What the label lists and what reports show
Sunitinib side effects
Sunitinib's FDA label: “The most common adverse reactions (≥25%) are fatigue/asthenia, diarrhea, mucositis/stomatitis, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia/altered taste, dyspepsia, and …” FAERS holds 39,092 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 diarrhoea (4,417 reports).
- Generic listed
- Boxed warning
Check it at the source: the sunitinib FDA label on DailyMed (effective February 20, 2026, Pfizer Laboratories Div Pfizer Inc); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of SUTENT?SUTENT may cause serious side effects, including: • See “ What is the most important information I should know about SUTENT? ” • Heart problems. Heart problems may include heart failure, heart attack and heart muscle problems (cardiomyopathy) that can lead to death. Tell your healthcare provider if you feel very tired, are short of breath, or have swollen feet and ankles. • Abnormal heart rhythm changes. Changes in the electrical activity of your heart called QT prolongation can cause irregular heart beats that can be life threatening. Your healthcare provider may do electrocardiograms and blood tests (electrolytes) to watch for these problems during your treatment with SUTENT. […]
Source: FDA drug label, NDA021938 (Cppi Cv), as published by Pfizer Laboratories Div Pfizer Inc, effective February 20, 2026 (SPL set 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥25%) are fatigue/asthenia, diarrhea, mucositis/stomatitis, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia/altered taste, dyspepsia, and thrombocytopenia.
Table 5. Adverse Reactions Reported in ≥10% of Patients With RCC Who Received SUTENT or Interferon Alfa Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. in Study 3
| Reaction | All Grades % | Grade 3–4 Grade 4 ARs in patients on SUTENT included back pain (1%), arthralgia (<1%),… | All Grades % | Grade 3–4 Grade 4 ARs in patients on interferon alfa included dyspnea (1%), fatigue (1%),… |
|---|---|---|---|---|
| Any Adverse Reaction | 99 | 77 | 99 | 55 |
| Diarrhea | 66 | 10 | 21 | <1 |
| Nausea | 58 | 6 | 41 | 2 |
| Mucositis/stomatitis | 47 | 3 | 5 | <1 |
| Vomiting | 39 | 5 | 17 | 1 |
| Dyspepsia | 34 | 2 | 4 | 0 |
| Abdominal pain Includes flank pain. | 30 | 5 | 12 | 1 |
| Constipation | 23 | 1 | 14 | <1 |
| Dry mouth | 13 | 0 | 7 | <1 |
| Oral pain | 14 | <1 | 1 | 0 |
| Flatulence | 14 | 0 | 2 | 0 |
| GERD/reflux esophagitis | 12 | <1 | 1 | 0 |
| Glossodynia | 11 | 0 | 1 | 0 |
| Hemorrhoids | 10 | 0 | 2 | 0 |
| Fatigue | 62 | 15 | 56 | 15 |
| Asthenia | 26 | 11 | 22 | 6 |
| Fever | 22 | 1 | 37 | <1 |
| Weight decreased | 16 | <1 | 17 | 1 |
| Chills | 14 | 1 | 31 | 0 |
| Chest Pain | 13 | 2 | 7 | 1 |
| Influenza like illness | 5 | 0 | 15 | <1 |
| Anorexia Includes decreased appetite. | 48 | 3 | 42 | 2 |
| Altered taste Includes ageusia, hypogeusia, and dysgeusia. | 47 | <1 | 15 | 0 |
| Headache | 23 | 1 | 19 | 0 |
| Dizziness | 11 | <1 | 14 | 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 described elsewhere in the labeling. • Hepatotoxicity [see Warnings and Precautions (5.1) ] • Cardiovascular Events [see Warnings and Precautions (5.2) ] • QT Interval Prolongation and Torsade de Pointes [see Warnings and Precautions (5.3) ] • Hypertension [see Warnings and Precautions (5.4) ] • Hemorrhagic Events [see Warnings and Precautions (5.5) ] • Tumor Lysis Syndrome [see Warnings and Precautions (5.6) ] • Thrombotic Microangiopathy [see Warnings and Precautions (5.7) ] • Proteinuria [see Warnings and Precautions (5.8) ] • Dermatologic Toxicities [see Warnings and Precautions (5.9) ] • Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions (5.10) ] • Thyroid Dysfunction [see Warnings and Precautions (5.11) ] • Hypoglycemia [see Warnings and Precautions (5.12) ] • Osteonecrosis of the Jaw [see Warnings and Precautions (5.13) ] • Impaired Wound Healing [see Warnings and Precautions (5.14) ] • The most common adverse reactions (≥25%) are fatigue/asthenia, diarrhea, mucositis/stomatitis, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia/altered taste, dyspepsia, and thrombocytopenia.
Source: FDA drug label, NDA021938 (Cppi Cv), as published by Pfizer Laboratories Div Pfizer Inc, effective February 20, 2026 (SPL set 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c), via openFDA; the full label on DailyMed
What do FAERS reports show?
39,092 reports list sunitinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 11,666 are coded as a death and 11,523 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, 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?
- Sunitinib: 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