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 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 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 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
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 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 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 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 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 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 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 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 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 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
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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