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Tarceva (Erlotinib) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tarceva (Erlotinib) 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 (1459)
Death (932)
Life Threatening Events (40)
Disability (7)

Reports by Reaction Type

Death (648)Diarrhoea (137)Rash (126)Disease Progression (66)Neoplasm Malignant (66)Fatigue (58)Nausea (53)Incorrect Dose Administered (53)Decreased Appetite (52)Dyspnoea (52)Vomiting (42)Pneumonia (38)

Below are a few examples of reports where side effects / adverse reactions may be related to Tarceva (Erlotinib). For a complete list or a specific selection of reports, please use the links above.

Possible Tarceva side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tarceva
    Indication: Bile Duct Cancer

Tarceva
    Indication: Pancreatic Carcinoma
    Start date: 2005-06-01

Avastin
    Indication: Pancreatic Carcinoma
    Start date: 2005-06-23



Possible Tarceva side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tarceva



Possible Tarceva side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Xeloda
    Indication: Gastric Cancer

Tarceva
    Indication: Product Used FOR Unknown Indication



Possible Tarceva side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Brain Neoplasm

Adverse event resulted in: death

Drug(s) suspected as cause:
Avastin

Tarceva
    Indication: Product Used FOR Unknown Indication

Avastin
    Indication: Brain Neoplasm Malignant



Possible Tarceva side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Terminal State

Drug(s) suspected as cause:
Tarceva



Possible Tarceva side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Avastin
    Indication: Bile Duct Cancer

Tarceva
    Indication: Product Used FOR Unknown Indication



Possible Tarceva side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Disease Progression

Drug(s) suspected as cause:
Tarceva
    Indication: Renal Cancer

Avastin
    Indication: Renal Cancer



Possible Tarceva side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male, weighing 77.0 kg (169.4 pounds)

Reactions: Mental Status Changes

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tarceva
    Dosage: 150 mg, uid/qd
    Administration route: Oral
    Indication: Lung Neoplasm Malignant
    Start date: 2012-08-03
    End date: 2012-08-06

Tarceva
    Dosage: 150 mg, uid/qd
    Administration route: Oral
    Start date: 2012-08-14
    End date: 2012-08-15



Possible Tarceva side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tarceva
    Indication: Metastases To Nervous System

Avastin
    Indication: Product Used FOR Unknown Indication

Tarceva
    Indication: Lung Neoplasm Malignant



Possible Tarceva side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Avastin
    Indication: Lung Neoplasm Malignant

Tarceva
    Indication: Lung Neoplasm Malignant



Possible Tarceva side effects in male

Reported by a health professional (non-physician/pharmacist) from China on 2012-08-27

Patient: male, weighing 74.0 kg (162.8 pounds)

Reactions: Henoch-Schonlein Purpura, Rash

Drug(s) suspected as cause:
Tarceva
    Dosage: 150 mg, uid/qd
    Administration route: Oral
    Indication: Lung Neoplasm Malignant
    Start date: 2009-01-15
    End date: 2009-03-16

Tarceva
    Dosage: 150 mg, uid/qd
    Administration route: Oral
    Start date: 2009-03-20



Possible Tarceva side effects in 43 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 43 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tarceva

Everolimus

Votrient

Sprycel
    Administration route: Oral
    Indication: Neoplasm Malignant
    Start date: 2012-05-02



Possible Tarceva side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Disease Progression

Drug(s) suspected as cause:
Avastin
    Indication: Haematological Malignancy

Avastin
    Indication: Malignant Respiratory Tract Neoplasm

Tarceva
    Indication: Product Used FOR Unknown Indication



Possible Tarceva side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tarceva
    Indication: Malignant Respiratory Tract Neoplasm

Avastin
    Indication: Product Used FOR Unknown Indication



Possible Tarceva side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Neoplasm Malignant

Adverse event resulted in: death

Drug(s) suspected as cause:
Tarceva



Possible Tarceva side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Avastin
    Indication: Pancreatic Carcinoma

Xeloda
    Indication: Pancreatic Carcinoma

Tarceva
    Indication: Pancreatic Carcinoma



Possible Tarceva side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Xeloda
    Indication: Malignant Melanoma

Tarceva
    Indication: Malignant Melanoma



Possible Tarceva side effects in 43 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 43 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Sprycel
    Administration route: Oral
    Indication: Neoplasm Malignant
    Start date: 2012-05-02

Votrient

Everolimus

Tarceva



Possible Tarceva side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tarceva
    Indication: Lung Neoplasm Malignant

Avastin
    Indication: Product Used FOR Unknown Indication



Possible Tarceva side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Disease Progression

Drug(s) suspected as cause:
Avastin
    Indication: Lung Neoplasm Malignant
    Start date: 2005-11-01

Tarceva
    Indication: Product Used FOR Unknown Indication
    Start date: 2005-06-01

Other drugs received by patient: Carboplatin; Taxotere; Taxol



Possible Tarceva side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tarceva



Possible Tarceva side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Rash, Deep Vein Thrombosis, Disease Progression

Drug(s) suspected as cause:
Avastin
    Indication: Renal Cancer
    Start date: 2004-08-01

Tarceva
    Indication: Renal Cancer
    Start date: 2004-12-26

Other drugs received by patient: Aredia; Thalidomide; Proleukin; Zometa



Possible Tarceva side effects in male

Reported by a physician from United States on 2012-08-25

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tarceva
    Indication: Colon Cancer

Xeloda
    Indication: Colon Cancer



Possible Tarceva side effects in

Reported by a consumer/non-health professional from United States on 2012-08-25

Patient:

Reactions: Death, Ill-Defined Disorder

Adverse event resulted in: death, disablity

Drug(s) suspected as cause:
Tarceva
    Indication: Brain Neoplasm Malignant

Tarceva

Xeloda
    Indication: Brain Neoplasm Malignant

Xeloda



Possible Tarceva side effects in male

Reported by a physician from United States on 2012-08-24

Patient: male

Reactions: Disease Progression

Drug(s) suspected as cause:
Avastin
    Indication: Malignant Urinary Tract Neoplasm

Tarceva
    Indication: Product Used FOR Unknown Indication

Avastin
    Indication: Renal Cancer



Possible Tarceva side effects in female

Reported by a health professional (non-physician/pharmacist) from China on 2012-08-24

Patient: female, weighing 55.0 kg (121.0 pounds)

Reactions: Electrocardiogram ST-T Segment Abnormal, Chest Discomfort, Palpitations

Drug(s) suspected as cause:
Tarceva



Possible Tarceva side effects in male

Reported by a health professional (non-physician/pharmacist) from China on 2012-08-24

Patient: male, weighing 65.0 kg (143.0 pounds)

Reactions: Haematuria

Drug(s) suspected as cause:
Tarceva



Possible Tarceva side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tarceva
    Indication: Lung Neoplasm Malignant

Activase
    Indication: Lung Neoplasm Malignant



Possible Tarceva side effects in male

Reported by a consumer/non-health professional from China on 2012-08-24

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Death, Purulence, Blindness

Adverse event resulted in: death, disablity

Drug(s) suspected as cause:
Tarceva



Possible Tarceva side effects in male

Reported by a physician from United States on 2012-08-23

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tarceva
    Indication: Embolism

Tarceva
    Indication: Lung Neoplasm Malignant

Activase
    Indication: Lung Neoplasm Malignant

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