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Ribavirin (Ribavirin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to 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 (2029)
Death (161)
Life Threatening Events (89)
Disability (71)

Reports by Reaction Type

Anaemia (335)Nausea (227)Fatigue (221)White Blood Cell Count Decreased (171)Weight Decreased (153)Vomiting (150)Asthenia (147)Dyspnoea (146)Rash (125)Dysgeusia (113)Depression (111)Headache (108)

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

Possible Ribavirin 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 Ribavirin side effects in male

Reported by a health professional (non-physician/pharmacist) from China on 2012-08-27

Patient: male, weighing 61.5 kg (135.3 pounds)

Reactions: Occult Blood, Anaemia, Faeces Discoloured

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pegasys
    Indication: Hepatitis C
    Start date: 2009-02-01
    End date: 2009-04-07

Ribavirin
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2008-08-01
    End date: 2009-04-07

Other drugs received by patient: Sirolimus



Possible Ribavirin side effects in

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

Patient:

Reactions: Breast Pain, Viral Load Increased, Varicose Vein Ruptured, Drug Ineffective, Pyrexia, Hypoaesthesia, Gynaecomastia, Malaise, Overdose, Swelling, Alopecia, Oedema Peripheral, Sensitivity of Teeth, Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ribavirin
    Dosage: unk, bid
    Administration route: Oral
    Start date: 2012-04-01
    End date: 2012-06-18

Victrelis
    Dosage: unk, tid
    Administration route: Oral
    Start date: 2012-04-01
    End date: 2012-06-18

Ribavirin
    Dosage: unk
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2005-01-01
    End date: 2005-01-01

Victrelis
    Dosage: 800 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-01-18
    End date: 2012-04-01

Ribavirin
    Dosage: unk
    Administration route: Oral
    Start date: 2011-12-01
    End date: 2012-04-01

Other drugs received by patient: Coumadin; Coumadin; Pegasys; Lansoprazole; Pegasys; Pegasys



Possible Ribavirin side effects in male

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

Patient: male, weighing 71.0 kg (156.2 pounds)

Reactions: Neutropenia

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

VX-950
    Dosage: unk
    Administration route: Oral
    Indication: Hepatitis C

Peginterferon Alfa-2A
    Indication: Hepatitis C

Other drugs received by patient: Dexeryl



Possible Ribavirin 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 Ribavirin side effects in

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

Patient:

Reactions: Irritability, Fatigue

Drug(s) suspected as cause:
PEG-Intron
    Dosage: 150 ?g, qw
    Indication: Hepatitis C
    Start date: 2012-05-16

Ribavirin
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Orgasuline Rapide; Antiviral (Unspecified)



Possible Ribavirin side effects in male

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

Patient: male

Reactions: Drug Ineffective, Diabetes Mellitus, Urinary Tract Infection, Musculoskeletal Stiffness, Diabetic Complication, Influenza Like Illness

Drug(s) suspected as cause:
Pegasys
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-02-08
    End date: 2006-06-16

Ribavirin
    Indication: Product Used FOR Unknown Indication



Possible Ribavirin side effects in male

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

Patient: male

Reactions: Night Sweats, Body Temperature Increased, Anaemia, Ascites, Dysgeusia, Insomnia, Blood Uric Acid Increased, Oedema Peripheral, Sinusitis

Drug(s) suspected as cause:
Ribavirin
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-11-20

VX-950
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-11-20
    End date: 2012-02-12

Pegasys
    Dosage: 180 a?g, unk
    Indication: Hepatitis C
    Start date: 2011-11-20



Possible Ribavirin side effects in female

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

Patient: female

Reactions: Dehydration, Anaemia, Lower Respiratory Tract Inflammation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
VX-950
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-02-15

Ribavirin
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-02-15

PEG-Intron
    Dosage: unk
    Indication: Hepatitis C
    Start date: 2012-02-15



Possible Ribavirin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient:

Reactions: Anaemia

Drug(s) suspected as cause:
Pegasys

Ribavirin

Victrelis
    Dosage: 800 mg, tid
    Start date: 2012-03-01
    End date: 2012-05-10

Other drugs received by patient: Simvastatin; Plavix; Lisinopril and Hydrochlorothiazide



Possible Ribavirin side effects in female

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

Patient: female

Reactions: Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ribavirin
    Dosage: 600 mg, unk
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-07-23

VX-950
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-07-23

Pegasys
    Dosage: 180 unk, unk
    Indication: Hepatitis C
    Start date: 2012-07-23



Possible Ribavirin side effects in

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

Patient:

Reactions: Anaemia

Drug(s) suspected as cause:
Ribavirin
    Dosage: 400 mg, qd
    Administration route: Oral
    Start date: 2012-02-08

PEG-Intron
    Dosage: 1.5 ?g/kg, qw
    Indication: Hepatitis C

Ribavirin
    Dosage: 800 mg, qd
    Administration route: Oral
    Indication: Hepatitis C
    End date: 2012-02-07

Antiviral (Unspecified)
    Dosage: 2250 mg, qd
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-01-04

Other drugs received by patient: Lorfenamin; Livalo; Epadel S; Claritin Reditabs; Sodium Ferrous Citrate



Possible Ribavirin side effects in female

Reported by a consumer/non-health professional from Russian Federation on 2012-08-27

Patient: female

Reactions: Tooth Extraction, Oedema, Dental Care

Drug(s) suspected as cause:
Pegasys
    Indication: Hepatitis C
    Start date: 2011-08-16
    End date: 2012-06-29

Ribavirin
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-08-16
    End date: 2012-06-29

Other drugs received by patient: Tmc435



Possible Ribavirin side effects in male

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

Patient: male, weighing 90.6 kg (199.3 pounds)

Reactions: Rash, Sensorimotor Disorder

Drug(s) suspected as cause:
Investigational Drug (Unspecified)
    Dosage: 2 df, qd
    Administration route: Oral
    Start date: 2012-01-19
    End date: 2012-03-13

Ribavirin
    Dosage: 600 mg, bid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-12-29
    End date: 2012-01-18

Placebo
    Dosage: 1 df, bid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-12-29
    End date: 2012-01-18

GS-5885
    Dosage: 3 df, qd
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-12-29
    End date: 2012-01-18

Investigational Drug (Unspecified)
    Dosage: 2 df, qd
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-12-29
    End date: 2012-01-18

Ribavirin
    Dosage: 600 mg, bid
    Administration route: Oral
    Start date: 2011-01-19
    End date: 2012-03-13

GS-5885
    Dosage: 3 df, qd
    Administration route: Oral
    Start date: 2012-01-19
    End date: 2012-03-13

Peginterferon Alfa-2A
    Dosage: 180 microgram, qw
    Indication: Hepatitis C
    Start date: 2012-01-19
    End date: 2012-03-09

Other drugs received by patient: Metoprolol Tartrate; Celexa; Codeine Sulfate; Sulindac; Zithromax; Tylenol; Aspirin; Ranitidine



Possible Ribavirin side effects in

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

Patient:

Reactions: Anaemia, Rash, Haemolytic Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Antiviral (Unspecified)
    Dosage: 1500 mg, qd
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-01-31
    End date: 2012-03-16

Ribavirin
    Dosage: 400 mg, qd
    Administration route: Oral
    Start date: 2012-04-24
    End date: 2012-05-21

Ribavirin
    Dosage: 500 mg, qd
    Administration route: Oral
    Start date: 2012-05-22

Ribavirin
    Dosage: 200 mg, qd
    Administration route: Oral
    Start date: 2012-03-21
    End date: 2012-04-03

Telavic
    Dosage: 1500 mg, qd
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-01-31
    End date: 2012-03-16

Ribavirin
    Dosage: 400 mg, qd
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-01-31
    End date: 2012-02-27

Ribavirin
    Dosage: 200 mg, qd
    Administration route: Oral
    Start date: 2012-02-28
    End date: 2012-03-17

Ribavirin
    Dosage: 300 mg, qd
    Administration route: Oral
    Start date: 2012-04-04
    End date: 2012-04-23

PEG-Intron
    Dosage: 1.5 microgram per kilogram, qw
    Indication: Hepatitis C
    Start date: 2012-01-31
    End date: 2012-03-15

Other drugs received by patient: Coniel; Famotidine; Allopurinol; Celestamine (Betamethasone (+) Dexchlorpheniramine Maleate (+) Fluphen; Isosorbide Dinitrate



Possible Ribavirin 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 Ribavirin side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: female

Reactions: Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ribavirin
    Indication: Hepatitis C
    Start date: 2007-11-15
    End date: 2008-10-01

Pegasys
    Indication: Hepatitis C
    Start date: 2007-11-15
    End date: 2008-10-01



Possible Ribavirin 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 Ribavirin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient:

Reactions: HIP Arthroplasty

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simvastatin

Simvastatin

Ribavirin

Simvastatin

Blinded Narlaprevir

Simvastatin

Blinded Boceprevir

Simvastatin

Simvastatin

Peginterferon Alfa-2B

Placebo



Possible Ribavirin side effects in male

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

Patient: male, weighing 90.7 kg (199.5 pounds)

Reactions: Fatigue, Wrist Fracture, Diarrhoea, Liver Function Test Abnormal, Anaemia, Haemorrhoids, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ribavirin
    Dosage: 1000 mg, bid
    Administration route: Oral
    Indication: Hepatitis C
    End date: 2012-07-01

VX-950
    Dosage: unk
    Administration route: Oral

VX-950
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-07-01
    End date: 2011-10-01

Pegasys
    Dosage: 180 unk, unk
    Indication: Hepatitis C
    End date: 2012-07-01



Possible Ribavirin 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 Ribavirin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-25

Patient: female

Reactions: Cholelithiasis, Weight Decreased, Peroneal Nerve Palsy, Fear, Transfusion, Asthenia, Myocardial Infarction, Blood Test Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ribavirin
    Indication: Hepatitis C
    Start date: 2011-09-16

Pegasys
    Indication: Hepatitis C
    Start date: 2011-09-16
    End date: 2012-06-27

Victrelis
    Indication: Hepatitis C
    End date: 2012-06-27

Ribavirin
    End date: 2012-06-27



Possible Ribavirin side effects in female

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

Patient: female, weighing 65.8 kg (144.8 pounds)

Reactions: Nausea, Haemorrhoids, Headache, Rash, Tremor, Loss of Consciousness, Dysgeusia, Haematochezia, Fatigue, Malaise, RED Blood Cell Count Decreased, Blood Potassium Decreased, Diarrhoea, Insomnia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ribavirin

Telaprevir
    Dosage: 375 mg 2 tablets tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-04-30
    End date: 2012-07-27

Pegasys
    Indication: Hepatitis C
    Start date: 2012-04-30

Ribavirin
    Dosage: divided doses
    Indication: Hepatitis C
    Start date: 2012-04-30

Other drugs received by patient: Cymbalta; Zofran; Vitamin D; Lisinopril; Omeprazole; Lasix; Trazodone Hydrochloride



Possible Ribavirin side effects in male

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

Patient: male

Reactions: Post Procedural Complication

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pegasys
    Dosage: 180mcg q week sq
    Indication: Hepatitis C
    Start date: 2012-06-14
    End date: 2012-07-10

Ribavirin
    Dosage: 1000mg daily po
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-06-14
    End date: 2012-07-10



Possible Ribavirin side effects in female

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

Patient: female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous, Pregnancy

Drug(s) suspected as cause:
Ribavirin



Possible Ribavirin side effects in 69 year old female

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

Patient: 69 year old female

Reactions: White Blood Cell Count Decreased, Haemoglobin Decreased

Drug(s) suspected as cause:
Peginterferon Alfa-2B
    Dosage: 80 unk, unk
    Indication: Hepatitis C
    Start date: 2012-02-07
    End date: 2012-02-21

Peginterferon Alfa-2B
    Dosage: 50 unk, unk
    Start date: 2012-02-28
    End date: 2012-07-27

Ribavirin
    Dosage: 200 mg, unk
    Administration route: Oral
    Start date: 2012-03-06
    End date: 2012-06-28

Ribavirin
    Dosage: 400 unk, qd
    Administration route: Oral
    Start date: 2012-06-29
    End date: 2012-07-26

Ribavirin
    Dosage: 600 mg, unk
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-02-07
    End date: 2012-02-20

Ribavirin
    Dosage: 400 mg, unk
    Administration route: Oral
    Start date: 2012-02-21
    End date: 2012-03-05

VX-950
    Dosage: 2250 mg, qd
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-02-07
    End date: 2012-03-22

VX-950
    Dosage: 1500 mg, qd
    Administration route: Oral
    Start date: 2012-03-23
    End date: 2012-05-04

Other drugs received by patient: Mucosta; Marzulene-S; Urso / 00465701 /; Famotidine



Possible Ribavirin side effects in 67 year old female

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

Patient: 67 year old female

Reactions: Nausea, Anaemia, Platelet Count Decreased, Blood Creatinine Increased, Hyperuricaemia, Decreased Appetite

Drug(s) suspected as cause:
PEG-Intron
    Dosage: 0.94 a?g/kg, unk
    Start date: 2012-04-06
    End date: 2012-04-26

Ribavirin
    Dosage: 200 mg, qd
    Administration route: Oral
    Start date: 2012-03-16
    End date: 2012-04-19

VX-950
    Dosage: 750 mg, qd
    Administration route: Oral
    Start date: 2012-03-23
    End date: 2012-04-13

Ribavirin
    Dosage: 400 mg, qd
    Administration route: Oral
    Start date: 2012-02-24
    End date: 2012-03-15

Ribavirin
    Dosage: 400 mg, qd
    Administration route: Oral
    Start date: 2012-04-20
    End date: 2012-08-02

PEG-Intron
    Dosage: 1.3 a?g/kg, unk
    Start date: 2012-03-30

VX-950
    Dosage: 1500 mg, qd
    Administration route: Oral
    Start date: 2012-02-24
    End date: 2012-03-22

PEG-Intron
    Dosage: 1.13 a?g/kg, unk
    Start date: 2012-04-27
    End date: 2012-05-10

VX-950
    Dosage: 2250 mg, qd
    Indication: Hepatitis C
    Start date: 2012-02-17
    End date: 2012-02-23

Ribavirin
    Dosage: 600 mg, qd
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-02-17
    End date: 2012-02-23

PEG-Intron
    Dosage: 1.3 a?g/kg, unk
    Start date: 2012-05-11
    End date: 2012-08-02

PEG-Intron
    Dosage: 1.5 a?g/kg, unk
    Indication: Hepatitis C
    Start date: 2012-02-17
    End date: 2012-03-29

PEG-Intron
    Start date: 2012-05-11

Other drugs received by patient: Diovan; Urso / 00465701 /; Innolet; Amlodipine



Possible Ribavirin side effects in 45 year old female

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

Patient: 45 year old female

Reactions: Abdominal Pain Upper

Drug(s) suspected as cause:
Ribavirin
    Dosage: 1200mg daily po
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-07-04

Pegasys
    Dosage: 180mcg weekly sq
    Indication: Hepatitis C
    Start date: 2012-07-04

Other drugs received by patient: Incivek



Possible Ribavirin side effects in male

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

Patient: male

Reactions: Hepatitis, Liver Transplant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ribavirin
    Indication: Hepatitis C
    End date: 2006-01-01

Interferon
    Indication: Hepatitis C
    End date: 2006-01-01



Possible Ribavirin side effects in

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

Patient:

Reactions: Neutropenic Colitis, Caecitis

Drug(s) suspected as cause:
Ribavirin
    Indication: Hepatic Cirrhosis

Ribavirin
    Dosage: 1200 mg, qd
    Indication: Hepatitis C
    Start date: 2011-12-01

Boceprevir
    Indication: Hepatic Cirrhosis

Boceprevir
    Dosage: 800 mg, tid
    Indication: Hepatitis C
    Start date: 2011-12-01
    End date: 2011-12-01

Peginterferon Alfa-2A
    Dosage: 180 ?g, qw
    Start date: 2011-12-01

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