What the label lists and what reports show
Ripretinib side effects
Ripretinib's FDA label: “The most common adverse reactions (≥20%) were alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia, and vomiting.” FAERS holds 5,217 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 (687 reports).
- No generic listed
Check it at the source: the ripretinib FDA label on DailyMed (effective May 12, 2025, Deciphera Pharmaceuticals, LLC); 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 QINLOCK?QINLOCK may cause serious side effects, including: A skin problem called palmar-plantar erythrodysesthesia syndrome. Skin problems are common and sometimes can be severe. Tell your healthcare provider right away if you develop redness, pain, blisters, bleeding, or swelling on the palms of your hands or soles of your feet, or severe rash during treatment with QINLOCK. New skin cancers. QINLOCK may cause skin cancers called cutaneous squamous cell carcinoma, keratoacanthoma, or melanoma. Talk to your healthcare provider about your risk for these cancers. Your healthcare provider should check your skin before and during treatment with QINLOCK to look for any new skin cancers. […]
Source: FDA drug label, Deciphera Pharmaceuticals, LLC, effective May 12, 2025 (SPL set 9f18e462-03dd-4296-a02a-a0577e3ee78d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥20%) were alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia, and vomiting.
Table 2: Adverse Reactions (≥10%) in Patients with Gastrointestinal Stromal Tumor Who Received QINLOCK in INVICTUS
| Reaction | Grades 1-4 | Grades 3-4 | Grades 1-4 | Grades 3-4 |
|---|---|---|---|---|
| Alopecia | 52 | 0 | 4.7 | 0 |
| Palmar-plantar erythrodysesthesia syndrome | 21 | 0 | 0 | 0 |
| Dry skin | 13 | 0 | 7 | 0 |
| Pruritus | 11 | 0 | 4.7 | 0 |
| Fatigue | 42 | 3.5 | 23 | 2.3 |
| Peripheral edema | 17 | 1.2 | 7 | 0 |
| Asthenia | 13 | 1.2 | 14 | 4.7 |
| Nausea | 39 | 3.5 | 12 | 0 |
| Abdominal pain | 36 | 7 | 30 | 4.7 |
| Constipation | 34 | 1.2 | 19 | 0 |
| Diarrhea | 28 | 1.2 | 14 | 2.3 |
| Vomiting | 21 | 3.5 | 7 | 0 |
| Stomatitis | 11 | 0 | 0 | 0 |
| Myalgia | 32 | 1.2 | 12 | 0 |
| Arthralgia | 18 | 0 | 4.7 | 0 |
| Muscle spasms | 15 | 0 | 4.7 | 0 |
| Decreased appetite | 27 | 1.2 | 21 | 2.3 |
| Decreased weight | 19 | 0 | 12 | 0 |
| Headache | 19 | 0 | 4.7 | 0 |
| Hypertension | 14 | 7 | 4.7 | 0 |
| Dyspnea | 13 | 0 | 0 | 0 |
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 elsewhere in the labeling: Palmar-Plantar Erythrodysesthesia Syndrome [see Warnings and Precautions ( 5.1 )] New Primary Cutaneous Malignancies [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Cardiac Dysfunction [see Warnings and Precautions ( 5.4 )] Photosensitivity [see Warnings and Precautions ( 5.6 )] The most common adverse reactions (≥20%) were alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia, and vomiting. The most common Grade 3 or 4 laboratory abnormalities (≥4%) were increased lipase and decreased phosphate. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Deciphera Pharmaceuticals, LLC, at 1-888-724-3274 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 observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, Deciphera Pharmaceuticals, LLC, effective May 12, 2025 (SPL set 9f18e462-03dd-4296-a02a-a0577e3ee78d), via openFDA; the full label on DailyMed
What do FAERS reports show?
5,217 reports list ripretinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 494 are coded as a death and 1,048 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. Reports rose sharply in 2025 (1,016, against a median of 303 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 17 reactions below, 11 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?
- Ripretinib: 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