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Ziagen (Abacavir) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ziagen (Abacavir) 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 (80)
Death (13)
Life Threatening Events (16)
Disability (3)

Reports by Reaction Type

Abortion Spontaneous (13)Renal Failure Acute (12)Death (10)Maternal Exposure During Pregnancy (10)Exomphalos (8)Renal Tubular Disorder (7)Pyrexia (7)Rash (7)Foetal Exposure During Pregnancy (6)Coronary Artery Occlusion (6)Hyperphosphaturia (5)Liver Disorder (5)

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

Possible Ziagen side effects in male

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

Patient: male

Reactions: Hypersensitivity, Angioedema

Drug(s) suspected as cause:
Ziagen

Other drugs received by patient: Nifedipine; Epzicom; Lipitor; Isentress



Possible Ziagen side effects in 24 year old male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 24 year old male

Reactions: Pulmonary Hypertension, Palpitations, Dizziness

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Crixivan
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-03-18
    End date: 2000-05-24

Efavirenz
    Dosage: interrupted from 07/25/00 to 09/25/00 24jul-25jul2000,25sep-02oct2000. film coated tab 200 mg
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-07-24
    End date: 2000-10-02

Epivir
    Dosage: tabs
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2004-05-15
    End date: 2008-09-19

Invirase
    Dosage: inter:03/18/00-05/24/00,caps 800mg:19jun99-18mar2000.divided dse:24may00-24dec2000,19jun1999-24dc00
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-06-19
    End date: 2001-03-31

Kaletra
    Dosage: 1df,25dec2000-24apr2004:1217 days
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-12-25
    End date: 2004-04-24

Norvir
    Dosage: 31mar2001(interrupted).caps 800mg:19jun99-31oct-99.divided dose:01nov99-24dec2000.25apr2004
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-06-19
    End date: 2008-09-19

Videx
    Dosage: 250,300,400mg12/19/94-3/7/97,3/07/97-7/21/01,7/21/01,125mg,19dc94-7mar97(810d),7mr97-21jl01(1598d)
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1994-12-19
    End date: 2001-07-21

Videx EC
    Dosage: divided dose
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2001-07-21
    End date: 2004-05-14

Zerit
    Dosage: 60 mg 8/25/97-27/2/98, 80 mg 2/27-8/3/98, 11/9/98 -6/19/99 and 12/25/00-10/20/01
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1997-08-25
    End date: 2001-10-20

Ziagen
    Dosage: interrupted from 07/25/00 to 10/20/01 tabs24jul-25jul2000.20oct2001-27oct2001.
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-07-24
    End date: 2001-10-27

Other drugs received by patient: Cross Eight M



Possible Ziagen side effects in male

Reported by a physician from United States on 2012-08-14

Patient: male, weighing 84.8 kg (186.6 pounds)

Reactions: Product Substitution Issue, Abdominal Distension

Drug(s) suspected as cause:
Ziagen



Possible Ziagen side effects in

Reported by a physician from United States on 2012-08-10

Patient:

Reactions: Liver Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isentress
    Dosage: unk
    Administration route: Oral

Sustiva
    Dosage: 400 mg, qpm
    Administration route: Oral

Ziagen
    Dosage: 300 mg, bid
    Administration route: Oral



Possible Ziagen side effects in male

Reported by a physician from Italy on 2012-08-09

Patient: male

Reactions: Coronary Artery Occlusion

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Norvir
    Dosage: 100mg twice per day
    Indication: Acute HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Prezista
    Dosage: 600mg twice per day
    Administration route: Oral
    Indication: Acute HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Ziagen
    Dosage: 300mg per day
    Administration route: Oral
    Indication: Acute HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Other drugs received by patient: Viread; Enalapril Maleate



Possible Ziagen side effects in female

Reported by a physician from France on 2012-08-09

Patient: female

Reactions: Lipoma, Lipohypertrophy

Drug(s) suspected as cause:
Videx
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-01-01
    End date: 2009-01-01

Zerit
    Dosage: 30mg twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1997-01-01
    End date: 2009-01-01

Ziagen
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-01-01

Other drugs received by patient: Diltiazem HCL; Aspirin; Atorvastatin



Possible Ziagen side effects in male

Reported by a physician from Italy on 2012-08-06

Patient: male, weighing 72.0 kg (158.4 pounds)

Reactions: Coronary Artery Disease

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Darunavir Ethanolate
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Norvir
    Indication: HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Ziagen
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Other drugs received by patient: Enalapril Maleate; Viread; Chlorthalidone



Possible Ziagen side effects in male

Reported by a physician from United States on 2012-08-03

Patient: male

Reactions: Liver Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isentress
    Dosage: tabs
    Administration route: Oral

Sustiva
    Dosage: dose reduced

Ziagen
    Administration route: Oral



Possible Ziagen side effects in

Reported by a physician from United States on 2012-07-31

Patient:

Reactions: Condition Aggravated

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isentress
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Sustiva
    Dosage: 400 mg, qd
    Indication: Product Used FOR Unknown Indication

Ziagen
    Dosage: 300 mg, bid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Ziagen side effects in 57 year old female

Reported by a physician from United States on 2012-07-30

Patient: 57 year old female

Reactions: Myocardial Infarction, Arrhythmia

Adverse event resulted in: death

Drug(s) suspected as cause:
Ziagen



Possible Ziagen side effects in male

Reported by a physician from Italy on 2012-07-27

Patient: male

Reactions: Coronary Artery Occlusion, Arteriosclerosis Coronary Artery

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Norvir
    Indication: Acute HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Prezista
    Administration route: Oral
    Indication: Acute HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Ziagen
    Administration route: Oral
    Indication: Acute HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Other drugs received by patient: Enalapril Maleate; Viread



Possible Ziagen side effects in 50 year old male

Reported by a physician from Japan on 2012-07-26

Patient: 50 year old male, weighing 52.0 kg (114.4 pounds)

Reactions: Tubulointerstitial Nephritis, Hallucination

Drug(s) suspected as cause:
Atazanavir
    Dosage: 300mg per day
    Administration route: Oral
    Start date: 2010-08-01

Atazanavir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-07-01
    End date: 2010-08-01

Efavirenz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-05-01
    End date: 2005-07-01

Epivir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-05-01
    End date: 2010-08-01

Epivir
    Dosage: 150mg per day
    Administration route: Oral
    Start date: 2010-08-01

Retrovir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-05-01
    End date: 2005-07-01

Ritonavir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-07-01
    End date: 2010-08-01

Ritonavir
    Dosage: 100mg per day
    Administration route: Oral
    Start date: 2010-08-01

Tenofovir Disoproxil Fumarate
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-07-01
    End date: 2008-11-01

Ziagen
    Dosage: 600mg per day
    Administration route: Oral
    Start date: 2010-08-01

Ziagen
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-11-01
    End date: 2010-08-01



Possible Ziagen side effects in 81 year old female

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: 81 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Epivir
    Dosage: 150mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-01-01
    End date: 2012-07-01

Ziagen
    Dosage: 600mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-01-01
    End date: 2012-07-01

Other drugs received by patient: Diabetes Medication; Heart Medication; Reyataz; Blood Pressure Medication



Possible Ziagen side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-13

Patient: male

Reactions: Liver Disorder

Adverse event resulted in: hospitalization

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

Sustiva
    Dosage: 400mg at night
    Indication: Product Used FOR Unknown Indication

Ziagen
    Dosage: 300mg twice per day
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Polypharmacy



Possible Ziagen side effects in male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-12

Patient: male, weighing 72.0 kg (158.4 pounds)

Reactions: Coronary Artery Disease

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Darunavir Hydrate
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Norvir
    Indication: HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Ziagen
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Other drugs received by patient: Enalapril Maleate; Chlorthalidone; Viread



Possible Ziagen side effects in 48 year old male

Reported by a consumer/non-health professional from France on 2012-07-09

Patient: 48 year old male, weighing 63.0 kg (138.6 pounds)

Reactions: Renal Tubular Disorder, Crystal Urine

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epivir
    Administration route: Oral
    Start date: 2008-12-01

Lasix

Norvir
    Administration route: Oral
    Start date: 2009-09-01
    End date: 2010-10-04

Prednisolone
    Administration route: Oral
    Start date: 2008-11-01
    End date: 2010-10-04

Ramipril

Reyataz
    Administration route: Oral
    Start date: 2009-09-01
    End date: 2010-10-04

Ziagen
    Administration route: Oral
    Start date: 2008-12-01

Other drugs received by patient: Gaviscon; Eupressyl; Lercanidipine; Atenolol; Ramipril; Ferrous Sulfate TAB; Hyperium; Pantoprazole Sodium; Crestor



Possible Ziagen side effects in 57 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-09

Patient: 57 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Ziagen



Possible Ziagen side effects in 57 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-06

Patient: 57 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Ziagen



Possible Ziagen side effects in male

Reported by a physician from Italy on 2012-07-05

Patient: male

Reactions: Coronary Artery Occlusion, Arteriosclerosis Coronary Artery

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Norvir
    Indication: Acute HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Prezista
    Administration route: Oral
    Indication: Acute HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Ziagen
    Administration route: Oral
    Indication: Acute HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Other drugs received by patient: Enalapril Maleate; Viread



Possible Ziagen side effects in male

Reported by a physician from France on 2012-06-27

Patient: male, weighing 63.0 kg (138.6 pounds)

Reactions: Renal Tubular Disorder, Renal Impairment, Renal Failure Acute, Diabetes Mellitus Inadequate Control, Crystal Urine

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epivir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-12-01

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-09-01
    End date: 2010-10-04

Prednisolone
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-11-01
    End date: 2010-10-04

Reyataz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-09-01
    End date: 2010-10-04

Ziagen
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-12-01

Other drugs received by patient: Atenolol; Crestor; Gaviscon; Lasix; Ramipril; Hyperium; Pantoprazole Sodium; Lercanidipine; Eupressyl; Ferrous Sulfate TAB



Possible Ziagen side effects in 48 year old male

Reported by a consumer/non-health professional from France on 2012-06-27

Patient: 48 year old male, weighing 63.0 kg (138.6 pounds)

Reactions: Renal Tubular Disorder, Crystal Urine

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epivir
    Administration route: Oral
    Start date: 2008-12-01

Lasix

Norvir
    Administration route: Oral
    Start date: 2009-09-01
    End date: 2010-10-04

Prednisolone
    Administration route: Oral
    Start date: 2008-11-01
    End date: 2010-10-04

Ramipril

Reyataz
    Administration route: Oral
    Start date: 2009-09-01
    End date: 2010-10-04

Ziagen
    Administration route: Oral
    Start date: 2008-12-01

Other drugs received by patient: Atenolol; Lercanidipine; Hyperium; Pantoprazole Sodium; Ferrous Sulfate TAB; Eupressyl; Gaviscon; Ramipril; Crestor



Possible Ziagen side effects in male

Reported by a physician from France on 2012-06-26

Patient: male, weighing 63.0 kg (138.6 pounds)

Reactions: Renal Tubular Disorder, Renal Impairment, Diabetes Mellitus, Renal Failure Acute, Crystal Urine

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epivir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-12-01

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-09-01
    End date: 2010-10-04

Prednisolone
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-11-01
    End date: 2010-10-04

Reyataz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-09-01
    End date: 2010-10-04

Ziagen
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-12-01

Other drugs received by patient: Lercanidipine; Hyperium; Lasix; Eupressyl; Pantoprazole Sodium; Crestor; Atenolol; Ramipril; Ferrous Sulfate TAB; Gaviscon



Possible Ziagen side effects in female

Reported by a physician from France on 2012-06-21

Patient: female

Reactions: Metabolic Acidosis, Fanconi Syndrome, Hypokalaemia, Hyperphosphaturia, Glycosuria, Nephropathy, Hyperchloraemia, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Norvir
    Dosage: 1unit per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-01-18
    End date: 2011-09-14

Reyataz
    Dosage: 300mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-01-18
    End date: 2011-09-14

Truvada
    Dosage: 1unit per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-01-18
    End date: 2011-09-14

Ziagen
    Dosage: 1unit twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-01-18



Possible Ziagen side effects in female

Reported by a physician from France on 2012-06-19

Patient: female

Reactions: Renal Tubular Disorder, Metabolic Acidosis, Fanconi Syndrome, Hyperphosphaturia, Glycosuria, Amino Acid Level Increased, Renal Failure Acute, Nephropathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Norvir
    Administration route: Oral
    Indication: HIV Test Positive
    Start date: 2010-01-18
    End date: 2011-09-14

Reyataz
    Administration route: Oral
    Indication: HIV Test Positive
    Start date: 2010-01-18
    End date: 2011-09-14

Truvada
    Administration route: Oral
    Indication: HIV Test Positive
    Start date: 2010-01-18
    End date: 2011-09-14

Ziagen
    Administration route: Oral
    Indication: HIV Test Positive
    Start date: 2010-01-18
    End date: 2011-09-14

Other drugs received by patient: Ziagen; Epivir; Isentress



Possible Ziagen side effects in male

Reported by a physician from Italy on 2012-06-18

Patient: male, weighing 72.0 kg (158.4 pounds)

Reactions: Coronary Artery Disease

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Darunavir Hydrate
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Norvir
    Indication: HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Ziagen
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Other drugs received by patient: Viread; Chlorthalidone; Enalapril



Possible Ziagen side effects in male

Reported by a physician from Italy on 2012-06-15

Patient: male

Reactions: Coronary Artery Occlusion

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Norvir
    Dosage: 100mg twice per day
    Indication: Acute HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Prezista
    Dosage: 600mg twice per day
    Administration route: Oral
    Indication: Acute HIV Infection
    Start date: 2006-10-30
    End date: 2011-10-30

Ziagen
    Dosage: 300mg per day
    Administration route: Oral
    Indication: Acute HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Other drugs received by patient: Enalapril; Viread



Possible Ziagen side effects in male

Reported by a consumer/non-health professional from Russian Federation on 2012-06-11

Patient: male

Reactions: Haemorrhoids, Insomnia, Pyrexia, Urinary Retention, Delirium, Hallucination

Drug(s) suspected as cause:
Efavirenz
    Dosage: 1tab per day
    Administration route: Oral
    Indication: HIV Infection

Epivir
    Dosage: 1tab per day
    Administration route: Oral
    Indication: HIV Infection

Reyataz
    Administration route: Oral
    Indication: HIV Infection

Ritonavir
    Administration route: Oral
    Indication: HIV Infection

Ziagen
    Dosage: 600mg per day
    Administration route: Oral
    Indication: HIV Infection



Possible Ziagen side effects in male

Reported by a physician from Italy on 2012-06-11

Patient: male

Reactions: Coronary Artery Occlusion, Arteriosclerosis Coronary Artery

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Norvir
    Indication: Acute HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Prezista
    Administration route: Oral
    Indication: Acute HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Ziagen
    Administration route: Oral
    Indication: Acute HIV Infection
    Start date: 2006-10-30
    End date: 2011-12-23

Other drugs received by patient: Enalapril Maleate; Viread



Possible Ziagen side effects in female

Reported by a physician from France on 2012-06-06

Patient: female

Reactions: Renal Tubular Disorder, Metabolic Acidosis, Fanconi Syndrome, Hyperphosphaturia, Glycosuria, Amino Acid Level Increased, Renal Failure Acute, Nephropathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Norvir
    Administration route: Oral
    Indication: HIV Test Positive
    Start date: 2010-01-18
    End date: 2011-09-14

Reyataz
    Administration route: Oral
    Indication: HIV Test Positive
    Start date: 2010-01-18
    End date: 2011-09-14

Truvada
    Administration route: Oral
    Indication: HIV Test Positive
    Start date: 2010-01-18
    End date: 2011-09-14

Ziagen
    Administration route: Oral
    Indication: HIV Test Positive
    Start date: 2010-01-18
    End date: 2011-09-14

Other drugs received by patient: Epivir; Isentress; Ziagen



Possible Ziagen side effects in female

Reported by a physician from France on 2012-06-06

Patient: female

Reactions: Renal Tubular Disorder, Metabolic Acidosis, Fanconi Syndrome, Hyperphosphaturia, Glycosuria, Amino Acid Level Increased, Nephropathy, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Norvir
    Administration route: Oral
    Indication: HIV Test Positive
    Start date: 2010-01-18
    End date: 2011-09-14

Reyataz
    Administration route: Oral
    Indication: HIV Test Positive
    Start date: 2010-01-18
    End date: 2011-09-14

Truvada
    Administration route: Oral
    Indication: HIV Test Positive
    Start date: 2010-01-18
    End date: 2011-09-14

Ziagen
    Administration route: Oral
    Indication: HIV Test Positive
    Start date: 2010-01-18
    End date: 2011-09-14

Other drugs received by patient: Ziagen; Isentress; Epivir

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