Nilotinib is a kinase inhibitor sold in the U.S. under 2 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.
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…
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…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
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From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Nilotinib Capsules
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Cipla USA, Inc. · Feb 18, 2026
Nilotinib Capsules
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Cipla USA, Inc. · Feb 18, 2026
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.
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 )
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…
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| Capsule |
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