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Trizivir (Abacavir / Lamivudine / Zidovudine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Trizivir (Abacavir / Lamivudine / Zidovudine) 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 (26)
Death (3)

Reports by Reaction Type

Abortion Induced (7)Foetal Exposure During Pregnancy (6)Maternal Exposure During Pregnancy (5)Anaemia (3)Tricuspid Valve Disease (2)Tricuspid Valve Incompetence (2)Cerebral Ventricle Dilatation (2)Congenital Cardiovascular Anomaly (2)Right Atrial Dilatation (2)LOW SET Ears (2)Congenital Anomaly (2)Pterygium Colli (2)

Possible Trizivir side effects in male

Reported by a physician from United States on 2012-08-15

Patient: male, weighing 1.2 kg (2.6 pounds)

Reactions: Cardiac Murmur, Premature Baby, Intraventricular Haemorrhage Neonatal, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Trizivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-05-16

Retrovir
    Dosage: 2mgkh per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-09
    End date: 2011-07-09

Retrovir
    Dosage: 1mgkh per day
    Start date: 2011-07-09
    End date: 2011-07-09



Possible Trizivir side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient: 30 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Induced

Drug(s) suspected as cause:
Lopinavir and Ritonavir
    Dosage: 4tab per day
    Administration route: Oral
    Indication: HIV Infection

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



Possible Trizivir side effects in 37 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26

Patient: 37 year old female

Reactions: Maternal Exposure During Pregnancy, Adverse Event, Hypertension, Premature Delivery

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trizivir
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-03-04

Retrovir
    Dosage: 480mgd per day
    Indication: Antiretroviral Therapy
    Start date: 2010-06-13
    End date: 2010-06-13



Possible Trizivir side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-25

Patient: 30 year old female

Reactions: Abortion Induced

Drug(s) suspected as cause:
Trizivir
    Dosage: 1 tab/cap daily
    Administration route: Oral
    Indication: Antiretroviral Therapy

Kaletra
    Administration route: Oral
    Indication: Antiretroviral Therapy



Possible Trizivir side effects in 52 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-24

Patient: 52 year old male

Reactions: Liver Function Test Abnormal, Cystitis Noninfective

Drug(s) suspected as cause:
Ketalar
    Dosage: 60 mg, daily
    Administration route: Oral
    Indication: Analgesic Therapy
    Start date: 2006-02-01
    End date: 2009-01-01

Nevirapine
    Indication: HIV Infection

Trizivir
    Indication: HIV Infection

Other drugs received by patient: Oxycontin; Ramipril; Movicol Sachets; Oxycodone HCL; Amitriptyline Hydrochloride; Testosterone; Acetaminophen



Possible Trizivir side effects in female

Reported by a physician from United States on 2012-07-19

Patient: female, weighing 3.1 kg (6.8 pounds)

Reactions: Foetal Exposure During Pregnancy, Tricuspid Valve Disease, Tricuspid Valve Incompetence, Congenital Pulmonary Valve Atresia, Congenital Cardiovascular Anomaly, Cerebral Ventricle Dilatation, Right Ventricular Hypertrophy, Systolic Dysfunction, Right Atrial Dilatation, LOW SET Ears, Patent Ductus Arteriosus, Congenital Anomaly, Pterygium Colli, Atrial Septal Defect, Ultrasound Antenatal Screen, Congenital Nose Malformation, Foetal Chromosome Abnormality, Foetal Cystic Hygroma, Congenital Pulmonary Artery Anomaly, Heart Disease Congenital

Adverse event resulted in: death

Drug(s) suspected as cause:
Retrovir
    Dosage: 630mg per day
    Indication: Antiviral Prophylaxis
    Start date: 2011-12-08
    End date: 2011-12-08

Trizivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy

Other drugs received by patient: Betamethasone; Nifedipine



Possible Trizivir side effects in female

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

Patient: female, weighing 3.1 kg (6.8 pounds)

Reactions: Foetal Exposure During Pregnancy, Tricuspid Valve Disease, Tricuspid Valve Incompetence, Cerebral Ventricle Dilatation, Congenital Cardiovascular Anomaly, Right Ventricular Hypertrophy, Congenital Pulmonary Valve Atresia, Right Atrial Dilatation, LOW SET Ears, Congenital Anomaly, Pterygium Colli, Congenital Nose Malformation, Ultrasound Antenatal Screen, Foetal Chromosome Abnormality, Foetal Cystic Hygroma, Congenital Pulmonary Artery Anomaly, Heart Disease Congenital

Drug(s) suspected as cause:
Trizivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy

Retrovir
    Dosage: 630mg per day
    Indication: Antiviral Prophylaxis
    Start date: 2011-12-08
    End date: 2011-12-08



Possible Trizivir side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-13

Patient: 30 year old female

Reactions: Abortion Induced

Drug(s) suspected as cause:
Kaletra
    Administration route: Oral
    Indication: Antiretroviral Therapy

Trizivir
    Administration route: Oral
    Indication: Antiretroviral Therapy



Possible Trizivir side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-12

Patient: 30 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Induced

Drug(s) suspected as cause:
Lopinavir and Ritonavir
    Dosage: 4mgd per day
    Administration route: Oral
    Indication: HIV Infection

Trizivir
    Dosage: 750mgd per day
    Administration route: Oral
    Indication: HIV Infection



Possible Trizivir side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-29

Patient: 30 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Induced

Drug(s) suspected as cause:
Trizivir
    Dosage: 750mgd per day
    Administration route: Oral
    Indication: HIV Infection

Lopinavir / Ritonavir
    Dosage: 4mgd per day
    Administration route: Oral
    Indication: HIV Infection



Possible Trizivir side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-24

Patient: 30 year old female

Reactions: Abortion Induced

Drug(s) suspected as cause:
Trizivir
    Administration route: Oral
    Indication: Antiretroviral Therapy

Kaletra
    Administration route: Oral
    Indication: Antiretroviral Therapy



Possible Trizivir side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-22

Patient: 30 year old female

Reactions: Abortion Induced

Drug(s) suspected as cause:
Kaletra
    Administration route: Oral
    Indication: Antiretroviral Therapy

Trizivir
    Administration route: Oral
    Indication: Antiretroviral Therapy



Possible Trizivir side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-25

Patient: male, weighing 1.2 kg (2.6 pounds)

Reactions: Cardiac Murmur, Premature Baby, Intraventricular Haemorrhage Neonatal, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Retrovir
    Dosage: 2mgkh per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-09
    End date: 2011-07-09

Retrovir
    Dosage: 1mgkh per day
    Start date: 2011-07-09
    End date: 2011-07-09

Trizivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-05-16



Possible Trizivir side effects in female

Reported by a health professional (non-physician/pharmacist) from Colombia on 2012-04-06

Patient: female

Reactions: Product Quality Issue, Conjunctivitis, Oedema Peripheral, Pain, Transmission of AN Infectious Agent VIA A Medicinal Product, Oedema, Rash

Drug(s) suspected as cause:
Trizivir



Possible Trizivir side effects in 38 year old female

Reported by a consumer/non-health professional from United States on 2012-03-02

Patient: 38 year old female

Reactions: Anaemia, Neutropenia

Drug(s) suspected as cause:
Trizivir



Possible Trizivir side effects in female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-02-27

Patient: female, weighing 76.0 kg (167.2 pounds)

Reactions: Mental Disorder

Adverse event resulted in: hospitalization

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

Abacavir Sulfate / Lamivudine
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Viramune



Possible Trizivir side effects in 38 year old female

Reported by a consumer/non-health professional from United States on 2012-02-13

Patient: 38 year old female

Reactions: Anaemia

Drug(s) suspected as cause:
Trizivir



Possible Trizivir side effects in 77 year old male

Reported by a physician from United States on 2011-12-22

Patient: 77 year old male

Reactions: Lipodystrophy Acquired

Drug(s) suspected as cause:
Trizivir



Possible Trizivir side effects in 50 year old male

Reported by a consumer/non-health professional from United States on 2011-12-22

Patient: 50 year old male

Reactions: Renal Impairment

Drug(s) suspected as cause:
Trizivir

Other drugs received by patient: Cimetidine; Bystolic; Wellbutrin; Hydrochlorothiazide; Lisinopril; Strattera



Possible Trizivir side effects in 33 year old female

Reported by a consumer/non-health professional from United States on 2011-12-22

Patient: 33 year old female

Reactions: Weight Decreased

Drug(s) suspected as cause:
Trizivir
    Dosage: 1cap twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-10-01

Viread
    Dosage: 300mg per day
    Administration route: Oral
    Start date: 2006-10-01

Other drugs received by patient: Multi-Vitamin



Possible Trizivir side effects in female

Reported by a health professional (non-physician/pharmacist) from Australia on 2011-12-19

Patient: female

Reactions: Mental Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abacavir Sulfate and Lamivudine
    Indication: Product Used FOR Unknown Indication

Trizivir
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Viramune



Possible Trizivir side effects in male

Reported by a physician from United States on 2011-12-14

Patient: male, weighing 0.2 kg (0.4 pounds)

Reactions: Intra-Uterine Death, Umbilical Cord Around Neck, Foetal Exposure During Pregnancy

Adverse event resulted in: death

Drug(s) suspected as cause:
Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-02-01
    End date: 2011-06-29

Trizivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-02-01
    End date: 2011-06-29



Possible Trizivir side effects in 28 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-14

Patient: 28 year old female

Reactions: Maternal Exposure During Pregnancy, Stillbirth

Drug(s) suspected as cause:
Trizivir
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-02-01

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-02-01



Possible Trizivir side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-08

Patient: female

Reactions: Umbilical Cord Around Neck, Foetal Exposure During Pregnancy

Adverse event resulted in: death

Drug(s) suspected as cause:
Trizivir
    Indication: Maternal Exposure Timing Unspecified

Kaletra
    Indication: Maternal Exposure Timing Unspecified



Possible Trizivir side effects in 42 year old female

Reported by a physician from Romania on 2011-10-28

Patient: 42 year old female

Reactions: Cytomegalovirus Hepatitis, Swelling Face, Hypersensitivity, Immune Reconstitution Syndrome, Nausea, Cytolytic Hepatitis, Rash Papular, Chills, Pyrexia, Transaminases Increased, Diarrhoea, Hepatotoxicity, Abdominal Distension, Bone Marrow Failure

Drug(s) suspected as cause:
Raltegravir
    Indication: Antiretroviral Therapy

Trizivir
    Indication: Antiretroviral Therapy
    Start date: 2010-01-01

Kaletra
    Indication: Antiretroviral Therapy
    Start date: 2010-01-01

Other drugs received by patient: Ganciclovir; Immune Globulin Intravenous (Human); Darunavir Ethanolate; Azathioprine



Possible Trizivir side effects in 26 year old female

Reported by a consumer/non-health professional from United States on 2011-10-07

Patient: 26 year old female

Reactions: Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epzicom
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-07-07

Kaletra
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-07-07

Trizivir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-04-21
    End date: 2010-07-07

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