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Epzicom (Abacavir / Lamivudine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Epzicom (Abacavir / Lamivudine) 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 (153)
Death (8)
Life Threatening Events (7)
Disability (1)

Reports by Reaction Type

Maternal Exposure During Pregnancy (25)Foetal Exposure During Pregnancy (21)Stillbirth (17)Immune Reconstitution Syndrome (10)Nausea (9)Renal Failure Acute (8)Anaemia (8)Regurgitation (7)Pyrexia (7)Tracheomalacia (7)Cough (7)Oxygen Saturation Decreased (7)

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

Possible Epzicom side effects in 65 year old male

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

Patient: 65 year old male, weighing 81.6 kg (179.6 pounds)

Reactions: Renal Function Test Abnormal, Drug Intolerance

Drug(s) suspected as cause:
Chantix
    Dosage: 0.5 mg, 1x/day
    Indication: Smoking Cessation Therapy
    Start date: 2012-01-01
    End date: 2012-01-01

Chantix
    Dosage: unk
    Start date: 2012-01-01

Epzicom
    Dosage: 300 mg, daily
    Indication: HIV Infection
    End date: 2012-01-01



Possible Epzicom side effects in 18 year old female

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

Patient: 18 year old female

Reactions: Amniotic Fluid Volume Decreased, Maternal Exposure During Pregnancy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epzicom
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16

Etravirine
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16

Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16

Ritonavir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16



Possible Epzicom side effects in 66 year old male

Reported by a physician from Japan on 2012-08-24

Patient: 66 year old male

Reactions: Glomerulonephritis Chronic

Drug(s) suspected as cause:
Epzicom
    Dosage: 1df: 1tab
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2007-06-27

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-09-15

Reyataz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-09-15

Other drugs received by patient: Depakene



Possible Epzicom side effects in 35 year old male

Reported by a physician from Japan on 2012-08-24

Patient: 35 year old male

Reactions: Renal Impairment, Cytomegalovirus Chorioretinitis, Hypoaesthesia, Mycobacterium Avium Complex Infection, Hyperuricaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epzicom
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-11
    End date: 2010-09-20

Mycobutin
    Administration route: Oral
    Indication: Mycobacterium Avium Complex Infection
    Start date: 2009-11-20
    End date: 2009-12-11

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2011-03-31

Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-03
    End date: 2011-03-31

Reyataz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2009-12-02

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2009-12-02

Valganciclovir
    Administration route: Oral
    Indication: Cytomegalovirus Chorioretinitis
    Start date: 2010-05-19
    End date: 2010-06-30

Valganciclovir
    Administration route: Oral
    Start date: 2010-07-01
    End date: 2011-01-20

Valganciclovir
    Administration route: Oral
    Indication: Cytomegalovirus Infection
    Start date: 2010-01-06
    End date: 2010-06-30

Valganciclovir
    Administration route: Oral
    Indication: Mycobacterium Avium Complex Infection
    Start date: 2010-02-16
    End date: 2010-03-24

Other drugs received by patient: Isentress; Pentamidine Isethionate; Intelence; Semen Coicis; Clindamycin Phosphate; Chlorhexidine Gluconate



Possible Epzicom side effects in 35 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-20

Patient: 35 year old female

Reactions: Breech Delivery, Live Birth, Maternal Exposure During Pregnancy, Liver Function Test Abnormal, Nephropathy

Drug(s) suspected as cause:
Epzicom
    Dosage: 1tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-11-25

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-11-25



Possible Epzicom side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 30 year old female

Reactions: Stillbirth, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Cocaine
    Indication: Drug Abuse

Epzicom
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-01-02

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



Possible Epzicom side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 30 year old female

Reactions: Stillbirth

Drug(s) suspected as cause:
Epzicom
    Dosage: 1 tab/caps daily; not used at conception
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-01-02

Kaletra
    Dosage: 4 tab/caps daily; not used at conception
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-01-02



Possible Epzicom side effects in female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-15

Patient: female, weighing 1.9 kg (4.2 pounds)

Reactions: Premature Baby, Foetal Exposure During Pregnancy

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

Kaletra
    Indication: Antiretroviral Therapy



Possible Epzicom side effects in male

Reported by a physician from France on 2012-08-15

Patient: male

Reactions: Regurgitation, Drooling, Foetal Exposure During Pregnancy, Tracheomalacia, Fungal Infection, Dysphonia, Oral Candidiasis, Foetal Heart Rate Disorder, Oesophageal Atresia, Venous Thrombosis Limb, Cough, Oxygen Saturation Decreased

Adverse event resulted in: life threatening event

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Maternal Exposure Timing Unspecified



Possible Epzicom side effects in 35 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-15

Patient: 35 year old female

Reactions: Breech Delivery, Maternal Exposure During Pregnancy, Live Birth, Liver Function Test Abnormal, Nephropathy

Drug(s) suspected as cause:
Epzicom
    Dosage: 1tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-11-25

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-11-25



Possible Epzicom side effects in male

Reported by a physician from Japan on 2012-08-14

Patient: male

Reactions: White Blood Cell Count Decreased, Pancytopenia, Liver Disorder, Hyperlipidaemia, White Blood Cell Count Abnormal, RED Blood Cell Count Decreased, Dermatitis, RED Blood Cell Count Abnormal

Drug(s) suspected as cause:
Epzicom
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-12-06
    End date: 2008-12-09

Kaletra
    Dosage: 4 tabs, 800mg/200mg, daily
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-10-04
    End date: 2011-06-07

Kaletra
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2003-05-09
    End date: 2006-10-03

Kaletra

Kaletra

Stavudine
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2004-08-24
    End date: 2006-12-05

Tegretol
    Start date: 2011-12-07
    End date: 2012-03-06

Tegretol
    Start date: 2012-03-07

Tegretol
    Start date: 2011-07-06
    End date: 2011-08-02

Tegretol
    Start date: 2011-08-03
    End date: 2011-11-07

Tegretol
    Start date: 2011-11-08
    End date: 2011-12-06

Tegretol
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2007-02-01
    End date: 2011-07-05

Zidovudine
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2003-05-09
    End date: 2004-08-23

Other drugs received by patient: Azithromycin; Fluconazole; Sulfamethoxazole and Trimethoprim; Distigmine Bromide; Aspirin; Serrapeptase; Emtricitabine / Tenofovir Disoproxil Fumarate; Omeprazole; Raltegravir; Bezafibrate; Cefcapene Pivoxil Hydrochloride; Lamivudine; Aspirin; Stavudine; Bezafibrate; Azithromycin



Possible Epzicom side effects in 31 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient: 31 year old female

Reactions: Anaemia

Drug(s) suspected as cause:
Combivir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-12

Epzicom
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-05-05

Invirase
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-12

Norvir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-12



Possible Epzicom side effects in 30 year old female

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

Patient: 30 year old female

Reactions: Stillbirth, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Epzicom
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-05-01

Norvir
    Dosage: 100mgd per day
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-05-01

Reyataz
    Dosage: 300mgd per day
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2010-05-01



Possible Epzicom side effects in 38 year old male

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 38 year old male

Reactions: Pruritus

Drug(s) suspected as cause:
Epzicom

Reyataz

Ritonavir



Possible Epzicom side effects in 51 year old male

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 51 year old male

Reactions: Staphylococcal Infection

Drug(s) suspected as cause:
Epzicom
    Start date: 2004-01-01

Reyataz
    Dosage: 1df:300mg/100
    Start date: 2004-01-01



Possible Epzicom side effects in 52 year old male

Reported by a physician from United States on 2012-08-02

Patient: 52 year old male

Reactions: Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atazanavir
    Indication: HIV Infection

Epzicom
    Dosage: 1df=1tablet
    Administration route: Oral
    Indication: HIV Infection

Ritonavir
    Indication: HIV Infection

Tenofovir Disoproxil Fumarate
    Indication: HIV Infection

Other drugs received by patient: Aspirin; Lisinopril; Coreg; Metformin Hydrochloride



Possible Epzicom side effects in 19 year old male

Reported by a physician from United States on 2012-08-02

Patient: 19 year old male, weighing 54.0 kg (118.8 pounds)

Reactions: Regurgitation, Dyspnoea, Vomiting, Nausea, Diarrhoea

Drug(s) suspected as cause:
Epzicom
    Indication: HIV Infection
    Start date: 2011-05-01
    End date: 2011-05-01

Norvir
    Dosage: tablets
    Indication: HIV Infection
    Start date: 2011-05-01
    End date: 2011-05-01

Reyataz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-01
    End date: 2011-05-01



Possible Epzicom side effects in 18 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient: 18 year old female

Reactions: Amniotic Fluid Volume Decreased, Maternal Exposure During Pregnancy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epzicom
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16

Etravirine
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16

Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16

Ritonavir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16



Possible Epzicom side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient: 30 year old female

Reactions: Stillbirth

Drug(s) suspected as cause:
Epzicom
    Dosage: 1 tab/cap daily
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-05-01

Norvir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-05-01

Reyataz
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-05-01



Possible Epzicom 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, Stillbirth

Drug(s) suspected as cause:
Cocaine
    Indication: Drug Abuse

Epzicom
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-01-02
    End date: 2011-03-09

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-01-02
    End date: 2011-03-09



Possible Epzicom side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27

Patient: 30 year old female

Reactions: Stillbirth

Drug(s) suspected as cause:
Epzicom
    Dosage: 1 tab/caps daily; not used at conception
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-01-02
    End date: 2011-03-09

Kaletra
    Dosage: 4 tab/caps daily; not used at conception
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-01-02
    End date: 2011-03-09



Possible Epzicom side effects in 49 year old male

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: 49 year old male

Reactions: Syncope, Hypersensitivity, Erythema, Fall

Adverse event resulted in: hospitalization

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

Epzicom
    Dosage: 600mg single dose
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-07-06
    End date: 2012-07-06

Other drugs received by patient: Ibuprofen; Isentress



Possible Epzicom side effects in

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient:

Reactions: LOW Birth Weight Baby, Foetal Growth Restriction, Small FOR Dates Baby, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Epzicom
    Dosage: 1 df, qd
    Start date: 2011-11-15
    End date: 2012-05-16

Intelence
    Dosage: 400 mg, qd
    Start date: 2011-11-15
    End date: 2012-05-16

Isentress
    Dosage: 800 mg, qd
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16

Norvir
    Dosage: 200 mg, qd
    Start date: 2011-11-15
    End date: 2012-05-16

Prezista
    Dosage: 1200 mg, qd
    Start date: 2011-11-15
    End date: 2012-05-16

Retrovir
    Dosage: 2000 mg, qd
    Start date: 2011-11-15
    End date: 2012-05-16



Possible Epzicom side effects in 44 year old male

Reported by a individual with unspecified qualification from Japan on 2012-07-26

Patient: 44 year old male, weighing 64.0 kg (140.8 pounds)

Reactions: Malaise, Overdose, Suicide Attempt, Asthenia, Renal Failure Acute, Haemodialysis, Hypersomnia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epzicom
    Dosage: see image
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-26
    End date: 2012-05-26

Epzicom
    Dosage: see image
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-06-08
    End date: 2012-05-25

Olmesartan Medoxomil
    Dosage: 20 mg (20 mg,1 in 1 d),per oral ; 1000-1200mg (1 in 1 d),per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-09-02
    End date: 2012-05-25

Olmesartan Medoxomil
    Dosage: 20 mg (20 mg,1 in 1 d),per oral ; 1000-1200mg (1 in 1 d),per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-05-26
    End date: 2012-05-26

Other drugs received by patient: Myslee (Zolpidem Tartrate) (Tablet) (Zolpidem Tartrate)



Possible Epzicom side effects in male

Reported by a physician from Japan on 2012-07-24

Patient: male

Reactions: Overdose, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epzicom
    Dosage: 90iuax per day
    Administration route: Oral
    Start date: 2012-05-26
    End date: 2012-05-26

Epzicom
    Dosage: 1iuax per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2007-12-01
    End date: 2012-05-26

Olmesartan Medoxomil
    Dosage: 20mg per day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2007-01-01
    End date: 2012-05-26

Olmesartan Medoxomil
    Dosage: 1200mg per day
    Administration route: Oral
    Start date: 2012-05-26
    End date: 2012-05-26

Zolpidem
    Dosage: 700mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-26
    End date: 2012-05-26

Other drugs received by patient: Norvir; Prezista



Possible Epzicom side effects in 59 year old male

Reported by a consumer/non-health professional from United States on 2012-07-19

Patient: 59 year old male

Reactions: Troponin Increased, Cardiogenic Shock, Death, Malaise, Chest Pain, Ventricular Tachycardia, Coronary Artery Occlusion, Electrocardiogram Change, Acute Myocardial Infarction

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Epzicom



Possible Epzicom side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19

Patient: 30 year old female

Reactions: Maternal Exposure During Pregnancy, Stillbirth

Drug(s) suspected as cause:
Cocaine
    Indication: Drug Abuse

Epzicom
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-01-02
    End date: 2011-03-09

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiviral Treatment
    Start date: 2011-01-02
    End date: 2011-03-09



Possible Epzicom side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-18

Patient: female, weighing 0.4 kg (0.9 pounds)

Reactions: Neural Tube Defect, Spina Bifida, Foetal Exposure During Pregnancy, Arnold-Chiari Malformation, Cerebral Ventricle Dilatation, Meningomyelocele

Drug(s) suspected as cause:
Epzicom
    Dosage: 1tab per day
    Indication: HIV Infection
    Start date: 2010-12-13

Viramune
    Dosage: 400mgd per day
    Indication: HIV Infection



Possible Epzicom side effects in 29 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-18

Patient: 29 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Induced

Drug(s) suspected as cause:
Epzicom
    Dosage: 1tab per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-12-13

Viramune
    Dosage: 400mgd per day
    Administration route: Oral
    Indication: HIV Infection



Possible Epzicom side effects in

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

Patient:

Reactions: Blood Bilirubin Increased, Blood Alkaline Phosphatase Increased, Blood Urine Present, Gamma-Glutamyltransferase Increased

Drug(s) suspected as cause:
Epivir
    Dosage: 300 mg, qd
    Administration route: Oral
    Start date: 2001-04-26
    End date: 2004-01-22

Epivir
    Dosage: 300 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2004-01-23
    End date: 2011-09-01

Epzicom
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-09-02

Isentress
    Dosage: 800 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-09-01

Norvir
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-12-15
    End date: 2011-09-01

Retrovir
    Dosage: 400 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-02-07
    End date: 2011-09-01

Reyataz
    Dosage: 400 mg, qd
    Administration route: Oral
    Start date: 2004-08-27
    End date: 2005-03-31

Reyataz
    Dosage: 300 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-04-01
    End date: 2011-09-10

Reyataz
    Dosage: 400 mg, qd
    Administration route: Oral
    Start date: 2005-04-01
    End date: 2005-12-14

Reyataz
    Dosage: 300 mg, qd
    Administration route: Oral
    Start date: 2005-12-15
    End date: 2006-03-31

Other drugs received by patient: Metformin HCL; Glyburide; Livalo; Magnesium Oxide; NU-Lotan Tablet 50

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