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Sutent Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 7432 

Optic Neuropathy, Macular Oedema (8462394-X)
on Jun 15, 2012 Male from JAPAN , 78 years of age, weighting 97.00 lb, was diagnosed with
  • gastrointestinal stromal tumour
and was treated with Sutent. Directly after, patient experienced the unwanted or unexpected Sutent side effects: optic neuropathy, macular oedema. Sutent dosage: Unk.

Oral Pain, Oedema Peripheral, Abdominal Pain Upper, Dysstasia, Nausea, Asthenia, Fatigue, Oral Mucosal Blistering, Diarrhoea (8462373-2)
Patient was taking Sutent. Patient felt the following Sutent side effects: oral pain, oedema peripheral, abdominal pain upper, dysstasia, nausea, asthenia, fatigue, oral mucosal blistering, diarrhoea on Jun 18, 2012 from BRAZIL Additional patient health information: Female , 65 years of age, weighting 116.8 lb, was diagnosed with
  • renal cell carcinoma
and. Sutent dosage: 50 Mg, Cyclic (4 By 2), Once Daily.
Multiple prescriptions taken:
  • Morphine
  • Fludrocortisone (5 Mg Daily)
  • Levothyroxine Sodium (75 Mg, 1x/day (in The Morning, Fasting))


(8462318-5)
Adverse event was reported on Jun 20, 2012 by a Male taking Sutent (Dosage: 25 Mg, 1x/day (qd)) was diagnosed with
  • renal cell carcinoma
and. Location: TAIWAN, PROVINCE OF CHINA , 72 years of age, .

Gastrointestinal Stromal Tumour, Disease Progression, Ascites (8462074-0)
on Jun 21, 2012 Male from CHINA , 45 years of age, was diagnosed with
  • gastrointestinal stromal tumour
and was treated with Sutent. Directly after, patient experienced the unwanted or unexpected Sutent side effects: gastrointestinal stromal tumour, disease progression, ascites. Sutent dosage: Unk.


Renal Cell Carcinoma, Disease Progression, Ascites, Multi-organ Failure (8462052-1)
on Jun 21, 2012 Male from CHINA , 34 years of age, was diagnosed with
  • renal cell carcinoma
and was treated with Sutent. Patient felt the following Sutent side effects: renal cell carcinoma, disease progression, ascites, multi-organ failure. Sutent dosage: N/A.

Diarrhoea, Skin Hypertrophy, Echocardiogram Abnormal, Abdominal Tenderness, Paraesthesia, Hepatic Function Abnormal, Renal Impairment, Dysgeusia (8461169-5)
Patient was taking Sutent. After Sutent was administered, patient encountered several Sutent side effects: diarrhoea, skin hypertrophy, echocardiogram abnormal, abdominal tenderness, paraesthesia, hepatic function abnormal, renal impairment, dysgeusia on Jun 20, 2012 from UNITED STATES Additional patient health information: Male , weighting 175.0 lb, was diagnosed with
  • metastatic renal cell carcinoma
  • dementia
and. Sutent dosage: 50 Mg, Cyclic Daily For 28 Days, Followed By A 14 Day Rest Period.
Multiple concurrent drugs taken:
  • Aricept (10 Mg, 1x/day, (one Tablet), At Night)
  • Flomax
  • Chondroitin/glucosamine (Unk)
  • Namenda (5 Mg, 2x/day, (2 Tablets Daily))


Weight Decreased, Chromaturia, Decreased Appetite, Hypothyroidism, Fatigue (8461154-3)
Adverse event was reported on Jun 20, 2012 by a Male taking Sutent (Dosage: 50 Mg Daily X28 Days Q 42 Days) was diagnosed with
  • renal cancer
and. Location: UNITED STATES , weighting 151.0 lb, Directly after, patient experienced the unwanted or unexpected Sutent side effects: weight decreased, chromaturia, decreased appetite, hypothyroidism, fatigue.
Associated medications used:
  • Lovenox (Unk)
  • Coumadin (Unk)
  • Metoprolol Succinate Extended Release (50 Mg, Unk)


Chest Pain, Musculoskeletal Discomfort, Blood Pressure Fluctuation, Decreased Appetite, Stomatitis, Hyperkeratosis, Fatigue, Chest Discomfort, Skin Disorder (8461128-2)
on Jun 18, 2012 Male from UNITED STATES , weighting 155.0 lb, was treated with Sutent. Patient felt the following Sutent side effects: chest pain, musculoskeletal discomfort, blood pressure fluctuation, decreased appetite, stomatitis, hyperkeratosis, fatigue, chest discomfort, skin disorder. Sutent dosage: 12.5 Mg, 3x/day.

Swollen Tongue, Ageusia, Dysgeusia, Rash (8461115-4)
on Jun 15, 2012 Female from UNITED STATES , weighting 200.0 lb, was diagnosed with
  • neoplasm malignant
and was treated with Sutent. After Sutent was administered, patient encountered several Sutent side effects: swollen tongue, ageusia, dysgeusia, rash. Sutent dosage: 50 Mg, Daily.

Disorientation, Ammonia Increased, Haemoglobin Decreased, Confusional State, Pyrexia, Red Blood Cell Count Decreased, Haematocrit Decreased, Hemiparesis, Blood Calcium Decreased (8455383-2)
Patient was taking Sutent. Directly after, patient experienced the unwanted or unexpected Sutent side effects: disorientation, ammonia increased, haemoglobin decreased, confusional state, pyrexia, red blood cell count decreased, haematocrit decreased, hemiparesis, blood calcium decreased on Jun 15, 2012 from GERMANY Additional patient health information: Male , 62 years of age, was diagnosed with
  • gastrointestinal stromal tumour
and. Sutent dosage: 50 Mg, 1x/day. Patient was hospitalized.

Hypoglycaemic Coma (8455318-2)
Adverse event was reported on Jun 18, 2012 by a Female taking Sutent (Dosage: 50 Mg Daily, 4 Weeks Followed By 15 Days Off) . Location: FRANCE , 81 years of age, Patient felt the following Sutent side effects: hypoglycaemic coma.

Insomnia, Blister, Skin Discomfort (8454949-3)
on Jun 15, 2012 Female from UNITED STATES , weighting 156.5 lb, was treated with Sutent. After Sutent was administered, patient encountered several Sutent side effects: insomnia, blister, skin discomfort. Sutent dosage: 37.5 Mg (25mg + 12.5mg).
Multiple concurrent drugs taken:
  • Allegra (Unk As Needed)
  • Allegra
  • Sandostatin (Unk)
  • Hydrochlorothiazide (20 Or 25mg In The Morning)
  • Protonix (40 Mg, 1x/day In The Morning)


Haemoglobin Decreased, Red Blood Cell Count Decreased, White Blood Cell Count Increased, Haematocrit Decreased, Red Cell Distribution Width Increased, Renal Impairment (8450860-2)
on Jun 13, 2012 Male from SOUTH AFRICA , 70 years of age, weighting 154.8 lb, was diagnosed with
  • metastatic renal cell carcinoma
and was treated with Sutent. Directly after, patient experienced the unwanted or unexpected Sutent side effects: haemoglobin decreased, red blood cell count decreased, white blood cell count increased, haematocrit decreased, red cell distribution width increased, renal impairment. Sutent dosage: 37.5 Mg, 1x/day.

Anal Abscess (8450383-0)
Patient was taking Sutent. Patient felt the following Sutent side effects: anal abscess on Jun 14, 2012 from FRANCE Additional patient health information: Male , 39 years of age, weighting 172.0 lb, was diagnosed with
  • metastatic renal cell carcinoma
and. Sutent dosage: Unk. Patient was hospitalized.

Oral Pain, Hypoaesthesia, Surgery (8449707-X)
Adverse event was reported on Jun 14, 2012 by a Female taking Sutent (Dosage: Unk) . Location: UNITED STATES , weighting 249.1 lb, After Sutent was administered, patient encountered several Sutent side effects: oral pain, hypoaesthesia, surgery.
Multiple concurrent drugs taken:
  • Vitamin D (Unk)
  • Vitamin E (Unk)


Heart Rate Increased, Constipation, Malaise, Diarrhoea, Weight Decreased, Dry Mouth, Hypertension, Nausea, Stomatitis (8448264-1)
on Jun 04, 2012 Female from UNITED STATES , weighting 231.0 lb, was treated with Sutent. Directly after, patient experienced the unwanted or unexpected Sutent side effects: heart rate increased, constipation, malaise, diarrhoea, weight decreased, dry mouth, hypertension, nausea, stomatitis. Sutent dosage: N/A.
Associated medications used:
  • Vitamin B-12
  • Nexium


Disease Progression, Cardiopulmonary Failure, Pleural Effusion, Gastrointestinal Stromal Tumour, Ascites (8447657-6)
on Jun 14, 2012 Male from CHINA , 57 years of age, was diagnosed with
  • gastrointestinal stromal tumour
and was treated with Sutent. Patient felt the following Sutent side effects: disease progression, cardiopulmonary failure, pleural effusion, gastrointestinal stromal tumour, ascites. Sutent dosage: N/A.

Myocardial Infarction (8447655-2)
Patient was taking Sutent. After Sutent was administered, patient encountered several Sutent side effects: myocardial infarction on Jun 14, 2012 from FRANCE Additional patient health information: Male , 35 years of age, . Sutent dosage: 50 Mg, 4 Weeks Out Of 6.
Multiple concurrent drugs taken:
  • Trandate


Gastrointestinal Stromal Tumour, Multi-organ Failure, Disease Progression (8447639-4)
Adverse event was reported on Jun 14, 2012 by a Male taking Sutent (Dosage: N/A) was diagnosed with
  • gastrointestinal stromal tumour
and. Location: CHINA , 61 years of age, Directly after, patient experienced the unwanted or unexpected Sutent side effects: gastrointestinal stromal tumour, multi-organ failure, disease progression.

Nausea, Cardiac Failure, Fatigue, Vomiting (8447398-5)
on Jun 12, 2012 Female from FRANCE , 60 years of age, was diagnosed with
  • renal cancer metastatic
and was treated with Sutent. Patient felt the following Sutent side effects: nausea, cardiac failure, fatigue, vomiting. Sutent dosage: Cyclic. Patient was hospitalized.

Cough, Urinary Retention, Blood Urine Present (8447391-2)
on Jun 14, 2012 Male from INDIA , 54 years of age, was diagnosed with
  • metastatic renal cell carcinoma
and was treated with Sutent. After Sutent was administered, patient encountered several Sutent side effects: cough, urinary retention, blood urine present. Sutent dosage: 50 Mg, 1x/day. Patient was hospitalized.

Pain In Extremity, Stomatitis, Nausea, Vomiting, Discomfort (8447247-5)
Patient was taking Sutent. Directly after, patient experienced the unwanted or unexpected Sutent side effects: pain in extremity, stomatitis, nausea, vomiting, discomfort on Jun 13, 2012 from UNITED STATES Additional patient health information: Female , weighting 174.0 lb, was diagnosed with
  • renal cell carcinoma
and. Sutent dosage: 50 Mg, Unk.
Associated medications used:
  • Stool Softener (Unk, Daily)


Platelet Count Decreased, Anaemia, Haemorrhage (8447234-7)
Adverse event was reported on Jun 14, 2012 by a Male taking Sutent (Dosage: Unk) was diagnosed with
  • renal cell carcinoma
and. Location: CHINA , 43 years of age, Patient felt the following Sutent side effects: platelet count decreased, anaemia, haemorrhage.

Hypothyroidism, Myxoedema Coma (8447124-X)
on Jun 14, 2012 Female from MEXICO , 62 years of age, was treated with Sutent. After Sutent was administered, patient encountered several Sutent side effects: hypothyroidism, myxoedema coma. Sutent dosage: 50 Mg, 1x/day.

Yellow Skin, Oral Mucosal Erythema, Constipation, Abdominal Abscess (8445793-1)
on May 18, 2012 Male from INDIA , 50 years of age, was diagnosed with
  • gastrointestinal stromal tumour
and was treated with Sutent. Directly after, patient experienced the unwanted or unexpected Sutent side effects: yellow skin, oral mucosal erythema, constipation, abdominal abscess. Sutent dosage: 50 Mg, 1x/day.

Showing 1-25 of 7432 

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Sutent Information

Alternative SUTENT Names:SUNITINIB

Active Ingredient: SUNITINIB

Sutent Dosage, Warnings, Usage.

Side Effects reported to FDA: 7432. View Sutent Adverse Reports

Sutent safety alerts: No

Reported deaths: 2049

Reported hospitalizations: 3521

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