Index of reports
> Life Threatening Events (30)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Incivek (Telaprevir) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 30 Next >>
Possible Incivek side effects in male
Reported by a physician from France on 2012-08-24
Patient: male, weighing 65.0 kg (143.0 pounds)
Reactions: Pancreatitis Acute, Pancreatic Necrosis
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Copegus
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-10-27
End date: 2012-01-23
Dedrogyl
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-27
End date: 2011-12-08
Incivek
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-10-27
End date: 2012-01-23
Pegasys
Indication: Hepatitis C
Start date: 2011-10-27
End date: 2012-01-23
Other drugs received by patient: Neorecormon
Possible Incivek side effects in 61 year old male
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: 61 year old male, weighing 61.2 kg (134.7 pounds)
Reactions: Chills, Rash, Headache, Disorientation, Incoherent, Feeling Jittery, NO Therapeutic Response, Dizziness
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Incivek
Indication: Hepatitis C
Pegasys
Ribasphere
Possible Incivek side effects in male
Reported by a physician from United States on 2012-08-17
Patient: male, weighing 65.4 kg (143.8 pounds)
Reactions: Renal Failure
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Incivek
Indication: Hepatitis C
Start date: 2012-07-13
End date: 2012-07-19
Pegasys
Indication: Hepatitis C
Start date: 2012-07-13
End date: 2012-07-19
Ribavirin
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-07-13
End date: 2012-07-19
Other drugs received by patient: Zantac; Lisinopril; Ramipril
Possible Incivek side effects in 56 year old male
Reported by a consumer/non-health professional from United States on 2012-08-15
Patient: 56 year old male, weighing 62.7 kg (137.8 pounds)
Reactions: Stomatitis, Pruritus, Swelling Face, Dyspnoea, Swollen Tongue, Rash, Skin Lesion, Gait Disturbance, Blister
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Incivek
Possible Incivek side effects in 50 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13
Patient: 50 year old male, weighing 99.4 kg (218.7 pounds)
Reactions: Febrile Neutropenia, Aplastic Anaemia, Pancytopenia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Incivek
Other drugs received by patient: Pegasys; Ribavirin
Possible Incivek side effects in 50 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10
Patient: 50 year old male, weighing 99.3 kg (218.5 pounds)
Reactions: Febrile Neutropenia, Pancytopenia, Aplastic Anaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Incivek
Dosage: 2 tab tid po
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-02-02
End date: 2012-04-12
Pegasys
Dosage: 180mcg/1200mg sq weekly/po daily other
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-02-02
End date: 2012-04-12
Possible Incivek side effects in male
Reported by a individual with unspecified qualification from United States on 2012-08-08
Patient: male, weighing 148.0 kg (325.6 pounds)
Reactions: Chromatopsia, Loss of Consciousness
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Incivek
Dosage: 2 tablets 3 times a day 7 to 9 hours apart
Indication: HIV Infection
Pegasys
Dosage: 1 a week
Indication: Hepatitis C
Start date: 2012-01-12
Ribavirin
Dosage: twice a day
Indication: HIV Infection
End date: 2012-03-12
Possible Incivek side effects in female
Reported by a physician from United States on 2012-07-31
Patient: female, weighing 87.6 kg (192.8 pounds)
Reactions: Respiratory Failure, Pneumonia Streptococcal, Acute Respiratory Distress Syndrome, Pneumococcal Bacteraemia, Delirium
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Incivek
Other drugs received by patient: Ribavirin; Pegasys
Possible Incivek side effects in 60 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 60 year old female, weighing 68.9 kg (151.7 pounds)
Reactions: Gastrointestinal Haemorrhage, Swelling Face, Dyspnoea, Headache, Tremor, Flushing, Bone Marrow Disorder, Haemoglobin Decreased, Dysgeusia, Heart Rate Decreased, Fatigue, Platelet Count Decreased, Dizziness, Asthenia, Decreased Appetite
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Incivek
Other drugs received by patient: Pegasys Pref; Ribapak 400 MG
Possible Incivek side effects in female
Reported by a individual with unspecified qualification from United States on 2012-07-19
Patient: female, weighing 56.7 kg (124.7 pounds)
Reactions: Adverse Event
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Incivek
Dosage: 2 tablets 7-9 hrs apart
Pegasys
Indication: Hepatitis C
Start date: 2011-09-03
End date: 2012-05-13
Pegasys
Indication: Disease Recurrence
Start date: 2011-09-03
End date: 2012-05-13
Ribavirin
Dosage: (6) a day
Victrelis
Dosage: 12 a day
Possible Incivek side effects in 58 year old female
Reported by a pharmacist from United States on 2012-07-18
Patient: 58 year old female, weighing 72.6 kg (159.7 pounds)
Reactions: Optic Ischaemic Neuropathy
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Incivek
Dosage: 750mg po tid
Administration route: Oral
Indication: Hepatitis C
Maintained ON Peginterferon Alfa and Ribavirin
Dosage: 750mg po tid
Administration route: Oral
Indication: Hepatitis C
Possible Incivek side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-16
Patient: female, weighing 87.6 kg (192.8 pounds)
Reactions: Pneumonia, Acute Respiratory Distress Syndrome
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Incivek
Other drugs received by patient: Ribavirin; Pegasys
Possible Incivek side effects in 68 year old male
Reported by a individual with unspecified qualification from Japan on 2012-07-11
Patient: 68 year old male
Reactions: Anaemia, Acute Myocardial Infarction
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Incivek
Administration route: Oral
Start date: 2012-05-30
End date: 2012-06-04
Incivek
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-03-16
End date: 2012-05-29
Other drugs received by patient: PEG-Intron; PEG-Intron; PEG-Intron; PEG-Intron; Rebetol; Rebetol; PEG-Intron; Rebetol; PEG-Intron; Rebetol; Rebetol; PEG-Intron; NEO-Minophagen C
Possible Incivek side effects in 60 year old male
Reported by a physician from United States on 2012-06-20
Patient: 60 year old male
Reactions: Lymphocyte Morphology Abnormal, Pyrexia, Thrombocytopenia, Drug Rash With Eosinophilia and Systemic Symptoms, Arthritis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Incivek
Other drugs received by patient: Ribavirin; Peginterferon Alfa-2A
Possible Incivek side effects in 50 year old male
Reported by a physician from United States on 2012-06-20
Patient: 50 year old male, weighing 90.8 kg (199.8 pounds)
Reactions: Renal Impairment, Pancytopenia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Incivek
Possible Incivek side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-20
Patient: female, weighing 76.3 kg (167.8 pounds)
Reactions: Fatigue, Malaise, Dyspnoea, Pneumonia Primary Atypical, Blood Uric Acid Increased, Chest Pain, Anaemia, Bronchitis, Oxygen Saturation Decreased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Incivek
Other drugs received by patient: Pegasys; Felodipine; Celexa; Ribavirin; Nexium; Diovan; Prozac
Possible Incivek side effects in 56 year old male
Reported by a consumer/non-health professional from United States on 2012-06-07
Patient: 56 year old male, weighing 62.6 kg (137.7 pounds)
Reactions: Stomatitis, Pruritus, Swelling Face, Dyspnoea, Rash, Swollen Tongue, Skin Lesion, Gait Disturbance, Blister
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Incivek
Possible Incivek side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-23
Patient: female, weighing 86.2 kg (189.6 pounds)
Reactions: Fluid Overload, Diarrhoea, Anaemia, Pain, Postmenopausal Haemorrhage, Asthenia, Muscle Spasms
Adverse event resulted in: death, life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Incivek
Other drugs received by patient: Pegasys; Ribavirin
Possible Incivek side effects in female
Reported by a individual with unspecified qualification from Spain on 2012-05-11
Patient: female, weighing 65.0 kg (143.0 pounds)
Reactions: Aplasia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Incivek
Other drugs received by patient: Peginterferon Alfa-2A; Ribavirin; Norfloxacin
Possible Incivek side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-05-04
Patient: male, weighing 49.0 kg (107.8 pounds)
Reactions: Rhabdomyolysis, Disseminated Intravascular Coagulation, Anaemia, Hepatic Failure, Lactic Acidosis, Factor V Deficiency, Fall, Multi-Organ Failure, Renal Failure, Peritoneal Dialysis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Incivek
Other drugs received by patient: Janumet; Pegasys; Neorecormon; Copegus; Copegus
Possible Incivek side effects in male
Reported by a physician from United States on 2012-03-20
Patient: male, weighing 99.9 kg (219.7 pounds)
Reactions: Blood Bilirubin Increased, Renal Failure, Acute Hepatic Failure, Blood Creatinine Increased, Terminal State
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Incivek
Other drugs received by patient: Pegasys; Methadone HCL; Ribavirin
Possible Incivek side effects in male
Reported by a consumer/non-health professional from United States on 2012-03-15
Patient: male, weighing 100.3 kg (220.7 pounds)
Reactions: Thrombosis, Pneumonia Streptococcal, Asthenia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Incivek
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-09-01
End date: 2012-02-01
Pegasys
Indication: Hepatitis C
Start date: 2011-09-01
End date: 2012-02-01
Ribavirin
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-09-01
End date: 2012-02-01
Other drugs received by patient: NPH Insulin; Lisinopril; Ranitidine
Possible Incivek side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-12
Patient: female, weighing 181.6 kg (399.5 pounds)
Reactions: Ammonia Increased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Incivek
Other drugs received by patient: Ribavirin; Incivek; Pegasys
Possible Incivek side effects in 50 year old male
Reported by a physician from United States on 2012-03-07
Patient: 50 year old male, weighing 90.8 kg (199.8 pounds)
Reactions: Renal Impairment, Pancytopenia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Incivek
Possible Incivek side effects in 61 year old male
Reported by a consumer/non-health professional from United States on 2012-03-06
Patient: 61 year old male, weighing 79.4 kg (174.6 pounds)
Reactions: Nerve Injury, Economic Problem, Headache, Cardiac Disorder, Dyspnoea Exertional, Neck Pain, Therapy Cessation, Dizziness, Diabetes Mellitus Inadequate Control, Blood Pressure Increased, Drug Effect Decreased, Viral Load Increased, Incorrect Dose Administered, Anaemia, Drug Prescribing Error, Dysstasia, Activities of Daily Living Impaired, Treatment Failure, Hepatic Siderosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Incivek
Other drugs received by patient: Ribavirin; Pegagsys
Possible Incivek side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-06
Patient: male
Reactions: Vomiting, Rectal Haemorrhage, Blood Blister, Pyrexia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Incivek
Other drugs received by patient: Ribavirin; Pegasys
Possible Incivek side effects in 39 year old male
Reported by a consumer/non-health professional from United States on 2012-02-13
Patient: 39 year old male, weighing 84.1 kg (185.0 pounds)
Reactions: Homicidal Ideation, Depression, Suicidal Ideation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Incivek
Dosage: 2 tabs q8h po
Administration route: Oral
Start date: 2012-02-04
End date: 2012-02-04
Ribavirin
Dosage: 3 tabs bid po
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-02-02
End date: 2012-02-04
Other drugs received by patient: Pegasys
Possible Incivek side effects in male
Reported by a consumer/non-health professional from United States on 2012-01-11
Patient: male
Reactions: Apnoeic Attack
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Incivek
Other drugs received by patient: Ribavirin; Pegasys
Possible Incivek side effects in 50 year old male
Reported by a physician from United States on 2011-11-10
Patient: 50 year old male, weighing 90.7 kg (199.6 pounds)
Reactions: Pancytopenia, Renal Failure Acute
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Incivek
Dosage: 375 mg
Administration route: Oral
Indication: Disease Recurrence
Start date: 2011-09-01
End date: 2011-10-21
Incivek
Dosage: 375 mg
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-09-01
End date: 2011-10-21
Possible Incivek side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-04
Patient: male
Reactions: Death
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Incivek
Other drugs received by patient: Coumadin; Peginterferon Alfa-2A; Ribavirin
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