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Sutent Side Effects

Common Sutent Side Effects


The most commonly reported Sutent side effects (click to view or check a box to report):

Death (1624)
Disease Progression (1336)
Diarrhoea (886)
Fatigue (809)
Nausea (616)
Asthenia (570)
Hypertension (522)
Vomiting (478)
Dyspnoea (397)
Dehydration (363)
Platelet Count Decreased (351)
Thrombocytopenia (343)
Renal Cell Carcinoma (342)
Decreased Appetite (338)
Palmar-plantar Erythrodysaesthesia Syndrome (315)
Anaemia (314)
Dysgeusia (310)
Pyrexia (305)
Blood Pressure Increased (269)
Stomatitis (266)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Sutent Side Effects Reported to FDA

The following Sutent reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Sutent on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Dizziness, Headache, Rash, Nausea
This is a report of a 53-year-old male patient (weight: NA) from US, suffering from the following symptoms/conditions: renal cancer, who was treated with Sutent (dosage: 50 Mg, 1x/day, start time: Feb 21, 2014), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Dizziness
  • Headache
  • Rash
  • Nausea
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sutent treatment in male patients, resulting in dizziness side effect.

Diarrhoea
This report suggests a potential Sutent Diarrhoea side effect(s) that can have serious consequences. A 60-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: renal cancer and used Sutent (dosage: 50 Mg, Daily) starting Apr 11, 2013. Soon after starting Sutent the patient began experiencing various side effects, including:
  • Diarrhoea
Drugs used concurrently:
  • Amlodipine (Unk)
  • Vitamin B12 (Unk)
  • Vitamin D (Unk)
  • Multivitamins
Although Sutent demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as diarrhoea, may still occur.

Dysgeusia, Fatigue
This Dysgeusia, Fatigue problem was reported by a health professional from US. A 66-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: renal cancer. On Feb 19, 2014 this consumer started treatment with Sutent (dosage: 50 Mg, Unk). The following drugs were being taken at the same time:
  • Benazepril-hydrochlorothiazide (Unk)
  • Hydrocodone-acetaminophen (Unk)
  • Docusate Sodium (Unk)
When commencing Sutent, the patient experienced the following unwanted symptoms/side effects:
  • Dysgeusia
  • Fatigue
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as dysgeusia, may become evident only after a product is in use by the general population.

Pain In Extremity, Local Swelling, Contusion
This is a report of a 65-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: renal cancer and was treated with Sutent (dosage: Unk, 1x/day) starting 201403. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Pain In Extremity
  • Local Swelling
  • Contusion
This opens a possibility that Sutent treatment could cause the above reactions, including pain in extremity, and some female subjects may be more susceptible.


Diarrhoea, Dysgeusia
A 70-year-old male patient (weight: NA) from US with the following symptoms/conditions: gastrointestinal carcinoma started Sutent treatment (dosage: Unk) on Feb 17, 2014. Soon after starting Sutent treatment, the subject experienced various side effects, including:
  • Diarrhoea
  • Dysgeusia
Concurrently used drugs:
  • Amlodipine Besylate (Unk)
  • Ciprofloxacin Hcl (Unk)
  • Doxazosin Mesilate (Unk)
This finding indicates that some male patients could be more vulnerable to Sutent.

Disease Progression, Thyroid Cancer, Off Label Use
A 66-year-old female patient from US (weight: NA) experienced symptoms, such as: thyroid cancer and was treated with Sutent(dosage: 50 Mg, Daily). The treatment was initiated on Feb 05, 2014. After that a consumer reported the following side effect(s):
  • Disease Progression
  • Thyroid Cancer
  • Off Label Use
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Sutent efficacy: NA.

Cardiopulmonary Failure, Disease Progression, Renal Cell Carcinoma
In this report, Sutent was administered for the following condition: renal cell carcinoma.A 50-year-old male consumer from CN (weight: NA) started Sutent treatment (dosage: Unk) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Cardiopulmonary Failure
  • Disease Progression
  • Renal Cell Carcinoma
A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Sutent treatment could be related to the listed above side effect(s).

Malaise, Deep Vein Thrombosis, Pulmonary Embolism
This is a report of the following Sutent side effect(s):
  • Malaise
  • Deep Vein Thrombosis
  • Pulmonary Embolism
A 61-year-old male patient from FR (weight: NA) presented with the following condition: NA and received a treatment with Sutent (dosage: 50 Mg, 1x/day) starting: Jan 27, 2014.The following concurrently used drugs could have generated interactions: NA.The patient was hospitalized.This report suggests that a Sutent treatment could be associated with the listed above side effect(s).

Fatigue, Nausea, Diarrhoea, Dehydration
This Sutent report was submitted by a 74-year-old female consumer from US (weight: NA). The patient was diagnosed with: renal cell carcinoma and Sutent was administered (dosage: 50 Mg Po Daily X4wk, Off 2wk, Repeat) starting: Jan 29, 2014. The consumer developed a set of symptoms:
  • Fatigue
  • Nausea
  • Diarrhoea
  • Dehydration
Other drugs used simultaneously: NA.The patient was hospitalized.Those unexpected symptoms could be linked to a Sutent treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Disease Progression, Renal Cell Carcinoma, Cardiopulmonary Failure
This is a report of a possible correlation between Sutent use and the following symptoms/side effect(s):
  • Disease Progression
  • Renal Cell Carcinoma
  • Cardiopulmonary Failure
which could contribute to an assessment of Sutent risk profile.A 46-year-old female consumer from CN (weight: NA) was suffering from renal cell carcinoma and was treated with Sutent (dosage: Unk) starting NS.Other concurrent medications: NA.


A 62-year-old male patient from AR (weight: NA) presented with the following symptoms: metastatic renal cell carcinoma and after a treatment with Sutent (dosage: 50 Mg, 4 Weeks On, 2 Weeks Off) experienced the following side effect(s):
    The treatment was started on Jan 28, 2014. Sutent was used in combination with the following drugs: NA.This report could alert potential Sutent consumers.


    In this report, a 78-year-old female patient from AR (weight: NA) was affected by a possible Sutent side effect.The patient was diagnosed with metastatic renal cell carcinoma. After a treatment with Sutent (dosage: Unk, start date: NS), the patient experienced the following side effect(s):
      The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Sutent treatment.


      This is a report of a 58-year-old male patient from US (weight: NA), who used Sutent (dosage: 50 Mg, Daily) for a treatment of renal cancer. After starting a treatment on Jul 22, 2013, the patient experienced the following side effect(s):
        The following drugs could possibly have interacted with the Sutent treatment NA.Taken together, these observations suggest that a Sutent treatment could be related to side effect(s), such as .

        Disease Progression, Renal Cancer
        This disease progression side effect was reported by a physician from US. A 56-year-old female patient (weight:NA) experienced the following symptoms/conditions: renal cancer. The patient was prescribed Sutent (dosage: 12.5 Mg, Unk), which was started on Nov 26, 2013. Concurrently used drugs: NA. When starting to take Sutent the consumer reported the following symptoms:
        • Disease Progression
        • Renal Cancer
        These side effects may potentially be related to Sutent.

        Fatigue
        This is a Sutent side effect report of a 74-year-old female patient (weight:NA) from US, suffering from the following symptoms/conditions: gastric cancer, who was treated with Sutent (dosage:25 Mg, 1x/day, start time: NS), combined with: NA., and developed a serious reaction and a fatigue side effect. The patient presented with:
        • Fatigue
        which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Sutent treatment in female patients suffering from gastric cancer, resulting in fatigue.

        Cough, Yellow Skin, Rash, Glossodynia
        This report suggests a potential Sutent cough side effect(s) that can have serious consequences. A 84-year-old female patient from US (weight:NA) was diagnosed with the following health condition(s): neoplasm malignant and used Sutent (dosage: 25 Mg, 1x/day) starting 201312. Soon after starting Sutent the patient began experiencing various side effects, including:
        • Cough
        • Yellow Skin
        • Rash
        • Glossodynia
        Drugs used concurrently:NA. Although Sutent demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as cough, may still occur.

        Blister, Rash, Off Label Use
        This blister problem was reported by a health professional from US. A 36-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): ovarian clear cell carcinoma.On 201312 a consumer started treatment with Sutent (dosage: 37 Mg, (1-25mg Capsule And 1-12.5 Mg)daily). The following drugs/medications were being taken at the same time: NA. When commencing Sutent, the patient experienced the following unwanted symptoms /side effects:
        • Blister
        • Rash
        • Off Label Use
        Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as blister, may become evident only after a product is in use by the general population.

        Renal Failure
        This is a Sutent side effect report of a 67-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: neuroendocrine tumour,carcinoid tumour and was treated with Sutent (dosage: 37.5 Mg, Unk) starting Jul 17, 2013. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
        • Renal Failure
        This opens a possibility that Sutent could cause renal failure and that some female patients may be more susceptible.

        Renal Failure Acute, Anuria, Nausea, Blood Creatinine Increased, Dehydration, Vomiting, Diarrhoea
        A 57-year-old male patient (weight: NA) from BG with the following symptoms: metastatic renal cell carcinoma started Sutent treatment (dosage: 50 Mg, 1x/day,four Weeks With Two Weeks Respite) on 201212. Soon after starting Sutent treatment, the consumer experienced several side effects, including:
        • Renal Failure Acute
        • Anuria
        • Nausea
        • Blood Creatinine Increased
        • Dehydration
        • Vomiting
        • Diarrhoea
        . Concurrently used drugs: NA. This finding indicates that some patients can be more vulnerable to developing Sutent side effects, such as renal failure acute.


        This death side effect was reported by a health professional from US. A 81-year-old male patient (weight:NA) experienced the following symptoms/conditions: renal cancer.The patient was prescribed Sutent (dosage: 50 Mg, Daily 4 Weeks On 2 Weeks Off), which was started on Jan 14, 2014. Concurrently used drugs: NA..When starting to take Sutent the consumer reported symptoms, such as:
          These side effects may potentially be related to Sutent.

          Cardiac Arrest, Asthenia, Mucosal Inflammation
          This is a report of a 62-year-old female patient (weight: NA) from PK, suffering from the following symptoms/conditions: NA, who was treated with Sutent (dosage: 25 Mg, Unk, 4 Tablets During The First Cycle, start time: 201308), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
          • Cardiac Arrest
          • Asthenia
          • Mucosal Inflammation
          which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sutent treatment in female patients, resulting in cardiac arrest side effect. The patient was hospitalized.

          Disease Progression, Malignant Neoplasm Of Islets Of Langerhans, Dry Skin
          This report suggests a potential Sutent Disease Progression, Malignant Neoplasm Of Islets Of Langerhans, Dry Skin side effect(s) that can have serious consequences. A 80-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: malignant neoplasm of islets of langerhans,gastrooesophageal reflux disease and used Sutent (dosage: 37.5 Mg, 1x/day) starting Jan 03, 2014. Soon after starting Sutent the patient began experiencing various side effects, including:
          • Disease Progression
          • Malignant Neoplasm Of Islets Of Langerhans
          • Dry Skin
          Drugs used concurrently:
          • Lansoprazole (40 Mg, 1x/day)
          Although Sutent demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as disease progression, may still occur.

          Myocardial Infarction, Disease Progression, Neoplasm Malignant
          This Myocardial Infarction, Disease Progression, Neoplasm Malignant problem was reported by a health professional from US. A 71-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: neoplasm malignant. On NS this consumer started treatment with Sutent (dosage: 12.5 Mg And 25 Mg, Daily). The following drugs were being taken at the same time: NA. When commencing Sutent, the patient experienced the following unwanted symptoms/side effects:
          • Myocardial Infarction
          • Disease Progression
          • Neoplasm Malignant
          Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as myocardial infarction, may become evident only after a product is in use by the general population.

          Rash, Diarrhoea, Disease Progression, Neoplasm Malignant
          This is a report of a 62-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: neoplasm malignant and was treated with Sutent (dosage: 50 Mg, Cyclic [4 Wks On, 2 Wks Off]) starting May 11, 2012. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
          • Rash
          • Diarrhoea
          • Disease Progression
          • Neoplasm Malignant
          This opens a possibility that Sutent treatment could cause the above reactions, including rash, and some male subjects may be more susceptible.

          Disease Progression, Neoplasm Malignant
          A 78-year-old female patient (weight: NA) from US with the following symptoms/conditions: neoplasm malignant started Sutent treatment (dosage: 25 Mg, Unk) on Aug 26, 2013. Soon after starting Sutent treatment, the subject experienced various side effects, including:
          • Disease Progression
          • Neoplasm Malignant
          Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Sutent.

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          Top 10 Sutent Side Effects for Women

          Women Side EffectsReports
          Death 486
          Disease Progression 435
          Diarrhoea 344
          Fatigue 312
          Nausea 279
          Asthenia 228
          Vomiting 207
          Hypertension 203
          Dehydration 175
          Thrombocytopenia 151

          Top 10 Sutent Side Effects for Men

          Men Side EffectsReports
          Death 1111
          Disease Progression 883
          Diarrhoea 527
          Fatigue 486
          Nausea 329
          Asthenia 326
          Hypertension 314
          Vomiting 265
          Dyspnoea 256
          Renal Cell Carcinoma 231

          Keep Track of Side Effects

          Note Your Observations

          It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

          Why Your Notes are Important

          Your notes could be helpful in several ways:

        • You can use them to remind you of details that may alert your health care professional(s) to a problem
        • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

        • Log Form

          You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

          Medicine Name and Dosage:
          Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
          Scale: 1 = very mild to 10 = very bad

          You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


          Discuss Sutent Side Effects

          Did You Have a Sutent Side Effect?

          Yes, Severe
          Yes, Moderate
          Yes, Minor
          No

          How Effective is Sutent for You?

          Exceeded Expectations
          Effective
          Somewhat Effective
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          Sutent Safety Alerts, Active Ingredients, Usage Information

          NDC0069-0550
          TypeHUMAN PRESCRIPTION DRUG
          Proprietary NameSUTENT
          NameSunitinib malate
          Dosage FormCAPSULE
          RouteORAL
          On market since20060126
          LabelerPfizer Laboratories Div Pfizer Inc
          Active Ingredient(s)SUNITINIB MALATE
          Strength(s)12.5
          Unit(s)mg/1
          Pharma ClassKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]

          Sutent Dosage, Warnings, Usage.

          Side Effects reported to FDA: 10619

          Sutent safety alerts: No

          Reported deaths: 3692

          Reported hospitalizations: 4457

          Latest Sutent clinical trials