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Zelboraf (Vemurafenib) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zelboraf (Vemurafenib) 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 (1002)
Death (335)
Life Threatening Events (35)
Disability (25)

Reports by Reaction Type

Death (241)Fatigue (182)Arthralgia (174)Rash (157)Nausea (122)Decreased Appetite (106)Myalgia (80)Disease Progression (73)Alopecia (72)Diarrhoea (66)Vomiting (65)Headache (63)

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

Possible Zelboraf side effects in male

Reported by a pharmacist from Canada on 2012-08-27

Patient: male

Reactions: Dysgeusia, Weight Decreased, Dyspepsia, Hypophagia, Blood Disorder, Fluid Intake Reduced, Asthenia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zelboraf
    Administration route: Oral
    Indication: Metastatic Malignant Melanoma
    Start date: 2012-07-02

Zelboraf
    Start date: 2012-07-16

Other drugs received by patient: Lovastatin; Propafenone HCL; Pioglitazone HCL; Methotrexate; Vitamin D; Multi-Vitamins; Metformin HCL; Warfarin Sodium; Metoprolol Tartrate; Gliclazide



Possible Zelboraf side effects in 63 year old male

Reported by a physician from Netherlands on 2012-08-24

Patient: 63 year old male, weighing 101.0 kg (222.2 pounds)

Reactions: Malignant Melanoma

Drug(s) suspected as cause:
Zelboraf



Possible Zelboraf side effects in 51 year old female

Reported by a physician from Germany on 2012-08-24

Patient: 51 year old female, weighing 93.4 kg (205.5 pounds)

Reactions: Visual Impairment

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zelboraf



Possible Zelboraf side effects in 58 year old female

Reported by a physician from Sweden on 2012-08-24

Patient: 58 year old female, weighing 95.5 kg (210.1 pounds)

Reactions: Fatigue, Tumour Lysis Syndrome

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Zelboraf
    Dosage: last dose prior to sae: 05/nov/2011
    Administration route: Oral
    Indication: Malignant Melanoma
    Start date: 2011-10-31

Zelboraf
    Administration route: Oral
    Start date: 2011-11-14

Zelboraf
    Start date: 2011-12-27

Zelboraf
    Start date: 2011-11-21
    End date: 2011-11-27

Zelboraf
    Start date: 2011-11-28
    End date: 2011-12-26

Other drugs received by patient: Acetaminophen; Metoclopramide; Xenical; Levotyroxin; Enoxaparin Natrium; Betametasona; Omeprazole



Possible Zelboraf side effects in 21 year old female

Reported by a physician from Croatia (Local Name: Hrvatska) on 2012-08-24

Patient: 21 year old female

Reactions: Pancreatitis Acute

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Zelboraf



Possible Zelboraf side effects in male

Reported by a physician from Canada on 2012-08-24

Patient: male

Reactions: Back Pain, Vomiting, Nausea, Haematuria, Rash, Kidney Infection

Drug(s) suspected as cause:
Zelboraf

Other drugs received by patient: Salmon OIL; Tridural; Tramadol HCL; Ramipril; Aspirin



Possible Zelboraf side effects in 72 year old female

Reported by a physician from Spain on 2012-08-24

Patient: 72 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Rash Erythematous, Keratoacanthoma, Toxic Skin Eruption

Drug(s) suspected as cause:
Zelboraf
    Dosage: last doe prior to sae: 26/mar/2012
    Administration route: Oral
    Indication: Malignant Melanoma
    Start date: 2012-02-27
    End date: 2012-04-13

Zelboraf
    Administration route: Oral
    Start date: 2012-04-26
    End date: 2012-06-21

Zelboraf
    Administration route: Oral
    Start date: 2012-06-27



Possible Zelboraf side effects in 71 year old

Reported by a physician from Netherlands on 2012-08-24

Patient: 71 year old , weighing 82.0 kg (180.4 pounds)

Reactions: Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zelboraf



Possible Zelboraf side effects in 47 year old female

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

Patient: 47 year old female

Reactions: Pneumocystis Jiroveci Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zelboraf

Other drugs received by patient: Dexamethasone



Possible Zelboraf side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23

Patient: female

Reactions: Arthralgia, Cystitis, Rash, Headache

Drug(s) suspected as cause:
Zelboraf



Possible Zelboraf side effects in 52 year old male

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

Patient: 52 year old male

Reactions: Hyperkeratosis, Renal Failure, Rash Papular, Eosinophilia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Zelboraf
    Dosage: dose reduced
    End date: 2012-05-19

Zelboraf
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-30



Possible Zelboraf side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female, weighing 104.4 kg (229.7 pounds)

Reactions: Stomatitis, Cellulitis, Skin Oedema, Erythema, Neuropathy Peripheral, Skin Papilloma, Neoplasm Skin, Ocular Hyperaemia, Dermal Cyst, Vision Blurred, Lacrimation Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zelboraf

Other drugs received by patient: Atarax



Possible Zelboraf side effects in 21 year old female

Reported by a physician from Croatia (Local Name: Hrvatska) on 2012-08-23

Patient: 21 year old female

Reactions: Pancreatitis Acute

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Zelboraf



Possible Zelboraf side effects in 57 year old female

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

Patient: 57 year old female

Reactions: Dysphagia

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Zelboraf
    Dosage: last dose prior to sae 02/jul/2012
    Administration route: Oral
    Indication: Metastatic Malignant Melanoma
    Start date: 2011-10-26
    End date: 2012-07-03

Zelboraf
    Administration route: Oral
    Start date: 2012-07-07

Other drugs received by patient: Zithromax; Nexium; Acetaminophen



Possible Zelboraf side effects in 64 year old female

Reported by a physician from Korea, Republic of on 2012-08-23

Patient: 64 year old female, weighing 60.4 kg (132.9 pounds)

Reactions: Cholecystitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zelboraf
    Dosage: last dose prior to sae: 11/may/2012
    Administration route: Oral
    Indication: Malignant Melanoma
    Start date: 2011-12-19
    End date: 2012-05-14

Zelboraf
    Start date: 2012-05-23

Zelboraf



Possible Zelboraf side effects in 55 year old male

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

Patient: 55 year old male

Reactions: Impaired Healing, Neoplasm Malignant

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Zelboraf



Possible Zelboraf side effects in male

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

Patient: male

Reactions: Fatigue, Pruritus, Mass, Arthralgia

Drug(s) suspected as cause:
Zelboraf

Other drugs received by patient: Zopiclone; Effexor; Ascorbic Acid; Lovaza; Vitamin D; Calcium; Oxycet



Possible Zelboraf side effects in

Reported by a pharmacist from Australia on 2012-08-23

Patient:

Reactions: Hepatic Function Abnormal, Pain, Gastrointestinal Disorder, Hepatic Enzyme Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zelboraf



Possible Zelboraf side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient: female, weighing 60.8 kg (133.8 pounds)

Reactions: Madarosis, Swelling Face, Pruritus, Mass, Skin Exfoliation, Chills, Rash, Erythema, Myalgia, Pericarditis, Arthralgia, Alopecia, Rash Erythematous

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zelboraf
    Start date: 2012-06-11

Zelboraf
    Start date: 2012-02-01

Zelboraf
    Dosage: therapy for 36 days

Zelboraf
    Administration route: Oral
    Indication: Malignant Melanoma
    Start date: 2011-12-26
    End date: 2012-01-04



Possible Zelboraf side effects in 54 year old male

Reported by a pharmacist from United States on 2012-08-22

Patient: 54 year old male

Reactions: Rash, DRY Skin

Drug(s) suspected as cause:
Zelboraf



Possible Zelboraf side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female, weighing 105.7 kg (232.5 pounds)

Reactions: Cellulitis, Squamous Cell Carcinoma, Squamous Cell Carcinoma of Skin

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zelboraf

Other drugs received by patient: Insulin Lispro; Fluoxetine HCL; Furosemide; Levemir; Spiriva; Oxycodone HCL; Simvastatin; Glipizide; Escitalopram; Furosemide; Levothyroxine Sodium; Gabapentin; Januvia; Eszopiclone



Possible Zelboraf side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Pruritus, Skin Reaction, Fall, Constipation, Fatigue, Arthropathy, Dizziness, Decreased Appetite, Blister, Cellulitis, Vomiting, Nausea, Squamous Cell Carcinoma, Skin Disorder, Rash, DRY Skin, Dysgeusia, Dysphonia, Diarrhoea, Arthralgia, Alopecia, Vision Blurred, Lacrimation Increased, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zelboraf

Other drugs received by patient: Motrin; Fexofenadine; Atorvastatin; Atenolol; Imodium



Possible Zelboraf side effects in male

Reported by a physician from Germany on 2012-08-22

Patient: male

Reactions: Vomiting, Nausea, Neoplasm Malignant, Metastases To Meninges, General Physical Health Deterioration

Drug(s) suspected as cause:
Zelboraf



Possible Zelboraf side effects in male

Reported by a physician from United States on 2012-08-22

Patient: male, weighing 71.3 kg (156.8 pounds)

Reactions: Jaundice, Hepatic Failure, Cerebrovascular Accident, Metastases To Central Nervous System

Adverse event resulted in: death

Drug(s) suspected as cause:
Lorazepam
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Morphine Sulfate
    Administration route: Oral
    Indication: Pain

Zelboraf
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-05
    End date: 2012-04-20

Other drugs received by patient: Vicodin; Roxanol; Dulcolax; Miralax; Dexamethasone; Acetaminophen; Atropine; Compazine; Levsin; Oxygen



Possible Zelboraf side effects in 76 year old male

Reported by a pharmacist from United States on 2012-08-22

Patient: 76 year old male

Reactions: Fatigue, Depression, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zelboraf



Possible Zelboraf side effects in male

Reported by a physician from United Kingdom on 2012-08-22

Patient: male, weighing 59.7 kg (131.3 pounds)

Reactions: Angioedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zelboraf

Other drugs received by patient: Amitriptyline Hydrochloride; Acetaminophen; Prednisolone; Prednisolone; Ranitidine; Oramorph SR; Moviprep; Ibuprofen; Prednisolone; Metoclopramide



Possible Zelboraf side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Cellulitis, Dysphonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zelboraf



Possible Zelboraf side effects in 54 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 54 year old female

Reactions: Weight Decreased, Acne, Bone Pain, Muscular Weakness, Hemiparesis, Rash, Faeces Pale, Fatigue, Skin Ulcer, Sensory Disturbance, Squamous Cell Carcinoma of Skin

Drug(s) suspected as cause:
Zelboraf



Possible Zelboraf side effects in female

Reported by a physician from Canada on 2012-08-22

Patient: female

Reactions: Pruritus, Squamous Cell Carcinoma, Pain in Extremity, Urticaria, Pyrexia, DRY Skin, Erythema, Eye Pain, Myalgia, Arthralgia, Alopecia, Memory Impairment, DRY Eye, Sinusitis

Drug(s) suspected as cause:
Zelboraf
    Administration route: Oral
    Indication: Metastatic Malignant Melanoma
    Start date: 2012-04-19

Zelboraf
    Dosage: dose reduced.
    Administration route: Oral
    Start date: 2012-05-01

Other drugs received by patient: Ativan; Vitamin D; COQ-10; Minocycline HCL; Multi-Vitamins; Potassium; Hydrocortisone; Coral Calcium; Shark Liver OIL; Benadryl



Possible Zelboraf side effects in 67 year old female

Reported by a physician from Germany on 2012-08-22

Patient: 67 year old female, weighing 69.0 kg (151.8 pounds)

Reactions: Pneumonia, Coma, Diabetic Ketoacidosis, Acute Myocardial Infarction, Multi-Organ Disorder, Escherichia Sepsis

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Zelboraf
    Dosage: dose reduced, temporarily interrupted
    Administration route: Oral
    Start date: 2011-10-21
    End date: 2011-12-20

Zelboraf
    Dosage: dose reduced, temporarily interrupted
    Start date: 2011-12-20
    End date: 2012-01-04

Zelboraf
    Dosage: last dose proir to sae was on 4/jan/2012
    Administration route: Oral
    Indication: Malignant Melanoma
    Start date: 2011-11-21

Other drugs received by patient: Ramipril; Mobilat; Simvastatin; Metoprolol Tartrate; Dermoxin (Germany); Clopidegrel; Travoprost and Timolol; Mometasone Furoate

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