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 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 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 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 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 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 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 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
Possible Zelboraf side effects in female
Reported by a physician from United States on 2012-08-22
Patient: female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Zelboraf
Possible Zelboraf side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: male
Reactions: Product Quality Issue, Metastatic Neoplasm, Drug Ineffective, Ascites
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
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