Short answer: In the label's 5-year trial in newly diagnosed chronic phase CML, the most common Sprycel side effects were fluid retention (38% vs 45% on imatinib), pleural effusion, fluid around the lungs (28% vs 1%), diarrhea (22% vs 23%), and headache, rash and musculoskeletal pain (14% each). Severe low blood counts were common. There is no boxed warning; warnings include bleeding, heart and lung problems.
What Sprycel is approved for: Sprycel is a kinase inhibitor approved for adults with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase; adults with chronic, accelerated or blast phase Ph+ CML resistant to or intolerant of prior therapy including imatinib; adults with Ph+ acute lymphoblastic leukemia (ALL) resistant to or intolerant of prior therapy; and children 1 year and older with chronic phase Ph+ CML or, with chemotherapy, newly diagnosed Ph+ ALL (section 1).
Source
SPRYCEL (dasatinib) tablets, for oral use, prescribing information. Bristol-Myers Squibb (E.R. Squibb & Sons). DailyMed, version published September 21, 2026. DailyMed setid 4764f37b-c9e6-4ede-bcc2-8a03b7c521df
No. The current Sprycel label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Sprycel.
| Adverse reaction | SPRYCEL all grades (%) n=258 | Imatinib all grades (%) n=258 | SPRYCEL grade 3/4 (%) | Imatinib grade 3/4 (%) |
|---|---|---|---|---|
| Fluid retention | 38 | 45 | 5 | 1 |
| Pleural effusion | 28 | 1 | 3 | 0 |
| Superficial localized edema | 14 | 38 | 0 | <1 |
| Pulmonary hypertension | 5 | <1 | 1 | 0 |
| Generalized edema | 4 | 7 | 0 | 0 |
| Pericardial effusion | 4 | 1 | 1 | 0 |
| Congestive heart failure/cardiac dysfunction | 2 | 1 | <1 | <1 |
| Pulmonary edema | 1 | 0 | 0 | 0 |
| Diarrhea | 22 | 23 | 1 | 1 |
| Musculoskeletal pain | 14 | 17 | 0 | <1 |
| Rash | 14 | 18 | 0 | 2 |
| Headache | 14 | 11 | 0 | 0 |
| Abdominal pain | 11 | 8 | 0 | 1 |
| Fatigue | 11 | 12 | <1 | 0 |
| Nausea | 10 | 25 | 0 | 0 |
| Myalgia | 7 | 12 | 0 | 0 |
| Arthralgia | 7 | 10 | 0 | <1 |
| Hemorrhage | 8 | 8 | 1 | 1 |
| Gastrointestinal bleeding | 2 | 2 | 1 | 0 |
| Other bleeding | 6 | 6 | 0 | <1 |
| CNS bleeding | <1 | <1 | 0 | <1 |
| Vomiting | 5 | 12 | 0 | 0 |
| Muscle spasms | 5 | 21 | 0 | <1 |
Sprycel 100 mg once daily vs imatinib, another CML medicine (not placebo). Includes reactions of special interest under 10%. Percent of patients.
| Lab abnormality | SPRYCEL (%) n=258 | Imatinib (%) n=258 |
|---|---|---|
| Neutropenia | 29 | 24 |
| Thrombocytopenia | 22 | 14 |
| Anemia | 13 | 9 |
| Hypophosphatemia | 7 | 31 |
| Hypokalemia | 0 | 3 |
| Hypocalcemia | 4 | 3 |
| Elevated SGPT (ALT) | <1 | 2 |
| Elevated SGOT (AST) | <1 | 1 |
| Elevated Bilirubin | 1 | 0 |
| Elevated Creatinine | 1 | 1 |
Grade 3/4 means severe or life-threatening lab changes. Neutropenia is low infection-fighting white cells; thrombocytopenia is low platelets.
| Adverse reaction | All grades (%) | Grade 3/4 (%) |
|---|---|---|
| Fluid retention | 48 | 7 |
| Superficial localized edema | 22 | 0 |
| Pleural effusion | 28 | 5 |
| Generalized edema | 4 | 0 |
| Pericardial effusion | 3 | 1 |
| Pulmonary hypertension | 2 | 1 |
| Headache | 33 | 1 |
| Diarrhea | 28 | 2 |
| Fatigue | 26 | 4 |
| Dyspnea | 24 | 2 |
| Musculoskeletal pain | 22 | 2 |
| Nausea | 18 | 1 |
| Skin rash | 18 | 2 |
| Myalgia | 13 | 0 |
| Arthralgia | 13 | 1 |
| Infection (including bacterial, viral, fungal, and non-specified) | 13 | 1 |
| Abdominal pain | 12 | 1 |
| Hemorrhage | 12 | 1 |
| Gastrointestinal bleeding | 2 | 1 |
| Pruritus | 12 | 1 |
| Pain | 11 | 1 |
| Constipation | 10 | 1 |
Sprycel 100 mg once daily (n=165), no comparison group. Percent of patients.
| Adverse reaction | All grades (%) | Grade 3/4 (%) |
|---|---|---|
| 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 |
Children with chronic phase CML on Sprycel alone, median follow-up about 51.1 months.
Across 2712 adults, 88% had adverse reactions at some point and 19% had reactions that led to stopping. In the newly diagnosed trial, 16% stopped for adverse reactions over at least 60 months.
At 60 months there were 26 deaths on Sprycel (10.1%) and 26 on imatinib (10.1%); 1 in each group was judged related to treatment.
In advanced phase CML on 140 mg, hemorrhage was reported in 19% to 26% and gastrointestinal bleeding in 8% to 9%, depending on phase (Table 10). Grade 3/4 neutropenia reached 58% to 79% and thrombocytopenia 63% to 85% (Table 13).
In 81 children with newly diagnosed Ph+ ALL on Sprycel with chemotherapy, the most common reactions were mucositis (93%), febrile neutropenia (86%), fever (85%), diarrhea (84%) and nausea (84%) (Table 14). 3 (4%) died of infections.
After 5 years in the newly diagnosed trial: cardiac ischemic events 3.9% vs 1.6% on imatinib, heart-related fluid retention 8.5% vs 3.9%, and conduction problems (mostly arrhythmia and palpitations) 7.0% vs 5.0%.
In children with chronic phase CML treated for at least 2 years, bone growth and development effects were reported in 5 (5.2%), including delayed growth plate fusion, osteopenia, growth retardation and breast enlargement.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Low blood counts (myelosuppression). Severe low platelets, neutrophils and red cells can occur, earlier and more often in advanced phase CML or Ph+ ALL. In chronic phase CML, blood counts are checked every 2 weeks for 12 weeks, then every 3 months; in advanced disease, weekly for 2 months, then monthly.
Bleeding. Sprycel can cause serious and fatal bleeding. Grade 3/4 bleeding occurred in 5.8% of adults and fatal bleeding in 0.4%, most often in the gut. Medicines that affect platelets or blood thinners may raise the risk.
Fluid retention. Fluid can build up, sometimes severely, including around the lungs (pleural effusion). New or worse shortness of breath, chest pain on breathing or dry cough is checked with a chest x-ray.
Heart problems and pulmonary arterial hypertension. Sprycel can cause heart dysfunction. It may also cause high blood pressure in the lung arteries at any time, even after more than a year; if confirmed, Sprycel is stopped for good. It may reverse after stopping.
QT prolongation. Sprycel may prolong the QT interval, especially with low potassium or magnesium, congenital long QT, or other QT-prolonging medicines. Low potassium and magnesium are corrected before and during treatment.
Skin reactions and tumor lysis syndrome. Severe skin reactions including Stevens-Johnson syndrome have been reported. Tumor lysis syndrome has occurred, mainly in advanced disease, so hydration and uric acid are managed before starting.
Harm to an unborn baby. Sprycel can cause fetal harm. Females who can become pregnant, and males with such partners, use effective contraception during treatment and for 30 days after the last dose.
Growth in children and liver injury. Bone growth and development are monitored in children. Liver tests are checked before starting and monthly, or as needed.
From the Patient Information that comes with Sprycel:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.