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Incivek (Telaprevir) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Incivek (Telaprevir) 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 (5594)
Death (188)
Life Threatening Events (30)
Disability (6)

Reports by Reaction Type

Nausea (874)Fatigue (733)Rash (646)Anaemia (627)Pruritus (502)Diarrhoea (490)Vomiting (488)Anorectal Discomfort (454)Headache (366)Dyspnoea (317)Pyrexia (283)Rash Generalised (277)

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

Possible Incivek side effects in male

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

Patient: male, weighing 77.0 kg (169.4 pounds)

Reactions: Pneumonia, Haemorrhage, Platelet Count Decreased, Liver Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Incivek

Other drugs received by patient: Ribavirin; Pegasys



Possible Incivek side effects in 59 year old female

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

Patient: 59 year old female, weighing 44.0 kg (96.8 pounds)

Reactions: Oesophageal Varices Haemorrhage, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Incivek
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Hepatitis C

PEG-Intron
    Dosage: 120 unk, unk
    Indication: Hepatitis C

Other drugs received by patient: Nadolol; Lasix; Atenolol; Spironolactone; Eprex



Possible Incivek side effects in male

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

Patient: male

Reactions: Nausea, Pancytopenia, Rash, Dysgeusia, Fatigue, Disturbance in Attention, Parosmia, Asthenia, Cough, Influenza Like Illness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Incivek

Other drugs received by patient: Ribasphere; Pegasys; Ribasphere



Possible Incivek side effects in female

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

Patient: female, weighing 83.0 kg (182.6 pounds)

Reactions: Tongue Ulceration, Thermoanaesthesia, Rash Pruritic, Oral Discomfort, Fatigue, Cough, Vomiting, Nausea, Haemorrhoids, Hypoaesthesia, Cognitive Disorder, Aptyalism, Anal Fissure, Anxiety, Throat Irritation, Diarrhoea, Dehydration, Insomnia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Incivek
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-07-27
    End date: 2012-08-04

Pegasys
    Dosage: 180 unk, unk
    Indication: Hepatitis C
    Start date: 2012-07-27
    End date: 2012-08-04

Ribavirin
    Dosage: 600 mg, bid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-07-27
    End date: 2012-08-04



Possible Incivek side effects in female

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

Patient: female

Reactions: Anaemia, Erythema Multiforme

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Incivek

Other drugs received by patient: Pegasys; Ribavirin



Possible Incivek side effects in male

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

Patient: male, weighing 81.6 kg (179.6 pounds)

Reactions: Fatigue, Dizziness, Vision Blurred, Feeling Abnormal, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Incivek
    Dosage: 750 mg, tid
    Administration route: Oral
    Start date: 2012-08-12

Ribavirin
    Dosage: unk
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-07-14
    End date: 2012-08-12

Ribavirin
    Dosage: unk
    Administration route: Oral
    Start date: 2012-08-12

Pegasys
    Dosage: 180 unk, unk
    Start date: 2012-08-12

Pegasys
    Dosage: 180 unk, unk
    Indication: Hepatitis C
    Start date: 2012-07-14
    End date: 2012-08-03

Incivek
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-07-14
    End date: 2012-08-10



Possible Incivek side effects in female

Reported by a physician from France on 2012-08-27

Patient: female, weighing 65.0 kg (143.0 pounds)

Reactions: Mucosal Ulceration, Purpura, Rash Maculo-Papular, Toxic Skin Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pegasys
    Dosage: dosage form: injection
    Indication: Hepatitis C
    Start date: 2012-06-01
    End date: 2012-07-17

Copegus
    Dosage: dosage form: tablets
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-06-01
    End date: 2012-07-17

Incivek
    Dosage: dosage form: tablet
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-06-01
    End date: 2012-07-15

Incivek
    Dosage: dosage form: tablet
    Administration route: Oral
    Start date: 2012-06-01
    End date: 2012-07-15



Possible Incivek side effects in

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

Patient:

Reactions: Hepatic Cirrhosis

Drug(s) suspected as cause:
Incivek

Other drugs received by patient: Peginterferon Alfa-2A; Ribavirin



Possible Incivek side effects in male

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

Patient: male

Reactions: Haematochezia, Pruritus, Anorectal Discomfort, Chest Pain

Drug(s) suspected as cause:
Incivek

Other drugs received by patient: Ribavirin



Possible Incivek side effects in

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

Patient: , weighing 117.9 kg (259.4 pounds)

Reactions: Abscess Rupture, Peritonitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Incivek
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-07-18
    End date: 2012-08-01

Incivek
    Dosage: 750 mg, tid
    Administration route: Oral
    Start date: 2012-01-20
    End date: 2012-05-18

Ribavirin
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2011-07-18
    End date: 2012-05-18

Pegasys
    Dosage: 180 a?g, unk
    Indication: Hepatitis C
    Start date: 2011-07-18
    End date: 2012-05-18



Possible Incivek side effects in male

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

Patient: male

Reactions: Transient Ischaemic Attack

Drug(s) suspected as cause:
Incivek

Other drugs received by patient: Interferon; Ribavirin



Possible Incivek side effects in male

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

Patient: male, weighing 79.0 kg (173.8 pounds)

Reactions: Swelling Face, Neutropenia, Rash Pruritic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Incivek
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-04-01

Pegasys
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-04-01

Ribavirin
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-04-01



Possible Incivek side effects in male

Reported by a pharmacist from United Kingdom on 2012-08-27

Patient: male, weighing 63.0 kg (138.6 pounds)

Reactions: Blood Urea Increased, Neutrophil Count Increased, Glomerular Filtration Rate Decreased, Urinary Tract Infection, Anaemia, Lower Respiratory Tract Infection, Haemoglobin Decreased, Renal Impairment, Escherichia Test Positive, C-Reactive Protein Increased, Flank Pain, Dysuria, Pollakiuria, Blood Creatinine Increased, White Blood Cell Count Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ibuprofen
    Administration route: Oral
    Indication: Pain
    End date: 2012-05-08

Ibuprofen
    Administration route: Oral

Incivek
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-02-26
    End date: 2012-05-09

Other drugs received by patient: Aranesp; Acetaminophen; Methadone HCL; Mirtazapine; Fluticasone Propionate / Salmeterol; Ribavirin; Peginterferon Alfa-2B; Albuterol Sulate; Tiotropium



Possible Incivek side effects in female

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

Patient: female

Reactions: Abscess Limb

Drug(s) suspected as cause:
Interferon
    Indication: Hepatitis C

Incivek
    Administration route: Oral
    Indication: Hepatitis C

Ribavirin
    Indication: Hepatitis C



Possible Incivek side effects in female

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

Patient: female, weighing 66.7 kg (146.8 pounds)

Reactions: Anaemia, Neutropenia, Thrombocytopenia

Drug(s) suspected as cause:
Pegasys
    Indication: Hepatitis C
    Start date: 2012-05-30
    End date: 2012-07-29

Incivek
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-05-31
    End date: 2012-07-29

Copegus
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-05-31
    End date: 2012-07-29



Possible Incivek side effects in 59 year old female

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

Patient: 59 year old female, weighing 44.0 kg (96.8 pounds)

Reactions: Anaemia, Melaena

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Incivek

Other drugs received by patient: Eprex; Spironolactone; Atenolol; Lasix; PEG-Intron; Nadolol



Possible Incivek side effects in female

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

Patient: female, weighing 62.6 kg (137.7 pounds)

Reactions: Vomiting, Nausea

Drug(s) suspected as cause:
Incivek

Other drugs received by patient: Ribavirin; Pegasys



Possible Incivek side effects in male

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

Patient: male, weighing 157.0 kg (345.4 pounds)

Reactions: Depression, Suicidal Ideation

Drug(s) suspected as cause:
Peginterferon Alfa-2A
    Dosage: unk
    Start date: 2012-05-24

Incivek
    Dosage: unk
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-05-24
    End date: 2012-08-10

Other drugs received by patient: Sertraline Hydrochloride; Methadone HCL; Ribavirin; Seroquel



Possible Incivek side effects in 60 year old male

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

Patient: 60 year old male, weighing 34.5 kg (75.9 pounds)

Reactions: Small Intestinal Obstruction, Off Label Use, Abdominal Pain, Abnormal Faeces

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Incivek

Other drugs received by patient: Famotidine; Calcium Carbonate; Levothyroxine Sodium; Peginterferon Alfa-2A; Ribavirin; Aspirin; Atripla; Diazepam; Haldol; Ibuprofen; Cogentin



Possible Incivek side effects in male

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

Patient: male

Reactions: Drug Interaction, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Incivek

Other drugs received by patient possibly interacting with the suspect drug:
Ribavirin
    Dosage: 1000 mg, unk
    Indication: Hepatitis C
    Start date: 2012-07-13
    End date: 2012-07-19

Ramipril
    Dosage: 5 mg, unk
    Indication: Product Used FOR Unknown Indication

Lisinopril
    Dosage: 5 mg, unk

Pegasys
    Dosage: 180 a?g, unk
    Indication: Hepatitis C
    Start date: 2012-07-13
    End date: 2012-07-19

Other drugs received by patient: Zantac



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:
Pegasys
    Indication: Hepatitis C
    Start date: 2011-10-27
    End date: 2012-01-23

Copegus
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-10-27
    End date: 2012-01-23

Incivek
    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

Other drugs received by patient: Neorecormon



Possible Incivek side effects in male

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

Patient: male, weighing 85.5 kg (188.0 pounds)

Reactions: Pemphigus, Stevens-Johnson Syndrome

Drug(s) suspected as cause:
Ribavirin
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-06-25
    End date: 2012-07-01

Incivek
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-06-25
    End date: 2012-07-01

Pegasys
    Indication: Hepatitis C
    Start date: 2012-06-25
    End date: 2012-07-01

Losartan Potassium
    Dosage: 50 mg, qd
    Administration route: Oral



Possible Incivek side effects in 63 year old male

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

Patient: 63 year old male

Reactions: Pruritus, Hypersensitivity, Nausea, Pyrexia, Generalised Erythema, Mood Altered, Asthenia, Decreased Appetite, Epistaxis

Drug(s) suspected as cause:
Incivek
    Indication: Product Used FOR Unknown Indication

Incivek
    Dosage: dosage form: tablet
    Indication: Hepatitis C
    Start date: 2012-06-10



Possible Incivek 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:
Incivek

Other drugs received by patient: Pegasys; Ribavirin



Possible Incivek side effects in

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

Patient:

Reactions: Weight Decreased, Pruritus, Rash Generalised, Tremor, Haemorrhoidal Haemorrhage, Haematochezia, Fatigue, Anal Pruritus, Diarrhoea, Anorectal Discomfort, Musculoskeletal Stiffness, Emotional Disorder, Decreased Appetite

Drug(s) suspected as cause:
Incivek

Other drugs received by patient: Pegasys; Ribavirin; Lorazepam; Sertraline Hydrochloride



Possible Incivek side effects in male

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

Patient: male

Reactions: Weight Decreased, Urinary Tract Infection, Tuberculosis, Crystal Urine Present, Urine Colour Abnormal, Thyroid Disorder

Drug(s) suspected as cause:
Incivek

Other drugs received by patient: Interferon Alfa; Ribavirine



Possible Incivek side effects in 49 year old male

Reported by a pharmacist from United Kingdom on 2012-08-24

Patient: 49 year old male, weighing 63.0 kg (138.6 pounds)

Reactions: Neutrophil Count Increased, Blood Urea Increased, Glomerular Filtration Rate Decreased, Urinary Tract Infection, Anaemia, Lower Respiratory Tract Infection, Haemoglobin Decreased, Renal Impairment, Escherichia Test Positive, C-Reactive Protein Increased, Flank Pain, Dysuria, Pollakiuria, Blood Creatinine Increased, White Blood Cell Count Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ibuprofen
    Dosage: 400 mg, tid
    Administration route: Oral
    Indication: Pain
    End date: 2012-05-08

Incivek
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-02-26
    End date: 2012-05-09

Other drugs received by patient: Mirtazapine; Acetaminophen; Ribavirin; Albuterol Sulate; Fluticasone Propionate / Salmeterol; Darbepoetin Alfa; Tiotropium; Methadone Hydrochloride; Peginterferon Alfa-2B



Possible Incivek side effects in male

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

Patient: male, weighing 114.0 kg (250.8 pounds)

Reactions: Retinal Detachment, Anal Pruritus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Incivek

Other drugs received by patient: Atenolol; Ribavirin; Atenolol; PEG-Intron



Possible Incivek side effects in

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

Patient:

Reactions: Haemoglobin Decreased, Hepatic Function Abnormal, Erythema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rebetol
    Dosage: 400 mg, qd
    Administration route: Oral
    Start date: 2012-04-20

Rebetol
    Dosage: 400 mg, once
    Administration route: Oral
    Start date: 2012-04-20
    End date: 2012-05-11

Rebetol
    Dosage: 800 mg, qd
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-01-13
    End date: 2012-04-19

PEG-Intron
    Dosage: 1.2mcg/kg/week
    Start date: 2012-03-23

Incivek
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-02-07
    End date: 2012-04-30

Antiviral (Unspecified)
    Dosage: 2250 mg, qd
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-02-07
    End date: 2012-04-30

PEG-Intron
    Dosage: 1.5mcg/kg/week
    Indication: Hepatitis C
    Start date: 2012-01-13
    End date: 2012-03-22

PEG-Intron
    Dosage: 1.5 microgram per kilogram, unk
    End date: 2012-05-04

Other drugs received by patient: Branute; Allegra; Selbex; Loxoprofen; Posterisan; Posterisan; Heparinoid; Flurbiprofen; Branute; Hirudoid; Livostin; Flurbiprofen; Livostin; Allegra



Possible Incivek side effects in

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

Patient:

Reactions: Nausea

Drug(s) suspected as cause:
PEG-Intron

Incivek
    Dosage: 2 df, q8h
    Administration route: Oral

Rebetol
    Administration route: Oral

Other drugs received by patient: Lorazepam; Ferrous Sulfate TAB; Levothyroxine Sodium; Tylenol

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