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Sutent (Sunitinib) - Side Effect Reports to FDA

 
 



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

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 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 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 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 2012-08-23

Patient: male

Reactions: Blood Pressure Increased

Drug(s) suspected as cause:
Sutent

Other drugs received by patient: Temazepam



Possible Sutent side effects in 72 year old male

Reported by a physician from Japan on 2012-08-23

Patient: 72 year old male, weighing 66.0 kg (145.2 pounds)

Reactions: Thyroiditis, Adrenal Insufficiency, Platelet Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sutent
    Dosage: 50 mg, 1x/day
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2011-01-26
    End date: 2011-02-07

Sutent
    Dosage: 37.5 mg, 1x/day
    Administration route: Oral
    Start date: 2011-02-25
    End date: 2011-03-18

Other drugs received by patient: Allopurinol



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 107.0 kg (235.4 pounds)

Reactions: Weight Decreased, Glossodynia, Blood Thyroid Stimulating Hormone Increased, Abdominal Discomfort, Fatigue, Dyspepsia, Blister, Blood Pressure Increased, White Blood Cell Count Decreased, Rash, Dysgeusia, Diarrhoea, Alopecia, Vitamin D Decreased, Sinus Headache, Neutrophil Count Decreased

Drug(s) suspected as cause:
Sutent

Other drugs received by patient: Diovan; Vitamin B-12; Keppra; Simvastatin; Vitamin D

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