This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Copegus (Ribavirin) 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 (1416)
Death (164)
Life Threatening Events (88)
Disability (51)
Reports by Reaction Type
Anaemia (233),
Pyrexia (105),
Thrombocytopenia (88),
Asthenia (74),
Pancytopenia (73),
Nausea (70),
Pneumonia (68),
White Blood Cell Count Decreased (67),
Fatigue (63),
Vomiting (62),
Syncope (62),
Dyspnoea (59)
Below are a few examples of reports where side effects / adverse reactions may be related to Copegus (Ribavirin). For a complete list or a specific selection of reports, please use the links above.
Possible Copegus 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 Copegus 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 Copegus side effects in female
Reported by a physician from Turkey on 2012-08-24
Patient: female, weighing 58.0 kg (127.6 pounds)
Reactions: Anaemia, Platelet Count Decreased, Leukopenia
Drug(s) suspected as cause:
VX-950
Dosage: dosage form: tablet, 3 times as two tablet
Administration route: Oral
Indication: Hepatitis C
Pegasys
Dosage: dosage form: unspecified
Indication: Hepatitis C
Copegus
Dosage: dosage form: unknown
Indication: Hepatitis C
Possible Copegus side effects in
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient:
Reactions: Urinary Tract Infection, Anaemia, Pain, Transfusion, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pegasys
Copegus
Administration route: Oral
Victrelis
Atenolol
Administration route: Oral
Other drugs received by patient: Benazepril Hydrochloride; Allopurinol; Estrogens (Unspecified)
Possible Copegus 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 Copegus side effects in female
Reported by a physician from Mexico on 2012-08-24
Patient: female, weighing 58.5 kg (128.7 pounds)
Reactions: Anaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
VX-950
Dosage: 1125 mg, qd
Indication: Hepatitis C
Start date: 2011-05-30
End date: 2011-08-22
Copegus
Dosage: 600 mg, unk
Administration route: Oral
Start date: 2011-08-31
End date: 2011-11-13
Pegasys
Dosage: 135 a?g, weekly
Start date: 2011-11-07
End date: 2011-11-07
Pegasys
Dosage: 135 a?g, weekly
Indication: Hepatitis C
Start date: 2011-07-01
End date: 2011-10-31
Pegasys
Dosage: 180 a?g, weekly
Start date: 2011-05-30
End date: 2011-06-30
Copegus
Dosage: 1000 mg, unk
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-05-30
End date: 2011-06-30
Copegus
Dosage: 600 mg, unk
Administration route: Oral
Start date: 2011-07-01
End date: 2011-08-22
Copegus
Dosage: unk mg, unk
Administration route: Oral
Start date: 2011-08-23
End date: 2011-08-30
Pegasys
Dosage: 90 a?g, weekly
Start date: 2011-11-01
End date: 2011-11-06
Other drugs received by patient: Erythropoetin; Valsartan; Erythropoetin; Nimodipine; Erythropoetin; Troxerutin; Coumarin; Acetaminophen
Possible Copegus side effects in female
Reported by a physician from United States on 2012-08-24
Patient: female
Reactions: Malaise, Dialysis, Congestive Cardiomyopathy, Pyrexia, Cholecystitis, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Copegus
Dosage: tdd: 1200 mg, last dose prior to sae: 03/may/2012
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-02-07
Pegasys
Dosage: tdd:180 microgram, last dose prior to sae: 03/may/2012
Indication: Hepatitis C
Start date: 2012-02-07
Blinded INX-08189
Dosage: last dose prior to sae: 03/may/2012
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-02-07
Other drugs received by patient: Sumatriptan; Benzocaine; Lisinopril; Lidocaine; Ibuprofen; Ondansetron; Metoprolol Tartrate; Theraflu (Unk Ingredients); Ibuprofen; Ibuprofen; Benadryl; Amoxicillin; Zosyn; Lorazepam; Prednisone TAB; Tylenol; Tylenol; Ambien; Norco; Robitussin (Canada); Dilaudid; Zofran; Methylprednisone (Unk Ingredients); Magnesium Oxide; Ferrous Gluconate; Fentanyl; Hydrocodone Bitartrate; Ibuprofen
Possible Copegus side effects in 75 year old female
Reported by a physician from Japan on 2012-08-23
Patient: 75 year old female
Reactions: Stomatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pegasys
Dosage: dosage is uncertain.
Indication: Hepatitis C
Start date: 2012-05-02
End date: 2012-08-13
Copegus
Dosage: dosage is uncertain.
Administration route: Oral
Indication: Hepatitis C
Possible Copegus side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23
Patient:
Reactions: Anaemia, Pain, Urinary Tract Infection, Transfusion, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Victrelis
Administration route: Oral
Pegasys
Atenolol
Administration route: Oral
Copegus
Administration route: Oral
Other drugs received by patient: Allopurinol; Estrogens (Unspecified); Victrelis; Benazepril Hydrochloride
Possible Copegus side effects in
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient:
Reactions: Subcutaneous Abscess, Anaemia, Anal Abscess, Neutropenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Copegus
Dosage: unk
End date: 2012-01-26
Victrelis
Dosage: 800 mg, tid
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-11-25
End date: 2012-01-26
Pegasys
Dosage: unk
End date: 2012-01-26
Possible Copegus side effects in male
Reported by a physician from Romania on 2012-08-23
Patient: male
Reactions: Clinically Isolated Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pegasys
Dosage: last dose prior to sae:28/feb/2012
Indication: Hepatitis C
Start date: 2011-05-24
Tg4040
Dosage: last dose prior to sae:19/sep/2011
Indication: Product Used FOR Unknown Indication
Start date: 2011-02-28
Copegus
Dosage: last dose prior to sae:04/mar/2012
Indication: Hepatitis C
Start date: 2011-05-24
Possible Copegus side effects in
Reported by a consumer/non-health professional from France on 2012-08-23
Patient:
Reactions: Oedema Peripheral, Neutropenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pegasys
Administration route: Oral
Copegus
Administration route: Oral
Victrelis
Administration route: Oral
Other drugs received by patient: Propranolol; Aldactone; Pantoprazole Sodium; Noroxin
Possible Copegus side effects in
Reported by a individual with unspecified qualification from Germany on 2012-08-23
Patient:
Reactions: Renal Failure, Nausea, Haemolysis
Drug(s) suspected as cause:
Copegus
Possible Copegus side effects in female
Reported by a physician from Japan on 2012-08-23
Patient: female, weighing 55.5 kg (122.1 pounds)
Reactions: Malaise
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Blinded BI 201335
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-12-06
End date: 2012-02-03
Pegasys
Indication: Hepatitis C
Start date: 2011-12-06
End date: 2012-01-30
Copegus
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-12-06
End date: 2012-02-03
Possible Copegus side effects in 54 year old male
Reported by a physician from Algeria on 2012-08-23
Patient: 54 year old male
Reactions: Pruritus Generalised, Rash Erythematous
Drug(s) suspected as cause:
Pegasys
Indication: Hepatitis C
Start date: 2010-07-19
Copegus
Indication: Hepatitis C
Start date: 2010-07-19
Possible Copegus side effects in female
Reported by a physician from France on 2012-08-22
Patient: female, weighing 52.0 kg (114.4 pounds)
Reactions: Gingival Bleeding, Ecchymosis, Anaemia, Rectal Haemorrhage, Thrombocytopenia, Epistaxis, Leukopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Copegus
Administration route: Oral
End date: 2012-07-03
Copegus
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-01-17
End date: 2012-07-03
Pegasys
Indication: Hepatitis C
Start date: 2012-01-17
End date: 2012-07-03
Pegasys
End date: 2012-07-03
Other drugs received by patient: Metformin HCL
Possible Copegus side effects in 67 year old female
Reported by a physician from Japan on 2012-08-22
Patient: 67 year old female
Reactions: Disseminated Intravascular Coagulation, Staphylococcal Sepsis, Anti-Neutrophil Cytoplasmic Antibody Positive Vasculitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pegasys
Dosage: dosage is uncertain.
Indication: Hepatitis C
Copegus
Dosage: dosage is uncertain.
Administration route: Oral
Indication: Hepatitis C
Possible Copegus side effects in
Reported by a physician from Germany on 2012-08-22
Patient:
Reactions: Foetal Malformation, Exposure VIA Father
Drug(s) suspected as cause:
Copegus
Indication: Hepatitis C
Blinded Daclatasvir
Indication: Hepatitis C
Pegasys
Indication: Hepatitis C
Possible Copegus side effects in
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient:
Reactions: Weight Increased, Swelling Face, Joint Swelling, Abdominal Distension, Influenza
Drug(s) suspected as cause:
Copegus
Dosage: 1200 mg devided doses
Victrelis
Dosage: 4 df, tid
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-09-10
Peginterferon Alfa-2A
Dosage: 180 microgram, qw
Indication: Hepatitis C
Start date: 2011-08-20
Copegus
Dosage: 1000 mg devided doses
Indication: Hepatitis C
Start date: 2011-08-20
Copegus
Dosage: 800 mg devided doses
Other drugs received by patient: Magnesium Hydroxide TAB; Neurontin; Zoloft
Possible Copegus side effects in 49 year old male
Reported by a individual with unspecified qualification from France on 2012-08-22
Patient: 49 year old male, weighing 96.0 kg (211.2 pounds)
Reactions: Vomiting, General Physical Health Deterioration, Pyrexia, Multi-Organ Failure, Neutropenia, Asthenia, Septic Shock, Leukopenia, Infectious Peritonitis
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Boceprevir
Dosage: 800 mg, tid
Indication: Hepatitis C
Start date: 2012-05-29
End date: 2012-06-06
Pegasys
Dosage: 180 ?g, qw
Indication: Hepatitis C
Start date: 2012-04-30
End date: 2012-06-06
Copegus
Dosage: 1200 mg, qd
Indication: Hepatitis C
Start date: 2012-04-30
End date: 2012-06-06
Other drugs received by patient: Vitamin D; Aldactone; Ixel; Neupogen; Delursan; Abilify; Lasix; Revolade
Possible Copegus side effects in
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-21
Patient:
Reactions: Rheumatoid Arthritis, Respiratory Disorder, Psychiatric Symptom, Endocrine Disorder, Pancytopenia, Skin Disorder, Neutropenia, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Peginterferon Alfa-2B
Indication: Hepatitis C
Pegasys
Indication: Hepatitis C
Copegus
Indication: Hepatitis C
Possible Copegus side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: male
Reactions: Confusional State, Dyspnoea, Disorientation, Rash Pruritic, Loss of Consciousness, Burning Sensation, Malaise, Hypersomnia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pegasys
Indication: Hepatitis C
Start date: 2012-05-14
End date: 2012-07-30
Copegus
Indication: Hepatitis C
End date: 2012-07-30
Telaprevir
Indication: Hepatitis C
End date: 2012-07-30
Possible Copegus side effects in
Reported by a physician from Brazil on 2012-08-21
Patient:
Reactions: Migraine, Pneumonia, Anaemia, Hyponatraemia, Cystitis, Oesophageal Varices Haemorrhage, Syncope, Neutropenia, Thrombocytopenia, Leukopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Peginterferon Alfa-2A
Indication: Hepatitis C
Copegus
Dosage: for 24 weeks
Administration route: Oral
Indication: Hepatitis C
Possible Copegus side effects in 50 year old male
Reported by a physician from Germany on 2012-08-21
Patient: 50 year old male, weighing 91.0 kg (200.2 pounds)
Reactions: Laryngeal Oedema
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pegasys
Indication: Hepatitis C
Start date: 2012-05-22
Copegus
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-05-22
Victrelis
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-07-02
Possible Copegus side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: male
Reactions: Vomiting, Pneumonia, Swelling Face, Haemorrhage, Anaemia, Bone Swelling, Ill-Defined Disorder, Platelet Count Decreased, Fluid Retention
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pegasys
Indication: Hepatitis C
Start date: 2012-05-23
Copegus
Indication: Hepatitis C
Start date: 2012-05-23
Telaprevir
Indication: Hepatitis C
Start date: 2012-05-23
Possible Copegus side effects in female
Reported by a physician from Germany on 2012-08-20
Patient: female, weighing 70.0 kg (154.0 pounds)
Reactions: Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pegasys
Indication: Hepatitis C
Start date: 2012-06-22
Copegus
Indication: Hepatitis C
Boceprevir
Indication: Hepatitis C
Possible Copegus side effects in 43 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-20
Patient: 43 year old male
Reactions: Oedema Peripheral, Neutropenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Victrelis
Administration route: Oral
Copegus
Pegasys
Other drugs received by patient: Propranolol; Aldactone; Pantoprazole Sodium; Noroxin
Possible Copegus side effects in 45 year old female
Reported by a physician from Japan on 2012-08-20
Patient: 45 year old female
Reactions: Sick Sinus Syndrome
Drug(s) suspected as cause:
Pegasys
Dosage: dosage is uncertain.
Indication: Hepatitis C
Copegus
Dosage: dosage is uncertain.
Administration route: Oral
Indication: Hepatitis C
Possible Copegus side effects in male
Reported by a physician from Belgium on 2012-08-20
Patient: male, weighing 84.0 kg (184.8 pounds)
Reactions: Back Pain, Pyrexia, Headache, Keratosis Follicular, Myalgia, Neck Pain, Dysuria, Gastroenteritis, Balanitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
BI 201335 (Hcv Protease Inhibitor)
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-11-10
End date: 2011-11-27
Pegasys
Dosage: last date of administration: 27 nov 2011
Indication: Hepatitis C
Start date: 2011-11-10
End date: 2011-11-27
Copegus
Dosage: last date of administration: 27 nov 2011
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-11-10
End date: 2011-11-27
Possible Copegus side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: male
Reactions: White Blood Cell Count Decreased, Blood Pressure Decreased, Loss of Consciousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pegasys
Indication: Product Used FOR Unknown Indication
Copegus
Indication: Product Used FOR Unknown Indication
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