Prescription medicine
Nilotinib Brand names: Tasigna, Danziten, Cavhanza
Nilotinib (Tasigna) is a prescription medicine with an FDA approval on record since 2007. FDA's NDC Directory lists it from 6 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the nilotinib FDA label on DailyMed (effective December 16, 2025, Novartis Pharmaceuticals Corporation); the NDA 22068 record on Drugs@FDA; every nilotinib label on DailyMed.
Highlights of the record
FDA label of December 16, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
QT PROLONGATION and SUDDEN DEATHS Tasigna prolongs the QT interval. Prior to Tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies [see Warnings and Precautions (5.2)]. Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments [see Warnings and Precautions (5.2, 5.3, 5.7, 5.12)]. Sudden deaths have been reported in patients receiving Tasigna [see Warnings and Precautions (5.3)]. Do not administer Tasigna to patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Contraindications (4), Warnings and Precautions (5.2)]. Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors [see Drug Interactions (7.1, 7.2)]. Avoid food 2 hours before and 1 hour after taking the dose [see Dosage and Administration (2.1)]. WARNING: QT PROLONGATION and SUDDEN DEATHS See full prescribing information for complete boxed warning. Tasigna prolongs the QT interval. Prior to Tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies. ( 5.2 ) Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments. ( 5.2 , 5.3 , 5.7 , 5.12) Sudden deaths have been reported in patients receiving Tasigna. […]
Used for
From the label: indications and usageTasigna is a kinase inhibitor indicated for the treatment of: Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
Forms and strengths
- 50 mg
- 60 mg
- 71 mg
- 80 mg
- 95 mg
- 150 mg
- 200 mg
Capsule; tablet; orally disintegrating tablet.
On the market
- Earliest approval on file
- October 29, 2007 Tasigna, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first January 5, 2024; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 6 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- October 7, 2032 Tasigna capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2026 0 Class I among all firms' recalls; latest February 18, 2026
- FAERS reports
- 29,318 through July 30, 2026
What is nilotinib used for?
From the label: indications and usageTasigna is a kinase inhibitor indicated for the treatment of: Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1 ) Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. ( 1.2 ) Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. […]
Conditions named in the indications of nilotinib's FDA labels, with every medicine labeled for each:
From other nilotinib labelsLeukemia, lymphoma and myeloma: … phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant or intolerant to prior therapy that included imatinib.
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Tasigna), Novartis Pharmaceuticals Corporation, effective December 16, 2025 (SPL set 6093952a-5248-45cb-ad17-33716a411146), via openFDA; the full label on DailyMed
What does the patient leaflet for nilotinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Tasigna?Tasigna can cause a possible life-threatening heart problem called QTc prolongation. QTc prolongation causes an irregular heartbeat, which may lead to sudden death. Your healthcare provider should check the electrical activity of your heart with a test called an electrocardiogram (ECG): • before starting Tasigna • 7 days after starting Tasigna • with any dose changes • regularly during Tasigna treatment You may lower your chances for having QTc prolongation with Tasigna if you: Take Tasigna on an empty stomach: Avoid eating food for at least 2 hours before the dose is taken, and Avoid eating food for at least 1 hour after the dose is taken. Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract during treatment with Tasigna. Food and grapefruit products increase the amount of Tasigna in your body. Avoid taking other medicines or supplements with Tasigna that can also cause QTc prolongation. Tasigna can interact with many medicines and supplements and increase your chance for serious and life-threatening side effects. Do not take any other medicine during treatment with Tasigna unless your healthcare provider tells you it is okay to do so. If you cannot swallow Tasigna capsules whole, you may open the Tasigna capsule and sprinkle the contents of each capsule in 1 teaspoon of applesauce (puréed apple). Swallow the mixture right away (within 15 minutes). For more information, see “How should I take Tasigna?” Call your healthcare provider right away if you feel lightheaded, faint, or have an irregular heartbeat during treatment with Tasigna. These can be symptoms of QTc prolongation.
From the patient leaflet: How should I store Tasigna?Store Tasigna at room temperature between 68°F to 77°F (20°C to 25°C). Safely throw away medicine that is out of date or no longer needed. Keep Tasigna and all medicines out of the reach of children.
Source: FDA drug label (Tasigna), Novartis Pharmaceuticals Corporation, effective December 16, 2025 (SPL set 6093952a-5248-45cb-ad17-33716a411146), via openFDA; the full label on DailyMed
Is there a generic for nilotinib (Tasigna)?
The FDA approved the first generic nilotinib on January 5, 2024. 6 generic applications are approved; 6 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists nilotinib from 6 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 6 patents for Tasigna capsules: the compound patent runs to April 7, 2032 (pediatric exclusivity to October 7, 2032); a patent listed only for Cavhanza tablets runs to April 30, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2007 earliest approval on file
- 2024 first generic approved
- 2032 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has nilotinib been recalled?
The FDA's Enforcement Report lists 2 recalls naming nilotinib since 2026: 0 Class I (the most serious), 0 Class II, 2 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 18, 2026 | Class III | 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 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the nilotinib label say about other medicines?
The nilotinib label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 26 other medicines name nilotinib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Imatinib | warnings and precautions | In a randomized trial in patients with newly diagnosed Ph+ CML in chronic phase comparing Tasigna and imatinib, Grade 3 or 4 hemorrhage occurred in 1.1% of patients in the Tasigna 300 mg twice daily arm, in 1.8% of patients in the Tasigna 400 mg twice daily arm, and 0.4% of patients in the imatinib arm. |
Other labels that name nilotinib
Source: FDA drug label (Tasigna), Novartis Pharmaceuticals Corporation, effective December 16, 2025 (SPL set 6093952a-5248-45cb-ad17-33716a411146), via openFDA; the full label on DailyMed
What do FAERS reports show for nilotinib?
The FDA Adverse Event Reporting System holds 29,318 reports that list nilotinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,616 are coded as a death and 6,425 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as nilotinib?
37 other medicines are given the same way (oral) and in the same FDA class as nilotinib or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Bosutinib | Leukemia, lymphoma and myeloma | 3 labelers | n/a | No current entry |
| Ibrutinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Ponatinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Acalabrutinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Pirtobrutinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Quizartinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does nilotinib compare with medicines for the same use?
3 side-by-side pages set nilotinib beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to nilotinib
- 37 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Nilotinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other