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Copegus (Ribavirin) - Side Effect Reports to FDA

 
 



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 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 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 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 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

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 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 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 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 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

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 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



Possible Copegus side effects in female

Reported by a physician from Switzerland on 2012-08-20

Patient: female, weighing 77.0 kg (169.4 pounds)

Reactions: Anaemia, Hypotension, Asthenia, Thrombocytopenia, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pegasys
    Indication: Hepatitis C
    Start date: 2011-07-20
    End date: 2011-10-11

Blinded BI 201335
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-07-20
    End date: 2011-10-11

Copegus
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-07-20
    End date: 2011-10-11

Other drugs received by patient: Excipial U Lipolotion; Lercanidipine; Losartan Potassium; Nebivolol HCL; Depakene; SUN Bath Protective Tanning Lotion; SUN Bath Protective Tanning Lotion



Possible Copegus side effects in male

Reported by a consumer/non-health professional from Chile on 2012-08-20

Patient: male, weighing 84.0 kg (184.8 pounds)

Reactions: Dyspnoea, Muscular Weakness, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pegasys
    Indication: Hepatitis C
    Start date: 2012-07-20
    End date: 2012-08-10

Copegus
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-07-20



Possible Copegus side effects in 65 year old female

Reported by a physician from Spain on 2012-08-20

Patient: 65 year old female

Reactions: Anaemia, Hyponatraemia, Oedema

Drug(s) suspected as cause:
Pegasys
    Indication: Hepatitis C
    Start date: 2012-02-01
    End date: 2012-03-07

Copegus
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-02-01
    End date: 2012-03-02

Copegus
    Administration route: Oral
    Start date: 2012-03-02
    End date: 2012-03-07

Boceprevir
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-03-02
    End date: 2012-03-07

Other drugs received by patient: Furosemide



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

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