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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