Two medicines, side by side
Imatinib vs nilotinib
Imatinib and nilotinib are both labeled for leukemia and lymphoma and myeloma. Drugs@FDA records approvals of imatinib since 2001 and of nilotinib since 2007. How each works, in its label's words: Imatinib, “Imatinib mesylate is a protein-tyrosine kinase inhibitor that inhibits the BCR-ABL tyrosine kinase, the constitutive abnormal tyrosine kinase created by the Philadelphia chromosome abnormality in CML.”; Nilotinib, “Nilotinib is an inhibitor of the BCR-ABL kinase.”
Check it at the source: the imatinib FDA label on DailyMed (effective September 8, 2026); the nilotinib FDA label on DailyMed (effective December 16, 2025).
Highlights of the imatinib record
Imatinib (Gleevec) · label of September 8, 2026
Used for
From the label: indicationsImatinib mesylate is a kinase inhibitor indicated for the treatment of: • Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase ( 1.1 ) • Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy ( 1.2 […]
On the market
- Earliest approval on file
- May 10, 2001
- Generic labelers
- 20 labelers
- Pharmacy cost
- $0.624 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 4
Highlights of the nilotinib record
Nilotinib (Tasigna) · label of December 16, 2025
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)].
Used for
From the label: indicationsTasigna 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. […]
On the market
- Earliest approval on file
- October 29, 2007
- Generic labelers
- 6 labelers
- Pharmacy cost
- Not in the survey
Supply and safety
- Shortage
- No current entry
- Recalls
- 2
Source: FDA drug labels via openFDA (Imatinib label of September 8, 2026, Nilotinib label of December 16, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do imatinib and nilotinib differ on the record?
How each works, in its label's words: Imatinib, “Imatinib mesylate is a protein-tyrosine kinase inhibitor that inhibits the BCR-ABL tyrosine kinase, the constitutive abnormal tyrosine kinase created by the Philadelphia chromosome abnormality in CML.”; Nilotinib, “Nilotinib is an inhibitor of the BCR-ABL kinase.”
Only the nilotinib label carries a boxed warning.
Both are in FDA's class kinase inhibitors.
Half-life, in each label's words: Imatinib, “Apparent oral clearance was similar to adult values (11.0 L/hr/m 2 in children vs 10.0 L/hr/m 2 in adults), as was the …”; Nilotinib, “Elimination The mean (CV%) apparent elimination half-life is estimated to be approximately 17 hours (69%) and the mean …”
Generics: imatinib since 2015; nilotinib since 2024 (Drugs@FDA).
| Imatinib | Nilotinib | |
|---|---|---|
| Labeled for | Leukemia, lymphoma and myeloma | Leukemia, lymphoma and myeloma |
| Pharmacologic class | Kinase Inhibitor | Kinase Inhibitor |
| How it works (label) | Imatinib mesylate is a protein-tyrosine kinase inhibitor that inhibits the BCR-ABL tyrosine kinase, the constitutive abnormal tyrosine kinase created by the Philadelphia chromosome abnormality in CML. | Nilotinib is an inhibitor of the BCR-ABL kinase. Nilotinib binds to and stabilizes the inactive conformation of the kinase domain of ABL protein. |
| Half-life (label) | Apparent oral clearance was similar to adult values (11.0 L/hr/m 2 in children vs 10.0 L/hr/m 2 in adults), as was the half-life (14.8 hours in children vs 17.1 hours in adults). | Elimination The mean (CV%) apparent elimination half-life is estimated to be approximately 17 hours (69%) and the mean (CV%) apparent clearance approximates 29 L/h (61%). |
| Earliest approval on file (Drugs@FDA) | May 10, 2001 | October 29, 2007 |
| First generic approved | December 3, 2015 | January 5, 2024 |
| Generic labelers (NDC) | 20 labelers | 6 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.624 per tablet (Imatinib mesylate 100 mg tablet) | n/a |
| 12-month price change | -32% | n/a |
| Boxed warning | No | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 4 | 2 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 41,417 | 29,318 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
Do their labels mention each other?
Imatinib label, warnings and precautionsIn a randomized trial in patients with newly diagnosed Ph+CML in chronic phase comparing imatinib mesylate and nilotinib, severe (Grade 3 or 4) fluid retention occurred in 2.5% of patients receiving imatinib mesylate and in 3.9% of patients receiving nilotinib 300 mg twice daily.
Imatinib label, warnings and precautionsIn a randomized trial in patients with newly diagnosed Ph+ CML in chronic phase comparing Gleevec and nilotinib, severe (Grade 3 or 4) fluid retention occurred in 2.5% of patients receiving Gleevec and in 3.9% of patients receiving nilotinib 300 mg twice daily.
Nilotinib label, warnings and precautionsIn 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.
Nilotinib label, warnings and precautionsIn a randomized trial in patients with newly diagnosed Ph+ CML in chronic phase comparing nilotinib and imatinib, Grade 3 or 4 hemorrhage occurred in 1.1% of patients in the nilotinib dosage equivalent to 120 mg of CAVHANZA twice daily arm, in 1.8% of patients in the nilotinib dosage equivalent to 160 mg of CAVHANZA twice daily arm, and 0.4% of patients in the imatinib arm.
Source: FDA drug labels via openFDA
What next?
- Alternatives to imatinib
- every medicine labeled for the same conditions