Leukemia, Chronic-Phase Myeloid Leukemia, Gastrointestinal Stromal Tumors.

What kind of drug is nilotinib?

The FDA classifies nilotinib as a kinase inhibitor. Kinase inhibitors block protein kinases, the enzymes that relay 'grow and divide' signals inside cells. By shutting down the overactive kinase signals that a tumor depends on, they help slow or stop cancer cells from multiplying. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take nilotinib with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run nilotinib against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is nilotinib sold under?

We track 3 nilotinib-containing products in the U.S.: Danziten, Tasigna and Cavhanza. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does nilotinib come in?

Across the brands we track, nilotinib is currently marketed as tablet, capsule and tablet, orally disintegrating, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic nilotinib?

We do not currently list a generic-labelled nilotinib product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Has nilotinib been recalled?

The FDA's Enforcement database lists 2 recall records whose product description mentions nilotinib. The most recent: Nilotinib Capsules (Feb 18, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

Cite this page

APA: pharmaranks. (2026, July 24). Nilotinib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/nilotinib
MLA: “Nilotinib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/nilotinib.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for nilotinib on DailyMed (NIH) ↗ — including its boxed warning in full.