This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Sutent (Sunitinib) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (3442)
Death (1086)
Life Threatening Events (78)
Disability (37)
Reports by Reaction Type
Disease Progression (591),
Death (551),
Diarrhoea (367),
Fatigue (333),
Nausea (307),
Decreased Appetite (222),
Vomiting (211),
Asthenia (201),
Dysgeusia (182),
Renal Cell Carcinoma (178),
Hypertension (169),
Weight Decreased (159)
Below are a few examples of reports where side effects / adverse reactions may be related to Sutent (Sunitinib). For a complete list or a specific selection of reports, please use the links above.
Possible Sutent side effects in 60 year old male
Reported by a consumer/non-health professional from Brazil on 2012-08-27
Patient: 60 year old male
Reactions: Death, Ageusia, Platelet Count Decreased
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Sutent
Other drugs received by patient: Phenobarbital TAB; Tramadol Hydrochloride
Possible Sutent side effects in 65 year old female
Reported by a pharmacist from Japan on 2012-08-27
Patient: 65 year old female
Reactions: Urinary Tract Infection, Bone Marrow Failure, Erythema
Drug(s) suspected as cause:
Sutent
Possible Sutent side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Diarrhoea
Drug(s) suspected as cause:
Sutent
Possible Sutent side effects in 69 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 69 year old female
Reactions: Urinary Tract Infection, Metastatic Renal Cell Carcinoma, Disease Progression
Drug(s) suspected as cause:
Afinitor
Indication: Breast Cancer
Lipitor
Sutent
Dosage: 25 mg, unk
Administration route: Oral
Indication: Metastatic Renal Cell Carcinoma
Start date: 2011-04-19
End date: 2012-06-01
Other drugs received by patient: Tramadol; Vitamin D; Nolvadex; Oxycodone; Tizanidine; Tylenol; Oystcal; Bactrim; Nitroglycerin
Possible Sutent side effects in 64 year old female
Reported by a physician from France on 2012-08-27
Patient: 64 year old female
Reactions: Multi-Organ Failure, Cardiac Failure, Secondary Hypothyroidism, Thrombocytopenia, Hypertension
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Sutent
Possible Sutent side effects in 70 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 70 year old female, weighing 48.5 kg (106.8 pounds)
Reactions: Weight Decreased, Blood Pressure Increased, Hyperaesthesia, Stomatitis, Impaired Healing, Skin Exfoliation, Herpes Zoster
Drug(s) suspected as cause:
Sutent
Dosage: 50 mg, cyclic 42 days
Indication: Renal Cancer Metastatic
Start date: 2011-02-01
End date: 2012-05-01
Sutent
Dosage: 50 mg, alternate day
Start date: 2012-01-01
Other drugs received by patient: Synthroid
Possible Sutent side effects in 78 year old male
Reported by a physician from United States on 2012-08-27
Patient: 78 year old male, weighing 99.3 kg (218.5 pounds)
Reactions: Grand MAL Convulsion, Fatigue, Hypotension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metoprolol Tartrate
Dosage: 25 mg, 2x/day
Administration route: Oral
Start date: 2012-01-23
Metoprolol Tartrate
Dosage: 12.5 mg, 2x/day
Indication: Hypertension
Sutent
Indication: Prostate Cancer
Sutent
Indication: Renal Cancer
Sutent
Indication: Metastatic Renal Cell Carcinoma
Sutent
Dosage: 50 mg (daily times 4 weeks every 6 weeks)
Indication: Bone Neoplasm Malignant
Start date: 2012-05-29
End date: 2012-06-01
Other drugs received by patient: Temazepam; Naproxen (Aleve); Lupron; Fentanyl; Aspirin; Dexamethasone; Metoprolol; Omeprazole; Zometa; Temazepam; Chlordiazepoxide; Rapaflo; Naproxen Sodium; Miralax; Docusate Sodium; Oxycodone HCL and Acetaminophen; Calcium Gluconate; Midazolam; Metoprolol; Silodosin; Levetiracetam; Levetiracetam; Meclizine; Percocet; Fentanyl; Aspirin; Dexamethasone; Enoxaparin; Sodium Chloride
Possible Sutent side effects in
Reported by a physician from Italy on 2012-08-27
Patient:
Reactions: Ejection Fraction Decreased, Cardiotoxicity
Drug(s) suspected as cause:
Sutent
Other drugs received by patient: Carvedilol
Possible Sutent side effects in
Reported by a physician from Taiwan, Province of China on 2012-08-27
Patient:
Reactions: Bone Marrow Failure
Drug(s) suspected as cause:
Sutent
Possible Sutent side effects in 72 year old male
Reported by a physician from United States on 2012-08-27
Patient: 72 year old male, weighing 125.1 kg (275.2 pounds)
Reactions: Dyspnoea, Stomatitis, Pain in Extremity, Pancytopenia, Neck Mass, Fatigue, Breath Sounds Abnormal, Upper Respiratory Tract Infection, Chest Pain, Feeling Hot, Gallbladder Disorder, Feeling Abnormal, Skin Swelling, Arthropod Bite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Sutent
Dosage: 37.5 mg (12.5 mg + 25 mg), 1x/day, 4 weeks on/2 weeks off
Administration route: Oral
Indication: Renal Cancer Metastatic
Start date: 2011-11-21
End date: 2011-12-11
Sutent
Dosage: 37.5 mg, 1x/day, 37.5 mg (12.5 mg + 25 mg), 1x/day, 2 weeks on/1 weeks off
Administration route: Oral
Start date: 2012-05-02
Sutent
Dosage: 37.5 mg, 1x/day, 4 weeks on/2 weeks off
Administration route: Oral
Possible Sutent side effects in 36 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 36 year old female
Reactions: Weight Bearing Difficulty, Pain in Extremity
Drug(s) suspected as cause:
Sutent
Possible Sutent side effects in 66 year old male
Reported by a consumer/non-health professional from Brazil on 2012-08-24
Patient: 66 year old male
Reactions: Dysgeusia, Intestinal Fistula, Yellow Skin, Skin Exfoliation, Arthralgia, Visual Impairment, Palmar-Plantar Erythrodysaesthesia Syndrome
Drug(s) suspected as cause:
Sutent
Other drugs received by patient: Tylenol; Vitamin E; Metoclopramide Hydrochloride; Paracetamol
Possible Sutent side effects in 52 year old female
Reported by a physician from United States on 2012-08-24
Patient: 52 year old female, weighing 96.1 kg (211.5 pounds)
Reactions: Weight Decreased, Glossodynia, Oral Herpes, Fatigue, Skin Lesion, Abdominal Distension, Exostosis, Muscle Spasms, Hypersomnia, Plantar Erythema, Stomatitis, Pain in Extremity, Blood Potassium Increased, Oral Pain, Blood Potassium Decreased, Lacrimation Increased, Hair Colour Changes
Drug(s) suspected as cause:
Sutent
Dosage: 12.5 mg, 3x/day
Indication: Hepatic Neoplasm Malignant
Start date: 2012-06-18
End date: 2012-07-01
Sutent
Dosage: 12.5 mg, 3x/day
Indication: Pancreatic Carcinoma
Start date: 2012-04-28
End date: 2012-06-13
Sutent
Dosage: unk
Indication: Pancreatic Neuroendocrine Tumour
Start date: 2012-07-04
Other drugs received by patient: Seroquel; Seroquel; Celexa; Lexapro; Lisinopril; Insulin; Lexapro; Zantac; Trazodone; Lipitor
Possible Sutent side effects in 59 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 59 year old female, weighing 67.5 kg (148.5 pounds)
Reactions: Nasopharyngitis, Vomiting, Nausea, Convulsion, Viith Nerve Paralysis, Abdominal Pain Upper, Seasonal Allergy, Malaise, Neoplasm Malignant, Brain Neoplasm, Cough
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Sutent
Dosage: 50 mg, unk
Indication: Metastatic Renal Cell Carcinoma
Start date: 2012-07-14
Sutent
Indication: Lung Cancer Metastatic
Sutent
Dosage: 50 mg, cyclic, 1x/day (daily)
Indication: Lung Disorder
Start date: 2012-06-01
Other drugs received by patient: Levetiracetam; Hydrocodone; Dexamethasone; Ondansetron; Benazepril
Possible Sutent side effects in 74 year old male
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 74 year old male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Sutent
Possible Sutent side effects in 75 year old male
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 75 year old male, weighing 86.6 kg (190.5 pounds)
Reactions: Platelet Count Decreased
Drug(s) suspected as cause:
Sutent
Dosage: 50 mg (unknown frequency)
Start date: 2012-01-01
End date: 2012-08-01
Sutent
Dosage: 50 mg (unknown frequency)
Indication: Bone Neoplasm Malignant
Start date: 2012-07-01
End date: 2012-07-01
Possible Sutent side effects in 72 year old male
Reported by a consumer/non-health professional from Brazil on 2012-08-24
Patient: 72 year old male
Reactions: Blood Pressure Increased, Vomiting, Oral Mucosal Erythema, Testicular Disorder, Urinary Tract Infection, Wound, Feeling Abnormal, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Sutent
Dosage: 50 mg, 1x/day / cycle 4x2
Administration route: Oral
Indication: Renal Cell Carcinoma
Start date: 2012-05-31
Sutent
Dosage: 37.5 mg, 1x/day / cycle 4x2
Administration route: Oral
End date: 2012-08-19
Other drugs received by patient: Finasteride; Metoprolol Succinate; Furosemide; Atlansil; Carvedilol; Phenytoin; Lasix; Tamsulosin HCL
Possible Sutent side effects in
Reported by a physician from Italy on 2012-08-24
Patient:
Reactions: Cholangitis, Pyrexia, Jaundice Cholestatic
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Sutent
Possible Sutent side effects in 77 year old female
Reported by a physician from Japan on 2012-08-24
Patient: 77 year old female
Reactions: Haemorrhagic Diathesis, Platelet Count Decreased, Neutrophil Count Decreased
Drug(s) suspected as cause:
Sutent
Dosage: 25 mg, 1x/day
Administration route: Oral
Indication: Insulinoma
Start date: 2011-07-25
End date: 2011-08-07
Sutent
Dosage: 12.5 mg, 1x/day
Administration route: Oral
Start date: 2011-08-08
End date: 2012-02-06
Possible Sutent side effects in female
Reported by a consumer/non-health professional from Ireland on 2012-08-24
Patient: female
Reactions: Fatigue, Nausea, Dyspepsia, Tumour Pain, Constipation, Epistaxis
Drug(s) suspected as cause:
Sutent
Possible Sutent side effects in 72 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: 72 year old female
Reactions: Renal Cancer, Disease Progression
Drug(s) suspected as cause:
Sutent
Possible Sutent side effects in
Reported by a physician from Japan on 2012-08-24
Patient:
Reactions: Hepatitis Fulminant
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Sutent
Possible Sutent side effects in 86 year old male
Reported by a physician from United States on 2012-08-24
Patient: 86 year old male
Reactions: Pancytopenia, Hypertension, Genital Rash
Drug(s) suspected as cause:
Sutent
Possible Sutent side effects in 61 year old male
Reported by a consumer/non-health professional from China on 2012-08-24
Patient: 61 year old male
Reactions: Tumour Pain
Drug(s) suspected as cause:
Sutent
Possible Sutent side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: male
Reactions: Malignant Urinary Tract Neoplasm, Disease Progression
Adverse event resulted in: death
Drug(s) suspected as cause:
Sutent
Possible Sutent side effects in 78 year old male
Reported by a physician from Japan on 2012-08-24
Patient: 78 year old male, weighing 63.4 kg (139.4 pounds)
Reactions: Platelet Count Decreased, Erythema Multiforme
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Sutent
Other drugs received by patient: Magmitt; Gorei-SAN; Famotidine; Depakene; Tamsulosin HCL
Possible Sutent side effects in
Reported by a consumer/non-health professional from India on 2012-08-24
Patient:
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Sutent
Possible Sutent side effects in 59 year old female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 59 year old female, weighing 83.9 kg (184.6 pounds)
Reactions: Pruritus, Nausea, Dizziness
Drug(s) suspected as cause:
Sutent
Other drugs received by patient: Losartan; Lisinopril; Amlodipine
Possible Sutent side effects in 66 year old male
Reported by a physician from Portugal on 2012-08-23
Patient: 66 year old male, weighing 71.0 kg (156.2 pounds)
Reactions: Arterial Thrombosis, Electrocardiogram ST Segment Elevation, Hypertension, Acute Coronary Syndrome
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Sutent
Other drugs received by patient: Furosemide; Sertraline; Risperidone; Levothyroxine Sodium; Amlodipine
Possible Sutent side effects in 55 year old female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 55 year old female, weighing 62.0 kg (136.4 pounds)
Reactions: Blood Pressure Increased, Weight Decreased, Vomiting, Blood Urine Present, Haemoptysis, Haematuria, Rectal Haemorrhage, Constipation, Haematochezia, Fatigue, Diarrhoea, Yellow Skin, Anal Haemorrhage, Asthenia, Hypersomnia, Decreased Appetite, Cough
Drug(s) suspected as cause:
Sutent
Dosage: 50 mg, 1x/day
Administration route: Oral
Indication: Lung Neoplasm Malignant
Start date: 2012-01-01
End date: 2012-01-01
Sutent
Dosage: 50 mg, 1x/day
Administration route: Oral
Indication: Metastatic Renal Cell Carcinoma
Start date: 2012-08-01
End date: 2012-08-15
Other drugs received by patient: Ondansetron; Warfarin; Amlodipine; Coumadin; Vicodin
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