Two medicines, side by side
Bosutinib vs nilotinib
Bosutinib and nilotinib are both labeled for leukemia and lymphoma and myeloma. Drugs@FDA records approvals of bosutinib since 2012 and of nilotinib since 2007. How each works, in its label's words: Bosutinib, “Bosutinib inhibits the BCR-ABL kinase that promotes CML; it is also an inhibitor of Src-family kinases including Src, Lyn, and Hck.”; Nilotinib, “Nilotinib is an inhibitor of the BCR-ABL kinase.”
Check it at the source: the bosutinib FDA label on DailyMed (effective March 10, 2026); the nilotinib FDA label on DailyMed (effective December 16, 2025).
Highlights of the bosutinib record
Bosutinib (Bosulif) · label of March 10, 2026
Used for
From the label: indicationsBOSULIF is indicated for the treatment of: • Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies ( 14.1 , 14.2 , 14.3 )]. […]
On the market
- Earliest approval on file
- September 4, 2012
- Generic labelers
- 3 labelers
- Pharmacy cost
- Not in the survey
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
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 (Bosutinib label of March 10, 2026, Nilotinib label of December 16, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do bosutinib and nilotinib differ on the record?
How each works, in its label's words: Bosutinib, “Bosutinib inhibits the BCR-ABL kinase that promotes CML; it is also an inhibitor of Src-family kinases including Src, Lyn, and Hck.”; 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.
Generics: bosutinib since 2025; nilotinib since 2024 (Drugs@FDA).
| Bosutinib | Nilotinib | |
|---|---|---|
| Labeled for | Leukemia, lymphoma and myeloma | Leukemia, lymphoma and myeloma |
| Pharmacologic class | Kinase Inhibitor | Kinase Inhibitor |
| How it works (label) | Bosutinib is a TKI. Bosutinib inhibits the BCR-ABL kinase that promotes CML; it is also an inhibitor of Src-family kinases including Src, Lyn, and Hck. | 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) | n/a | 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) | September 4, 2012 | October 29, 2007 |
| First generic approved | May 23, 2025 | January 5, 2024 |
| Generic labelers (NDC) | 3 labelers | 6 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | n/a | n/a |
| 12-month price change | n/a | n/a |
| Boxed warning | No | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 0 | 2 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 8,931 | 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)
What next?
- Alternatives to bosutinib
- every medicine labeled for the same conditions