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Incivek (Telaprevir) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



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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