Index of reports
> Cases with Foetal Exposure During Pregnancy (21)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Epzicom (Abacavir / Lamivudine) where reactions include foetal exposure during pregnancy. The selected reports were submitted to the FDA during the sample period of about a year.
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:
Retrovir
Indication: Maternal Exposure Timing Unspecified
Epzicom
Indication: Maternal Exposure Timing Unspecified
Kaletra
Indication: Maternal Exposure Timing Unspecified
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:
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
Epzicom
Dosage: 1 df, 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
Isentress
Dosage: 800 mg, qd
Indication: HIV Infection
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
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 female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-21
Patient: female
Reactions: Foetal Growth Restriction, Small FOR Dates Baby, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Prezista
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Intelence
Indication: Maternal Exposure Timing Unspecified
Norvir
Indication: Maternal Exposure Timing Unspecified
Epzicom
Indication: Maternal Exposure Timing Unspecified
Isentress
Indication: Maternal Exposure Timing Unspecified
Possible Epzicom side effects in
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-24
Patient:
Reactions: Neural Tube Defect, Foetal Exposure During Pregnancy, Meningomyelocele, Cerebral Ventricle Dilatation
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 2012-05-09
Patient:
Reactions: Premature Baby, Live Birth, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Norvir
Indication: Antiretroviral Therapy
Start date: 2009-11-05
End date: 2010-12-27
Reyataz
Indication: Antiretroviral Therapy
Start date: 2009-11-05
End date: 2010-12-27
Epzicom
Indication: Antiretroviral Therapy
Start date: 2009-11-05
End date: 2010-12-27
Possible Epzicom side effects in male
Reported by a physician from France on 2012-02-17
Patient: male
Reactions: Regurgitation, Drooling, Foetal Exposure During Pregnancy, Tracheomalacia, Fungal Infection, Oral Candidiasis, Foetal Heart Rate Disorder, Dysphonia, Oesophageal Atresia, Venous Thrombosis Limb, Cough, Oxygen Saturation Decreased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Retrovir
Indication: Maternal Exposure Timing Unspecified
Kaletra
Indication: Maternal Exposure Timing Unspecified
Epzicom
Indication: Maternal Exposure Timing Unspecified
Possible Epzicom side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-08
Patient: male
Reactions: Premature Baby, Foetal Exposure During Pregnancy, Congenital Choroid Plexus Cyst
Drug(s) suspected as cause:
Norvir
Indication: Maternal Exposure Timing Unspecified
Epzicom
Indication: Maternal Exposure Timing Unspecified
Reyataz
Indication: Maternal Exposure Timing Unspecified
Possible Epzicom side effects in male
Reported by a physician from Japan on 2012-01-31
Patient: male, weighing 2.7 kg (5.9 pounds)
Reactions: Foetal Exposure During Pregnancy, Anaemia
Drug(s) suspected as cause:
Retrovir
Dosage: 20.8mg per day
Administration route: Oral
Indication: Prophylaxis Against HIV Infection
Start date: 2011-11-29
End date: 2012-01-09
Epzicom
Dosage: 1iuax per day
Indication: HIV Infection
Norvir
Dosage: 1iuax per day
Indication: HIV Infection
Retrovir
Dosage: 400mg per day
Start date: 2011-11-29
End date: 2011-11-29
Lexiva
Dosage: 2iuax per day
Indication: HIV Infection
Possible Epzicom side effects in male
Reported by a physician from France on 2012-01-04
Patient: male
Reactions: Regurgitation, Drooling, Foetal Exposure During Pregnancy, Tracheomalacia, Dysphonia, Fungal Infection, Oral Candidiasis, Foetal Heart Rate Disorder, Oesophageal Atresia, Venous Thrombosis Limb, Oxygen Saturation Decreased, Cough
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Kaletra
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Epzicom
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 2011-12-22
Patient: 35 year old female
Reactions: Liver Function Test Abnormal, Foetal Exposure During Pregnancy, 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 France on 2011-12-21
Patient: male
Reactions: Regurgitation, Drooling, Foetal Exposure During Pregnancy, Tracheomalacia, Fungal Infection, Oral Candidiasis, Dysphonia, 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 France on 2011-12-21
Patient: male
Reactions: Foetal Exposure During Pregnancy, Foetal Cardiac Disorder, Tracheomalacia, Salivary Hypersecretion, Oesophageal Atresia, Cough, Oxygen Saturation Decreased, Laryngeal Disorder
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Epzicom
Dosage: 600mg per day
Indication: HIV Infection
Start date: 2011-05-04
End date: 2011-09-11
Kaletra
Dosage: 2unit per day
Indication: HIV Infection
Start date: 2011-05-04
End date: 2011-09-11
Possible Epzicom side effects in male
Reported by a physician from France on 2011-12-09
Patient: male
Reactions: Regurgitation, Drooling, Foetal Exposure During Pregnancy, Tracheomalacia, Fungal Infection, Dysphonia, Foetal Heart Rate Disorder, Oral Candidiasis, Oesophageal Atresia, Venous Thrombosis Limb, Cough, Oxygen Saturation Decreased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Kaletra
Indication: Maternal Exposure Timing Unspecified
Epzicom
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Possible Epzicom side effects in male
Reported by a physician from Japan on 2011-12-08
Patient: male, weighing 2.0 kg (4.4 pounds)
Reactions: Anaemia Neonatal, Foetal Exposure During Pregnancy, Neonatal Tachypnoea
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Retrovir
Dosage: 2amp per day
Indication: HIV Infection
Start date: 2010-06-29
End date: 2010-06-29
Reyataz
Dosage: 300mg per day
Indication: HIV Infection
Start date: 2009-11-01
End date: 2009-12-22
Kaletra
Dosage: 2tab twice per day
Indication: HIV Infection
Start date: 2009-12-23
Norvir
Dosage: 100mg per day
Indication: HIV Infection
Start date: 2009-11-01
End date: 2009-12-22
Epzicom
Dosage: 1tab per day
Indication: HIV Infection
Start date: 2009-11-01
End date: 2011-02-08
Other drugs received by patient: Magnesium Sulfate; Efavirenz; Ritodrine Hydrochloride; Ritodrine Hydrochloride
Possible Epzicom side effects in male
Reported by a physician from Japan on 2011-12-06
Patient: male
Reactions: Anaemia, Foetal Exposure During Pregnancy, Tachypnoea
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kaletra
Indication: Maternal Exposure Timing Unspecified
Epzicom
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Norvir
Indication: Maternal Exposure Timing Unspecified
Reyataz
Indication: Maternal Exposure Timing Unspecified
Possible Epzicom side effects in male
Reported by a physician from France on 2011-11-14
Patient: male
Reactions: Regurgitation, Drooling, Foetal Exposure During Pregnancy, Tracheomalacia, Fungal Infection, Foetal Heart Rate Disorder, Oral Candidiasis, Dysphonia, Oesophageal Atresia, Venous Thrombosis Limb, Oxygen Saturation Decreased, Cough
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Kaletra
Indication: Maternal Exposure Timing Unspecified
Epzicom
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Possible Epzicom side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-09
Patient: female
Reactions: Underweight, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Norvir
Indication: Maternal Exposure Timing Unspecified
Reyataz
Indication: Maternal Exposure Timing Unspecified
Epzicom
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Possible Epzicom side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-07
Patient: male
Reactions: Penile Curvature, Foetal Exposure During Pregnancy, Hypospadias
Drug(s) suspected as cause:
Invirase
Indication: Maternal Exposure Timing Unspecified
Truvada
Indication: Maternal Exposure Timing Unspecified
Kaletra
Indication: Maternal Exposure Timing Unspecified
Epzicom
Indication: Maternal Exposure Timing Unspecified
Possible Epzicom side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-04
Patient: male
Reactions: Penile Curvature, Foetal Exposure During Pregnancy, Maternal Exposure During Pregnancy, Hypospadias
Drug(s) suspected as cause:
Kaletra
Indication: Maternal Exposure During Pregnancy
Epzicom
Indication: Maternal Exposure During Pregnancy
Truvada
Indication: Maternal Exposure During Pregnancy
Invirase
Indication: Maternal Exposure During Pregnancy
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