What the label lists and what reports show
Dasatinib side effects
Dasatinib's FDA label: “Most common adverse reactions (≥15%) in patients receiving dasatinib as single-agent therapy included myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain.” FAERS holds 9,103 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 pleural effusion (1,186 reports).
- Generic listed
Check it at the source: the dasatinib FDA label on DailyMed (effective November 12, 2025, Alembic Pharmaceuticals Limited); 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 dasatinib tablets?Dasatinib tablets may cause serious side effects, including: • Low blood cell counts. Low blood cell counts are common with dasatinib tablets and can be severe, including low red blood cell counts (anemia), low white blood cell counts (neutropenia), and low platelet counts (thrombocytopenia). Your healthcare provider will do blood tests to check your blood cell counts regularly during your treatment with dasatinib tablets. Call your healthcare provider right away if you have a fever or any signs of an infection during treatment with dasatinib tablets. • Bleeding problems. Bleeding problems are common with dasatinib tablets. Sometimes these bleeding problems can be serious and lead to death. […]
Source: FDA drug label, Alembic Pharmaceuticals Limited, effective November 12, 2025 (SPL set 645fcf26-1b2f-40c5-881b-8effe02defbd), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥15%) in patients receiving dasatinib as single-agent therapy included myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | All Grades Adverse Reaction | Grade 3/4 Percent (%) of Patients |
|---|---|---|
| Headache | 28 | 3 |
| Nausea | 20 | 0 |
| Diarrhea | 21 | 0 |
| Skin rash | 19 | 0 |
| Vomiting | 13 | 0 |
| Pain in extremity | 19 | 1 |
| Abdominal pain | 16 | 0 |
| Fatigue | 10 | 0 |
| Arthralgia | 10 | 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 are discussed in greater detail in other sections of the labeling: • Myelosuppression [see Dosage and Administration (2.5) and Warnings and Precautions (5.1)]. • Bleeding-related events [see Warnings and Precautions (5.2)]. • Fluid retention [see Warnings and Precautions (5.3)]. • Cardiovascular toxicity [see Warnings and Precautions (5.4)]. • Pulmonary arterial hypertension [see Warnings and Precautions (5.5)]. • QT prolongation [see Warnings and Precautions (5.6)]. • Severe dermatologic reactions [see Warnings and Precautions (5.7)]. • Tumor lysis syndrome [see Warnings and Precautions (5.8)]. • Effects on growth and development in pediatric patients [see Warnings and Precautions (5.10)]. • Hepatotoxicity [see Warnings and Precautions (5.11)]. Most common adverse reactions (≥15%) in patients receiving dasatinib as single-agent therapy included myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain. (6) To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Alembic Pharmaceuticals Limited, effective November 12, 2025 (SPL set 645fcf26-1b2f-40c5-881b-8effe02defbd), via openFDA; the full label on DailyMed
What do FAERS reports show?
9,103 reports list dasatinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,338 are coded as a death and 2,784 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 21 reactions below, 16 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?
- Dasatinib: 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