What the label lists and what reports show
Midostaurin side effects
Midostaurin's FDA label: “The most common adverse reactions (≥ 20%) were febrile neutropenia, nausea, mucositis, vomiting, headache, petechiae, musculoskeletal pain, epistaxis, device-related infection, hyperglycemia, electrocardiogram (ECG) QT prolonged, and upper respiratory tract …” FAERS holds 1,943 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 nausea (166 reports).
- No generic listed
Check it at the source: the midostaurin FDA label on DailyMed (effective June 8, 2026, 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 RYDAPT?RYDAPT may cause serious side effects, including: Lung problems. RYDAPT may cause lung problems that may lead to death when used alone or in combination with other chemotherapy medicines. Get medical help right away if you have any new or worsening lung symptoms, including cough, chest discomfort, or shortness of breath. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective June 8, 2026 (SPL set 11fa3fc9-6776-49a6-b1c1-653f627c3e58), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 20%) were febrile neutropenia, nausea, mucositis, vomiting, headache, petechiae, musculoskeletal pain, epistaxis, device-related infection, hyperglycemia, electrocardiogram (ECG) QT prolonged, and upper respiratory tract infection.
Table 4: Adverse Reactions Reported in ≥ 10% of Patients with Advanced Systemic Mastocytosis (Study 2 and Study 3)
| Adverse Reaction a | All Grades % | Grade ≥ 3 % |
|---|---|---|
| Nausea | 82 | 6 |
| Vomiting | 68 | 6 |
| Diarrhea a | 54 | 8 |
| Abdominal pain a | 34 | 6 |
| Constipation | 29 | < 1 |
| Gastrointestinal hemorrhage a | 14 | 9 |
| Edema a | 40 | 7 |
| Fatigue a | 34 | 9 |
| Pyrexia | 27 | 4 |
| Upper respiratory tract infection a | 30 | 1 |
| Urinary tract infection a | 16 | 3 |
| Pneumonia a | 10 | 8 |
| Herpesvirus infection a | 10 | 1 |
| Musculoskeletal pain a | 35 | 4 |
| Arthralgia | 19 | 2 |
| Headache a | 26 | 1 |
| Dizziness | 13 | 0 |
| Dyspnea a | 23 | 7 |
| Cough a | 18 | < 1 |
| Pleural effusion | 13 | 4 |
| Epistaxis | 12 | 3 |
| Rash a | 14 | 3 |
| QT prolonged | 11 | < 1 |
| Insomnia | 11 | 0 |
| Renal insufficiency a | 11 | 5 |
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 serious adverse reactions are described elsewhere in the labeling: Pulmonary Toxicity [see Warnings and Precautions (5.2)] AML : The most common adverse reactions (≥ 20%) were febrile neutropenia, nausea, mucositis, vomiting, headache, petechiae, musculoskeletal pain, epistaxis, device-related infection, hyperglycemia, electrocardiogram (ECG) QT prolonged, and upper respiratory tract infection. ( 6.1 ) ASM, SM-AHN, or MCL : The most common adverse reactions (≥ 20%) were nausea, vomiting, diarrhea, edema, musculoskeletal pain, abdominal pain, fatigue, upper respiratory tract infection, constipation, pyrexia, headache, and dyspnea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 and/or at https://report.novartis.com/ 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, Novartis Pharmaceuticals Corporation, effective June 8, 2026 (SPL set 11fa3fc9-6776-49a6-b1c1-653f627c3e58), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,943 reports list midostaurin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 465 are coded as a death and 502 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, 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?
- Midostaurin: 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