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 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 2012-08-27
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 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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