What the label lists and what reports show
Nilotinib side effects
Nilotinib's FDA label: “The most commonly reported non-hematologic adverse reactions (≥ 20%) in adult and pediatric patients were nausea, rash, headache, fatigue, pruritus, vomiting, diarrhea, cough, constipation, arthralgia, nasopharyngitis, pyrexia, and night sweats.” FAERS holds 29,318 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (2,112 reports).
- Generic listed
- Boxed warning
Check it at the source: the nilotinib FDA label on DailyMed (effective December 16, 2025, Novartis Pharmaceuticals Corporation); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Tasigna?Tasigna may cause serious side effects, including: See “What is the most important information I should know about Tasigna?” Low blood cell counts. Low blood cell counts (red blood cells, white blood cells, and platelets) are common with Tasigna, but can also be severe. Your healthcare provider will check your blood counts regularly during treatment with Tasigna. Call your healthcare provider or get medical help right away if you develop any signs or symptoms of low blood counts, including: fever chills or other signs of infection unexplained bleeding or bruising unexplained weakness shortness of breath Decreased blood flow to the leg, heart, or brain. People who have recently been diagnosed with Ph+ CML and take Tasigna may develop decreased blood flow to the leg, the heart, or brain. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective December 16, 2025 (SPL set 6093952a-5248-45cb-ad17-33716a411146), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most commonly reported non-hematologic adverse reactions (≥ 20%) in adult and pediatric patients were nausea, rash, headache, fatigue, pruritus, vomiting, diarrhea, cough, constipation, arthralgia, nasopharyngitis, pyrexia, and night sweats.
Table 7: Most Frequently Reported Non-Hematologic Adverse Reactions (Regardless of Relationship to Study Drug) in Adult Patients With Newly Diagnosed Ph+ CML-CP (greater than or equal to 10% in Tasigna 300 mg twice…
| Reaction | Tasigna 300 mg twice daily N = 279 | imatinib 400 mg once daily N = 280 | Tasigna 300 mg twice daily N = 279 | imatinib 400 mg once daily N = 280 |
|---|---|---|---|---|
| Rash | 38 | 19 | < 1 | 2 |
| Nausea | 22 | 41 | 2 | 2 |
| Headache | 32 | 23 | 3 | < 1 |
| Fatigue | 23 | 20 | 1 | 1 |
| Myalgia | 19 | 19 | < 1 | < 1 |
| Cough | 17 | 13 | 0 | 0 |
| Nasopharyngitis | 27 | 21 | 0 | 0 |
| Eyelid edema | 1 | 19 | 0 | < 1 |
| Insomnia | 11 | 9 | 0 | 0 |
| Hypertension | 10 | 4 | 1 | < 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions can occur with Tasigna and are discussed in greater detail in other sections of labeling: Myelosuppression [see Warnings and Precautions (5.1)] QT Prolongation [see Boxed Warning, Warnings and Precautions (5.2)] Sudden Deaths [see Boxed Warning, Warnings and Precautions (5.3)] Cardiac and Arterial Vascular Occlusive Events [see Warnings and Precautions (5.4)] Pancreatitis and Elevated Serum Lipase [see Warnings and Precautions (5.5)] Hepatotoxicity [see Warnings and Precautions (5.6)] Electrolyte Abnormalities [see Boxed Warning, Warnings and Precautions (5.7)] Hemorrhage [see Warnings and Precautions (5.9)] Fluid Retention [see Warnings and Precautions (5.13)] The most commonly reported non-hematologic adverse reactions (≥ 20%) in adult and pediatric patients were 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 Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, 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?
29,318 reports list nilotinib among the medicines taken, 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. Of the 23 reactions below, 20 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Nilotinib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions