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Combivir (Lamivudine / Zidovudine) - Premature Baby - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Premature Baby (68)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Combivir (Lamivudine / Zidovudine) where reactions include premature baby. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 68   Next >>

Possible Combivir side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient:

Reactions: Atrial Septal Defect, Jaundice, Cardiac Murmur, Dysmorphism, Premature Baby, Foetal Exposure During Pregnancy, Anaemia, Ascites, Hydrops Foetalis, Talipes

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir side effects in male

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

Patient: male

Reactions: Premature Baby, Foetal Exposure During Pregnancy

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

Combivir
    Indication: Maternal Exposure Timing Unspecified

Kaletra
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir side effects in male

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

Patient: male, weighing 2.0 kg (4.4 pounds)

Reactions: Trisomy 21, Premature Baby, Patent Ductus Arteriosus, Foetal Exposure During Pregnancy, Limb Malformation, Acoustic Stimulation Tests Abnormal

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-15

Epivir
    Dosage: 300mgd per day
    Indication: Antiretroviral Therapy
    End date: 2011-07-15

Retrovir
    Dosage: 2mgkh per day
    Indication: Antiretroviral Therapy
    Start date: 2011-10-07
    End date: 2011-10-07

Viramune
    Dosage: 400mgd per day
    Indication: Antiretroviral Therapy

Zerit
    Dosage: 40mgd per day
    Indication: Antiretroviral Therapy
    End date: 2011-07-15



Possible Combivir side effects in

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

Patient:

Reactions: Congenital Aortic Stenosis, Dandy-Walker Syndrome, Premature Baby, Foetal Exposure During Pregnancy, Congenital Pulmonary Artery Anomaly, Sepsis, Foetal Heart Rate Abnormal, Heart Disease Congenital, Talipes

Adverse event resulted in: death

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: HIV Infection
    Start date: 2010-08-30

Kaletra
    Dosage: 4tab per day
    Indication: HIV Infection
    Start date: 2010-08-30



Possible Combivir side effects in male

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

Patient: male

Reactions: Premature Baby, Hypotonia Neonatal, Foetal Exposure During Pregnancy, Congenital Myopathy

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir side effects in

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

Patient:

Reactions: Premature Baby, Foetal Exposure During Pregnancy

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient: male, weighing 2.7 kg (5.9 pounds)

Reactions: Foetal Growth Restriction, Premature Baby, Foetal Exposure During Pregnancy

Adverse event resulted in: death

Drug(s) suspected as cause:
Combivir
    Dosage: unk
    Indication: Maternal Exposure During Pregnancy
    Start date: 2011-04-21
    End date: 2011-09-15

Kaletra
    Dosage: unk
    Indication: Maternal Exposure During Pregnancy
    Start date: 2011-04-21
    End date: 2011-04-28

Norvir
    Dosage: 100 mg/day
    Start date: 2011-05-11

Norvir
    Dosage: 200 mg/day
    Indication: Maternal Exposure During Pregnancy
    Start date: 2011-04-28
    End date: 2011-05-10

Prezista
    Dosage: 800 mg/day
    Indication: Maternal Exposure During Pregnancy
    Start date: 2011-04-28

Zidovudine
    Dosage: 2.0 mg/day
    Indication: Maternal Exposure During Pregnancy
    Start date: 2011-09-15
    End date: 2011-09-15



Possible Combivir side effects in

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

Patient:

Reactions: Dandy-Walker Syndrome, Congenital Aortic Stenosis, Premature Baby, Foetal Exposure During Pregnancy, Sepsis, Congenital Pulmonary Artery Anomaly, Talipes, Heart Disease Congenital, Foetal Heart Rate Abnormal

Adverse event resulted in: death

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: HIV Infection
    Start date: 2010-08-30

Kaletra
    Dosage: 4tab per day
    Indication: HIV Infection
    Start date: 2010-08-30



Possible Combivir side effects in male

Reported by a physician from United States on 2012-08-09

Patient: male, weighing 2.1 kg (4.6 pounds)

Reactions: Premature Baby, Foetal Exposure During Pregnancy, Rash, Congenital Cytomegalovirus Infection, Foetal Growth Restriction, Microcephaly, Laboratory Test Abnormal, Hepatomegaly, Hypervitaminosis

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-14

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-14
    End date: 2011-12-05

Retrovir
    Indication: Antiretroviral Therapy
    Start date: 2011-12-05
    End date: 2011-12-05



Possible Combivir side effects in male

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

Patient: male, weighing 2.7 kg (5.9 pounds)

Reactions: Foetal Growth Restriction, Premature Baby, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-04-21
    End date: 2011-09-15

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-04-21
    End date: 2011-04-28

Norvir
    Dosage: 200mgd per day
    Indication: Antiretroviral Therapy
    Start date: 2011-04-28
    End date: 2011-05-10

Norvir
    Dosage: 100mgd per day
    Start date: 2011-05-11

Prezista
    Dosage: 800mgd per day
    Indication: Antiretroviral Therapy
    Start date: 2011-04-28

Zidovudine
    Dosage: 2mgd per day
    Indication: Prophylaxis
    Start date: 2011-09-15
    End date: 2011-09-15



Possible Combivir side effects in male

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

Patient: male, weighing 2.1 kg (4.6 pounds)

Reactions: Atrial Septal Defect, Congenital Anaemia, Cardiac Murmur, Dysmorphism, Premature Baby, Foetal Exposure During Pregnancy, Jaundice Neonatal, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-09-22

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-09-22

Other drugs received by patient: Metronidazole



Possible Combivir side effects in male

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

Patient: male, weighing 2.3 kg (5.1 pounds)

Reactions: Prenatal Screening Test Abnormal, Premature Baby, Foetal Exposure During Pregnancy, Polyhydramnios

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiviral Treatment
    Start date: 2011-03-21

Kaletra
    Dosage: 6tab per day
    Indication: Antiviral Treatment
    Start date: 2011-03-21

Sustiva
    Dosage: 600mg per day
    Indication: Antiviral Treatment
    Start date: 2008-10-01
    End date: 2011-03-21

Truvada
    Dosage: 1tab per day
    Indication: Antiviral Treatment
    Start date: 2008-07-24
    End date: 2011-03-21



Possible Combivir side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient:

Reactions: Jaundice, Atrial Septal Defect, Cardiac Murmur, Dysmorphism, Premature Baby, Anaemia, Foetal Exposure During Pregnancy, Limb Malformation, Ascites, Hydrops Foetalis, Talipes

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir side effects in male

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

Patient: male, weighing 2.1 kg (4.6 pounds)

Reactions: Atrial Septal Defect, Cardiac Murmur, Dysmorphism, Congenital Anaemia, Premature Baby, Foetal Exposure During Pregnancy, Jaundice Neonatal, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-09-22

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-09-22

Other drugs received by patient: Metronidazole



Possible Combivir side effects in male

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

Patient: male, weighing 2.0 kg (4.4 pounds)

Reactions: Trisomy 21, Premature Baby, Foetal Exposure During Pregnancy, Limb Malformation

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-15

Epivir
    Dosage: 300mgd per day
    Indication: Antiretroviral Therapy
    End date: 2011-07-15

Retrovir
    Dosage: 2mgkh per day
    Indication: Antiretroviral Therapy
    Start date: 2011-10-07
    End date: 2011-10-07

Viramune
    Dosage: 400mgd per day
    Indication: Antiretroviral Therapy

Zerit
    Dosage: 40mgd per day
    Indication: Antiretroviral Therapy
    End date: 2011-07-15



Possible Combivir side effects in female

Reported by a physician from United States on 2012-07-24

Patient: female, weighing 1.7 kg (3.7 pounds)

Reactions: Atrial Septal Defect, Hydronephrosis, Pulmonary Valve Stenosis, Premature Baby, Foetal Exposure During Pregnancy, Congenital Renal Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2012-01-12

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2012-01-12



Possible Combivir side effects in male

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

Patient: male, weighing 2.1 kg (4.6 pounds)

Reactions: Foetal Growth Restriction, Hepatomegaly, Microcephaly, Laboratory Test Abnormal, Premature Baby, Foetal Exposure During Pregnancy, Rash, Hypervitaminosis, Congenital Cytomegalovirus Infection

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-14

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-14

Kaletra
    Dosage: 6tab per day
    Start date: 2011-09-22
    End date: 2011-12-05

Retrovir
    Indication: Antiretroviral Therapy
    Start date: 2011-12-05
    End date: 2011-12-05



Possible Combivir side effects in female

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

Patient: female

Reactions: Atrial Septal Defect, Hydronephrosis, Premature Baby, Pulmonary Valve Stenosis, Foetal Exposure During Pregnancy, Congenital Renal Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2012-01-12

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2012-01-12



Possible Combivir side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-17

Patient: male

Reactions: Full Blood Count Abnormal, Premature Baby, Foetal Exposure During Pregnancy, Rash, Congenital Cytomegalovirus Infection, Foetal Growth Restriction, Hepatomegaly, Microcephaly, Hypervitaminosis

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir side effects in male

Reported by a physician from United States on 2012-07-17

Patient: male

Reactions: Atrial Septal Defect, Cardiac Murmur, Congenital Anaemia, Dysmorphism, Premature Baby, Foetal Exposure During Pregnancy, Jaundice Neonatal, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-09-22

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-09-22

Other drugs received by patient: Metronidazole



Possible Combivir side effects in female

Reported by a physician from United States on 2012-07-09

Patient: female

Reactions: Atrial Septal Defect, Hydronephrosis, Premature Baby, Pulmonary Valve Stenosis, Foetal Exposure During Pregnancy, Congenital Renal Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2012-01-12

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2012-01-12



Possible Combivir side effects in male

Reported by a physician from United States on 2012-06-28

Patient: male

Reactions: Atrial Septal Defect, Dysmorphism, Congenital Anaemia, Cardiac Murmur, Premature Baby, Foetal Exposure During Pregnancy, Jaundice Neonatal, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-09-22

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-09-22

Other drugs received by patient: Metronidazole



Possible Combivir side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-28

Patient:

Reactions: Atrial Septal Defect, Jaundice, Cardiac Murmur, Dysmorphism, Premature Baby, Foetal Exposure During Pregnancy, Anaemia, Limb Malformation, Ascites, Hydrops Foetalis, Talipes

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir side effects in male

Reported by a pharmacist from United States on 2012-06-26

Patient: male, weighing 2.1 kg (4.6 pounds)

Reactions: Ventricular Hypokinesia, Premature Baby, Hyperkalaemia, Colitis Ulcerative, Anaemia, Maternal Exposure During Pregnancy, General Physical Health Deterioration, Toxicity To Various Agents, Cardiac Failure, Electrocardiogram Abnormal, Hypotonia, Abdominal Distension, Bradycardia, Sinoatrial Block, Renal Failure Acute

Adverse event resulted in: hospitalization

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified

Kaletra
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-05-26
    End date: 2007-05-30

Saquinavir
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir side effects in female

Reported by a pharmacist from United States on 2012-06-26

Patient: female, weighing 2.2 kg (4.8 pounds)

Reactions: Hyperkalaemia, Premature Baby, Maternal Exposure During Pregnancy, Toxicity To Various Agents, Haemoglobin Decreased, Reticulocyte Count Increased, Abdominal Distension, Bradycardia, Renal Failure Acute

Adverse event resulted in: hospitalization

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

Kaletra
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-05-26
    End date: 2007-05-30

Kaletra
    Indication: Maternal Exposure Timing Unspecified

Saquinavir
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-20

Patient:

Reactions: Jaundice, Atrial Septal Defect, Cardiac Murmur, Dysmorphism, Premature Baby, Foetal Exposure During Pregnancy, Anaemia, Limb Malformation, Ascites, Hydrops Foetalis, Talipes

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-20

Patient: male

Reactions: Premature Baby, Hypotonia Neonatal, Foetal Exposure During Pregnancy, Congenital Myopathy

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir side effects in

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

Patient:

Reactions: Congenital Aortic Stenosis, Dandy-Walker Syndrome, Premature Baby, Foetal Exposure During Pregnancy, Sepsis, Congenital Pulmonary Artery Anomaly, Talipes, Heart Disease Congenital, Foetal Heart Rate Abnormal

Adverse event resulted in: death

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: HIV Infection
    Start date: 2010-08-30

Kaletra
    Dosage: 4tab per day
    Indication: HIV Infection
    Start date: 2010-08-30



Possible Combivir side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-11

Patient:

Reactions: Premature Baby, Foetal Exposure During Pregnancy

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir side effects in female

Reported by a health professional (non-physician/pharmacist) from Nigeria on 2012-05-25

Patient: female

Reactions: Dysmorphism, Premature Baby, Tachycardia, Foetal Exposure During Pregnancy, Respiratory Distress, Congenital Musculoskeletal Anomaly, Trisomy 21, Congenital Eye Disorder, Tachypnoea, Talipes, Hepatosplenomegaly

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Combivir
    Indication: HIV Infection
    Start date: 2011-12-07

Fortovase
    Dosage: 1000mgd per day
    Indication: HIV Infection
    Start date: 2011-12-07

Kaletra
    Indication: HIV Infection
    Start date: 2011-03-04

Raltegravir
    Dosage: 800mgd per day
    Indication: HIV Infection
    Start date: 2011-03-04
    End date: 2011-12-07



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